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Minutes for 246th Meeting of Registration Board held on 10-11th December, 2014.

Item No. Detail of Item Page No(s)

Item No.I Confirmation of minutes of 245th meeting Registration Board 06-08

Item No.II Agenda points referred by Members, Registration Board 08-10

Item No.III Cases for conduction of Clinical Trials – Pharmacy Services Division 11-15

Item No.IV Matters referred for deliberation by Registration Board 16-56

Item No.V Registration of drugs - Pharmaceutical Evaluation Cell 57-272

Item No.VI Miscellaneous cases - Pharmaceutical Evaluation & Registration Division 273-385

Item No.VII Registration of Biological Drugs – Biological Evaluation & Research Division 386-410

Item No.VIII Quality Control Cases – Quality Assurance & Lab Testing Division 411-461

Item No.IX Registration of Medical Devices – Medical Devices Division 462-472

Item No.X Local Manufacturing of Biological Drugs. 473-480

Item No.XI Applications for transfer of registrations 481-496


246th meeting of Registration Board was held on 10-11th December, 2014 in the

Committee Room, M/o National Health Regulation Services and Coordination, Islamabad. The

meeting was chaired by Mr. Ghulam Rasool Dutani, Director, Pharmaceutical Evaluation &

Registration Division. The meeting started with the recitation of Holy Verses. The meeting was

attended by the following:-

1. Lt General (R) Karamat Ahmed Karamat.

Member

2. Prof.Dr.Rafi uz Zaman Saeedul Haq Assocaite Dean, Faculty of Pharmacy, University of Lahore, Islamabad

Member

3. Brig (R). Dr. Muzammil Hasan Najmi, Associate Dean, Basic Sciences Division, Foundation Medical University, Rawalpindi.

Member

4. Brig.Dr.Aslam Khan, Professor of Medicine, Military Hospital Rawalpindi.

Member

5. Dr. Muhammad Arshad,

President, Pakistan Veterinary Medical Council

Member

6. Abdul Razak Director Drugs Testing Laboratory Government of Sind, Karachi.

Member

7. Dr.Muhammad Khalid Khan Director Drugs Testing Laboratory Government of Khyber Pakhtunkhwa, Peshawar.

Member

8. Dr.Amanullah Khan Director Drugs Testing Laboratory Government of Baluchistan, Quetta.

Member

9. Shaikh Ansar Ahmad Director Biological Drugs, DRAP

Member

10. Dr.Noor Muhammad Shah Director MD&MC, DRAP

Member

11. A.Q.Javed Iqbal Director QA &LT, DRAP

Member

12. Dr. Obaidullah, Deputy Director General (Reg.I). Secretary/Member


Dr. Muhammad Arshad did not attend the meeting on 10.12.2014 and Dr. Muhammad

Khalid Khan did not attend the meeting on 11.12.2014. Both days, meeting started at 09:30 AM

and continued till 08:00 PM.

Dr.Masud ur Rehman DDG (Biological), Dr. Abdur Rasheed DDG (Pharmacovigilance),

Dr. Tariq Siddique (DDG R.II), Muhammad Arif (DDC R.I), Muhammad Amin (DDC R.V),

Babar Khan (Incharge, PEC), Muneeb Ahmad Cheema ADC (PEC), Ammad Zaka ADC (PEC),

Atiq ul Bari ADC (PEC), Tehreem Sara (DDC MD&MC), Asif Jalil (ADC MD&MC) and

Khalid Mehmood (DDC QC) assisted relevant Directors and Secretary of the Board with agenda.

Mr.Shamim Ahmad and Abuzar Faizy, Mr.Nadeem Alamgeer and Muhammad Farooq

Memon attended the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA

respectively.

In addition to routine agenda, the Board discussed and decided various other matters, as

follows:

1. In future agenda will be circulated about 07 days before the meeting.

2. Registration Board deliberated on agenda point referred by Director DTL, Quetta

regarding attending the meeting by observers (PPMA, Pharma Bureau and PCDA). The

Board decided that respective observer will leave the meeting by ownself, when agenda

related to its company will be discussed. All observers also consented to the decision

3. Registration Board authorized its Chairman for grant of registration for export purpose on

contract manufacturing basis excluding controlled drugs and new drug as per contract

manufacting policy.

4. Dr.Aslam Khan Director Malaria Control Program and Dr.Qutub-ud-Din Kakar, WHO

National Professional Officer briefed the Board about irrational use of antimalarial drugs

in the country particularly injectable anti-malarial therapy and development of emerging

artemisinin resistance. Keeping in view briefing by experts, Registration Board decided

that Malaria Control Program will hold a consultative meeting of all the stakeholders


including DRAP, prescribers, provincial governments, pharmaceutical manufacturers etc

for framing recommendations on the matter.

5. Registration Board discuused comments of its members, stakeholders and international

practices and agreed that for all topical preparations viz. eye / ear preparations, external

preparations (cream / ointment / gel / lotion / spary) and aerosols, steroid manufacturing

may be permitted on campaign manufacturing basis in general manufacturing areas for

these dosage forms provided that manufacturer has segregated dispensing booths,

validation and controls studies for processes and adequate system to minimize any

potential risk of cross contamination. Registration Board decided to forward above

recommendation to Licensing Division for ultimate decision by Central Licensing Board.

6. Registration Board deliberated on the storage requirement for Misoprostol and keeping in

view EMA’s assessment report decided that Misoprostol 1% HMPC dispersion

(processed material) will be permitted for use in tablet dosage form with storage

condition of 5+3 °C.

7. Registration Board discussed matter regarding non-availability of finished drugs in

country of origin and advised stake holders (PPMA, Pharma Bureau and PCDA) to

forward their comments till 15.01.2015 to already constituted committee for framing its

recommendations for considerartion by Registration Board.

8. Registration Board advised stake holders (PPMA, Pharma Bureau and PCDA) to forward

their comments on case of re-registration of drugs till 15.01.2015 for considerartion by

Registration Board.

9. While discussing case for grant of registration for export purpose, Mr.A Q Javed Iqbal,

Director QA &LT opined that for export purpose only those formulations should be

registered, which are already registered in Pakistan. For new fornulations (which are not

registered in Pakistan), manufacturers should first conduct stability studies and then

registration for export purpose be granted. Prof. Muzammil H Najmi also endorsed it.

Registration Board after deliberation decided that inorder to facilitate export of quality


drugs (non-me too drugs), export registration will be granted and manufacturer will

comply following conditions before export of drug:

Manufacturer will export the product after complying all the conditions as required under Drug Act, 1976 including No objection certificate from concerned DRAP office. Moreover, Federal Inspector of drugs will take sample from each consignemnet for analysis from CDL, Karachi.

Manufacturer will also furnish export documents endorsed from custom authorities in order to ensure the export of the product.

These conditions will also be applicable to products approved for exports

(Sofosbuvir) by Chairman, registration Board.

10. Chairman again advised all members, PPMA and Pharma Bureau to forward their

scientific comments and relevant references on manufacturing requirements till

15.01.2015 for following classes of drugs:

a. Immunosuppresants. b. Clomiphene and letrozole c. Prostaglandins and its analogues. d. Vancomycin

11. On the direction of the Honorable Ombudsman, the case for local manufacturing of

biological drugs was re-examined by Registration Board. Representatives of local

manufacturers (Hilton, Getz, Nextar and Macter) were also heard and the Board then

decided the matter in light of directions of Ombudsman.

12. Registration Board discussed the matter regarding issuance of registration letter of

products for which product specific inspections have been conducted and recommended

by the panel of inspectors or cases where product specific inspections are not required /

exempted as per Import Policy for Finished Drugs. The Board authorized its Chairman

for issuance of registration letter in both aforementioned cases. In cases where there is

any ambiguity in inspection reports or products not recommended by panel of inspectors

then such cases will be placed before Regisrtration Board for decision.


Item No I: Confirmation of minutes of 245th meeting Registration Board.

245th meeting of Registration Board was held on 28-29th September, 2014 and minutes

were circulated to all members through e-mail. Two members forwarded following comments, as

follows:

Dr. Amanullah Khan (Director, DTL, Quetta): Agenda Item No II:

The following comments may be added as discussed in the 245th Registration Board Meeting regarding

Registration of Sofosbuvier which is very important drug and very badly required for the country man.

“The stability study shall be conducted by the manufacturer and accordingly stability data must be submitted to the Registration Board before the launch of their product into the market, my point is this that registration may be granted to the firms with the undertaking that they will provide stability study before the launch of their product into the market as per previous practice.”

Case No. 50. Cases deferred by Registration Board. M/s Ideal Pharma, Lahore- Product Specific Inspection-

There is typographic error and needs correction for record purpose, the inspection for product specific

inspection was carried out by two members only that is Director DTL, Quetta and area FID.

Mr.A.Q.Javed Iqbal, Director QA & LT, DRAP.

g. Import of raw materials for experimental purpose and stability studies etc.

Director QA stated that any such Import for trial batch is not discouraged subject to meet all

codal formalities required for the production of commercial batch as per defined policy

Item No.VII: Miscellenous cases. Case No.15. Change in company name from M/s. Bayer Schering Pharma AG to M/s. Bayer Pharma AG.

Company also informed that German authorities have confirmed the GMP of manufacturer of this

product & product is available in Switzerland and UK which is part of EMA/ SRA.

Minutes were approved after incorporation of above points.

Registration Board in 245th meeting discussed and approved following case but erroneously

decision was not recorded in minutes. However, later on Chairman, Registration Board approved

correction in minutes as decided by the Board.


Case No.30 Registration of Drugs for export purpose-Not me too Drugs.

Following firms have requested for registration of following drugs for export purpose

only which are not me-too. Details are as under:-

S. No.

Name of Company

Name of product(s) Date of application, Diary No. & Form

1. M/s PharmEvo

Karachi

Procoxam Forte 1500mg Tablet Each tablet contains:- Glucosamine HCl ....1500mg

13-05-2014 688

Rs.20,000/-

2. -do- Procoxam 625mg Tablet Each tablet contains:- Glucosamine HCl …..625mg

13-05-2014 686

Rs.20,000/- 3. M/s

Medisure Labs,

Karachi

Calvita Syrup Each 5ml contains:- Calcium lacatate Gluconate…………..40mg Vitamin A ………….1200IU Vitamin D3 ………….100IU Vitamin B1 HCl …….1mg Vitamin B2 5-sodium phosphate …….. …….1mg Vitamin B5 HCl.. …0.5mg Nicotinamide ………..5mg Dexpanthenol ……….2mg Vitamin C…….. …….50mg Vitamin E acetate ……1mg

15-04-2014 668

Rs.20,000/-

4. M/s Kaizen Pharma, Karachi

Vitacal Syrup Calcium lacatate Gluconate…………..40mg Vitamin A ………….1200IU Vitamin D3 ………….100IU Vitamin B1 HCl …….1mg Vitamin B2 5-sodium phosphate …….. …….1mg Vitamin B5 HCl.. …0.5mg Nicotinamide ………..5mg Dexpanthenol ……….2mg

26-06-2014 701

Rs.20,000/-


Vitamin C…….. …….50mg Vitamin E acetate ……1mg

5. M/s Genix

Pharma, Karachi

Apitonic Syrup Each 5ml contains:- Cyproheptadine HCl (anhydrous) BP ……..2mg Thiamine HCl (B-1) ...2mg Riboflavin BP (as 5-phosphate sodium)…2mg Pyridoxine HCl ….0.75mg D-Panthenol BP ….2.5mg Nicotinamide BP ….22.5mg

27-08-2014 719

Rs.20,000/-

6. -do- Calceg Injection 100mg/ml Each ml contains:- Calcium gluconate (10%)……. …….10mg

27-08-2014 720

Rs.20,000/-

7. -do- Tyca Tablet 90 Each tablet contains:- Ticagrelor ………90mg

27-08-2014 726

Rs.20,000/-

Decision: Registration Board approved minutes of 245th meeting with above correction

/ amendment in already approved minutes.

Item No II: Agenda points referred by Members, Registration Board.

Dr. Amanullah Khan, Director DTL, Quetta:

a. PPMA Representation from North zone.

Reference to the above , it is submitted that for the last few DRB Meetings it is observed

that PPMA from North Zone/Region nominates that member for to attend the DRB Meetings

whose case is part of the agenda and in my opinion its a matter of conflict of interest. Therefore

it is requested that in the forthcoming meeting of DRB , this matter may be placed as agenda

item before the DRB and take decision whether such conflict of interest nomination may be

allowed or otherwise. Furthermore it is expected that PPMA from both the regions may

nominate(s) a member for DRB for a specified period.


Decision: Registration Board deliberated on the point and it was decided that respective observer will leave the meeting by ownself, when agenda related to its company will be discussed. All observers also consented to the decision.

b. Registration of drugs under Drugs Act, 1976.

Reference DRAP letter No. F.1-20/2000-Reg-I(Pt) dated 23rd April 2014 on the subject cited

above, in this regard it is submitted that DRAP has constituted a panel to carryout inspection

abroad at Argentina, the panel comprised of the following officials,

(I) Dr. Amanullah Khan, Director Drugs Testing Laboratory Government of

Balochistan, Quetta/ Member Drug Registration Board DRAP. (II) Ms Sara Naeem, Assistant Drugs Controller, DRAP Lahore.

As per said letter there were four (04) importers / firms who have requested for the

import of their products from Argentina and accordingly on the request of the importers/firms the

panel was constituted to carry out inspections of their Principals abroad for the purpose of

registration of drugs under Drugs Act, 1976. The following is the list of firms/importers who had

requested for registration of drugs under the Drugs Act 1976.

i. M/s Pine International Lahore. ii. M/s Atco Pharma International (Pvt) Ltd Karachi.

iii. M/s Oncogene Pharmaceuticals Karachi. iv. M/s Nawab Sons, Karachi.

As per procedure of the DRAP the letter for inspection is issued only when all the

prerequisite documents/information for the Registration of the Drugs is completed and

accordingly the said letter is also issued on the same grounds by the competent authority,

however regret to mention that M/s Pine International Lahore has declined to carryout

inspection of their Principal abroad so there is need that the Firm has to clear their position and

explain their position for refusing inspection abroad and why action may not be taken against

them in wasting the time of the officials/inspectors and by enlarge of the DRAP.

Regret to mention that M/s Oncogene Pharmaceuticals Karachi as per DRAP, changed

their principal without approval from the DRAP which is not accepted ethically and officially.

They kept the inspection in grey and at any stage never accepted their mistake of change of

Principal and ultimately on 16th October 2014 the coordinator of the inspection team from Atco

Pharma has forwarded an e-mail from Mr Zubair Khalil owner of M/s Oncogene


Pharmaceuticals Karachi, and explained that DRAP has refused our request for change of

Principal and further added that i will be obliged if Atco Pharma etc takes my case to DRAP for

not carryout inspection abroad. As a Member Drug Registration Board i am not comfortable with

such offensive statement issued from M/s Oncogene Pharmaceuticals Karachi and there is need

to ask them explain their position on such offended statement.

M/s Atco Pharma International (Pvt) Ltd Karachi and M/s Nawab Sons, Karachi also

declined to carry out their inspection abroad by giving no reason.

Keeping in view an exercise of more than six months wherein the Inspectors from time to

time has to reschedule their official activities for the purpose to carryout inspection abroad

smoothly , but regret to say that the inspectors have been kept in dark by the firms/importers and

there was nobody who could come up with truth that we are not in position to carryout

inspection , as from the beginning it was apparent that the importers/firms were not interested to

carryout inspection abroad and it was also apparent that among the firms/importers blame game

has started which was not a good sign for inspection.

I would like that the case may be kept as Agenda Point in the forthcoming meeting of

DRB and a decision may be taken against the firm/importers who are responsible for this Act.

The cases may be dealt as per Drug Act and as per Policy of DRAP to stop such practices in

future and the offenders may be treated as per policy/Drug Act and I also request for the

cancellation of their requested products.

Decision: Registration Board advised pharmaceutical Evaluation & Registration

Division to present update status of these cases in its forthcoming meeting.

Mr.A.Q.Javed Iqbal, Director QA & LT, DRAP.

c. This point should be brought into discussion of next meeting that Board should define

uniform guidelines to scrutinize variations if it is related to API / quality of Drug substance in

light of ICH guidelines (Q 8, Q9 & Q10) for all originators and for generic products as well.

Moreover the all respective change should be assessed under the scope of applied variations.

Decision: Registration Board discussed the matter and it was decided that QA & LT

Division will develop guidelines for this purpose in consultation with PPMA and Pharma

Bureau.


Item No.III Cases for conduction of Clinical Trials – Pharmacy Services Division

Case No.01. Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm Community Based Randomized Trial, Karachi. Pakistan.

Aga Khan University has applied for the clinical trial to be conducted in collaboration

with WHO in assistance with EPI Programme.

The key feature of the trial is as under:

Title Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm Community Based Randomized Trial, Karachi. Pakistan.

Phase III Background Polio disease is present in only three countries including Pakistan. Since the

injectable polio vaccine has better results, WHO “Polio Endgame Strategy ” is to slowly withdraw the current vaccines replace all oral polio vaccine with injectable polio vaccine.

Objective The over all purpose of this study is to compare the suggested five different polio vaccine strategies to see which produces the best immunity for Pakistani Children and prevents the spread of polio.

Participating Country/Sites.

Pakistan Outreach Primary clinics in Karachi at Rehri Goth, Ali Akber Shah Goth, Ibrahim Hyderi and Bhains Colony.

Number of participants

1000 children each study group (arm) will have 200 children.

Duration of Trial.

One year (June 2014-15)

Study Interventions.

Oral Bivalent vaccine – Available from EPI Oral Trivalent Vaccine – Available from EPI Inactivated Polio Vaccine (IPV) – To be imported Inactivated Polio Vaccine2 (IPV2) – To be imported Oral Monovalent Vaccine2 (mOPV2) – To be imported at a later stage

in the study. An amendment and request will be sent to DRA at that time.

Study Outcomes

To determine which vaccine best protects the children from polio

Quantity of Drug to be Imported.

IPV= 1510 Doses IPV= 230 Doses Other vaccines are already registered and standard of care. These will

be purchased from EPI. Registration Status of drugs in Pakistan.

Oral Bivalent, trivalent polio vaccine is provided to EPI by WHO.


Monitor of the Trial.

Dr. Maha Mohamed Saadeldine Salama Head Clinical Research Sector/VACSERA, Cairo Egypt.

Sponsor World Health Organization (Geneva)

Bilthoven Biologicals BV (BBIO) has been a manufacturer of IPV and monovalent bulk

components since 1994. The company has now developed an investigational monovalent high

dose inactivated poliovirus vaccine (m-IPV2 HD) in alignment with the Global Polio Eradication

Initiative (GPEI) and World Health Organization (WHO)’s strategic advisory group of experts

(SAGE) recommendation for the eradication of polio. The m-IPV2 HD vaccine contains 32 D-

antigen (D-Ag) units of inactivated type 2 poliovirus, which is four times the current dose of type

2 polioviirus in the trivalent inactivated poliovirus vaccine (t-IPV). This high dose of antigen

should permit the one step immunization of children against type 2 polioviirus while avoiding

the safety issues associated with the attenuated type 2 poliovirus used in the oral poliovirus

vaccine (OPV).

Bulk virus was initially produced in monkey kidney cells and is now produced in Vero

cell line. Full nonclinical toxicology testing was performed on the trivalent polio vaccine.

Manufactured using bulk viruses produced in monkey kidney cells. Extensive clinical data were

also obtained for this formulation. When production of IPV was switched from sub cultured

monkey kidney cells to Vero cells, a limited number of preclinical and clinical studies were

conducted to compare the safety and the efficacy of IPV produced in Vero cells (IPV-Vero) to

the safety and the efficacy of IPV produced in subculture monkey kidney cells (IPV-MK). A

nonclinical toxicology study in rats showed no unexpected toxicological findings.

There are currently no clinical data with the m-IPV-HD. However, clinical studies

showed that t-IPV-Vero is a safe, well-tolerated vaccine that induces as effective immune

response similar to that of IPV-MK. The safety and effectiveness of IPV-Vero is further

supported by post-marketing surveillance bases on a 15-year follow-up of more than 90 million

IPV-Vero vaccine doses distributed worldwide in close to 60 countries.


As per procedure in vogue the submitted trial was referred to three experts for expert

opinion to facilitate the decision making process by the Registration Board. The same is

summarized as under:

S.No. Expert Name Opinion

1. Syed Sohail Zahoor Zaidi, Chief Scientist (Virology) Head of Department of Virology

It is hereby informed that the subject study is well planned to determine the improved effect of vaccination with combined formulations i.e bivalent OPV + IPV vaccines to fill-in the gaps in immunity type 2 polioviruses among Pakistani Children. The study will be conducted with the financial and technical support of WHO Head Quarters, Geneva and does not pose any apparent burden on the GoP/National or international stake holders providing assistance for the Polio Eradication program in the country. I hope that the findings and outcomes of this interventional study will improve our understanding and help to devise progressive recommendations for vaccination to achieve the goal of Polio eradication.

2. Mr.Mazharullah Memon, Principal Scientific Officer/Manager Quality Control Laboratory.

The five arms plan for End Game Polio Virus, the pattern of dosing as described are suitable for the subject study and the subject clinical trial is suggested in my opinion and there is no financial burden on the Government of Pakistan.

3. Dr. Haider Sherazi, Neonatology, PIMS, Islamabad.

Comments are still awaited in spite of reminders

The institution has also requested for import of the following trial material to supplied by the WHO

through EPI:

Drug Name Quantity required

Inj IPV 1510 Doses

Inj IPV2 230 Doses

Decision: Registration Board discussed trial for its all prons and cons keeping in view

the prevalence of polio in the country. Dr.Abdur Rasheed, DDG (Pharmacovigilance)


informed that Dr. Haider Sherazi has also given his expert views in favor of the trial.

However, after thorough deliberation the Board deferred the case for presentation by

Principal Investigator of the trial.

Case No.02. Phase III (b) Clinical Trial for use of Buprenorphine for treatment and

detoxification of injectable drug users in Pakistan.

Pakistan is signatory to the Millennium Development Goals (MDGs). Goal 6 state that

Pakistan will halt and begin to reverse the spread of HIV/AIDs Globally the most

recommendation intervention to halt the spread of HIV/AIDs infections among the group of

injectable drug users is Buprenorphine which is being used by the drug users for Detoxification,

treatment or at lease substitute the other injectable drugs with oral dosage form.

National AIDs Control Programme, Ministry of National Health Services, Regulation &

Coordination Islamabad has submitted a project proposal to the subject cited above. It is

hypothesized that Buprenorphine has challenges of misuse considering the non regulated

environment if produced and made available in higher doses.. Safety, as reflected by Adverse

Events (AEs) and severe Adverse Events (SAEs), withdrawal severity, stabilization dose and

treatment retention during the study will also be explored.

This is an open-label study, 1,000 (One Thousand) IDU’s seeking treatment for opiate

dependence will be enrolled in 5 centers across Pakistan. Participants are expected to be

predominantly males and non-pregnant and non-lactating females who are at least 18 years-of-

age at the time of enrollment. Following screening, there will be a 28 day stabilization period on

Buprenorphine. All participants will be inducted onto the drug over a period of 3 days with doses

not to exceed 8mg on the first day, 12 mg on the second day and 16mg of third day. Until the end

of the third week doses may be adjusted in 4 or 8mg increments to a total dose of 8, 16, 24mg

based on clinical need, as judged by the treating physician/investigator. The duration of study

participation for each participant will be a maximum of approximately 6 months, including

screening, stabilization, tapering, post-tapering and follow-up, results from this study will add to

the knowledge bases of the clinical use of Buprenorphine in Pakistani population and provide

clinicians/regulatory bodies with data to guide the process of Buprenorphine treatment.


Principal investigator has submitted ethical approval issued by the National Bioethics

Committee (NBC Pakistan) on 5.11.2014. The trial material is proposed to be arranged from two

following sources if approved by the Registration Board:-

S.No Name of Firms 2mg tablets 8mg tablets

1. M/s. Valor Pharmaceutical, Islamabad 1,80,000 tabs 1,80,000 tabs

2. M/s. Wilshire Labs, Lahore 1,80,000 tabs 1,80,000 tabs

Decision: Dr.Basir Achakzai, Director National AIDS Control Programme and his

team presented in detail background of the case with special refrenece to Pakistan scenario.

The Board also discussed that internationally such therapies are available in combination

with Naloxone for patients admitted in hospital. After detailed deliberation, registration

Board deferred the case dor following:

National AIDs Control Programme will revise its protocol in line With International Best Practices recommended / adopted for this purpose.

Pharmacy Services Division, DRAP will forward revised protocols to Narcotic Control Division anf following expert for their views:

o Prof.Dr.Rizwan Taj, PIMS, Islamabad. o Maj.Gen.Saleem Jehangeer, AFIMH, Pawalpindi. o Prof.Dr.Ghulam Rasool, Quetta.


Item No.IV Matters referred for deliberation by Registration Board

a. Comments of Director Malaria Control, Islamabad regarding injectable anti-malarial therapy.

Registration Board in 245th meeting discussed following comments of Director Malaria

Control, Islamabad.

“The matter has been discussed with the National Professional Officer, MCE, WHO Pakisan

and technical team of this Directorate. Due to emerging Artemisinin resistance in the South East

Asia, which also threatened Pakistan, because of uncontrolled / irrational use of parental

Artemisinin Monotherapy derivatives including Artemether in uncomplicated P. Falciparium

case and also in clinical Malaria cases by the unregulated Private Sector. During the recent 6th

Inter Country Meeting of National Malaria Control Managers held at Cairo, Egypt on 13th – 14th

August, 2014 WHO EMRO Region showed their serious concern on production of Artemisinin

monotherapy and injectable chloroquine in Pakistan. According to the approved National Anti-

Malaria Drug Policy only Injection Artesunate is recommended for confirmed severe

Falciparium Malaria cases in hospital settings and as pre-referral treatment in RHCs /BHUs.

Directorate of Malaria Control intends to convene a meeting with Drug Regulatory Authority of

Pakistan along-with other stake holders to share the views on emerging artemisinin resistance

and irrational use of antimalarial drugs in the country. It is also requested to halt further

registration Antimalarial Drugs”.

Registration Board in 245th meeting deferred all injectable anti-malarial drugs and invited

Director Malaria Control, Islamabad in forthcoming meeting for detailed discussion.

Discussion: Dr.Aslam Khan Director Malaria Control Program and Dr.Qutub-ud-Din Kakar,

WHO National Professional Officer briefed the Board about irrational use of antimalarial drugs

in the country particularly injectable anti-malarial therapy and development of emerging

artemisinin resistance. Crux of the briefing is as follows:

a. Resistance to antimalarial drugs is the biggest challenge to malaria control in the country

resulting from “increased drug pressure” due to irrational use of antimalarial drugs

particularly the “monotherapies”.


b. Malaria is re-emerging due to “failure” of control interventions particularly the low coverage

of “effective treatment” and vector control.

c. Effective treatment is the “Foundation stone” of malaria control today which is dependent on

correct lab diagnosis and effective medicines. Effective treatment is the most effective tool to

reduce transmission potential due to reduction in parasite reservoir in human hosts.

d. Malaria Control programmes have been left with limited choices of treatment for confirmed

cases and there has been no development made in the development of new effective and safe

drugs in near future. This calls for rational and restricted use of available regimens where the

mainstay of treatment is Artemesinin Combination Therapies.

e. In Pakistan the positivity rate in suspected cases has been lower than 5% in highly endemic

areas and <1% in low endemic province of Punjab, treatment of malaria cases on clinical

grounds is mostly wrong in 98% of suspected cases, which is the major reason of misuse of

these drugs. No antimalarial drug should be dispensed in Pakistan without confirmatory test,

is the national policy and promotion of produced “anti-malarial” molecules by the industry

has led to the indiscriminate prescriptions by the untrained physicians, paramedics and

kwakes.

f. As per policy injectable quinine and Artesunate only can be sued in the treatment of

complicated and severe malaria cases, which are only seen in a fraction malaria cases due to

falciparum species only. The total estimated number of confirmed cased due to falciparum

malaria in the country are not >200,000 cases and the number of true severe malaria cases

will not be more than 20,000 warranting treatment with injectable quinine and Artesunate.

g. Treatment of severe cases of malaria is a medical emergency requiring intravenous

medication with above mentioned drugs and can only be dealt in at Secondary or tertiary care

hospitals only.

h. Huge quantities of Artesunate injections have been provided by the Global Fund from WHO

Pre-Qualified manufacturer (Guillin Pharma) sufficient to cover all the country needs of

dealing with severe cases.

i. Resistance is rapidly developing against artemisinin group and within short time the care

delivery system will be unable to treat the complicated cases at hospitals.


Decision: Registration Board appreciated the concern raised during the briefing. It

was then decided that Malaria Control Program will hold a consultative meeting of all the

stakeholders including DRAP, prescribers, provincial governments, pharmaceutical

manufacturers etc for framing recommendations on the matter.

b. Transfer of registered drugs.

Under Rule 27 of Drugs (Licensing, Registering & Advertisement) Rules 1976, a

certificate for registration is issued for a period of five years unless earlier suspended or

cancelled. As per practice in vogue, if a firm applies for transfer of registration, such cases are

transferred according to the following provisions incorporated in schedule F vide SRO

877(I)/2000 dated 09th December, 2000:-

An application for:- (i) transfer of registration from one importer or manufacturer to another, (ii) transfer from import to local manufacture, (iii) import in bulk and repacking locally, and (iv) change of name of registered drug, shall be considered as for grant of a new

registration and shall be made as per rule 26(1).

Registration Board in its 240th meeting also approved the following SOPs to stream line

the transfer of registrations and delegated its powers to the Chairman Registration Board to

approve such cases:-

Transfer of registration:

i) With change in manufacturing site: a. Application with Form-5 and required fee as per relevant SRO. b. Copy of registration letter and renewal status. c. NOC for CRF clearance. d. Copy of approved section by Central Licensing Board. e. Copy of last inspection report. f. NOC from existing manufacturer / registration holder permitting for transfer of

product. g. Statement / undertaking that applicant do not have registration of same products.

If so, it has to apply for cancellation of product. h. Accelerated stability studies of 6 months with to conduct real time stability

studies up to assigned shelf life & report if any result falls outside shelf life specifications with proposed action).


i. Validated method of analysis, master formula and product development data

ii) Change in name / title of manufacturer (site of manufacturing remains the same) a. Application on Form-5 with required fee as per relevant SRO. b. Copy of registration letter and renewal status. c. NOC for CRF clearance. d. Approval of new name / title from CLB. e. Undertaking that the formulation, API source & Specifications, manufacturing

process, analytical test methods, release & shelf life specifications have not changed.

However, schedule F was amended as per SRO 1117(I)/2012 dated 10th September, 2012

and above provisions defined for transfer of registration vide SRO 877(I)/2000 dated 09th

December, 2000 have been omitted now.

In view of above, directions /guidance of Registration Board is solicited to process cases

of transfer of registration of drugs.

Decision: Registration Board deliberated on the matter and it was decided that

following procedure will be adopted for these cases.

Registration will be cancelled from name of existing registration holder. The

applicant will comply all requiremenrs for grant of registration and then

registration Board will decide the case for grant of registration keeping in view

safety, efficacy and quality parameters.

For imported drugs, Import Policy for Finished Drugs will be followed.

A reference will be sent to Cost & Pricing Division whether such cases for grant of

registration shall be considered at existing MRP or otherwise.

Cases will be divided into any of following category and requisite documents will be

as follows:

o Registration of drug for local manufacturing. a. Application with Form-5 and required fee as per relevant SRO. b. Copy of registration letter and renewal status. c. NOC for CRF clearance. d. Copy of approved section by Central Licensing Board. e. Copy of last inspection report.


f. NOC from existing manufacturer / registration holder permitting for cancellation of product from its name and grant to new registration holder / manufacturer.

g. Statement / undertaking that applicant do not have registration of same products. If so, it has to apply for cancellation of product.

o Registration of drug for import (Change of authorized agent in Pakistan only). a. Application on Form 5A with required fee as per relevant SRO. b. Copy of registration letter and last renewal status. c. Notorized termination letter (original) from manufacturer for previous importer. d. Notorized authority letter/sole agent letter (original) from manufacturer. e. NOC from existing importer / registration holder permitting for cancellation of

product from its name and grant to new importer / registration holder.

o Registration of drug when title of firm has been changed by firm and approved by Central Licensing Board (manufacturing site remains the same).

Registration Board discussed that in this case registration will not be cancelled from

previous name as there is no change in manufacturing site and only title of registration

holder has been changed. Thus case will be processed for change of title of the firm and

firm will submit following documents.

a. Application on Form-5 with required fee as per relevant SRO. b. Copy of registration letter and renewal status. c. NOC for CRF clearance. d. Approval of new name / title from CLB. e. Undertaking that the formulation, API source & Specifications, manufacturing process, analytical test methods, release & shelf life specifications have not been changed.

c. Re-registration of drugs.

Under Rule 27 of Drug (Licensing Registration and Advertising) rule, 1976, a certificate

of registration, shall unless earlier suspended or cancelled, be in force for a period of five

years from the date of registration of the drug and may thereafter be renewed for periods not

exceeding five years. Provided that an application for the renewal of registration shall not be

entertained unless it has been made within sixty days after the expiry of the registration and

when and application has been made as aforesaid the registration shall subject to the orders

passed on the application for renewal continue in force for the next period of five years.


Previously, in case a firm applies for re-registration of drug i.e after expiry of renewal

of registration of a drug, such cases were processed for re-registration on payment of full

registration fee and submission of form-5. Chairman Registration Board was authorized to

approve such cases on file.

Decision: Registration Board advised stake holders (PPMA, Pharma Bureau and

PCDA) to forward their comments till 15.01.2015 for considerartion by Registration Board.

d. Registration of 10 Products per section for New Drug Manufacturing Licence/ Additional Section.

Registration Board in 245th meeting constituted following committee to review policy of

registration of 10 products per section to new manufacturers/ additional sections.

- Prof. Muzamil Hassan Najmi, Member Registration Board - Mr. A Q Javed, Director QA, DRAP. - Mr. Arif Chowdhry, DDC Reg-I

The Committee forwarded following recommendations:

To achieve the standards as laid down in GMP, the present practice of granting registrations of ten products in a section to the new licensees may be continued.

The operational status of the manufacturer may be assessed by a panel inspection after 60 days of commencement of manufacturing activity.

Subject to compliance of GMP, as determined by the inspection panel, another ten products per section may be granted to the new licensees on priority.

Decision: Registration Board was informed that DRAP’s Policy Board has also discussed and deferred instant matter for further deliberation. The Board decided that above points will be forwarded to DRAP’s Policy Board as recommendation from Registration Board.


e. Non-Availability of finished drugs in country of origin.

Registration Board in 245th meeting discussed that in some cases, finished drug of a

manufacturing site is neither available / authorized for sale in country of origin / manufacture

nor approved by any of regulatory authority of USFDA, Australian TGA, Japan or EMA, but

applicant intend to import finished product from that site. The Board constituted following

committee to look into the matter keeping in view international practices in such cases and

frame its recommendations.

‐ Prof. Muzamil Hassan Najmi, Member Registration Board. ‐ Mr. A Q Javed, Director QA & LT ‐ Mrs. Sara Mahreen ADC, PEC

Mrs. Sara Mahreen could not join the committee due to her posting in DRAP, Lahore and

Mr.Ammad Zaka, ADC was assigned the task.

The Committee forwarded following recommendations:

If any such drug which is not available in country of origin and not approved by reference regulatory authorities i.e., USFDA, Australian TGA, Japan or EMA, it may be considered for registration or approval of post registration variation, provided:

o Its registration has not been cancelled / withdrawn by any ICH member countries, which are considered SRA, for safetyreasons.

o There is no new toxicity data reported about the drug requiring re-evaluation of its status.

o It is available in atleast threeSRAcountries as notified by International Conference onHarmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH) on www.ich.org.

Decision: Registration Board advised stake holders (PPMA, Pharma Bureau and

PCDA) to forward their comments till 15.01.2015 to already constituted committee for

framing its recommendations for considerartion by Registration Board.


f. Export of drugs with same brand name of different manufacturers

M/s Ambrosia Pharmaceuticals, Islamabad has informed that they have exported following drug:-

Name of product Regn No. for M/s Ambrosia in Pakistan

Regn No. for M/s Ambrosia in Kingdom of Combodia

Util Capsule 40mg (Esomeprazole)

046889 CAM 0279-10

Firm has submitted that they were surprise and shock that M/s Medisure Labs, Karachi

exporting their same molecule “Esomeprazole” with same brand name “Util” to Kingdom of

Combodia with printed same registration number granted to them in Cambodia. This kind of act

is not only hurting their marketing and market share and image in Kingdom of Combodia as their

product are more effective and superior quality but more importantly damaging the image of

DRAP. At this time their distributor in Combodia has refused to place any further orders or

accept shipments of above products till such time they receive letter from DRAP stating that

DRAP will cancel these EX registrations of M/s Medisure and also confirmed that this brand

name will not be issued to any other manufacturers / companies in Pakistan by DRAP for export

purposes in the future.

Decision: Registration Board was informed that M/s Ambrosia Pharmaceuticals,

Islamabad has also submitted similar type of complaint against M/s English Pharma,

Lahore. Thus the Board decided to call these three manufacturers in forthcoming

Registration Board meeting with relevant record for presentation of their case.

g. Registration of generic Nilotinib

Advocate Mr. Kazim Hasan, Barrister-at-Law of M/s Novartis Pharma Limited has informed

that they have been instructed by Novartis to advise the Drug Registration Board of the DRAP

that the intellectual property rights to Nilotinib vests in Novartis globally. Nilotinib is a

breakthrough treatment of Lukemia and it has been developed by Novartis. M/s Novartis has

come to know that M/s Genix Pharma has applied for generic registration of Nilotinib under the

trade name Lukopenil. Being intellectual property rights to Nilotinib vests in Novartis globally a

generic Nilotinib would be a violation intellectual property rights.


Advocate Mr. Kazim Hasan has further submitted that such registration would also constitute

a sovereign breach, as Pakistan is a signatory to international treaties which guarantee protection

of intellectual property rights. He requested that application filed by Genix Pharma for generic

registration of a Novartis product may be rejected and Drug Registration Board should not even

entertain any application for generic registration Nilotinib under any trade name.

Decision: Registration Board decided to forward instant letter to IPO, Pakistan for its

comments for consideration by the Board.

h. Recommendation of Review committee.

Registration Board in 245th meeting considered following recommendations of review

committee and advised PPMA and Pharma Bureau to forward their comments for consideration

of Registration Board. Now both stake holders forwarded their comments on these

recommendations, as follows:

PPMA:

A. Trimethyl Phologlucinol 80mg+Phloroglucinol 80mg.

i. Products Containing Phloroglucinol are available in many countries of the world, including Italy, France, Switzerland, Luxemburg, Belgium, China and South Korea where more than 42 Companies including Multinationals have market since many years.

ii. In Italian health system, inclusion of Phloroglucinol as a fully reimbursed product is a further

guarantee of its efficacy and safety. In June , 2011 the transparency Committee of the Prestigious HAS, France as recommended continued inclusion on the list of medicines refundable by national health insurance and on the list of medicines approved for hospital uses in the indication of “Symptomatic Treatment of Pain Related to Functional Disorder of the Gastrointestinal tract including IBS and dosages given in the marketing authorization”.

iii. The product containing this molecule in France has been in the market since very long and is one of the highest used specialties in gynaecology. Today about 15 French and multinational companies have marketed their brands in France only.

iv. Also in Pakistan where this is the most used specialty for renal colic, biliary colic, abdominal colics, IBS andfor the facilitation of labor, since almost 20 years with excellent safety and efficacy.

v. All the leading medical specialists of Pakistan in related fields confirm its usefulness and are completely satisfied.

vi. The clinical trials conducted within Pakistan have been included in International Literatures. Volumes of data speak about its safety and efficacy.


vii. Phloroglucinol is well documented in well reputed medical reference books including Extra pharmacopeia Martindale and Merck Index.

viii. The molecule Phloroglucinol is not under any review by EMA (European Medicine Agency) and FDA (Food and Drug Authority of America).

ix. Only authentic documents about the safety of a product in Europe are PSUR (Periodic Safety Update Report), which confirms the safety of the product.

B. Omeprazole + Sodium Bicarbonate 20mg, 40mg.

i. The product is safe for use to cure GERD. Authentic clinical trials/study attached to your reference to use product for short term only (4 to 8 weeks) depending upon the patient health severity. Minor side effects like hypokalemia, alkalosis and problem with acids base balance only related with long term use. Companies already not recommended product for long term use.

ii. Product is approved in USFDA and on under prescription.

C. Citicoline.

i. Availability in Multiple Countries:

Citicoline is available in multiple European, North America and Asia Pacific Countries. It highlights the wide spread usage of Citicoline as Nootropic and Neurotonic agent with established efficacy and safety.

ii. Evidence of Citicoline’s Mode of Action as Neuroprotective:

A study of International Society for Neurochemistry in Journal of Neurochemistry has established Citicoline as an intermediate in the biosynthesis of phosphahatidylcholine which has beneficial effects in number of CNS injury models and patholological conditions of brain.

iii. Reference of Citicoline in Authentic & Reputable Journals:

a. British Medical Journal has highlighted Citicoline as more effective if given within 24 hours of stroke than placebo while referring the study of clinical trial “Stroke Management” by Elizabeth Warburton; Josef A Alawneh; Philip L Clatworthy; Rhiannon S Morris”.

b. Journal of the American Heart Association has highlighted beneficial therapeutic effect of the long term treatment of Citicoline in acute cerebral infarction.

c. According to Clinical Interventions in Aging, a world renowned journal, Citicoline is effective and well tolerated in patients with mild vascular cognitive impairment.

iv. Citicoline Granted Novel Food Ingredient Status in EU


Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) delivered a scientific opinion on Citicoline as a novel food ingredient (NFI), which concluded on October 2013 that Citicoline is safe under the proposed use and use levels.

The Commission Implementing Decision 2014/423/EU on July 1, 2014 authorized Kyowa Hakko, New York, NY, to market and manufacture Citicoline as a NFI under Regulation (EC) No 258/97 of the European Parliament and of the Council.

v. Huge prescription base in Pakistan

According to the latest “Sales” data, around 700,000 injections of 250mg whereas 1,000,000 tablets have been selling in a year in Pakistan. It reflects strong confidence of leading neurologists and neuro-surgeons in efficacy and safety of the product which leads to such a massive prescription base.

D. Diacerein.

i. The molecule is registered with the European Medicines Agency. ii. The product is very effective for the treatment of Osteoarthritis Specially in advanced age

iii. The product is available and authorized to be used in the European Union Including France.

E. Calcium Dobesilate.

i. The molecule is included in the European Pharmacopoeia. ii. Molecule is registered and available in Switzerland (COPP available)

iii. Molecule is registered in more than sixty countries of the world and marketed in more than fifty countries.

iv. The molecule has been registered and marketed since 1972 and available in European Union since 1975.

F. Smectite.

i. The molecule is available in France, Greek and USA. ii. The molecule is extremely useful in the treatment of Acute Diarrhea.

iii. It is a time tested and important product for treatment of Dierrhea specially in children. iv. The molecule is available in the European Union including Switzerland, Germany, Austria, Italy,

Spain and countries of Eastern Europe as well as South America and South Anastasia. v. It is an important molecule to prevent Hepatotoxicity.

G. Saccharomyces Boulardi.

i. Clinical efficacy has been established for chronic disease like Crohn disease, Ulcerative Colitis, Irritable Bowel Syndrome, Parasitic infection & Human Immunodeficiency virus related Diarrhea. An overdose of saccharomyces boulardii and long term use ae not likely to cause life-threatening symptoms.


ii. USFDA are withdrawing a notice of eligibility and recommendation of safety data for consideration as OTC product and recommended product monograph for antidiarrheal drug..

iii. Product is already approved and recommended by TGA. iv. In many of countries like in Vietnam, Product registered as drug and in Pakistan this product is

under price control and if product transfers to OTC division then market price might be change and ultimately effect on patient.

H. Piracetam.

i. Availability in Multiple Countries:

Piracetam is available as “Central Stimulant” and “Nootropic Agent” in large number of countries including multiple European, South America and Asia Pacific Countries. Among them the most significant are Germany, France, Belgium, India, Malaysia, Turkey, Singapore etc.

ii. Authentic References:

‐ Assay method given in “British Pharmacopoeia” highlighting the authenticity of the product. ‐ Piracetam has been mentioned in “Martindale - The extra Pharmacopoeia” 36th Edit on with

mode of action and its therapeutic uses. iii. Mode of Action:

Mode of Action of Piracetam is well-explained which highlights its beneficial influence on neuronal and vascular functions. Further Piracetam also improves the function of neurotransmitter acetylcholine.

iv. Wide-spread Usage of Piracetam by leading Neurologists & Neuro-Surgeons in Pakistan:

There are significant number of Piracetam users all around the Pakistan who are very much satisfy with therapeutic results as Nootropic and Neurotonic Agent.

v. Huge Prescription Base in Pakistan:

According to the latest “Sales” data, around 400,000 syrups have been selling in a year in Pakistan. It reflects strong confidence of leading neurologists and Neuro-surgeons in efficacy and safety of the product which leads to such a massive prescription base.

I. Thiocolchicoside.

i. Committee for Medicinal Products for Human use (CHMP) of the European medicines agency in its assessment report no. EMA/40340/2014 dated 17th January, 2014 as made the following conclusion.

a. Having considered all available data from pre-clinical studies, Pharmacoepidemiological studies,

published literature, post-marketing experience on the safety of thiocolchicoside containing medicinal products for systemic use with regards to its genotoxicity, the Committee considered


that thiocolchicoside containing medicinal products for systemic use remain an effective adjuvant treatment of painful muscle contractures in acute spinal pathology.

b. However, having considered the risks, thiocolchicoside containing medicinal products for systemic use should only be administered to patients over 16 years of age in acute conditions. With treatment duration limited to 7 (oral) and 5 (IM) consecutive days. In that respect, the CHMP was of the view that the indication in “Parkinson’s disease and drug-induced Parkinsonism with special consideration to neurodyslectic syndrome” should be removed as this is a chronic condition which requires longer treatment duration. The package size should be adapted to new recommended treatment-days.

c. The committee considered also that thiocolchicoside containing medicinal products for systemic use should be contraindicated during the entire pregnancy period. These products should also be contraindicated in women of childbearing potential not using contraception and during lactation. The CHMP also recommended further changes to the product information including information on fertility.

d. The Committee as consequence concluded that the benefit-risk balance of thiocolchicoside containing medicinal products for systemic use as adjuvant treatment of painful muscle contractures acute spinal pathology in adults and adolescents from 16 years onwards remains favorable, subject to the restrictions, warnings, other changes to the products information, additional pharmacovigilance activities and risk minimization measures agreed.

ii. The molecule is available in France, Greece, Italy, Portugal, Malta, Spain, Hungary, Czech Republic, India and many countries of the Fareast.

iii. The molecule has been in use in Europe since last more than 30 years.

J. Dry Powder Suspension of Famotidine.

Famotidine has many advantages in the Dry Powder form (reconstitute before use) as compared to liquid suspension due to the following reasons.

i. International Availability of Dry Powder Suspension by the Innovator: Please see the attached Annexure, I, which clearly shows that in USA, the research company Merck & Co is manufacturing Famotidine in Dry Powder Suspension. We have attached Product information available freely on internet for your perusal and record.

ii. Proof of availability of this formulation i.e. Dry Powder Suspension is attached as Annexure II – IV, which shows that renowned companies such as Zydus Pharmaceutical USA, Paddock Laboratories Inc., Minneapolis and Lupin Pharmaceuticals Inc., USA are manufacturing and marketing their products in USA which is approved by USA FDA. We have attached the product details downloaded from Internet.

iii. Pharmacopeial Monograph: For your kind record, please note that Dry Powder Suspension is mentioned in the Monograph of Famotidine in USP (Please see Annexure - V ). It is mentioned in


the monograph that total impurities in the Oral suspension should not be more than 2.0%. it is very unlikely that Famotidine that is not stable in water could meet criteria of impurities of 2% if provided in the form of liquid suspension.

iv. Comments on Stability: Famotidine stability in aqueous solution is temperature dependent, therefore storage condition for Famotidine injection is recommended at 2-8oC(See Annexure VI). Various studies are available in the literature which supports termal degradation of Famotidine in Aqeouse Solution at room temperature (See Annesure VII), hence liquid suspension degrade at room temperature.

v. Based on the above authentic references, it may be noted that Dry Powder Suspension is more stable and is used within 30 days after reconstitution (USA product brief). Therefore this formulation is the benchmark as marked by its researcher. Therefore liquid suspension at room temperature is not stable and should be look into for patient safety.

K. Silymarin

Silymarin is mentioned in more than one standards books like:

1) Martindale: The complete drug Reference, which is a comprehensive & reliable reference

source on drug & medicines used throughout the world.

2) U.S.P 34: Silymarin is prescribed in more than 50 countries of the world, we are enclosing

herewith reference of substantial internationally available brands.

S.No Brand name Manufacturing/Availability

1 Lagalon

Austria,Bahrain,Balgaria,China,Colombia,Georgia Germany, Italy,Hungary,Mexico,Philippine, Poland, Portugal,Romania, South Africa, Spain, Switzeland,Slovakia,Thailand, Venezuela.

2 Simepar Switzerland

3 Cefasilymarin Germany

4 Samarin 140 Thailand

5 Doindi Vietnam

6 Silymarin Forte Romania

7 Silymarin Duo Macedonia

8 Hepasil Bangladesh


9 Esimerin Plus India

10 Good Liver India

11 Heptosil 200ml India

12 Livoriv-B India

13 Livosil-B India

14 Silyvit India

15 Tezaliv India

It is an important molecule used in various liver disorders. Various studies regarding

usage of Silymarin are available in different medical Journals.

Various manufacturers have also forwarded their comments on various formulations.

Recommendations of review committee considered by Registration Board in 245th meeting

are as follows:

S. No

Drug Name Generic (Brands)

Approval by International Regulatory Bodies

Status in Authentic Textbooks (Pharmacological basis of therapeutics-Goodman & Gilman, Basic & Clinical pharmacology-B G Katzung, Current Medical Diagnosis & Treatment – 2013)

Research published in Reputed/ Authentic Journals

Concluding Remarks & Recommendation

1. Keto Injection Yes Recommend Numerous Ketamine is


Each vial contains:- Ketamine HCl Ketamine 500 mg (General Anesthetics)

FDA EMA & others

ed for use in general anesthesia.

chemically related to phencyclidine and therefore has a potential for abuse. The drug is included in the controlled list and is placed in Schedule III in USA. In view of its useful role in anesthesia, Ketamine is recommended to be retained as a registered drug. However, it should be dealt with narcotics and appropriate restrictions may be applied to prevent its abuse. Recommended for registration.

2. Fluoxetine + Olenzapine Citrate Each capsule contains:- Fluoxetine HCl 25 mg Olenzapine Citrate Olenzapine 12 mg (Antidepressant)

FDA only

The individual drugs are recommended but the combination has not been mentioned.

Available Fluoxetine is an SSRI and can interact with MOAIs to cause serotonin–syndrome. Since it is converted into a very long acting metabolite, the interaction can occur during 4 weeks after cessation of Fluoxetine. The risk of QT prolongation and causing Torsade de pointes also exists. The Fixed-Dose combination may be allowed with relevant warning and to be dispensed on prescription by qualified psychiatrist only.


Recommended for registration.

3. Each capsule contains:- Omeprazole 20 mg Sodium Bicarbonate 1100 mg (Proton Pump Inhibiter)

Tentative approval by FDA only. Not approved by EMA, PMDA, TGA


No independent scientifically designed studies available to support the combination of these two drugs.

Omeprazole, a PPI, is a prodrug which requires acidic environment for conversion into active form. It blocks the H/K ATPase irreversibly and reduces the gastric acid secretion to very low levels (most potent among all anti- secretory drugs). Sodium bicarbonate is a rapidly acting systemic antacid. It absorbs into blood and long-term use may cause systemic alkalosis, besides other toxicity. It is irrational to combine the two drugs as the antacid may impair activation of Omeprazole. Further, in the face of strong acid-inhibiting effect of Omeprazole, it is superfluous to administer an antacid on regular basis. The combination adds to the cost and increases adverse effects. Not Recommended for registration.

4. Each capsule contains:- Omeprazole 40 mg Sodium Bicarbonate 1100

Tentative approval

The individual drugs are

No independent scientifically designed studies

Omeprazole, a PPI, is a prodrug which requires acidic


mg (Proton Pump Inhibiter)

by FDA only. Not approved by EMA, PMDA, TGA

recommended but the combination has not been mentioned.

available to support the combination of these two drugs.

environment for conversion into active form. It blocks the H/K ATPase irreversibly and reduces the gastric acid secretion to very low levels (most potent among all anti- secretory drugs). Sodium bicarbonate is a rapidly acting systemic antacid. It absorbs into blood and long-term use may cause systemic alkalosis, besides other toxicity. It is irrational to combine the two drugs as the antacid may impair activation of Omeprazole. Further, in the face of strong acid-inhibiting effect of Omeprazole, it is superfluous to administer an antacid on regular basis. The combination adds to the cost and increases adverse effects. Not Recommended for registration.

5. U-Fit 10 mg Dry Suspension Each 5ml contains:- Famotidine 10 mg (Antiulcer)

Famotidine in dry suspension form is not approved by any reputed

NA NA Famotidine is widely available in Tablet, Capsule, Suspension, Chewable & Dispersible tablet forms. Dry suspension does not seem to offer any


international agency

advantage over the existing formulations and is not supported by international market scenario. Not Recommended for registartion.

6. Sacopan Sachets Each sachet contains:- Saccharomyces Boulardii 250mg (anti Diarrhoeal)

Not approved by FDA, EMA, PMDA Approved by TGA only

Some studies about the role of probiotics in IBS and CD infection have been published but their role requires more elucidation.

The probiotics are in evaluation stage and their benefits in IBS, Crohn’s disease, C. difficle infection etc. have not been established. In immune-compromised patients these may cause life-threatening infection. In most of the countries these are available as food-supplements or OTCs. Some of these are already available as additives in milk formulas for infants. May be de-registered as drug and allowed as food supplements.

7. Ritocin-B Dry Suspension 200 mg Each 5ml contains:- Erythromycin Ethyl Succinate. Erythromycin 200mg Bromhexine HCl 4mg (Macrolide)

Not approved by FDA, EMA, TGA & PMDA.

Erythromycin as single drug is recommended by books for infections by susceptible organisms. Bromhexine is not even mentioned.

Studies have been published showing in vitro effect of bromhexine as mucolytic. There is no evidence for such action in vivo after oral administration.

Mucolytics are useful in management of COPD after administration by inhalation. Evidence is lacking for any benefit after oral administration. All oral formulations containing bromhexine as single drug or in combination with other drugs, are recommended to be


de-registered.8. Spardix Tablets 100mg

Each tablet contains:- Sparfloxacin 100 mg (Anti-infective, Fluoroquinolone)


Mentioned as member of fluoroquinolone group.

Studies have been published showing activity of sparfloxacin against Gram positive bacteria. Reports are published describing potassium channel blocking activity causing QT prolongation and life-threatening torsade de pointes arrhythmias.

Several of the Fluoroquinolones have been reported to cause QT prolongation and cardiac arrhythmias. The potential is highest for Sparfloxacin. In view of the unfavorable risk/benefit ratio, the drug is not recommended for registration.

9. ES ZIN 20mg Tablets Each tablet contains:- Esomeprazole 20mg Magnesium 700mg Sodium Bicarbonate 20mg



No independent scientifically designed studies available to support the combination of these drugs.

The comments given above at No.3 also hold good for this preparation. All dosage strengths recommended for de-registration.

10. ES ZIN 40mg Tablets Each tablet contains:- Esomeprazole 40 mg Magnesium 700 mg Sodium Bicarbonate 40mg



No independent scientifically designed studies available to support the combination of these drugs.

The comments given above at No.3 also hold good for this preparation. All dosage strengths recommended for de-registration.

11. Calzob-500 Capsules Each capsule contains:- Calcium dobesilate 500mg (Vasotherapeutics, Coagulants, Haemostatics)


Not mentioned in any standard textbook.

The published clinical trials have shown that calcium dobesilate does not reduce the occurrence of

Calcium dobesilate was developed for prevention of diabetic retinopathy. Theoretically its mechanism of action (inhibition of aldose


diabetic retinopathy in patients.

reductase and reduction of capillary permeability) supports its use for this purpose. However, in evidence-based medicine, benefits of this drug could not be established. Recommended for de-registration.

12. Ciprozan Tablets 1gm Each film coated SR-tablet contains:- Ciprofloxacin ……… 1 gm (Quinolone Antibiotic)

One Gm SR dosage form not approved by FDA, EMA, TGA & PMDA.

One Gm extended-release tablet mentioned by B G Katzung

The strength is within the therapeutic range of dose described in published studies.

The slow release tablet of 1 Gm is not in vogue but has been described by the standard textbook and lies within the therapeutic range of dose. The applicant may be asked to provide full justification for the formulation, quoting examples of countries where similar forms are available. Final decision may be pended till point of view of the applicant is evaluated.

13. Diacin 50mg Capsules Each capsule contains:- Diacerein 50mg ( Anti-Rheumatic )

Not approved by FDA, TGA & PMDA. Approved by EMA for use in epidermolysis bullosa

Not mentioned in any standard textbook

Some in vitro studies on chondrocytes have been published. Clinical trials have reported slight but statistically significant

Diacerein is an anti-inflammatory drug acting by inhibition of Interleukin-1beta. It has been used in osteoarthritis where it may produce slight improvement. In limited number of countries where it is


only superiority over placebo.

available, it is being reviewed and withdrawn due to hepatotoxicity. In view of the limited usefulness and concerns of toxicity, diacerein is not recommended for registration.

14. Swanliag 5 mg Tablet Each tablet contains:- Cyclobenzaprine 5mg (Skeletal Muscle Relaxant)

Not approved by EMA, TGA & PMDA. 5 mg dosage-form discontinued by FDA.

Mentioned by BG Katzung

Studies have been published in which cyclobenzaprine was found to be superior to placebo and equivalent to other spasmolytics.

Although 5 mg dosage form has been discontinued by FDA, but other dosage forms contain higher doses which may be associated with more side effects. By virtue of its non-addictive nature It may be superior to benzodiazepines. In view of the scientific evidence for efficacy of the drug, Cyclobenzaprine may be retained as a registered drug.

15. Mepridone 20mg Capsules Each capsule contains:- Esomeprazole Magnesium Trihydrate Pellets eq. to Esomeprazole 20 mg Domperidone 30mg (Proton Pump Inhibitor / Anti-Dopaminergic)

Not approved by FDA, EMA, TGA & PMDA


Studies on individual drugs are available but not on this combination.

Besides the combination, Domperidone as an individual drug is not approved by FDA. It has been associated with cardiac arrhythmias. The combination is irrational and carries the risk of toxicity. Recommended to be de-registered.

16. Each Sachet contains:- Omeprazole 20 mg Sodium Bicarbonate 1100 mg

Tentative approval by FDA

The individual drugs are recommende

No independent scientifically designed studies available to

Omeprazole, a PPI, is a prodrug which requires acidic environment for


(Proton Pump Inhibiter) only. Not approved by EMA, PMDA, TGA

d but the combination has not been mentioned.

support the combination of these two drugs.

conversion into active form. It blocks the H/K ATPase irreversibly and reduces the gastric acid secretion to very low levels (most potent among all anti- secretory drugs). Sodium bicarbonate is a rapidly acting systemic antacid. It absorbs into blood and long-term use may cause systemic alkalosis, besides other toxicity. It is irrational to combine the two drugs as the antacid may impair activation of Omeprazole. Further, in the face of strong acid-inhibiting effect of Omeprazole, it is superfluous to administer an antacid on regular basis. The combination adds to the cost and increases adverse effects. Not Recommended for registration.

17. Floronol Tablets Each tablet contains:- Phloroglucinol hydrate 80 mg Trimethyl Phloroglucinol 80 mg (Anti Spasmodic)


Not mentioned by any standard textbook

No scientifically designed clinical studies are available. In vitro and toxicological studies have been published.

Phloroglucinol is a synthetic phenol having antispasmodic properties. However its use in medicine has remained restricted due to toxicity concerns. It


is mainly used in explosive industry. The adverse effects reported by FDA include neutropenia, hepatotoxicity, renal failure, metabolic acidosis, hyperkalemia and allergic reactions. In view of severely unfavorable benefit/risk ratio all preparations containing phloroglucinol are recommended to be de-registered.

18. EsmoDome 20 Tablets Each tablet contains:- Esomeprazole Magnesium Esomeprazole 20 mg Domperidone Maleate Domperidone 30 mg (Antiemetics & Antinauseants)





19. EsmoDome 40 Tablets Each tablet contains:- Esomeprazole as Magnesium……..40mg Domperidone Maleate Domperidone 30 mg (Antiemetics & Antinauseants)






20. Piram 1 gm Syrup Each 5 ml contains:- Piracetam 1g (Psychostimulants, Nootropic, Neurotonic)



Scientifically conducted clinical studies have not shown any benefit of piracetam.

Piracetam is used in treatment of cognitive disorders and myoclonus but scientific evidence for efficacy is lacking. Side effects including anxiety, insomnia, irritability, headache, agitation, nervousness, tremor, and hyperkinesia, have been reported with its use. Not Recommended for registration.

21. Wincoline 250 mg Injection Each 2ml ampoule contains:- Citicoline Sodium Citicholine 250 mg (Nootropics & Neurotonic)


Not mentioned by any standard textbook.

Efficacy has not been established in scientifically conducted clinical trials.

Citicoline is cytidine diphosphate choline which is said to increase dopaminergic receptor density in brain. It has been used in cognitive and some other disorders on this basis but evidence for efficacy is lacking. Not recommended for registration.

22. Each film coated tablet contains:- Citicoline Sodium Citicholine 500 mg (Nootropics and Vasotherapeutic)



Efficacy has not been established in scientifically conducted clinical trials.

Citicoline is cytidine diphosphate choline which is said to increase dopaminergic receptor density in brain. It has been used in cognitive and some other disorders on this basis but evidence for efficacy is lacking.


Not recommended for registration.

23. Esso Forte Tablets Each tablet contains:- Naproxen USP 500 mg Esomeprazole Magnesium Trihydrate Esomeprazole 20mg ( NSAID + PPI )

Delayed release tablets are approved by FDA and TGA. Not approved by EMA & PMDA.

This particular combination is not mentioned but combining NSAIDs with PPIs and H2 blockers is recommended in general for prevention of gastropathy.

Studies on this particular combination are not found.

It is rational to combine NSAIDs with PPIs for prevention of gastropathy. Both the drugs individually are well established in their respective categories. Recommended for registration.

24. Valex Talets Each film coated tablet contains:- Phloroglucinol hydrate 80 mg Trimethyl Phloroglucinol 80 mg (Gastrointestinal/Antispasmodics)



No scientifically designed clinical studies are available. In vitro and toxicological studies have been published.

Phloroglucinol is a synthetic phenol having antispasmodic properties. However its use in medicine has remained restricted due to toxicity concerns. It is mainly used in explosive industry. The adverse effects reported by FDA include neutropenia, hepatotoxicity, renal failure, metabolic acidosis, hyperkalemia and allergic reactions. In view of severely unfavorable benefit/risk ratio all preparations containing phloroglucinol are Recommended to


be de-registered.25. S.OM-D 30mg Capsules

Each capsule contains:- Esomeprazole Enteric Coated Pellets eq. Esomeprazole 40 mg Domperidone 30mg (Proton Pump Inhibitor / antiemetic)





26. Thicol 4mg Capsules Each capsule contains:- Thiocolchicoside……..4 mg (Muscle Relaxant)

Not approved by FDA, EMA & TGA


No reference found in authentic journals

Thiocolchicosideis a muscle relaxant with anti-inflammatory and analgesic effects. It acts as a competitive GABAA receptor antagonist and also glycine receptor antagonist. A variety of adverse effects have been reported with this drug. Particularly of concern are its ability to cause seizures and potential to cause tratogenecity and male infertility. Not recommended for registration.

27. Darcin ER 15mg Tablets Each extended release tablet contains:- Darifenacin 15 mg (Anti-Cholinergic)

Approved by EMA & TGA. Tentative approval

Recommended for use in genito-urinary disorders.

Available. Darifenacin is a M 3 selective antimuscarinic drug used for control of urinary incontinence in adults. A congener, solifenacin


granted by FDA.

is already registered. Recommended for registration.

28. Darcin ER 7.5mg Tablets Each extended release tablet contains:- Darifenacin ………. 7.5mg (Anti-Cholinergic)

Approved by EMA & TGA. Tentative approval granted by FDA.

Recommended for use in genito-urinary disorders.

Available. Darifenacin is a M 3 selective antimuscarinic drug used for control of urinary incontinence in adults. A congener, solifenacin is already registered. Recommended for registration.

29. CarionJect 500mg Injection Each 10 ml injection contains:- Iron Ferric Carboxymaltose Iron Element 500mg (Haematinic)

Approved by FDA (750mg/15 ml) & TGA (500mg/10ml)

This particular preparation not mentioned.

Few but available.

It is a new parenteral form of iron. Comparable to the existing formulations in efficacy and safety profiles. Recommended for registration.

30. C-Zyme Tablet Each tablet contains:- Metoclopramide HCl 6mg Sodium dehydrocholate 20 mg Bromelain 35000 PU Pancreatin 210 FIPPU Simethicone 50 mg



No reference found in authentic journals.

A completely irrational combination containing drugs whose efficacy is not established. Not recommended for registration.

31. Carolate Injection Each 1ml ampoule contains:- Glycopyrrolate 0.5 mg Neostigmine methylsulphate 2.5mg


This particular combination is not mentioned but use of atropine-like drugs to counter the muscarinic effects of anticholinesterases is recommended.

Available Neostigmine is generally used to reverse muscle paralysis induced by curare-like drugs during anesthesia. This action is exerted on nicotinic receptors but is accompanied with unwanted muscarinic stimulation. This is countered by administration of antimuscarinic drugs like glycopyrrolate.


Recommended for registration.

32. Isotretinoin Cap/ Isotretinoin Tablet

Recdommended for severe acne and certain malignant disorders.

Available Isotretinoin is 13-cis retinoic acid. It is used in treatment of cystic acne, squamous cell carcinoma of skin and certain other malignancies. In view of its established efficacy, the drug is recommended to be retained. Any issues related to dosage form/formulation may be resolved after obtaining view point of manufacturers.

33. Amoxicillin + Sulbactum The general principal for combining penicillins with beta lacatmase inhibitors is described.

It is rational to combine penicillin with beta lactamase inhibitors but Amoxicillin is generally combined with clavulanate. The manufacturers may be asked to provide reasons for using sulbactam along with references in the favor of this combination. May be deferred for the time being.

34. Silymarin Not approved by FDA, EMA, TGA & PMDA.


No scientifically designed studies available in authentic journals.

Silymarin is a dried extract obtained from Milk thistle plant. Efficacy in hepatic disorders has not been proved in authentic clinical trials. Adverse effects have been reported in patients


using milk thistle capsules. Not recommended for registration.

35. Aescin Not approved by FDA, EMA, TGA & PMDA.



Aescin is a mixture of saponins present in horse chestnut plant. It is claimed to have anti inflammatory and vasoprotective effects but this has not been proved in scientifically designed clinical studies Not recommended for registration.

36. Solcoseryl Not approved by FDA, EMA, TGA & PMDA.



Solcoseryl is deproteinated blood of calves. It has been used in a variety of formulations for various purposes but scientific evidence for efficacy is lacking. Not recommended for registration.

37. Serratiopeptidase Not approved by FDA, EMA, TGA & PMDA.



Serratiopeptidase is a proteolytic enzyme present in silkworm gut which helps it to dissolve the cocoon. It has been used as an anti-inflammatory agent without any scientific evidence of efficacy.Takeda Pharmaceuticals, the brand leader Japanese company, had agreed for voluntary withdrawal


from market in 2011. Not recommended for registration.

38. Smectite Not mentioned by any standard textbook.

No clinical studies available to support efficacy.

Smectite is mineral clay having adsorbent properties. It is similar to kaolin in its medicinal value. Not recommended for registration.

Decision: Keeping in view recommendations of Review Committee and comments of

stake holders, Registration Board decided as follows:

Following formulations will be considered for registration by Registration Board

and thus the Board advised P E & R Division to place all deferred cases in agenda of

the meeting.

i. Ampoule (1ml) containing Glycopyrrolate 0.5 mg Neostigmine + methylsulphate 2.5mg

ii. Injection (10 ml) containing Iron Ferric Carboxymaltose Iron Element 500mg. iii. Extended release tablet containing Darifenacin 7.5mg, 15mg. iv. Tablet containing Naproxen USP 500 mg + Esomeprazole Magnesium Trihydrate

Esomeprazole 20mg. v. Tablet containing Cyclobenzaprine 5mg.

vi. Capsule containing Fluoxetine HCl 25 mg + Olenzapine Citrate Olenzapine 12 mg.

vii. Injection containing Ketamine HCl Ketamine 500 mg

Registration Board discussed comments of stakeholders for following formulations

and decided that Review Committee will review these comments for framing its final

recommendation. The Board also advised the committee to take assistance of any

expert (if required) and can also call any stakeholder for their views. These

formulations are as follows:

viii. Trimethyl Phologlucinol 80mg+Phloroglucinol 80mg. ix. Omeprazole + Sodium Bicarbonate 20mg+1100mg, 40mg+1100mg. x. Citicoline.

xi. Diacerein. xii. Calcium Dobesilate.


xiii. Smectite. xiv. Saccharomyces Boulardi. xv. Piracetam.

xvi. Thiocolchicoside. xvii. Dry Powder Suspension of Famotidine.

xviii. Silymarin

Keeping in view recommendations of Review Committee, Registration Board

decided to proceed further for cancellation of registration as per procedure laid

down in Drugs (L R & A) Rules, 1976 of following items.

xix. Suspension containing Erythromycin Ethyl Succinate Erythromycin 200mg + Bromhexine HCl 4mg

xx. Sparfloxacin 100mg xxi. Tablets containing Esomeprazole 20mg + Magnesium 700mg + Sodium Bicarbonate 20mg

xxii. Tablets containing Esomeprazole 40mg + Magnesium 700mg + Sodium Bicarbonate 20mg xxiii. Capsule and tablet containing Esomeprazole 20mg, 40mg + Domperidone 30mg xxiv. Serratiopeptidase. xxv. Solcoseryl

xxvi. Aescin xxvii. Tablet containing Metoclopramide HCl 6mg + Sodium dehydrocholate 20 mg + Bromelain

35000 PU + Pancreatin 210 FIPPU + Simethicone 50 mg.

Registration Board advised Review Committee to finalize recommendation for

following formulations. The Board also advised the committee to take assistance of

any expert (if required) and can also call any stakeholder for their views. These

formulations are as follows:

xxviii. Amoxicillin + Sulbactum xxix. Isotretinoin Capsule/ Tablet xxx. Film coated Sustained release containing 1 gm Ciprofloxacin

f. Manufacturing requirement for various classes of drugs.

Registration Board in 245th meeting discussed manufacturing requirements for various

classes of drugs, and Chairman advised all members, PPMA and Pharma Bureau to forward their

scientific comments and relevant references on manufacturing requirements for following classes

of drugs:

- Steroids. - Immunosuppresants. - Clomiphene and letrozole - Prostaglandins and its analogues.


- Storage requirement of Misoprostol - Vancomycin Two members and PPMA has forwarded their comments on manufacturing requirements for

steroids, as follows:

Dr. Amanullah Khan (Director, DTL, Quetta).

For all steroidal preparations except topical preparations must have separate

manufacturing area, so it may be added that topical preparations may be manufactured in the

same approved area and exempted from separate area.

Lt General (R) Karamat Ahmed Karamat.

Reference to the Board meeting proceedings, all non-inflammatory steroids like

prednisolone, Dexamethasone are manufactured in the same general area on campaign basis.

Topical steroids like eye preparations/drops, otic drops, creams and ointments are manufactured

through wet process and should be allowed to manufacture across the board as everywhere in the

world. However, sensitive steroids which fall under category A like penicillin, cytotoxic

substances, Beta lactam and sex hormones may be considered to be manufactured in the

dedicated area.

PPMA.

Requirement by international regulatory agencies / cGMP

Internationally the dedicated facility is recommended for certain hormones, as evident from the following:

Medicinal Control Agency U.K Requirements:

The Orange book published by Medicine Control Agency (MCA) of U.K in chapter 3 dealing with premises and equipment, of guide to Good Manufacturing Practices for Medicinal Products, under section 3.6 states requirements which are very close to section 5.2 of Pakistan drug rules.

“In order to minimize the risk of serious medical hazard due to cross contamination, dedicated and self contained facilities must be available for the production of particular medicinal products, such as highly sensitizing materials {e.g Penicillin} or biological preparations {e.g from live microorganism}. The production of certain additional products, such as certain antibiotics, Certain hormones, certain cytotoxics, certain highly active drugs and non medicinal products


should not be conducted in the same facilities. For those products, in exceptional cases, the principle of campaign working in the same facilities can be accepted provided that specific precautions are taken and the necessary validation made. The manufacture of technical poisons, such as pesticides and herbicides, should not be allowed in premises used for the manufacture of medicinal products.

As can be observed that requirement is for certain hormones. Canadian GMP: 11. Prevention of cross-contamination druring manufacturing is the responsibility of the fabricator and packager. They must demonstrate that the premises are designed in such a manner that the risk of cross-contamination between products is minimized. 11.1 In order to minimize the risk of a serious health hazard due to cross-contamination, additional controls, including the need for self-contaiment, should be considered for particular drugs such as: -Certain hormones (e.q. estrogen) -Certain cytotoxic drugs -other highly active drugs Factors to consider are the manufacturing process, use of closed systems, dedication of product contact equipment parts, HVAC controls, engineering controls such as fail safe systems, coupled with validation and ongoing monitoring using highly sensitive analytical methods. 11.2 Campaign production can be accepted where, on a product by product by basis, proper justification is provided, validation conducted and rigorous, validated controls and monitoring are in place and demonstrate the minimization of any risk of cross contamination. As can be observed tht requirment is for certain hormones, Specifically Canadian cGMP refers to Estrogens, Further Canadian GMP allows campaign production provided validation conducted. Indian cGMP Schedule M describing GMP & requirements of Premises Plant & equipment for pharmaceuitcal product, under section 8.2 states as under: The licensee shall ensure processing or sensitive drugs like Beta-Lactum antibiotics, Sex hormones and cycotoxic substances in segregated areas or isoliated production areas within the


building with independent air-handling unit and proper pressure differentials. The effective segregation of these areas shall be demonstrated with adequate records of maintenance and services. As can be observed tht requirment is for certain hormones which are sex hormones. Technical perspective In order to exercise better control on Steroids, the PPMA Technial Committee members observed that there should be clarity between the definition of “Anabolic Steroids” and “Corticosteroids”. References reveal that in human body, adrenal glands produce an anti-inflammatory steroid similar to cortisone {corticosteroids}. Simulating human body secretion, synthetic Cortisone are developed and prescribed to treat asthma, rashes, and various kinds of swelling or inflammation. Whereas, another kind of steroids are calles anabolic steroids. The term anabolic means building up of a bodily substance. Anabolic steroids are related to the major sex hormones, which are produced in both men and women and their synthetic substitutes are uese as supporitve therapy. Ref. Hormone Abuse Overview, http://www.hormone.org/Abuse/overview.com Above references cleary state that all Steroids doesn’t fall under the category of “Highly sensitizing materials”. Furhter, that the Steroids are classified as Corticosteroids (Anti-Inflammatory hormones) and Anabolic Steroids (Sex hormones) and later are requirmed to be manufactured under special controlled conditions. Based on above submissions, our recommendations are;

1. That all Steroids do not fall in the category of “Highly sensitizing materials” 2. Anabolic/Sex hormones e.q. Progesterone., Testosteron and Contraceptive hormone

needs special conditions for manufacturing. 3. Corticosteroids, Dexamethasone, Prednisolone and others are used as anti-inflammatory

drugs which are not included in the category of “highly sensitizing materials” as such should be allowed tomanufacture in general purpose are exercising standard controls to avoid cross contamination.

4. Since several companies have been granted license to manufracture sex hormones in their existing facility, campaign manufacturing may be allowed if necessary precautions have been taken and that future plans for seprate facility are in place.


M/s Sante Pharmaceuticals, Karachi.

1. Drugs (Licensing, Registration & Advertisement) Rules 1976. Schedule B- 5.2. Dedicated Facility for production states that:

Dedicated and self -contained facilities for the production of particular drugs shell be provided in addition to general facilities such as highly sensitizing materials ( e.g. penicillin) or biological preparation (e.g. live microorganism) or cytotoxic substances or veterinary immunological preparations or sterile products or for that matter such other highly active pharmaceutical products, antibiotics, hormones as may be identified by the Central Licensing Board at any stage in order to minimize the risk of serious medical hazard due to cross- contamination. In exceptional cases of emergency, the principal of campaign working in the same facilities may be allowed by the Central Licensing Board provided that specific precautions are taken and necessary validations are made.

2. In 195th Meeting of Central Licensing & Registration Board held on 24th Nov. 2005 a presentation was made by PPMA and Pharma Bureau

Item No.3.

Dedicated /Segregated Facilities for Particular Drugs : Detailed history of dedicated facilities was discussed.

A team of Pharma Bureau and PPMA members presented their view about the matter of segregated facilities for “Quinolones / Antibiotics (except Beta lactam antibiotics) and psychotropic / Narcotic drugs. They explained that the dedicated facilities are required for highly sensitizing drugs e.g. Penicillin, Cephalosporin, and Biological which fall under category A drugs.

Decision of Registration Board:

It was decided that the permission to manufacture the Quinolone products will be allowed on the basis of campaign manufacturing, subject to compliance to the GMP and cGMP regulation. HVAC system and cleaning validation is mandatory.

3. EU guideline for GMP for Medicinal Products and Veterinary Use Part I Chapter 5:Production

Section 3.6: Production Area states that:

Dedicated facilities are required for manufacturing when a medicinal product present a risk;

a) Which cannot be adequately controlled by operational and/ technical measures.

b) Scientific data does not support threshold values ( e.g. allergic potential from highly sensitizing materials such as beta lactam) or

c) Threshold values derived from toxicological evaluation are below the level of detection

4. GMP and requirements of Premises, Plant and Equipments of PHARMACEUTICAL PRODUCTS

PART II-SECTION 3, SUB-SECTION (i)] - Ministry of Health -New Delhi- INDIA


SCHEDULE M. Production area.—

In order to avoid the risk of cross-contamination, separate dedicated and self contained facilities shall be made available for the production of sensitive pharmaceutical products like penicillin or biological preparations with live micro-organisms. Separate dedicated facilities shall be provided for the manufacture of contamination causing and potent products such as Beta lactam, Sex Hormones and Cytotoxic substances.

5. ICH guideline

“Self-contained facilities shall be made available for the production of highly sensitive pharmaceutical products like penicillin or biological preparations with live micro-organisms. Separate dedicated facilities shall be provided for the manufacture of contamination causing and potent products such as Beta lactam, Sex Hormones and Cytotoxic substances.”

6. Based on the current guidelines by EU Orange Guide, ICH, WHO, Indian GMP guidelines, Saudi FDA and others;

“Dedicated facility is required for highly sensitive products like Beta lactam, Sex Hormones, Cephalosporin and Cytotoxic products”

DEFINITION OF HORMONES

1. Different types of steroid hormones, a class of hormones chemically similar to each other, have different functions. For example, the adrenal glands produce an anti-inflammatory steroid similar to cortisone. Cortisone may be prescribed to treat asthma, rashes, and various kinds of swelling or inflammation.

2. The term anabolic means building up of a bodily substance. Anabolic steroids are related to the major male hormone testosterone, which is produced in the testes in men and in the adrenal glands in both men and women. These chemicals are recognized for their effects on building up muscle.

3. Anabolic steroids should not be confused with corticosteroids, which are used routinely as anti-inflammatory medications to help treat illnesses in which inflammation is part of the disease process.

4. Steroids include the dietary fat cholesterol, the sex hormones estradiol and testosterone, and the anti-inflammatory drug Dexamethasone.

5. Steroid: One of a large group of chemical substances classified by a specific carbon structure. Steroids include drugs used to relieve swelling and inflammation, such as Prednisone and Cortisone.

IMPACT OF CROSS CONTAMINATION

There are certain categories of hormones


1. Sex Hormones

Sex hormones comes under category A. In category A, Sex hormones like progesterone (female sex hormone), testosterone (male sex hormone) contraceptive hormones (estrogens). They fall under “Highly sensitizing materials” where cross contamination in very less quantity (microgram) can cause risk of serious health hazard. The cross contamination of male sex hormone with in a manufacturing process can produce changes in the secondary behavior in female like extra hair growth, voice change etc. and vice versa female sex hormone cross contamination during manufacturing operation can cause serious health hazard like diminishing of sexual desire, enlargement of mammary glands etc. therefore in order to minimize the risk of serious health hazard due to cross contamination addition control during manufacturing operation, used of closed system, dedicated product contact equipment parts, HVAC control are necessary.

2. Anabolic Steroids

They also fall in category A and are those used for muscle building weight gain and weak anabolic activities. Same principal followed during the manufacturing operation for cross contamination.

3. Corticosteroids (Dexamethasone, Prednisolone & Hydrocortisone)

Corticosteroids should not be confused with sex hormones as they do not fall in category A of highly sensitive materials and used in topical preparations as anti inflammatory drugs in Eye preparation, Otic preparation and Eye / Skin Ointments. The cross contamination of corticosteroids during the manufacturing operation can not impact the same health hazards as sex hormones even in micro grams quantities hence no dedicated self contained facility is suggested by international guideline agencies like Eur. ICH, and orange guide where they recommend use of same facility with following instructions on campaign bases and cleaning validation.

RISK ASSESSMENT / ANALYSIS OF CROSS CONTAMINATION DURING MANUFACTURING OPERATION

What is the risk involved in case a cross contamination of corticosteroids occur during the manufacturing operation in spite of observing instructions and guidelines provided by the international agencies due to certain negligence and improper supervision? The quantities of API (Active Pharmaceutical Ingredients i.e. Dexamethasone, Prednisolone, Mometasone, Betamethasone, and Triamcenolone) is very minute i.e. in 0.1%, 0.2% up to 0.5%. The entire manufacturing process is wet process, after the dispensing of API it is transferred to glass jar under Laminar Air Flow hood in a diluent system comprising of HPMC / water dispersion, then these glass jars with glass beads are placed on Ball Mill to get the desired particle size finally blend was transferred to main bulk container in liquid form there is no less chances of dust generation during the process. During the product change over a cleaning validation procedure is followed by QC who only allows next batch processing after their approval.

There are two strong arguments in favor of using the same facility for steroid and non-steroid preparations.


1. If there is any risk of health hazard involved due to cross contamination of corticosteroids during the manufacturing operation the international agencies like European Union (Orange Guide), WHO and ICH will never recommend the same facility on campaign basis following the cleaning validation method as in case of sex hormones because corticosteroids are not classified under the highly sensitizing materials even the cross contamination of corticosteroids cannot impact any bad health hazard.

2. Currently topical steroid containing preparations are produced in same facility (Non Steroids) under toll manufacturing agreement for international brands like Allergan, Alcon, Bausch & Lomb etc. and there audit for facility will also conducted by their corporate office under international GMP guidelines, who allows them to manufacture steroids and non steroids in the same facility. So far no adverse drug reaction was reported internationally and nationally which is due to cross contamination.

CONCLUSION

1. All Steroids do not fall in the category of “Highly sensitizing materials”.

2. Sex hormones e.g. Progesterone, Testosterone and Contraceptive hormone may be classified in category A.

3. Anabolic Steroids are those used for muscles building and used by weightlifters, wrestlers and sportsmen may be classified in category A

4. Corticosteroids (Dexamethasone, Prednisolone, Mometasone, Betamethasone, and Triamcenolone) are used as anti-inflammatory drug and are not potent and highly sensitizing materials.

Corticosteroids do not fall in the category of highly sensitive materials and the companies like Alcon, Allergan, Bausch & Lomb and many Local Companies are manufacturing eye drops, ointments, creams etc. containing steroids like Dexamethasone, Prednisolone, Mometasone, Betamethasone and Triamcenolone in the same facility with following the instructions on campaign basis.

MANUFACTURING OF EYE DROPS, OINTMENT & CREAMS

In eye drops the entire manufacturing method is wet process except dispensing of materials.

The concentration of steroids in Topical and Tropical preparations

Ophthalmic Preparation is 0.1 to 0.2 %

Otic Preparations (Drops and Ointments) is 0.1 to 0.2%

The steroids are dispensed in dispensing booth with laminar flow having strong extraction system.

These steroids are immediately transferred under laminar flow, into glass jars containing a mixture of water and HPMC

Tightly close Jars are placed on ball mill to reduce the particle size of steroids.

Then ready slurry is transferred into bulk under laminar flow.


Eye Drops, Eye Ointments, Otic Drops and Creams are being manufactured by local manufacturers

having Dexamethasone, Prednisolone, Hydrocortisone in the same manufacturing facility for the last

many years.

Decision: Registration Board discuused comments of its members, stakeholders and international practices and agreed that for all topical preparations viz. eye / ear preparations, external preparations (cream / ointment / gel / lotion / spary) and aerosols, steroid manufacturing may be permitted on campaign manufacturing basis in general manufacturing areas for these dosage forms provided that manufacturer has segregated dispensing booths, validation and controls studies for processes and adequate system to minimize any potential risk of cross contamination. Registration Board decided to forward above recommendation to Licensing Division for ultimate decision by Central Licensing Board.

Storage requirement of Misoprostol.

- M/s Pfizer Pakistan, Karachi.

There is an obligation to maintain a temperature of -200C and has to kept in an air tight container.

- M/s Rasco Pharma, Lahore.

The firm has provided assessment report (EMA) of misoprostol API which is reproduced as under:-

Misoprostol, as described in the Ph.Eur., is an only liquid which is very unstable and difficult to be process into a drug product in liquid form. The stability of misoprostol is significantly enhanced when it is dispersed in hypromellose. Hence, misoprostol dispersed in hypromellose is used as an intermediate in the manufacture of misoprostol tablet. The dispersion consists of a powder that can be stored at 5+3 °C, whereas the actual active substance is an oily liquid that needs to be stored at -20 °C.

The certificate of analysis of the misoprostol API of the firm shows that the product is Misoprostol 1% HMPC dispersion (White to off-white powder) and it is to be stored at 2-8 °C.

Decision: Registration Board deliberated on the matter indetail and keeping in view EMA’s assessment report decided that as per EMA,s report, Misoprostol 1% HMPC (processed material) dispersion will be permitted for use in tablet dosage form with storage condition of 5+3 °C.


Chairman again advised all members, PPMA and Pharma Bureau to forward their

scientific comments and relevant references till 15.01.2015 on manufacturing requirements

for following classes of drugs:

a. Immunosuppresants. b. Clomiphene and letrozole c. Prostaglandins and its analogues. d. Vancomycin


Item No. V Registration of drugs – Pharmaceutical Evaluation Cell.

Case No.01. Correction in minutes M-245

S/N Name and address of manufacturer / Applicant

1. Brand Name 2. Dosage Form 3. Composition 4. Pharmacological group

1. Type of Form 2. Type of application 3. Demanded Price / Pack size 4. Initial date, diary. 5. Date on which fee becomes complete according to type of application /or Form

1.Finished Product Specification 2. Facility where drug has to be manufactured with status whether approved by CLB or not 3. Last GMP inspection report with date & status.

Decision in 245th meeting of the Registration Board

Correction required by the applicant

Decision

1. M/s. Ali Gohar & Company (Pvt) Limited, Karachi. Manufacturer M/s. Boehringer Ingelheim Pharma GmbH & Co. KG, Located in Binger Strasse 173, 55216 Ingelheim am Rhein, Germany.

Jentadueto 2.5mg/850mg Tablets Each Film Coated Tablets contains:- Linagliptin…..2.5 mg Metformin Hydrochloride…….850mg (Drugs used in Diabetes, combination of oral blood glucose lowering drugs).

Form 5 A 01-07-2013 Rs.50000/- Rs. 7130/ Per packs of 60 Tablets.

International: Jantadueto 2.5/850 (FDA) Local: Me too (M 243)

Approved. The firm applied for packs of 10’s & 30’s as under just before meeting of Registration Board that’s why it was missed in agenda & minutes. Rs. 0.9 x 10 USD for 10’s Rs. 0.9 x 30 USD for 30’s & Rs. 7130/ Per packs of 60 Tablets. (Word CIF as appeared in firm’s request was inadvertantl

The Board acceded to the request of the firm with approval of following price & pack sizes. 1. Rs. 7130/ Per packs of 60 Tablets. 2. CIF price for 10’s pack size: 0.9 x 10 USD for 10’s 3. CIF price for 30’s pack size: 0.9 x 30 USD for 30’s


y missed for 10’s & 30’s pack sizes).

2. M/s. Ali Gohar & Company (Pvt) Limited, Karachi. Manufacturer M/s. Boehringer Ingelheim Pharma GmbH & Co. KG, Located in Binger Strasse 173, 55216 Ingelheim am Rhein, Germany.

Jentadueto 2.5mg/1000mg Tablets Each Film Coated Tablets contains:- Linagliptin…..2.5 mg Metformin Hydrochloride…….1000mg (Drugs used in Diabetes, combination of oral blood glucose lowering drugs).

Form 5 A 01-07-2013 Rs.50000/-Rs.7130/ Per packs of 60 Tablets

International: Jantadueto 2.5/1000 (FDA) Local: Me too (M 243)

Approved. The firm applied for packs of 10’s & 30’s as under just before meeting of Registration Board that’s why it was missed in agenda & minutes. Rs. 0.9 x 10 USD for 10’s Rs. 0.9 x 30 USD for 30’s & Rs. 7130/ Per packs of 60 Tablets. (Word CIF as appeared in firm’s request was inadvertantly missed for 10’s & 30’s pack sizes).

The Board acceded to the request of the firm with approval of following price & pack sizes. 1. Rs. 7130/ Per packs of 60 Tablets. 2. CIF price for 10’s pack size: 0.9 x 10 USD for 10’s 3. CIF price for 30’s pack size: 0.9 x 30 USD for 30’s



Brand Name

(Proprietary name + Dosage Form + Strength)

Composition

Pharmacological Group

Finished product Specification

Type of Form

Initial date, diary

Fee including differential fee

Demanded Price / Pack size

Decision of Previous Meeting

Remarks on the formulation (if any) including International status in stringent drug regulatory agencies / authorities.

Decision

3. M/s. Medisearch Pharmacal (Pvt) ltd, 5-Km, Raiwind Manga Road, Lahore.

Molus Dry Suspension When reconstituted Each 5ml contains:- Montelukast Sodium…..5mg (anti-asthmatic) (Manufacturer’s Spec.s)

Form-5 20-12-2013(1308) Rs.20,000/- As per SRO/60ml

Approved. Letter will be issued after rectification of shortcomings. (M-243)

The Formulation was erroneously approved by the Drug Registration Board. This Formulation is under review by the Review Committee.

Deferred till review of formulation by Review Committee.

4. M/s Allmed Pvt. Ltd. (Formerly, EverGreen Pharmaceuticals, Pvt. Ltd. Plot.No.590, Sundar Industrial Estate Lahore.

Reevo Tablets Each tablet contains: Levocarnitin……………….250mg (Aminoacid derivative/suppliment)

Form5 06-08-2010 Rs.8000/- 11-10-2012 Rs.12,000/- Rs.350/10’s

Deferred for confirmation of pharmacological group as applied by firm. (M-244)

Initially the Firm had applied for Levocarnitine……………250mg per Tablet formulation on Form 5. Before the formation of Pharmaceutical Evaluation Cell some Registration applications were sent to various DRAP officers for evaluation including this one. Agenda of these applications

Deferred for the following: 1) Fee for application on Form 5D for 330 mg Tablet strength. 2) Evaluation of Form 5D. 3) Confirmation of pharmacolog


was prepared for M-242 but could not be discussed. Later on the Firm submitted Form 5-D for this formulation and changed the formulation to Levocarnitine…330mg mg per Tablet. The left over agenda of M-244 was discussed in M-244 but the change was not incorporated. The Registration Board considered the formulation as Levocarnitine…250mg per Tablet and deffered it merely for confirmation of pharmacological group as applied by firm. Registration Board may ask the firm to submit the firm to submit differential fee required for application on Form 5-D and evaluate the application accordingly.

ical group as applied by the firm.


Evaluator – III

Case No.02. Registration of a Patent Drug – Iodine Complex

M/s MTI Medical (Pvt) Limited Lahore has informed that they have developed Iodine complex

molecule in their Research & Development Laboratories and the said molecule has been awarded patent in

Pakistan. The firm submitted that they have conducted preclinical studies in UVAS (University of Veterinary

& Animal sciences, Lahore) and human studies in different teaching hospitals in Pakistan. Results of these

studies have been published in international and national journals which show that addition of iodine complex

with standard therapy of Hepatitis gives significant results.

S/N

Brand Name (Proprietary name + Dosage Form + Strength)

Composition Pharmacological Group (as submitted by the firm) Finished product Specification

Type of Form Initial date, diary Fee including differential fee Demanded Price / Pack size

1. IODIRIN Tablets 200mcg

Each tablet contains: Iodine complex equivalent to elemental Iodine…….200mcg Iodine deficiency disorder/ Antithyroid Manufacturer

Form-5E 23-10-14 Dy. No: 1271 50,000/- Not provided

2. IDOMARINE Capsules 50mg

Each capsule contains: Iodine complex equivalent to elemental Iodine…….50mg Iodine deficiency disorder/ Antithyroid/ Immunomodulator Manufacturer


3. RENESSANS Capsule 200mg

Each capsule contains: Iodine complex equivalent to elemental Iodine…….200mg Antiviral/ Hepatic Preps/ Antithyroid/ Immunomodulator

Form-5E 23-10-14 Dy. No: 1271 50,000/-


The firm has also claimed that the above mentioned molecule is a major breakthrough avoiding and

treating some deadly diseases and diseases due to iodine deficiency, therefore requested to register the drug on

fast track basis in public interest. In this regard, they have submitted registration applications on Form-5 E in

different dosage forms. Details of which are tabulated below.

2. The request of the firm has been evaluated / assessed by the cell. Prima facie the following

observations have been noticed:

a. The applicant has been granted patent for the said molecule named as “Iodine Complex” for cure

against Hepatitis C. Here, the question arises that whether patent is valid for purpose of getting

the registration for a patent drug or not.

b. The application has been filed on Form 5-E for the purpose of registration of a patent drug and

currently the Pharmaceutical Evaluation Cell has no approved check list for the said form. There

are many clauses of the said form wherein the applicant is unable to answer properly. Evaluation

reports clearly depicts the same.

c. The Safety & Efficacy aspects of the drug are important to be evaluated in the instant case (being

new molecule not else- where approved in the world). At present, the Cell for the said purpose

(especially in cases of new drug molecule), relies on the approvals by the Stringent or Reference

Drug Regulatory Agencies of the world like USFDA, EMA, TGA, Health Canada & PMDA

Japan etc. While the drug under discussion has no such approval from any of the drug regulatory

agency in the world.

5. In the light of the above observations, the case was handed over to Pharmacy Services Division, who has

taken up the case. The said Division has forwarded the submitted clinical trial data / research publication

of the applicant to the Executive Director of PMRC for the validity of the trials / research conducted.

Their reply is awaited. The case is therefore, placed for consideration before Registration Board.

Decision: Dr. Muhammad Ajmal and his team appeared and presented before the Board

about development of above formulations and results of clinical trials conducted on the above

Manufacturer

Not provided

4. RENESSANS Suspension 15mg/ 5ml

Each 5ml contains: Iodine complex equivalent to elemental Iodine…….15mg Antiviral/ Hepatic Preps/ Antithyroid/ Immunomodulator Manufacturer



formulations. Registration Board then directed the applicant to provide all the documents

related to development of formulations and their clinical studies for confirmation of safety and

efficacy Prof. Dr. Muzammil H.Najmi, Member Registration Board for further evaluation.

Recommendations / views the expert will be considered by the Board for further processing of

case.

Case No.03. Grant of registrations of newly approved DMLs (Drug Manufacturing Licenses).

Evaluator – II


Brand Name


Composition



Type of Form

Initial date, diary



Remarks on the formulation (if any) including International status in stringent drug regulatory agencies / authorities

Me-too status

GMP status as depicted in latest inspection report (with date) by the Evaluator

Decision

1. M/s Sigma Pharma International Pvt. Limited E-50, N.W.I.Z., Port Qasim Karachi (Tablet General: No. F.6-6/2014-Lic (M-237 dated 17-10-2014)

Klar 250mg Tablet Each film coated Tablet contains:- Clarithromycin(USP)…250mg (Macrolide Antibiotic) (USP Spec,s)

Form 5 17-11-2014 (232) Rs. 20,000/- As Per SRO/ Pack 10’s

BNF: Klaricid (Abbott Healthcare) Claritek 250mg Tablet Getz Pharma Pvt. Ltd. Karachi New Licensee

Approved

2. -do- Klar 500mg Tablet Each film coated Tablet contains:- Clarithromycin(USP)…

Form 5 17-11-2014(228) Rs. 20,000/- As Per SRO/

BNF: Klaricid (Abbott Healthcare) Claritek 250mg Tablet

Approved


500mg (Macrolide Antibiotic) (USP Spec,s)

Pack 10’s

Getz Pharma Pvt. Ltd. Karachi New Licensee

3. -do- Monti 10mg Tablet Each film coated Tablet contains:- Montelukast Sodium as Montelukast…10mg (Bronchodilators & Anti-asthma (Leukotriene antagonist)) (Manufacturer’s Spec.s)

Form 5 17-11-2014(229) Rs. 20,000/- As Per SRO/ Pack 14’s

Singulair 10mg Tablet of Merck & Co. Inc. USA Myteka 10mg Tablet Hilton Pharma Pvt. Ltd. Karachi New Licensee

Approved

4. -do- Cip 250mg Tablet Each film coated Tablet contains:-Ciprofloxacin as Ciprofloxacin HCl…250mg (Quinolones Antibiotic) (B.P Spec,s)


CIPROXIN 250mg Tablet Bayer Australia Limited

GETCIPRO 250mg Tablet Getz Pharma (Pvt.) Ltd. Karachi

New Licensee

Approved

5. -do- Cip 500mg Tablet Each film coated Tablet contains:-Ciprofloxacin as Ciprofloxacin HCl…500mg (Quinolones Antibiotic) (B.P Spec,s)

Form 5 17-11-2014 Rs. 20,000/- As Per SRO/ Pack 10’s

CIPROXIN 500mg Tablet Bayer Australia Limited

GETCIPRO 500mg Tablet Getz Pharma (Pvt.) Ltd. Karachi

New Licensee

Approved

6. -do- Levof 250mg Tablet Each film coated Tablet contains:- Levofloxacin (as hemihydrate)…250mg (Quinolones Antibiotic) (USP Spec,s)


LEVAQUIN 250mg Tablet Janssen Pharma USA

LEFLOX 250mg Tablet Getz Pharma (Pvt.) Ltd Karachi

New Licensee

Approved

7. -do- Levof DS 500mg Tablet Each film coated Tablet contains:-

Form 5 17-11-2014(233) Rs. 20,000/-

LEVAQUIN 500mg Tablet Janssen Pharma

Approved


Levofloxacin (as hemihydrate)…500mg (Quinolones Antibiotic) (USP Spec,s)

As Per SRO/ Pack 10’s

USA

LEFLOX 500mg Tablet Getz Pharma (Pvt.) Ltd Karachi

New Licensee 8. -do- Moxif 400mg Tablet

Each film coated Tablet contains:- Moxifloxacin (as Moxifloxacin HCl)…400mg (Quinolones Antibiotic) (Manufacturer’s Spec.s)


VIGAMOX 400mg Tablet Alcon Lab, USA

MOXIGET 400mg Tablet Getz Pharma (Pvt.) Ltd.

New Licensee

Approved

9. -do- Mecob 500mcg Tablet Each sugar coated Tablet contains:- Mecobalamin (JP)…500mcg (Co-enzyme Vitamin B12) (Manufacturer’s Spec.s)

Form 5 17-11-2014(230) Rs. 20,000/- As Per SRO/ Pack 20’s 50’s & 100’s

METHYCOBAL 500mcg Tablet Eisai Co Ltd. JAPAN

METHYCOBAL 500mcg Tablet Hilton Pharma (Pvt.) Ltd Karachi

New Licensee

Approved

10. -do- Trump 37.5/325mg Tablet Each film coated Tablet contains:- Tramadol HCl…37.5mg Paracetamol…325mg (Opiate analogue/analgesic ) (USP Spec,s)


BNF: Tramacet (Gru¨nenthal)

TONOFLEX Tablet Sami Pharmaceuticals Karachi

New Licensee

Approved

11. M/s Sigma Pharma International Pvt. Limited E-50, N.W.I.Z., Port Qasim Karachi (Capsule General: No. F.6-6/2014-

Coxib 200mg Capsule Each Capsule Contains:- Celecoxib…200mg (Cox-2 Inhibitor) (Manufacturer’s Spec.s)


CELEBREX 200mg Capsule of Pfizer Laboratories USA

CELBEX 200mg Capsule Getz Pharma Pvt. Ltd. Karachi

New Licensee

Approved


Lic (M-237 dated 17-10-2014)

12. -do- Coxib 100mg Capsule Each Capsule Contains:- Celecoxib…100mg (Cox-2 Inhibitor) (Manufacturer’s Spec.s)

Form 5 18-11-2014(Nil) Rs. 20,000/- As Per SRO/ Pack 20’s

CELEBREX 100mg Capsule of Pfizer Laboratories USA

CELBEX 100mg Capsule Getz Pharma Pvt. Ltd. Karachi

New Licensee

Approved

13. -do- Profile 20mg Capsule Each Capsule Contains:- Omeprazole enteric coated Pellets 8.5% equivalent to Omeprazole…20mg (Source of Pellets: M/s Titan Laboratories Private Limited Plot No. E27/1, E27/2, MIDC, Mahad Village Jite District, Raigad, Maharashtra, India) (Proton pump inhibitor) (Manufacturer’s Spec.s)


BNF: Losec (AstraZeneca)

RISEK 20mg Capsule Getz Pharma (Pvt.) Ltd

New Licensee

1. Original Legalized Copy of Valid GMP certificate of manufacturer of Pellets is required.

Approved. Firm will provide legalized GMP of the manufacturer of pellets and then registration letter will be issued after approval of Chairman, RB.

14. -do- Profile 40mg Capsule Each Capsule Contains:- Omeprazole enteric coated Pellets 8.5% equivalent to Omeprazole…40mg (Source of Pellets: M/s Titan Laboratories Private Limited Plot No. E27/1, E27/2, MIDC, Mahad Village Jite District, Raigad,


BNF: Losec (AstraZeneca)

RISEK 40mg Capsule Getz Pharma (Pvt.) Ltd

New Licensee

1. Original Legalized Copy of Valid GMP certificate of



Maharashtra, India) (Proton pump inhibitor) (Manufacturer’s Spec.s)

manufacturer of Pellets is required.

15. -do- Somep 40mg Capsule Each Capsule Contains:- Esomeprazole enteric coated Pellets 22.50% equivalent to Esomeprazole…40mg (Source of Pellets: M/s Titan Laboratories Private Limited Plot No. E27/1, E27/2, MIDC, Mahad Village Jite District, Raigad, Maharashtra, India) (Proton pump inhibitor) (Manufacturer’s Spec.s)


NEXIUM 40mg Capsule AstraZeneca

E-CAP 40mg Capsule Brookes Pharmaceutical Laboratories

New Licensee



16. -do- Somep 20mg Capsule Each Capsule Contains:- Esomeprazole enteric coated Pellets 22.50% equivalent to Esomeprazole…20mg (Source of Pellets: M/s Titan Laboratories Private Limited Plot No. E27/1, E27/2, MIDC, Mahad Village Jite District, Raigad, Maharashtra, India) (Proton pump inhibitor) (Manufacturer’s Spec.s)


NEXIUM 40mg Capsule AstraZeneca

E-CAP 40mg Capsule Brookes Pharmaceutical Laboratories

New Licensee




17. -do- Zith 250mg Capsule Each Capsule contains:- Azithromycin (as Dihydrate)…250mg (Macrolide Antibiotic) (USP Spec,s)

Form 5 17-11-2014(194) Rs. 20,000/- As Per SRO/ Pack 6's & 10's

ZITHROMAX 250mg Capsule Pfizer Laboratories

ZETRO 250mg Capsule Getz Pharma (Pvt.) Ltd.

New Licensee

Approved

18. -do- Malrid Capsule

Each Capsule contains:- Dihydroartemisinin… 40mg Piperaquine Phosphate… 320mg (Anti-Malarial) (Manufacturer’s Spec.s)

Form 5 17-11-2014(195) Rs. 20,000/- As Per SRO/ Pack 8's

Not confirmed

DIPIP 40/320mg Capsule Hilton Pharma (Pvt.) Ltd

New Licensee

1. Availability in SRA’s not confirmed. Firm has provided international availability in Italy.

Deferred for views of recommendations of WHO.

19. -do- Tranex 500mg Capsule

Each Capsule contains:-

Tranexamic Acid…500mg (Haemostatic/ Fibrinolytic) (Manufacturer’s Spec.s)

Form 5 17-11-2014(197) Rs. 20,000/- As Per SRO/ Pack 20's & 100's

Not confirmed

XED 500mg Capsule Indus Pharma

New Licensee

1. Availability in SRA’s not confirmed. Firm has provided international availability in Bangladesh.

Deferred for confirmation of formulation / strength whether approved in reference Stringent Regulatory Agencies or not.


20. -do- Flucap 150mg Capsule

Each Capsule contains:- Fluconazole …150mg (Antifungal) (Manufacturer’s Spec.s)

Form 5 17-11-2014(198) Rs. 20,000/- As Per SRO/ Pack 1's

CANESTEN 150mg Capsule Bayer Healthcare

FLUDERM 150mg Capsule Nabiqasim Industries (Pvt.) Ltd

New Licensee

Approved.

21. M/s Sigma Pharma International Pvt. Limited E-50, N.W.I.Z., Port Qasim Karachi (Sachet General: No. F.6-6/2014-

Lic (M-237 dated 17-10-2014)

Onitum 2gm Sachet

Each Sachet contains:- Strontium Ranelate… 2g (Anti-osteoporotic) (Manufacturer’s Spec.s)


PROTELOS Sachet Les Laboratoires Servier Industrie

ONITA Sachet PharmEVO

New Licensee

Approved.

22. -do- Monti 4mg Sachet

Each Sachet contains:- Montelukast Sodium equivalent to Montelukast 4mg (Bronchodilators & Anti-asthma (Leukotriene antagonist) (Manufacturer’s Spec.s)


Singulair (MSD

MONTIKA 4mg Sachet Sami Pharmaceutical (Pvt.) Ltd

New Licensee

Approved.

23. -do- Malrid 15/120mg Sachet

Each Sachet contains:- Dihydroartemisinin… 15mg Piperaquine Phosphate …120mg (Anti-Malarial) (Manufacturer’s Spec.s)


Not confirmed

ARMIQIN Sachet PharmEVO

New Licensee

1. Availability in SRA’s not confirmed. Firm has provided international availability in Taiwan



24. -do- Citrosalt 4mg Sachet Each Sachet contains:- Sodium Bicarbonate… 1.716gm Sodium Citrate Anhydrous… 0.613gm Citric Acid Anhydrous…0.702gm Tartaric Acid… 0.856gm (Antacids, Anti-flatulents) (Manufacturer’s Spec.s)

Form 5 17-11-2014(217) Rs. 20,000/- As Per SRO/ Pack 20’s & 100’s

Not confirmed

CITRO SODA Sachet Abbott Laboratories, Pakistan

New Licensee

1. Availability in SRA’s not confirmed. Firm has provided international availability in India.

Deferred for confirmation of approval in reference Stringent Regulatory Agencies.

25. -do- Profile 20mg Sachet

Each Sachet contains:- Omeprazole… 20mg Sodium Bicarbonate… 1680mg (Proton pump inhibitor/antacid) (Manufacturer’s Spec.s)

Form 5 17-11-2014(206) Rs. 20,000/- As Per SRO/

Pack 10’s

FDA: Zegerid

RISEK INSTA Powder 20mg Sachet Getz Pharma (Pvt.) Ltd

New Licensee

1. Formulation is under review by the Review Committee of DRB.


26. -do- Profile 40mg Sachet

Each Sachet contains:- Omeprazole… 40mg Sodium Bicarbonate …1680mg (Proton pump inhibitor/antacid) (Manufacturer’s Spec.s)

Form 5 17-11-2014(212) Rs. 20,000/- As Per SRO/

Pack 10’s

FDA: Zegerid

RISEK INSTA Powder 40mg Sachet Getz Pharma (Pvt.) Ltd

New Licensee

1. Formulation is under review by the Review Committee of DRB.


27. -do- ORES Sachet Form 5 17-11-2014(213)

BNF: Oral Rehydration Salts

Approved.


Each Sachet contains:- Sodium Chloride… 2.6g Sodium Citrate…2.9g Potassium Chloride… 1.50g Glucose Anhydrous… 13.50g (Electrolytes) (BP Spec,s)

Rs. 20,000/- As Per SRO/

Pack 20's

(Non-proprietary) WHO Formulation

OEM Sachet Indus Pharma Pvt. Ltd.

New Licensee

28. -do- Cysteine Sachet

Each Sachet contains:- Acetylcysteine …200mg (Mucolytic Agent) (Manufacturer’s Spec.s)

Form 5 17-11-2014 (210) Rs. 20,000/- As Per SRO/

Pack 30’s

Not confirmed (ACC Sandoz Switzerland by Firm)

MUCOLATOR 200mg Sachet Abbott Laboratories (Pakistan) Ltd

New Licensee

1. Availability in SRA’s not confirmed. Firm has provided international availability in Switzerland.


29. -do- Laxit Sachet

Each Sachet contains:- Polyethylene Glycol 3350… 13.125g Sodium Chloride… 0.3507g Sodium Bicarbonate… 0.1785g Potassium chloride… 0.0466g (Laxatives) (Manufacturer’s Spec’s)

Form 5 17-11-2014 (211) Rs. 20,000/- As Per SRO/

Pack 10’s

Not confirmed

MOVCOL Sachet Genix Pharma Private Limited

New Licensee

1. Availability in SRA’s not confirmed in same strength.

Approved as it is BNF approved formulation


30. -do- Gastolyte Sachet

Each Sachet contains:- Rice Powder …6g Sodium Citrate …0.580g Sodium Chloride …0.350g Potassium Chloride… 0.3g (Electrolytes) (Manufacturer’s Spec.s)

Form 5 17-11-2014(216) Rs. 20,000/- As Per SRO/

Pack

1 x 10’s

BNF: Dioralyte Relief (Sanofi-Aventis)

GASTROLYTE Sachet Sanofi-Aventis Pakistan Limited

New Licensee

Approved.

31. M/s Sigma Pharma International Pvt. Limited E-50, N.W.I.Z., Port Qasim Karachi (Oral Dry Powder Suspension General: No. F.6-6/2014-Lic (M-237 dated 17-10-2014)

Klar 125mg/5ml Dry Suspnsion Each 5ml contains:- Clarithromycin…125mg (Macrolide Antibiotic) (USP Spec.s) {Source of Clarithromycin taste masked Granules: M/s Surge Lab10th KM Faisalabad road Sheikhupura}

Form 5 17-11-2014(222) Rs. 20,000/- As Per SRO/ Pack 30ml & 60ml

BNF . Klaricid (Abbott)

(Klaricid (Abbott))

New Licensee

Approved

32. -do- Klar 250mg/5ml Dry Suspnsion Each 5ml contains:- Clarithromycin…250mg (Macrolide Antibiotic) (USP Spec.s) {Source of Clarithromycin taste masked Granules: M/s Surge Lab10th KM Faisalabad road Sheikhupura}

Form 5 17-11-2014(223) Rs. 20,000/- As Per SRO/ Pack 60ml

BNF . Klaricid (Abbott)

(Klaricid (Abbott))

New Licensee

Stability studies of zone IV-A of granules Valid GMP certificate.

Approved

33. -do- Fantin 15mg/90mg/5ml Dry Suspnsion Each 5ml contains:- Artemether… 15mg Lumefantrine… 90mg (Antimalarial )


ATRENAM 15/90mg/5ml Dry Suspension Areneco Pharma Belgium

ARTHEGET 15/90mg/5ml Dry

Approved.


(Manufacturer’s Spec.s) 30ml & 60ml Suspension Getz Pharma (Pvt.) Ltd. Karachi

New Licensee

34. -do- Fantin DS

30mg/180mg/5ml Dry Suspnsion Each 5ml contains:- Artemether… 30mg Lumefantrine… 180mg (Antimalarial ) (Manufacturer’s Spec.s)

Form 5 17-11-2014(221) Rs. 20,000/- As Per SRO/ Pack 30ml & 60ml

ATRENAM 30/180mg/5ml Dry Suspension Areneco Pharma

Belgium ARTHEGET 30/180mg/5ml Dry Suspension Getz Pharma (Pvt.) Ltd. Karachi New Licensee

Approved.

35. -do- Cip 250mg/5ml Dry Suspnsion Each 5ml contains:- Ciprofloxacin (as Ciprofloxacin HCl Monohydrate) 250mg ( Quinolones Antibiotic ) (Manufacturer’s Spec.s)


CIPROXIN Bayer (Formulation is different)

HIFLOX Hilton Pharma (Pvt.) Ltd Karachi

New Licensee

1. Formualtion is under review by the Review Committee of DRB.

Deferred till review of formulation by Review Committee

36. -do- Zith 200mg/5ml Dry Suspnsion Each 5ml contains:- Azithromycin (as Azithromycin Dihydrate)…200mg (Macrolide Antibiotic ) (USP Spec.s)

Form 5 17-11-2014(224) Rs. 20,000/- As Per SRO/ Pack 15ml, 22.5ml, 25ml, 30ml, & 60ml

BNF: Zithromax (Pfizer)

ZETRO Getz Pharma (Pvt.) Ltd Karachi.

New Licensee

Approved.

37. -do- Eryt 200mg/5ml Dry Suspnsion

Form 5 17-11-2014(225)

Not confirmed

ERYTHROCIN Indus

Deferred for confirmation of


Each 5ml contains:-Erythromycin Ethyl succinate Monohydrate equivalent to Erythromycin… 200mg ( Macrolide Antibiotic ) (USP Spec.s)

Rs. 20,000/- As Per SRO/ Pack 60ml

Pharma Karachi.

New Licensee 1. Availability in

same strength in SRA’s not confirmed. Firm has provided international availability in Jordan.

formulation approval in reference Stringent Regulatory Agencies

38. -do- Fosil 250mg/5ml Dry Suspnsion Each 5ml contains:- Fosfomycin (as Fosfomycin Calcium)…250mg (Anti Bacterial Agent ) (Manufacturer’s Spec.s)

Form 5 17-11-2014 (219) Rs. 20,000/- As Per SRO/ Pack 60ml

FOSFOCINA Laboratories ERN, Spain

MIFOS 250mg/5ml Dry Suspension Remington Pharma Lahore

New Licensee

1. Availability in same strength in SRA’s not confirmed. Firm has provided international availability in Spain.

Deferred for confirmation of formulation approval in reference Stringent Regulatory Agencies

39. -do- Flucap 50mg/5ml Dry Suspnsion Each 5ml contains:- Fluconazole…50mg (Antifungal) (USP Spec.s)


BNF: Diflucan (Pfizer)

FLUCANOL 50mg/5ml Dry Suspension Rock Pharma Nawshehra

New Licensee

Approved.

40. -do- Linz 100mg/5ml Dry Suspnsion

Form 5 20-11-2014(Nil) Rs. 20,000/-

BNF: Zyvox(Pharmacia)

Approved.


Each 5ml contains:- Linezolid 100mg (Antibacterial ) (Manufacturer’s Spec.s)

As Per SRO/ Pack 60ml

NEZOCIN 100mg/5ml Dry Suspension Brookes Pharma (Private) Limited

New Licensee


Evaluator – III


Brand Name (Proprietary name + Dosage Form + Strength) Composition Pharmacological Group Finished product Specification


Remarks on the formulation (if any) including International status in stringent drug regulatory agencies / authorities Me-too status GMP status as depicted in latest inspection report (with date) by the Evaluator

Recommendations by the Evaluator

41. M/s MTI Medical (Pvt) Limited, 586-587 Sunder Industrial Estate, Raiwind Road Lahore. (Tablet General)

LOFAMIN Tablet 250mg Each film coated tablet contains: Levofloxacin as hemihydarte…..250mg Fluoroquinolone Manufacture

Form-5 Dy No: 1258 dated 20-10-2014 20,000/- As per SRO/ Pack of 10’s

Levaquin Tablet of Janssen Pharms (USFDA) Leflox of Getz Karachi. The CLB in its 236th meeting approved the grant of DML by the way of formulation with sections namely: a. Oral Liquid

General b. Tablet General c. Capsule General d. Oral Dry Powder

suspension General

Approved.

42. -do- LOFAMIN Tablet 500mg Each film coated tablet contains: Levofloxacin as hemihydarte…..500mg Fluoroquinolone Manufacture


Levaquin Tablet of Janssen Pharms (USFDA) Leflox of Getz Karachi.

Approved.


43. -do- TEMURIN Tablet 100mg Each chewable tablet contains: Iron III Hydroxide Polymatose Complex equivalent to elemental Iron…..100mg Anti- Anemic Manufacturer (Word film coated has been replaced with chewable as firm applied as chewable)

Form-5 Dy No: 1018 dated 26-09-2014 20,000/- As per SRO/ Pack of 1x10’s, 2x10’s

International availability requires confirmation. Rubifer Chewable Tablets of AGP (Pvt) Limited, Karachi.

Approved.

44. -do- TEMURIN-F Tablet 100mg Each chewable tablet contains: Iron III Hydroxide Polymaltose Complex equivalent to elemental Iron…..100mg Folic acid……0.35mg Anti- Anemic Manufacturer (Word film coated has been replaced with chewable as firm applied as chewable)

Form-5 Dy No: 1261 dated 20-10-2014 20,000/- As per SRO Pack of 1x10’s, 2x10’s

International availability requires confirmation. Rubifer-F Chewable Tablet of AGP (Pvt) Limited Karachi.

Deferred for product specific inspection by panel comprising of Director DTL & Area FID

45. -do- CYTO Tablet 250mg Each film coated tablet contains:- Ciprofloxacin as hydrochloride….250mg Fluoroquinolone BP

Form-5 Dy No: 1019 dated 26-09-2014 20,000/- As per SRO 1x10’s

Cipro of Bayer Health Care Cipro of Bayer Health Care Karachi

Approved.


46. -do- CYTO Tablet 500mg Each film coated tablet contains:- Ciprofloxacin as hydrochloride….500mg Fluoroquinolone BP

Form-5 Dy No: 1017 dated 26-09-2014 20,000/- As per SRO/ Pack of 1x10’s

Cipro of Bayer Health Care Cipro of Bayer Health Care Karachi

Approved.

47. -do- PRIZO Tablets 100mg Each film coated tablet contains:- Flurbiprofen…..100mg Cyclo-oxygenase Inhibitor, Analgesic, Anti-inflammatory BP

Form-5 Dy No: 1054 dated 26-09-2014 20,000/- As per SRO/ Pack of 3x10’s

Ansaid of Pharmacia (USFDA) Ansaid of Pfizer Karachi

Approved.

48. -do- OSTIM Tablets 50mg Each film coated tablet contains: Clomiphene Citrate…..50mg Antioestrogen USP

Form-5 Dy No: 1020 dated 26-09-2014 20,000/- As per SRO/ Pack of 1x10’s, 2x10’s and 3x10’s

Serophene of EMD Serno (USFDA) Cerophene of Hilton Pharma Karachi.

Deferred till decision on the manufacturing requirement for this product.

49. -do- MOZEX Tablet 400mg Each film coated tablet contains: Moxifloxacin as HCL….400mg Fluoroquinolone Manufacturer (Word film coated has been omitted in the agenda so has been added in the minutes)


Avelox Tablet of Bayer Health Care Avelox of Bayer Health Care Karachi

Approved.


50. -do- (Capsule General)

ESTO Capsules 20mg Each capsules contains:- Esomeprazole Magnesium Trihydrate enteric coated pellets (22.5%) equivalent to Esomeprazole……20mg PPI Manufacturer Source: M/s Vision Pharmaceuticals, Islamabad.

Form-5 Dy No: 1047 dated 26-09-2014 20,000/- As per SRO/ 1x10’s & 1x7’s

Nexium of AstraZeneca USFDA Esso Capsules of Shaigan Pharmaceuticals, Islamabad.

Approved.

51. -do- ESTO Capsules 40mg Each capsules contains:- Esomeprazole Magnesium Trihydrate enteric coated pellets (22.5%) equivalent to Esomeprazole………40mg PPI Manufacturer Source: M/s Vision Pharmaceuticals, Islamabad.


Nexium of AstraZeneca USFDA Esso Capsules of Shaigan Pharmaceuticals, Islamabad.

Approved.

52. -do- AZOl Capsules 250mg Each capsule contains: Azithromycin as dihydrate…..250mg Macrolide USP


Zithromax of Pfizer (USFDA). Zithromax of Pfizer Karachi.

Approved.

53. -do- GRIBOL Capsules 150mg Each capsule contains: Fluconazole…..150mg Antifungal Manufacturer

Form-5 Dy No: 1260 dated 20-10-2014 20,000/- As per SRO/ 1x4’s

Diflucan of Pfizer (USFDA) Diflucan Of Pfizer Karachi.

Approved.

54. -do- GOTEC Capsules 40mg

Form-5

Prilosec of AstraZeneca

Approved.


Each capsule contains: Omeprazole enteric coated pellets (8.5%) equivalent to Omeprazole ……40mg PPI BP Source: M/s Vision Pharmaceuticals, Islamabad.

Dy No: 1055 dated 26-09-2014 20,000/- As per SRO/ 1x10’s, 1x14’s

(USFDA) Risek of Getz Karachi

55. -do- GOTEC Capsules 20mg Each capsule contains: Omeprazole enteric coated pellets (8.5%) equivalent to Omeprazole ……20mg PPI BP Source: M/s Vision Pharmaceuticals, Islamabad.

Form-5 Dy No: 1044 dated 26-09-2014 20,000/- As per SRO/ 1x10’s, 1x14’s

Prilosec of AstraZeneca (USFDA) Risek of Getz Karachi

Approved.

56. -do- Oral liquid (General)

APRIN Syrup Each ml contains: Cetirizine dihydrochloride ………1mg Antihistamine Manufacturer

Form-5 Dy No: 1051 dated 26-09-2014 20,000/- As per SRO Pack of 30ml and 60ml bottle

Benadryl Allergy Oral Syrup of McNeil Products UK

Baydal of Bayer Health Care Karachi.

Approved.

57. -do- APHOLAC Suspension Each 5ml contains: Lactulose…..3.35gm Laxative BP

Form-5 Dy No: 1052 dated 26-09-2014 20,000/- As per SRO/ Pack of 120ml & 240ml bottle

Duphalac of Solvay (USFDA) Duphalac of Abbot Pharma, Karachi Firm has submitted invoice of purchase of Refractive Index detector.

Deferred for: 1. confirmation of dosage form & verification of HPLC equipped with RI detector by area FID. 2. Fee for import. 3. Legalized GMP of source. 4. Stability studies.


58. TEMURIN Syrup Each 5ml contains: Iron III Hydroxide Polymatose Complex equivalent to elemental Iron…….50mg Anti-anemic Manufacturer

Form-5 Dy No: 1053 dated 26-09-2014 20,000/- As per SRO/ Pack of 60ml & 120ml bottle

Availability in SRA’s need confirmation Engfer Syrup of English Pharma Lahore

Approved.

59. -do- (Oral Dry Powder Suspension General)

AZOL Suspension Each 5ml contains: Azithromycin dihydrate equivalent to Azithromycin …..200mg Macrolide USP

Form-5 Dy No: 1257 dated 20-10-2014 20,000/- As per SRO/ Pack of 15ml bottle

Zithromax of Pfizer (USFDA) Zithromax of Pfizer Karachi

Approved.

60. -do- CYTO Suspension Each 5ml contains: Ciprofloxacin as HCL taste masked pellets 25% equivalent to Ciprofloxacin..…..250mg Fluoroquinolone Manufacturer

Form-5 Dy No: 1259 dated 20-10-2014 20,000/- As per SRO/ 60ml bottle

Not available in SRA’s Novidat of Sami Pharma Karachi


Evaluator – III (Veterinary New DML)




Remarks on the formulation (if any) including International status in stringent drug regulatory agencies / authorities Me-too status GMP status as depicted in latest inspection report

Recommendations by the Evaluators


(with date) by the Evaluator

61. M/s Izfaar Pharmaceutical Industries, Lahore Veterinary Liquid Injection (General Antibiotic)

TRIOZIN Injection Each ml contains: Sulphadiazine…..400mg Trimethoprim……80mg Antibiotic Manufacturer

Form-5 10-07-14 Dy. No: 64 20,000/- Decontrolled/ 50ml vial

Trisolizin of Star Labs Lahore. The CLB in its 236th meeting of Registration Board approved the grant of DML with following sections namely:

a. Veterinary Liquid Injection (General Antibiotic)

b. Veterinary Liquid Injection (General)

Deferred for confirmation of TOC analyzer & Liquid Particle Counter.

62. -do- TYLOGEN Injection Each ml contains: Tylosin Tartrate….10mg Gentamicin as sulphate…..50mg Antibiotic Manufacturer


Tygent Injection of Selmore Pharmaceuticals Lahore


63. -do- OXY FAR LA Injection Each ml contains: Oxytetracycline as Hydrochloride…….200mg Antibiotic Manufacturer


Oxy-LA injection of Selmore Pharmaceuticals, Lahore


64. -do- OXY FAR Injection Each ml contains: Oxytetracycline as Hydrochloride…….50mg Antibiotic Manufacturer

Form-5 10-07-14 Dy. No: 63 20,000/- Decontrolled/ 50ml Vial

Oxy-5 injection of Selmore Pharmaceuticals, Lahore


65. -do- ENRO-100 Injection Form-5 Enroxsel of Selmore Deferred for


Each ml contains: Enrofloxacin….100mg Fluoroqunolone Antibacterial

03-07-14 Dy. No: 17 20,000/- Decontrolled/ 50ml vial

Pharmaceuticals Lahore

confirmation of TOC analyzer & Liquid Particle Counter.

66. -do- FLOXIN Injection Each ml contains: Oxytetracycline as HCL…..300mg Flunixin as Meglumine……20mg Antibiotic/ Analgesic, Anti-inflammatory Manufacturer


I-Fom of International Pharma Labs Lahore


67. -do- TYLOFAR Injection Each ml contains: Tylosin Tartrate……200mg Antibiotic


Tylosel of Selmore Pharmaceuticals, Lahore


68. -do- Ketoxay LA Each ml contains: Oxytetracycline as HCL…….200mg Ketoprofen….30mg Antibiotic/ Analgesic Manufacturer


Oxyfen-LA of Selmore Pharmaceuticals, Lahore


69. -do- TYLOPRIM Injection Each ml contains: Sulphamethoxypyridazine……150mg Trimethoprim……30mg Tylosin tartrate…..50mg Antibiotic


Tylotrim of Selmore Pharmaceuticals Lahore



Manufacturer

70. -do- DICOTYL Injection Each ml contains: Tylosin tartrate….50mg Colistin sulphate…..10mg Dimetridazole…..100mg Antibiotic/ Anti-Protozoal Manufacturer

Form-5 03-07-14 Dy. No: 17 20,000/- Decontrolled/, 50ml vial

Bacticom of Selmore Pharmaceuticals Lahore


71. -do- IVERIN Injection Each ml contains: Ivermectin….10mg Anthelmintic BP


Actimec Injection of Selmore Pharmaceuticals Lahore

Deferred for confirmation of Liquid Particle Counter.

72. -do- PARACTIN Injection Each ml contains: Ivermectin….20mg Anthelmintic BP


Elvomec D/S of Elko Karachi

Deferred for confirmation of Liquid Particle Counter.

73. -do- MELOXAM Injection Each ml contains: Meloxicam…….7.5mg Analgesic/ Anti-inflammatory BP

Form-5 03-07-14 Dy. No: 14 20,000/- Decontrolled/ 50 ml vial

Calimox of Selmore Pharma


74. -do- B-Vita Injection Each ml contains: Cyanocobalamin…..125mcg Vitamin

Form-5 03-07-14 Dy. No: 15 20,000/-

B-Vita of Kakasian Pharma Lahore



USP

Decontrolled/ Pack of 50 ml vial

75. -do- ADE-FAR Injection Each ml contains: Vitamin A…….100,000IU Vitamin D3……40,000IU Vitamin E…….40mg Vitamin and Growth promoters Manufacturer


Nawan Laboratories Karachi


76. -do- VITOBION Injection Each ml contains: Thiamine HCL……5mg Riboflavin……2.5mg Pyridoxine HCL……2.5mg Nicotinamide……37.5mg Vitamin Manufacturer

Form-5 03-07-14 Dy. No: 15 20,000/- Decontrolled/ 50 ml vial

Thiaprin Injection of Star Labs Karachi


77. -do- HEPAFAR Injection Each ml contains: Phenoxy-2-methyl-2-propionic acid…..100mg Hepatoprotectant/ Liver Tonic Manufacturer


Hepaguard of Star Labs Lahore


78. -do- IMIDO-FAR Injection Each ml contains: Imidocarb dipropionate……120mg Antiprotozoal


IMIPRO of Selmore Pharmaceuticals, Lahore


79. -do- AAVIL Injection Form-5 Anril Injection of Deferred for


Each ml contains: Pheniramine maleate…..11.35mg Antihistamine Manufacturer

03-07-14 Dy. No: 15 20,000/- Decontrolled/ 50ml vial

Syman Pharma Lahore confirmation of TOC analyzer & Liquid Particle Counter.

80. -do- ATRO Injection Each ml contain: Atropine Sulphate…..1mg Anti-muscarinic BP

Form-5 03-07-14 Dy. No: 15 20,000/- Decontrolled/ Pack of 50ml vial

Atrovet Injection of Selmore Pharmaceuticals Lahore



Case No.04. Grant of registrationsfor additional sectionsof already licensed manufacturers.

Evaluator – II


Brand Name


Composition



Type of Form

Initial date, diary




Me-too status


Decision

81. M/s Pharmatec Pakistan (Pvt.) Limited, D-86/A, S.I.T.E., Karachi-75700. (Cream/Oint General: No. F.6-6/2014-Lic (M-237 dated 14-10-2014)

Adagel Gel Contains:- Adapalene (B.P)…0.1%w/w Benzoyl Peroxide (B.P)…2.5%w/w (Anti-acne Preperation) (Manufacturer’s Spec.s)

Form 5 13-10-2014 (31) Rs. 20,000/- As Per SRO/15gm, 30gm

BNF: Epiduo (Galderma) ADAPLUS

(BIOGEN PHARMA,Islamabad) Grant of additional section Cream/Ointment (General) recommended.(24-07-2014)

Approved.


82. -do- Pamulin Ointment Contains:- Retapamulin…1.0%w/w (Antibiotic and chemotherapeutic for dermatological use) (Manufacturer’s Spec.s)

Form 5 13-10-2014 (34) Rs. 50,000/- As Per SRO/5gm,15gm

BNF: Altargo (GSK) Altapam Ointment of M/s Atco Lab, Regn No 061764 Grant of additional section Cream/Ointment (General) recommended.(24-07-2014) 1. Me-too status has been given as Altapam Ointment of M/s Atco Lab (Reg. No 061764) that needs confirmation. Pricing of formulation has been done in 9th PAC.

Approved

83. M/s Sami Pharmaceuticlas (Pvt.) Limited, F-95, S.I.T.E.

Karachi-Pakistan

Tablet (Psychotropic) Section (No. F.6-

5/2014-Lic (M-236) dated 8th Sep, 2014.

Pralzo 0.25mg Tablets Each tablet contains:- Alprazolam (USP)…0.25mg (Benzodiazepine) (USP Spec.s)

Form 5 09-09-2014 (240) Rs. 20,000/- Rs.157.47/30’s

BNF: Alprazolam (Non-proprietary) XANAX (PFIZER LABORATORIES LTD.,Karachi) Very good, Panel recommends all the additional sections as per approved layout plan. (24-06-14) 1. Alprazolam is a

controlled drug substance.

Approved.

84. -do- Pralzo 0.5mg Tablets

Form 5 09-09-2014

BNF: Alprazolam (Non-proprietary)

Approved.


Each tablet contains:- Alprazolam (USP)…0.5mg (Benzodiazepine) (USP Spec.s)

(239) Rs. 20,000/- Rs.157.47/30’s

XANAX (PFIZER LABORATORIES LTD.,Karachi) Very good, Panel recommends all the additional sections as per approved layout plan. (24-06-14) 1. Alprazolam is a

controlled drug substance.

85. -do- Tablet (General) Section (No. F.6-

5/2014-Lic (M-236) dated 8th Sep, 2014.

Gasicol Chewable Tablets Each Chewable tablet contains:- Sodium Alginate(BP)…500mg Potassium Bicarbonate (BP)…100mg (Antacid) (Manufacturer’s Spec.s)

Form 5 03-04-2014 (201) Rs. 20,000/- Rs. 5 per Tablet, Rs. 80/16’s

BNF: Gaviscon Advance Not confirmed Very good, Panel recommends all the additional sections as per approved layout plan. (24-06-14) 1. Verification of

photocopy of fee receipt is required.

2. Me-too status needs confirmation.

Deferred for application on Form -5D alongwith requisite fee & other codal formalities.

86. -do- Solfy 5mg Tablets Each film coated tablet contains:- Solifenacin Succinate…5mg (Muscarinic antagonist) (Manufacturer’s Spec.s)

Form 5 21-10-2014 (72) Rs. 20,000/- As per PRC

BNF: Vesicare (Astellas) Fenaso (Highnoon) Very good, Panel recommends all the additional sections as per approved layout plan. (24-06-14)

Approved.


87. -do- Urigo 80mg Tablets Each film coated tablet contains:- Febuxostat…………….…80mg (Xanthine Oxidase Inhibitor) (Manufacturer’s Spec.s)

Form 5 21-10-2014 (73) Rs. 20,000/- As per PRC

FDA: Uloric Zurig (Getz) Very good, Panel recommends all the additional sections as per approved layout plan. (24-06-14)

Approved.

88. -do- Urigo 40mg Tablets Each film coated tablet contains:- Febuxostat…40mg (Xanthine Oxidase Inhibitor) (Manufacturer’s Spec.s)

Form 5 21-10-2014 (71) Rs. 20,000/- As per PRC

FDA: Uloric Zurig (Getz) Very good, Panel recommends all the additional sections as per approved layout plan. (24-06-14)

Approved.

89. -do- Capsule (General) Section (No. F.6-

5/2014-Lic (M-236) dated 8th Sep, 2014.

Beritex 150mg Capsules Each capsule contains:- Polysaccharide Iron Complex equivalent to Elemental Iron…150mg (Iron compound) (Manufacturer’s Spec.s)

Form 5 09-09-2014 (241) Rs. 20,000/- As per PRC

Not confirmed Ferricure (S. J. & G) Very good, Panel recommends all the additional sections as per approved layout plan. (24-06-14) 1. Availability in

SRA’s not confirmed. Firm has provided international availability of un approved products in USA, Canada,

Approved.


Evaluator – III






Decision

90. M/s Rasco Pharma, 5.5 Km Raiwind Road, Lahore Liquid Injection General (Small Volume Vial)

PARA-RAS Infusion Each 100ml vial contains; Paracetamol (BP)…..1000mg Antipyretic/ Analgesic Manufacturer

Form-5 Dy No: 659 dated 22-09-2014 20,000/- As per SRO 1x 100ml

PERFALGAN 10 mg/ml, solution for infusion (100 ml vial contains 1000 mg paracetamol) of BMS UK Provas of

Firm has submitted the invoices of purchase of Liquid Particle counter and TOC analyzer.

Approved. Area FID will confirm instalation & operational qualifications of TOC & Liquid Particle Counter and then

UK.


Sami Karachi The inspection of firm was carried out on 03-06-2014 by the panel of inspectors and recommended the renewal of DML and additional section namely Liquid Injection General (Small Volume Vial)

registration letter will be issued after approval of Chairman, RB.

91. -do- LEVOFLOXA Infusion Each 100ml vial contains: Levofloxacin hemihydarte equivalent to Levofloxacin USP…..500mg Quinolone Manufacturer


Tevanic of Sanofi Aventis (BNF) Levocil of CCL Pharma Lahore.

Approved. Area FID will confirm instalation & operational qualifications of TOC & Liquid Particle Counter and then registration letter will be issued after approval of Chairman, RB.


92. -do- LEVOFLOXA Infusion Each 100ml vial contains: Levofloxacin hemihydarte equivalent to Levofloxacin USP…..250mg Quinolone Manufacturer


250mg levofloxacin (as hemihydarte) in 50ml solution (Tavanic of sanofi) Levocil of CCL Pharma Lahore

Deferred for confirmation of approval by the reference Stringent Regulatory Agencies for this strength / volume.

93. -do- CIP-RX Infusion Each 100ml vial contains: Ciprofloxacin lactate equivalent to Ciprofloxacin USP….400mg Quinolone USP


Ciprofloxacin 2 mg/ml Solution for Infusion 400mg/200ml vial of Hospira UK Limited Novidat of Sami Karachi

Deferred for confirmation of approval of formaulation in Stringent Regulatory Agencies in the same strength.

94. -do- CIP-RX Infusion Each 100ml vial contains: Ciprofloxacin lactate equivalent to Ciprofloxacin USP….200mg Quinolone USP


Ciprofloxacin 2 mg/ml Solution for Infusion 200mg/100ml vial of Hospira UK Limited Novidat of Sami Karachi



95. -do- LINZO Infusion Each 100ml contains: Linezolid….200mg Oxazolidinone Manufacturer


Zyvox of Pfizer USA Nezocin of Brookes Pharma


96. -do- RESGYL Infusion Each 100ml contains: Metronidazole…500mg Antiprotozoal Manufacturer


Flagyl of Sanofi (USFDA) Metrozine of Searle Karachi


97. -do- RE-VED Infusion Each 100ml contains: Ofloxacin HCL equivalent to Ofloxacin……200mg Quinolone Manufacturer


Teravid of Sanofi USA Loxat of Siza Lahore

Approved. Area FID will confirm instalation & operational qualifications of TOC & Liquid Particle Counter and then registration letter will be


issued after approval of Chairman, RB.

98. -do- MOXILINE Infusion Each 250ml vial contains: Moxifloxacin HCL equivalent to Moxifloxacin……400mg Quinolone Antibiotic Manufacturer


Avelox of Bayer Health Care USA Moxiget of Getz Karachi

Applied volume is 250ml however the approval of section is for Liquid Injection General (Small Volume Vial)


99. M/s Arsons Pharmaceuticals Industries (Pvt) Limited, Lahore (Tablet Psychotropic)

RELAXIM Tablet 3mg Each tablet contains: Bromazepam…….3mg Benzodiazepine Manufacturer

Form-5 23-09-14 Dy. No: 793 20,000/- As per SRO 3x10’s

Lexotan Tablets of Roche (TGA Approved) Tensium Tablets of Werrick Pharma Islamabad. The inspection of the firm was conducted on 08-05-2014 by the panel of inspectors and recommended the renewal of DML and

Approved with change in applied brand name.


grant of additional section of tablets psychotropic.

100. -do- ARVOTRIL Tablets 0.5mg Each tablet contains: Clonazepam……0.5mg Benzodiazepine BP


Clonazepam Tablet of Teva (USFDA) Clonzil of English Pharma Lahore


101. -do- ARVOTRIL Tablets 2mg Each tablet contains: Clonazepam……2mg Benzodiazepine BP


Clonazepam Tablet of Teva (USFDA) Clonzil of English Pharma Lahore


102. -do- ARTIVAN Tablets 1mg Each tablet contains: Lorazepam……1mg Benzodiazepine BP


Ativan of Pfizer (USFDA) Ativan of Pfizer Karachi



103. -do- ARTIVAN Tablets 2mg Each tablet contains: Lorazepam……2mg Benzodiazepine BP


Ativan of Pfizer (USFDA) Ativan of Pfizer Karachi


104. -do- XALLIUM Tablets 5mg Each tablet contains: Diazepam………5mg Benzodiazepine BP


Diazeoam of Wockhardt UK Valium of Martin Dow Karachi


105. -do- ARMICUM Tablet 7.5mg Each tablet contains: Midazolam as meleate……7.5mg Benzodiazepine Manufacturer


Hypnovel tablets of Roche New Zealand Dormicum of Martin Dow Karachi


5. Left-over agenda (245)

a) Remaining application of previously approved new sections

Evaluator - II



Brand Name


Composition



Type of Form

Initial date, diary




Me-too status


Decision

106. M/s Herbion Pakistan (Pvt) Ltd., Kahuta

Road, industrial Triangle, Humak,

Rawalpindi- Islamabad.

EsNovex/AciNovex/GastriNovex Capsules 20mg Each capsule contains:-Enteric coated pellets of Esomeprazole Magnesium Trihydrate eq. to Esomeprazole…20mg ( Antipeptic Ulcerants / Proton Pump Inhibitor) (Manufacturer’s Spec.s) {Source of Pellets: M/s Glukem Pharmaceuticals (P) Ltd Plot # 205/2A, 1st Floor , IDA, Phase-II, Cherlapally, Hyderabad-Andhra Pradesh, India}

Form 5 02-05-2014 Dy.No.2076

Rs.20,000/=+Rs. 80,000/- (05-09-

2014) Rs.200.00/

2x7’s

Nexium of AstraZeneca Esso of Shaigan Pharmaceuticals Islamabad. Grant of DML recommended (23-24th January 2014) 1. Valid and

legalized GMP Certificate of Source, COA and stability studies according to zone IV-a of pellets are required.

The stability & COA have been provided by the applicant before the meeting of the Board.


107. -do- EsNovex/AciNovex/GastriNovex

Capsules 40mg Each capsule contains:-Enteric coated pellets of

Form 5

02-05-2014 Dy.No.2077 Rs.20,000/- +

Rs. 80,000/- (05-

Nexium of AstraZeneca Esso of Shaigan Pharmaceuticals Islamabad.

Approved. Firm will provide legalized GMP of the manufacturer of pellets and then registration letter will be issued after


Esomeprazole Magnesium Trihydrate eq. to Esomeprazole …40 mg ( Antipeptic Ulcerants / Proton Pump Inhibitor) (Manufacturer’s Spec.s)

{Source of Pellets: M/s Glukem Pharmaceuticals (P) Ltd Plot # 205/2A, 1st Floor , IDA, Phase-II, Cherlapally, Hyderabad-Andhra Pradesh, India}

09-2014)

Rs.371.00/2x7’s

Grant of DML recommended (23-24th January 2014) 1. Valid and

legalized GMP Certificate of Source, COA and stability studies according to zone IV-a of pellets are required.

The stability & COA have been provided by the applicant before the meeting of the Board.

approval of Chairman, RB.

108. -do- OmeNovex / SecNovex / PeptiNovex Capsules 20mg Each capsule contains:- Omeprazole enteric coated Pellets eq. to Omeprazole …20mg ( Antipeptic Ulcerants / Proton Pump Inhibitor) (Manufacturer’s Spec.s) {Source of Pellets: M/s Vision Pharmaceuticals, Plot No.224, Street No.1, I-10/3, Industrial Area, Islamabad.}

Form 5 02-05-2014 Dy.No.2078 Rs.20,000/= Rs.290.00/

2x7’s

Losec (Astrazeneca) Omega(Ferozsons) Grant of DML recommended (23-24th January 2014)

Approved.


109. -do- OmeNovex / SecNovex / PeptiNovex 40mg Capsules Each capsule contains:- Omeprazole enteric coated Pellets eq. to Omeprazole… 40mg ( Antipeptic Ulcerants / Proton Pump Inhibitor) (Manufacturer’s Spec.s) {Source ofPellets:

M/s Vision Pharmaceuticals, Plot No.224, Street No.1, I-10/3, Industrial Area, Islamabad.}

Form 5 02-05-2014 Dy.No.2079 Rs.20,000/= Rs.354.00/

2x7’s

Losec (Astrazeneca) Omega(Ferozsons) Grant of DML recommended (23-24th January 2014)

Approved.

110. -do- FluNovex / CF-Novex / TheraNovex Extra Tablets Each film coated tablet contains:- Paracetamol BP ….…..650mg Chlorphenirmine Maleate BP………………..……..4mg Phenylephrine HCl BP…10mg (Analgesic + Decongestant Combination) (Manufacturer’s Spec.s)

Form 5-D 24-02-2014 Dy.No.194

Rs.20,000+Rs. 30,000/- (07-05-

14)

Rs.230.00/ 10x10’s

Not confirmed Form 5-D Grant of DML recommended (23-24th January 2014) 1. The firm had

applied on Form 5 , after evaluation the Firm applied on Form 5-D and submitted additional fee of Rs. 30,000/-

2. International availability not confirmed in stringent DRS’s.

Deferred for confirmation of approval in reference Stringent Regulatory Agencies. It will be followed by assessment of stability studies and expert opinions by Brig Aslam, Dr.Rehana Kauser and Dr.Shazli Manzoor.


111. -do- VitaNovex / CilaNovex / BonNovex Suspension Each 5ml contains:- Ossein Mineral Complex …250mg Vitamin D … 400 i.u (Calcium-Phosphorus Supplements) (Manufacturer’s Spec.s)

Form 5 26-02-2014 Dy.No.211 Rs.20,000

Rs.144.00/

60ml

Not confirmed Not confirmed Grant of DML recommended (23-24th January 2014) 1. International

availability not confirmed in stringent DRA’s.

2. Me-too status not confirmed.

3. Firm has claimed that they possess Atomic Absorption (PerkinElmer- A Analyst 300) spectrophometer and has submitted that it can be verified by area FID.

Deferred for approval in reference Stringent Regulatory Agencies & me-too status alongwith installational & operational qualification of atomic absorption spectrophotometer by area FID.


Evaluator – I

S/N Name and address of Manufacturer / Applicant

Brand Name (Proprietary name + Dosage form + Strength) Composition Pharmacological Group Finished product specification

Type of Form Initial date, diary. Fee including differential fee Demanded Price / Pack size

International status in stringent regulatory agencies Me-too status GMP status as depicted in inspection report (dated)

Remarks / Observations

Decision

112. M/s Hiranis Pharmaceuticals (Pvt) Ltd., Plot No. E-145 – E-149, North Western Industrial Zone, Port Qasim, Karachi.

Acen Effervescent Tablet 200mg Each effervescent tablet contains: N-acetylcysteine …………..200mg (Manufacturer’s Specs) Mucolytic agent

Form-5D New License 28-05-2014 804 R&I Rs. 800 / per 10’s Rs. 50,000/-

ACC™ 200 effervescent tablets N-acetylcysteine 200mg South Africa

References and data of various international clinical studies have been provided along with 06 months accelerated and real time stability summary.

Deferred for approval in reference Stringent Regulatory Agencies to establish safety & efficacy of product.


Glucort S.R. Tablet 5mg Each enteric coated tablet contains:- Beclomethasone Dipropionate ... 5mg (Manufacturer’s Specs) Corticosteroid

Form-5D New License 28-05-2014 808 R&I Rs. 1,000 / per 10’s Rs. 50,000/-

CLIPPER Gastro-resistant prolonged release tablet 5mg MHRA

References and data of various international clinical studies has been provided along with 06 months accelerated and real time stability summary. Firm has also submitted undertaking to submit comparative dissolution profile with established brand before marketing the product.

Deferred for expert opinions by Brig Aslam, Dr.Rehana Kauser and Dr.Shazli Manzoor and evaluation of stability studies by Incharge, PEC.



Lafelax Liquid Sachet Each 15ml sachet contains:- Lactulose………67% w/v (USP Specification) Laxative Source: M/s Fresenius Kabi, Austria

Form-5D New License 28-05-2014 811 R&I Rs. 250 / per 10’s Rs. 50,000/- 28/05/2014 Rs. 50,000/- 24/09/2014 Total fee: Rs. 100,000/-

LAEVOLAC 10g/15ml Sachet MHRA

References and data of various international clinical studies / literature have been provided along with 06 months accelerated and real time stability summary. GMP certificate of the source of Lactulose dated 13-02/2012 with the statement that this certificate reflects the status of manufacturer at the time of inspection (31-01-2012) and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection.

Deferred for confirmation of same strength internationally, evaluation of stability studies, confirmation of HPLC equipped with RI detector & legalized GMP of source.


Diolyte Rice Sachet

Each sachet contains:-

Rice Powder…6g

Sodium Citrate……. 0.58g

Sodium Chloride ………….. 0.35g

Potassium Chloride …………… 0.3g

(Manufacturer’s Specs)

Form 5

New License 05-05-2014 662 R&I As per PRC 10’s Rs. 20,000/-

DIAROLYTE GASTROLYTE Sanofi

Approved with change in brand name.


ORS

116. M/S Pharma Lord (Pvt) Ltd., 12 Km, Lahore Road, Layyah.

Tablet (General) Capsule (General) Oral Dry Powder Suspension (General)

CPRO 125mg/5ml Suspension

Dry Suspension

Each reconstituted 5ml contains:

Ciprofloxacin ………..... 125mg

(Anti-infective / Quinolone)

Reference formulation:

CIPRO Oral Suspension (M/s Bayer HealthCare Pharmaceuticals Inc.)

Ciprofloxacin Oral Suspension is available in 5% (5 g ciprofloxacin in 100 mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. Ciprofloxacin Oral Suspension is a white to slightly yellowish suspension with strawberry flavor which may contain yellow-orange droplets. It is composed of ciprofloxacin microcapsules and diluent which are

Form 5

Rs. 125/- per 60ml

R&I diary No. and date not available

Rs.20,000 (Duplicate)

NOVIDAT 125mg/5ml Sami Panel inspection report for grant of DML dated 14th December, 2012 attached.

1. Under international availability Cipro of M/s Bayer, Italy has been mentioned. 2. Role of ingredients has not been provided. 3. Ciprofloxacin 25% granules had been proposed earlier. However, now firm has proposed dry powder suspension containing Ciprofloxacin (base) with water as diluent which is different from the reference international brand*. 4. Copy of latest GMP report required.

Deferred for review of formulation.


mixed prior to dispensing. The components of the suspension have the following compositions:

Microcapsules–ciprofloxacin, povidone, methacrylic acid copolymer, hypromellose, magnesium stearate, and Polysorbate 20. Diluent–medium-chain triglycerides, sucrose, lecithin, water, and strawberry flavor.


Evaluator – III





Decision

117. M/s Faas Pharmaceuticals (Pvt) Limited, F-748/ L S.I.T.E. Karachi (Tablet General)

Ciploxin Tablet 250mg Each film coated tablet contains: Ciprofloxacin as HCL…..250mg Anti-Infective USP

Form-5 Dy No:977 dated 12-06-2014 20,000/- As per SRO

Cipro of Byaer Health Care Cipro of Bayer Healthcare Karachi Inspection of the firm was conducted on 18-03-2014 by the area FID and GMP compliance was found satisfactory.

Approved.

118. -do- Ciploxin Tablet 500mg Each film coated tablet contains: Ciprofloxacin as HCL…..500mg Anti-Infective USP


Cipro of Byaer Health Care Cipro of Bayer Healthcare Karachi

Approved.

119. -do- Levoquin Tablet 250mg Each film coated tablet contains: Levofloxacin as hemihydarte…..250mg


Levaquin Approved USFDA Leflox of Getz Pharma Karachi

Approved.


Anti-Infective Manufacturer

120. -do- Levoquin Tablet 500mg Each film coated tablet contains: Levofloxacin as hemihydarte…..500mg Anti-Infective Manufacturer


Levaquin Approved USFDA Leflox of Getz Pharma Karachi

Approved.

121. -do- Capsule (General)

Omezole-D Capsule Each capsule contains:- Blended pellets of Omeprazole 20mg EC….20mg Domperidone IR ….10mg Anti-Ulcer and Anti-Emetic Manufacturer Source: M/s Glukem Pharmaceuticals, Plot No. 205/2A, IDA, Phase II, Chedapally, Hyderabad, India


Not available in stringent SRA,s Me too status is not submitted by the firm. a. Evidence of

approval of same dosage form and strength in FDA, TGA, EMA, MHLW, and Health Canada is required.

b. GMP certificate of the source (which shall be legalized) and stability studies as per ZONE-IV A needs to be submitted.

Deferred till review of formulation.

122. M/s Martin Dow Limited, Plot No. 37, Sector 19, Korangi Industrial Area, Karachi

Sparta Sachet Each sachet conatins:- L-Ornithine –L-Aspartate……3gm Cholagogues and Hepatic Protectors\ Manufacturer

Form-5 Dy No. 1067 dated : 30-06-2014 As per brand leader price/ Pack of 5,10 & 30’s

Hepa-MerzMerz Pharmaceuticals Germany Hepa-Merz of Brookes Pharma, Karachi.

Deferred for confirmation of approval in reference Stringent Regulatory Agencies & me too status.


123. -do- Olyte Sachet Each sachet contains:- Precooked Rice Powder ……6gm Sodium citrate…..0.58gm Sodium chloride…..0.35gm Potassium chloride……0.30gm

Form-5 Dy No. 1069 dated : 30-06-2014 As per brand leader price/ Pack of 6,10 & 20’s

Doalyte Relief Black current sachet of Aventis Pharma UK Diarolyte of Sanofi Avnetis Karachi

Approved.

124. -do- Evrease Sachet Each sachet contains: Mebeverine as Hydrochloride: 135mg Physillium Husk…..3.5gm Antispasmodic and Laxative Manufacturer

Form-5 Dy No. 1070 dated : 30-06-2014 Rs.155.52 per pack of 10’s Rs. 310.50 per pack of 20’s Rs.465.75 per pack of 30’s

Fybogel Mebeverine of Reckitt Benkiser UK Ispamer Sachet of Getz, Karachi

Approved.

125. M/s Elite Pharma (Pvt) Limited, 9.5 Km Sheikhupura Road Lahore

Flucolite Infusion 50ml Each ml contains:- Fluconazole……2mg Antifungal Manufacturer

Form-5 Dy No. 885 dated : 25-11-2013 20,000/- Price not submitted /Pack of 100ml of 1’s

Diflucan of Pfizer. Diflucan of Pfizer Labs Karachi Evidence of availability of TOC is required as BP specifications are claimed. Panel inspection of the firm was conducted on 28-01-13 and the panel recommended the liquid injectable infusion (100ml)

Deferred for confirmation of installation and performance qualification of TOC analyser & Liquid Particle Counter by Area FID.


126. -do- Percemol Infusion 1gm/100ml Each 100ml conatins:- Paracetamol……1gm Analgesic Manufacturer


Perfalgan of BMS, UK Provas of SAMI Pharmaceuticals Karachi Evidence of availability of TOC is required as BP specifications are claimed.

Deferred for confirmation of installation and performance qualification of TOC analyser & Liquid Particle Counter by Area FID.

127. -do- Capronic Infusion 50mg/ml Each ml contains:- Aminocaproic acid…..50mg Hemostatis


Not available in SRA,s. Me too is not provided by the company. Evidence of availability of TOC is required as BP specifications are claimed.

Deferred for confirmation of following: 1. Installation and performance qualification of TOC analyser & Liquid Particle Counter by Area FID. 2. Me too status & approval by referenece Stringent Regulatory Agencies.

128. -do- Elite Reserbelakta Each ml contains:- Sorbitol…..200mg Sodium Lactate…..1.9mg So+dium chloride…..6mg Calcium chloride…..0.1mg Potassium Chloride……0.3mg Magnesium Chloride…..0.2mg Hyperosmoler complex and infusion solution Manufacturer


Not available in stringent SRA’s. Firm has submitted the applied product is available in Ukraine (Saorbilactum infusion of Yuria Pharma) which also needs verification. Firm submitted that product is not available locally. Evidence of availability of TOC is required as BP specifications are claimed.

Deferred for confirmation of folowing: 1. Installation and performance qualification of TOC analyser & Liquid Particle Counter by Area FID. 2. Me too status & approval by referenece Stringent Regulatory Agencies.


129. -do- Elite Reserbelakta Each ml contains:- Sorbitol…..200mg Sodium Lactate…..1.9mg Sodium chloride…..6mg Calcium chloride…..0.1mg Potassium Chloride……0.3mg Magnesium Chloride…..0.2mg Hyperosmoler complex and infusion solution Manufacturer


Not available in stringent SRA’s. Firm has submitted the applied product is available in Ukraine (Saorbilactum infusion of Yuria Pharma) which also needs verification. Firm submitted that product is not available locally. Evidence of availability of TOC is required as BP specifications are claimed.

Deferred for confirmation of folowing: 1. Installation and performance qualification of TOC analyser & Liquid Particle Counter by Area FID. 2. Me too status & approval by referenece Stringent Regulatory Agencies.

b) Routine applications

Evaluator – II


Brand Name


Composition



Type of Form

Initial date, diary




Me-too status


Decision

130. M/s Maple Pharmaceuticals (Pvt.) Ltd., 147/23, Korangi

Faxim-E 200mg Tablet Each film coated

Form-5 15-07-2010 (N/A)

BNF: Xifaxanta (Norgine)

Approved. Reference will be sent


Industrial Area, Karachi.

Tablet contains:-Rifaximin (B.P)…200mg (Antibacterial) (Manufacturer’s Spec.s)

Rs.8,000/-+Rs. 12,000 (14-05-2013) As per PAC

Nimixa (Getz Pharma)

Overall cGMP measures are followed in the Firm (31-03-2014) 1. Verification of

photocopies of fee challan is required.

to B & A Division, DRAP for verification of photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.

131. -do- Faxim 550mg Tablet Each Tablet contains:-Rifaximin (B.P)…550mg (Antibacterial) (Manufacturer’s Spec.s)

Form-5 15-07-2010 (N/A) Rs.8,000/-+Rs. 12,000 (25-07-2013) As per PAC

BNF: Xifaxanta (Norgine)

Nimixa (Getz Pharma)

Overall cGMP measures are followed in the Firm (31-03-2014) 1. Verification of

photocopies of fee challan is required.

Approved. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.

132. M/s Sami Pharmaceuticlas (Pvt.) Limited, F-95, S.I.T.E. Karachi-Pakistan

Neege 20mg Tablets Each delayed release Tablet contains:- Pantoprazole Sodium Sesuiquihydrate equivalent to Pantoprazole (USP)…20mg

Form 5

06-07-2010 Rs.8,000/ (69)

+Rs. 12000 (10-05-2013)

As Per PRC

BNF. Pantoprazole (Non-proprietary) Zentro (Bosch) Good (28-11-2013) Very good (24-06-2014) Grant of Additional sections

Approved. Reference will be sent to B & A Division, DRAP for verification of photocopy


1. The Routine applications checked by the Field Officers before establishment of Cell Evaluator - II

S/N Name and address of manufacturer/Applicant


1.Type of Form 2. Type of application3. Demanded Price / Pack size 4. Initial date, diary. 5. Date on which fee becomes complete according to type of application /or Form (total Fee)

1. Finished Product Specification 2. Me-too status

Comments / observation on the product (if any)

Decision

Registration-II

133. M/s Barrett Hodgson Pakistan Pvt. Ltd. F/423, SITE, Karachi

1.DutaBar 2.Capsule 3.Each Capsule contain: Dutasteride………….0.5mg 4.Alpha-Reductase

1.Form5 2.Routine 3. Rs. 1200/20’s 4.28/09/2010 Dy. No. 1738 Form 5 Rs. 8000/- (Original)

Me too confirmed Advodart of GSK

FDA : Avodart (GSK)

Deferred for confirmation of formualtion in soft gelatin capsule form. Reference will be sent to B & A Division, DRAP for verification of

(Proton Pump Inhibitor) USP Spec.s)

Satisfactory (07-11-2013) Routine 1. Verification of

photocopy of fee of Rs. 12000/- is required.

of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.


Inhibitors 21-5-2013 Rs.12,000/- (Photo copy)

photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.

134. -do- 1.MindSet 2.Capsules 3.Each Capsule contains: Ziprasidone ……….20mg 4.Atypical Anti-Psychotropic Agent

1.Form5 2.Routine 3. Rs. 900/14’s 4.28/09/2010 Dy. No. 1742 Form 5 Rs. 8000/- (Original) 21-5-2013 Rs.12,000/- (Photo copy)

Me too status confirmed.

FDA : Geodon (Pfizer)

Approved with change in applied brand name. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.

135. -do- 1.MindSet 2.Capsules 3.Each Capsule contains: Ziprasidone……….40mg 4.Atypical Anti-Psychotropic Agent

1.Form5 2.Routine 3. Rs. 1500/14’s 4.28/09/2010 Dy. No. 1741 Rs. 8000/- (Original) 21-5-2013 Rs.12,000/- (Photo copy)

Me too status confirmed.



136. -do- 1.MindSet 2.Capsules 3.Each Capsule contains: Ziprasidone ……….60mg 4.Atypical Anti-Psychotropic Agent

1.Form5 2.Routine 3. Rs. 2100/14’s 4.28/09/2010 Dy. No. 1740 Rs. 8000/- (Original) 21-5-2013 Rs.12,000/- (Photo copy)

Ziprox of Nabi qasim



137. -do- 1.MindSet 2.Capsules 3.Each

1.Form5 2.Routine 3. Rs.

Me too status confirmed




Capsule contains: Ziprasidone……….80mg 4.Atypical Anti-Psychotropic Agent

2800/14’s 4.28/09/2010 Dy. No. 1739 Rs. 8000/- (Original) 21-5-2013 Rs.12,000/- (Photo copy)

Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.

138. M/s Macter International Ltd. F-216, SITE, Karachi

1.Amlotel 2.Tablet 3.Each tablet contains: Telmisartan……………….40mg Amlodipine……………..….5mg 4.antihypertensive

1.Form5 2.Routine 3.14’s / As per PRC 4.22/09/2010 Dy. No. 1709 Rs. 8000/- (Original) 22-5-2013 Rs.12,000/- (Not attached)

Me too confirmed FDA: Generic (TORRENT PHARMS LTD)


139. -do- 1.Amlotel 2.Tablet 3.Each tablet contains: Telmisartan……………….80mg Amlodipine……………..….5mg 4.antihypertensive




140. -do- 1.Amlotel 2.Tablet 3.Each tablet contains: Telmisartan……….40mg Amlodipine…………10mg 4.antihypertensive




141. -do- 1.Amlotel 2.Tablet 3.Each tablet

1.Form5 2.Routine 3.14’s / As


FDA: Generic (TORRENT PHARMS LTD)

Approved. Reference will be sent to B & A


contains: Telmisartan……………….80mg Amlodipine……………..….10mg 4.antihypertensive

per PRC 4.22/09/2010 Dy. No. 1707 Rs. 8000/- (Original) 22-5-2013 Rs.12,000/- (Not attached)

Division, DRAP for verification of photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.

142. -do- 1.Prophed 2.Suspension 3.Each 5ml contains: Ibuprofen.100mg Pseudoephedrine HCI……15mg 4.Pain reliever /fever reducer nasal decongestant)

1.Form5 2.Routine 3. 60ml/As per PRC 4.22/09/2010 Dy. No. 1711 Rs. 8000/- (Original) 22-5-2013 Rs.12,000/- (Not attached)

Rovinac of Rock pharmaceutical

Int. avail not confirmed in Str DRAs. Psychotropic precursor (For Psychotropic Precursors, there is no requirement for dedicated / separate manufacturing facility)

Deferred for confirmation of approval in reference Stringent Regulatory Agencies. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan.

143. M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi industrial Area, Karachi.

1.Qutex 2.Tablet 3.Each film coated tablet contains: Quetiapine fumarate eq to quetiapine.100mg 4.anti psychotic, dibenzothiazepine) Specs: NabiQasim

1.Form5 2.Routine 3. 10’s, 30’s/ As per PRC 4.16/09/2010 Dy. No. 1699 Rs. 8000/- (Original) 14-5-2013 Rs.12,000/- (Photo copy)


FDA: Generic (DR. REDDYS LABS LTD)


144. -do- 1.Bepcor 2.Tablet 3.Each film coated tablet contains: Bosentan (as monohydrate)…………...125mg

1.Form5D 2.Routine 3. Rs. 30,000/10’s 4.16/09/2010 Dy. No. 1690 Rs. 15000/- (Original) 14-5-2013

1. It is a me too 2. At the time of filing application, the drug was new. The firm submitted Form 5-D with fee Rs. 15,000/-. Now the drug has become registered.

FDA: Tracleer Approved. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. If confirmed, then Chairman, RB will


4.Pulmonary arterial hypertension) (PAH), systemic sclerosis with ongoing digital ulcer disease Specs: NabiQasim

Rs.5000/- (Photo copy)

The firm has submitted the from 5.

permit issuance of registration letter.

145. -do- 1.Qrist 2.Tablets 3.Each extended release tablet contains: Desvenlafaxine succinate eq to desvenlafaxine ……….50mg 4.Antidepressant Specs: NabiQasim

1. Form 5 2.Routine 3. 10’s, 14’s, / As per PRC 4.16/09/2010 Dy. No. 1689 Rs. 8000/- (Original) 14-5-2013 Rs.12,000/- (Photo copy)

1.Me too status confirmed Denla XR 50mg&100mg of M/s Semos Pharma, (Reg.No.070433&070434) 2.The firm has submitted the undertaking regarding submission of comparative dissolution profile before marketing of the product

FDA : Khedezla Approved. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.

146. -do- 1.Qrist 2.Tablets 3.Each extended release tablet contains: Desvenlafaxine succinate eq to desvenlafaxine………..….100mg 4.antidepressant Specs: NabiQasim

1. Form 5 2.Routine 3. 10’s,14’s/As per PRC 4.16/09/2010 Dy. No. 1693 Rs. 8000/- (Original) 14-5-2013 Rs.12,000/- (Photo copy)

1.Me too status confirmed Denla XR 50mg&100mg of M/s Semos Pharma, (Reg.No.070433&070434) 2.The firm has submitted the undertaking regarding submission of comparative dissolution profile before marketing of the product

FDA: Kheedezla Approved. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.

147. -do- 1.Qutex 2.Tablet 3.Each film coated tablet

1. Form 5 2.Routine 3. 10’s,30’s/As


FDA: Seroquel Approved. Reference will be sent to B & A Division, DRAP for


contains: Quetiapine fumarate eq to quetiapine..25mg 4.anti psychotic, dibenzothiazepine Specs: NabiQasim

per PRC 4.16/09/2010 Dy. No. 1698 Rs. 8000/- (Original) 14-5-2013 Rs.12,000/- (Photo copy)

verification of photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.

148. -do-

1.Qutex 2.Tablet 3.Each film coated tablet contains: Quetiapine fumarate eq to quetiapine.200mg 4.anti psychotic, dibenzothiazepine Specs: NabiQasim

1. Form 5 2.Routine 3. 10’s, 30’s / As per PRC 4.16/09/2010 Dy. No. 1695 Rs. 8000/- (Original) 14-5-2013 Rs.12,000/- (Photo copy)


FDA: Seroquel Approved. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.

149. -do- 1.Bepcor 2.Tablet 3.Each film coated tablet contains: Bosentan (as monohydrate)……..62.5mg 4.Pulmonary arterial hypertension (PAH) Specs: NabiQasim

1. Form 5 2.Routine 3. Rs. 19000/10’s 4.16/09/2010 Dy. No. 1696 Rs. 15000/- (Original) 14-5-2013 Rs.5000/- (Photo copy)

1. It is a me too. 2. The firm has now submitted form 5.

FDA: Tracleer Approved. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.


Registration-V

150. M/s Care Pharmaceuticals,

8Km, Thokor Raiwind Road,

Lahore

1.Sinocare 2.Cream 3.Each gm contains: Fluocinolone acetonide..2.5mg 4.Corticosteroid

1.Form5 2.Routine 3.Rs.50/15gm, Rs.90/30gm 4.30-09-2010 Dy.No.4032 Rs.8000/- Rs.12,000/- 13-5-2013

Reply has been received.

FDA: Generic (Taro)

Deferred for confirmation of steroidal section.

151. -do- 1.Fusidcare 2.Cream 3.Each gm contains: Fusidic Acid (2%)…….20 mg 4.Antibacterial

1.Form5 2.Routine 3.Rs.65/5gn, Rs.165/15gm 4.30-09-2010 Dy.No.4033 Rs.8000/- 15-05-2013 Rs.12,000/-

Reply is still awaited. The firm was communicated twice. They have stated that they are no more interested in the product registration.

BNF: Fucidin (Leo)

Last reminder will be issued to the firm for rectification opf shortcomings.

152. -do- 1.Clomezole 2.Cream 3.Each gm contains: Clotrimazole………….10 mg 4.Antifungal

1.Form5 2.Routine 3. Rs.41/10gn, Rs.70/20gm 4.30-09-2010 Dy.No.4029 Rs.8000/- 15-05-2013 Rs.12,000/-

Reply is still awaited. The firm was communicated twice. They have stated that they are no more interested in the product registration.

FDA: Generic (Taro)

Last reminder will be issued to the firm for rectification opf shortcomings.

153. M/s CCL Pharmaceuticals, Pvt. Ltd. 62-Industrial Estate, Kot Lakhpat, Lahore

1.Cip 2.Suspension 3.Each 5ml contains: Ciprofloxacin hydrochloride eq. to ciprofloxacin…..................125mg 4.Antibiotic.

1.Form5 2.Routine 3.60ml/ Price not mentioned 4.06-09-2010 Rs.8000/- (Photo copy) 20-05-2013 20-05-2013 Rs.12,000/- (Original)

FDA: Cipro (Different formulation) The originator’s (M/s Bayer) formulation contains ciprofloxacin in base form, however the firm has submitted that a number of products in

Deferred for review of formulation by Review Committee.


Pakistan are registered in which ciprofloxacin is present in HCl form. The firm has also provided labeling and outer packaging of Novidate (product of Sami pharmaceuticals, Karachi) which confirms the stance of the firm.

154. M/s Schazoo Pharmaceuticals Laboraories Pvt. Ltd. Kaolawala Stop, 20, KM Jaranwala Road, District Shehikhupura.

1.Cavrex 2.Tablet 3.Each film coated tablet contains: Entecavir as monohydrate (M.S)……1 mg 4.Anti viral.

1.Form5 2.Routine 3.Rs.15,000/30’s 4.24-09-2010 Rs.8000/- (Original) 28-05-2013 Rs.12,000/- (Original)

Tacavair of M/s Consolidated chemical Lab.

FDA: Baraclude Me too status confirmed

Approved.

155. -do- 1.Ceretek 2.Injection 3.Each 1ml contains: Haloperidol as lactate…5mg 4.Anti Psychotic

1.Form5 2.Routine 3.Rs.300/(2x5) 1ml Ampoule 4.24-09-2010 Rs.8000/- (Original) 28-05-2013 Rs.12,000/- (Original)

FDA: Generic (Sagent Pharms) Me too status confirmed

Deferred for confirmation of installation and operational qualification of TOC analyser & Liquid Particle Counter by area FID.

156. -do- 1.Ceretek

2.Tablet 3.Each tablet contains: Haloperidol Usp……….20mg 4. Anti Psychotic

1.Form5D 2.Routine 3.Rs.300/3x10’s 4.24-09-2010 Rs.8000/- (Original) 28-05-2013 Rs.12,000/- (Original)

1. It is new drug. 2. Differential fee of Rs. 30,000/- is required to be deposited by the applicant.

FDA: Generic (Sandoz) The firm has been asked for submission of fee. Her responses still awaited.

Deferred for submission of differential fee, assessment of stability studies & opinion by the experts.


Registration – II

157. M/s Genix

Pharma (Pvt.) Ltd; 44, 45-B, Korangi Creek Road,

Karachi

Diphos Dry Suspension Each 5ml contains: Dihydroartemisinin………15mg Piperaquine Phosphate……...…120mg

1.Form5 2.Routine 3. 30 ml Rs. 250/- 60 ml Rs. 500/- 80 ml Rs. 667/- 4.14-09-2010 5.Dy. No.72 Rs.8,000/- Rs.12,000/- 21-05-2013

Me too confirmed Int. avail not confirmed in Stringent DRAs. The firm has submitted reference of Me too as Poart susp. of Neutro pharma (62770)


158. -do- Diphos DS Sachet 30/240mg Each Sachet contains: Dihydroartemisinin (Ph.I)….30mg Piperaquine Phosphate Anhydrous…….….. 240mg

1.Form5 2. Routine 3. per sachet Rs. 45/- 10’s Rs.450/- 16’s Rs. 720/- 4.14-09-2010 5.Dy. No.64 Rs.8,000/- Rs.12,000/- (21-5-2013)

1. Me too status needs confirmation

Int. avail not confirmed in Str DRAs.


159. -do- 1.Diphos 2. Syrup 3.Each 5ml contains: Dihydroartemisinin……..15mg Piperaquin Phosphate ………120mg 4.Anti Malarial

1.Form5-D 2. Routine 3. 30 ml Rs. 250/- 60 ml Rs. 500/- 80 ml Rs. 667/- 4.14-09-2010 Dy. No.73 Rs.8,000/- Rs.12,000/- (21-5-2013)

1. Me too status needs confirmation




160. -do- 1.Diapil 2.Tabs 3.Each film coated tablet contains: Saxagliptin HCl e.q to Saxagliptin……….…5mg 4.Anti Diabetc

1.Form5D 2.Routine 3. Rs. 4500/10’s Rs. 9000/20’s Rs. 13500/30’s 4.14/09/2010 Dy. No. 1684 Rs. 15000/- Rs.12,000/- 21-5-2013

Gliplyza 5mg Tablet, Regn no.076316, M/s Macter int, Karachi

FDA: Onglyza Approved

161. -do- 1.Diapil 2.Tablet 3.Each film coated tablet contains: Saxagliptin HCl e.q to Saxagliptin………..……2.5mg 4. Anti Diabetc

1.Form5D 2.Routine 3. Rs. 2500/10’s Rs. 5000/20’s Rs. 7500/30’s 4.14/09/2010 Dy. No. 1681 Rs. 15000/- Rs.12,000/- 21-5-2013

Gliplyza 2.5mg Tablet, Regn no.076316, M/s Macter int, Karachi.

FDA: Onglyza Approved

162. -do- 1.Diphos DS 2.Tablet 3.Each Tablet contains: Dihydroartemisinin (Ph.I)…….80mg Piperaquine Phosphate (M.S) 640mg 4.Anti Malarial

1.Form-5 D 2.Routine 3. Rs.800/8’s 4.14/09/2010 Dy. No. 67 (Moh) Rs. 8000/- Rs.12,000/- 21-5-2013

Me too status needs confirmation.




163. -do- 1.Diphos DS 2.Suspension 3.Each 5ml contains: Dihydroartemisinin (PhI)….30mg Piperaquine Phosphate Anhydrous………..…240mg 4.Anti Malarial

1.Form-5 2.Routine 3. Rs. 450/10’s Rs. 720/16’s 4.16/09/2010 Dy. No. 69 (Moh) Rs. 8000/- Rs.12,000/- 21-5-2013

Me too status needs confirmation.



164. M/s Noa Hemis Pharmaceuticals,

Plot No. 154, Sector-23, Korangi

Industrial Area, Karachi-74900

Loxicam 4mg Tablet

Each film coated tablet contains:

Lornoxicam …………4 mg

(NSAID)

(Manufacturer’s Spec.s)

Form-5

30-7-2010

Dy.No.1507

Rs.8000/-+Rs. 12000/- (10-05-

13)

Rs.1200/-/10’s

The formulation found to be EMA approved but appeared as not confirmed in the agenda erroneously.

Xefast (Pharmevo)

Good (09-06-2014)

2. Verification of photocopy of fee of Rs. 8000/- is required.

3. International availability in stringent DRA,s not confirmed.

Approved (as found approved by EMA). Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.

165. -do- Loxicam-DS 8mg Tablet


Lornoxicam …………8 mg

Form-5

30-7-2010

Dy.No.1505

Rs.8000/-

+Rs. 12000/-

The formulation found to be EMA approved but appeared as not confirmed in the agenda erroneously.

Xefast (Pharmevo)

Approved (as found approved by EMA). Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of


(NSAID)


(10-05-13)

Rs.2300/-/10’s

Good (09-06-2014)



registration letter.

166. -do- Resipa 1mg Tablet


Risperidone …1 mg

(Antipsychotic)


Form-5

30-7-2010

Dy.No.1500

Rs.8000/-+Rs. 12000/- (14-05-

13)

As per PRC

BNF : Risperdal

(Janssen)

Risperdal

(Janssen)

Good (09-06-2014)





Risperidone…2 mg

(Antipsychotic)


Form-5

30-7-2010

Dy.No.1509

Rs.8000/-+Rs. 12000/- (14-05-

13)

As per PRC

BNF : Risperdal

(Janssen)

Risperdal

(Janssen)

Good (09-06-2014)


Approved Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.



Risperidone ...3 mg

Form-5

30-7-2010

Dy.No.1503

Rs.8000/-+Rs.

BNF : Risperdal

(Janssen)

Risperdal

Approved Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. If confirmed,


(Antipsychotic)


12000/- (14-05-13)

As per PRC

(Janssen)

Good (09-06-2014)


then Chairman, RB will permit issuance of registration letter.

169. -do- Gasiton 50mg Tablet

Each tablet contains:

Itopride Hydrochloride………….50 mg

(Gastroprokinetic)


Form-5

30-7-2010

Dy.No.1508

Rs.8000/-+Rs. 12000/- (10-05-

13)

As per PRC

Not confirmed GANATON

(ABBOTT)

Good (09-06-2014)



3. Formulation is under review by the review committee.


170. -do- Etecav 0.5 mg Tablet


Entecavir (as monohydrate)…………...0.5 mg

(Anti Viral)


Form-5

30-7-2010

Dy.No.1506

Rs.8000/-+Rs. 12000/- (10-05-

13)

As per PRC

BNF : Baraclude (Bristol-Myers Squibb) Centauru S (Ferozsons)

Good (09-06-2014)


2. Amount of active drug is very less (500mcg), may be considered for Product specific

Deferred for product specific inspection by panel comprising of Director DTL Karachi, DDG (E & M) & area FID.


inspection. 171. -do- Proxat 20mg Tablet


Paroxetine (as HCl)…..…20 mg

(Antidepressant, selective serotonin reuptake inhibitor)

(B.P Spec.s)

Form-5

30-7-2010

Dy.No.1504

Rs.8000/-+Rs. 12000/- (10-05-

13)

As per PRC

BNF : Seroxat (GSK)

Seroxat (GSK)

Good (09-06-2014)



172. -do- Muscolex 4mg Capsule

Each capsule contains:

Thiocolchicoside……..4 mg

(Muscle relaxant)


Form-5

30-7-2010

Dy.No.1502

Rs.8000/-+Rs. 12000/- (10-05-

13)

As per PRC

Not confirmed

Muscoril (Searle)

Good (09-06-2014)



3. Formulation is under review by the review committee.


173. -do- Gabagyl 200mg Capsule


Gabapentin……………...200 mg

(Anticonvulsant)

(Manufacturer’s

Form-5

30-7-2010

Dy.No.1510

Rs.8000/-+Rs. 12000/- (10-05-

13)

As per PRC

Gebapentin in 200mg strength Not found in FDA & UK

Gabin of PharmEvo

Good (09-06-2014)

1. Verification of photocopy of fee of Rs. 8000/- is

Deferred for confirmation of approval in reference Stringeny Regulatory Agencies.


Spec.s) required. 2. International

availability in stringent DRA,s not confirmed.

174. -do- Zofen 0.25mg/5ml Syrup

Each 5ml contains:

Pizotifen( as Hydrogen Maleate)…………………………..0.25 mg

(Appetite stimulant)


Form-5

30-7-2010

Dy.No.1501

Rs.8000/-+Rs. 12000/- (10-05-

13)

As per PRC

BNF : Sanomigran (Novartis)

Not confirmed Good (09-06-2014)


2. The firm has applied the formulation as appetite stimulant which is not rational.

Rejected on the grounds that the applicant applied the formulation for wrong pharmacological indication.


2. Veterinary applications

S/N Name of Applicant

Name of Drug(s) / Composition

Price/Pack Size

Shelf Life Date of application receiving.

Decision

175. M/s. Nawan Laboratories (Pvt) Ltd., Karachi.

Pameron Injection

Each ml contains:-

Methampyrone……………100mg

Chlorpheniramine Maleate…..1mg

Caffeine……10mg

(Antipyretic and Analgesic).

Decontrolled 10ml 50ml

100ml

2 years 24-12-2010

Rs.8000 + Rs. 12000 =

Rs.20,000/-

Deferred for confirmation of installation and operational qualification of TOC analyser and Liquid Particla Counter, Me-too status & GMP status of the firm.

176. M/s. Mallard Pharmaceuticals (Pvt) Ltd., Multan.

Shina Gold Drench

Each ml contains:-

Oxyclozanide……….…..62.50mg

Oxfendazole………….…25mg

Cobalt Sulphate…..2mg

Sodium Selenite……0.5mg

(Anthelmentic).

Decontrolled

100ml

250ml

500ml

1000ml

2.5 Liter

2 years 15-12-2010

Rs.8000 + Rs. 12000 =

Rs.20,000/-

Deferred for name change, Me-too & GMP status of the firm.


Shinazan Plus Drench

Each ml contains:-

Oxyclozanide…………...30mg

Levamisole

Decontrolled

100ml

150ml

250ml

500ml

2 years 15-12-2010

Rs.8000 + Rs. 12000 =

Rs.20,000/-



HCI………...15mg

Cobalt Sulphate………....0.75mg

Sodium Selenite……..…..0.35mg

Vitamin K……………....3mg

(Anthelmentic).

1000ml

2.5 Liter


Shina Fax Liquid

Each ml contains:-

Oxfendazole………..22.65mg

Zinc Sulphate………2.6mg

(Anthelmentic).

Decontrolled

100ml

250ml

450ml

500ml

1000ml

2.5 Liter

2 years 15-12-2010

Rs.8000 + Rs. 12000 =

Rs.20,000/-



Shina Zole 12.5% SC Liquid

Each ml contains:-

Albendazole……………..125mg

Sodium Selenite ………..1.67mg

Cobalt Sulphate…………0.50mg

(Anthelmentic).

Decontrolled

30ml

100ml

250ml

500ml

1000ml

2.5 Liter

2 years 15-12-2010

Rs.8000 + Rs. 12000 =

Rs.20,000/-



180. M/s. Sanna Laboratories, Faisalabad.

Sanoxicam Injection

Each ml contains:-

Meloxicam...7.5mg

(Analgesic).

Decontrolled 10ml 30ml 50ml

100ml

2 years 30-12-2010

Rs.8000 + Rs. 12000 =

Rs.20,000/-

Deferred for Me-too & GMP status of the firm.


SCS-Forte Injection

Each ml contains:- Colistin Sulphate……...1 MIU

(Polymyxin Antibiotic).

Decontrolled 50ml

100ml

2 years 30-12-2010

Rs.8000 + Rs. 12000 =

Rs.20,000/-



Sanacol-50 Water Soluble Powder

Each gram contains:-

Colistin Sulphate…….50,00,000 IU

(Polymyxin Antibiotic).

Decontrolled 100gm 300gm 500gm 1 Kg

2 years 30-12-2010

Rs.8000 + Rs. 12000 =

Rs.20,000/-



ECS-150 Oral Liquid

Each 100ml contains:-

Enrofloxacin …………10gm

Colistin Sulphate…50,000,000 IU

(Antibiotic).

Decontrolled 100ml 500ml 1 Liter

2 years 30-12-2010

Rs.8000 + Rs. 12000 =

Rs.20,000/-



Evaluator – I

S. N Name and address of Manufacturer / Applicant





Decision

184. M/s Ray Pharma (Pvt.) Ltd, S-58, S.I.T.E. Extension Hawksbay Road, Karachi

Raylox Tablet

Film Coated Tablet

Each Film Coated Tablet Contains.

Levofloxacin as Hemihydrate ..........750mg

(Quinolone group Antibacterial)

Manufacturers Specifications

Form 5

10’s /Rs.299/-

Dy. No. Not mentioned (Duplicate Dossier) Dossier dated 29-06-2010 Rs.8000/- (17-05-2010) Dy. No. Not mentioned Rs.12,000/- dated 26-09-2013 (Fee challans are duplicate) Total Rs.20,000/-

LEVAQUIN 750mg Film coated tablet US FDA LEFLOX 750mg Getz Inspection report dated 06/05/2014 good level of GMP compliance reported.

Approved.


Rayart DS Tablet

Tablet

Each Tablet Contains.

Form 5

8’s /Rs.264/-

Dy. No. Not mentioned (Duplicate

ARTHEGET 40/240mg tablet Getz Inspection report dated 06/05/2014 good level of

Approved


Artemether ……….40mg Lumefantrine…….240mg

(Anti Malarial)


Dossier) Dossier dated 29-06-2010 Rs.8000/- (17-05-2010) Dy. No. Not mentioned Rs.12,000/- dated 26-09-2013 (Fee challans are duplicate) Total Rs.20,000/-

GMP compliance reported.


Rayart Tablet

Tablet


Artemether ……….80mg Lumefantrine…….480mg

(Anti Malarial)


Form 5

4’s /Rs.220/-

Dy. No. Not mentioned (Duplicate Dossier) Dossier dated 19-07-2010 Rs.8000/- (17-05-2010) Dy. No. Not mentioned Rs.12,000/- dated 26-09-2013 (Fee challans are duplicate) Total Rs.20,000/-

ARTHEGET 80/480mg tablet Getz Inspection report dated 06/05/2014 good level of GMP compliance reported.

Approved.

187. M/s Ray Pharma (Pvt.) Ltd, S-58, S.I.T.E.

Rayaz Tablet Form 5 3’s /Rs.160/- Dy. No. Not

ZITHROMAX 500mg tablets US FDA

Approved.


Extension Hawksbay Road, Karachi

Tablet

Each Film Coated Tablet Contains.

Azithromycin as dihydrate …………………. 500mg

(Macrolide Antibiotic)


mentioned (Duplicate Dossier) Dossier dated 29-06-2010 Rs.8000/- (17-05-2010) Dy. No. Not mentioned Rs.12,000/- dated 26-09-2013 (Fee challans are duplicate) Total Rs.20,000/-

AZOMAX 500mg tablet Novartis Inspection report dated 06/05/2014 good level of GMP compliance reported.

188. M/s Macter International (Pvt.) Ltd. F-216, S.I.T.E., Karachi

Micam

Tablet

Each film coated tablet Contains:-

Lornoxicam …..4mg

(Analgesic and anti-inflammatory)

Form 5

5’s and 10’s/As Per PRC

Dy No 255 R&I dated 23-07-2010 Rs.8000/-

Rs.12,000/- 22-05-2013

VICTRA 4mg tablet Scitech Lornoxicam 4mg f/c tablet EMA Inspection report dated 10-04-2014 considered to be operating at satisfactory level of GMP. Capsule section mentioned in inspection report.

Approved.

189. M/s Bosch Pharmaceutical, 221, Bosch House, Sector 23, Korangi Industrial Area, Karachi.

Falgan 500mg/50ml

Infusion

Each Vial Contains.

Paracetamol ….(B.P) 500mg/50ml

Form 5-D

1,s /Rs.60/-

Dy No.1386/R&I dated 22-07-2010/ Rs.15,000/-

PERFALGAN 10mg/ml (50ml Vial) MHRA Injectable Liquid section granted vide letter No. F. 2-4/91-Lic (Vol-II) (M-196). Routine GMP

1. Copy of cashiers’ cheque amounting to 168,000/- (Rs. 12,000/- each for 14 products, including Falgan 500mg/50ml). However, the cheque or the covering is not endorsed by STO

Deferred for rectification of following shortcomings in the dossier: 1. Copy of cashiers’ cheque amounting to 168,000/- (Rs. 12,000/- each for 14


(Analgesics and Antipyretics)


Copy of cashiers cheque amounting to 168,000/- (Rs. 12,000/- each for 14 products, including Falgan 500mg/50ml). However, the cheque or the covering is not endorsed by STO and is also not the prescribed fee for Form-5D applications.

inspection report dated 12-08-2014 cGMP level rated as good.

and is also not the prescribed fee for Form-5D applications. 2. Pyrogen free distilled water has been mentioned in the master formulation whereas, the reference brand contains WFI for which evidence of TOC analyzer and liquid particle counter is required. However, firm has provided copies of operator’s manual of particle counter only, as evidence. 3. Stability summary at 30 C and 65% RH for only one batch of 3,000/- vials submitted.

products, including Falgan 500mg/50ml). The cheque or the covering is not endorsed by STO and is also not the prescribed fee for Form-5D applications. 2. Pyrogen free distilled water has been mentioned in the master formulation whereas, the reference brand contains WFI for which evidence of TOC analyzer and liquid particle counter is required. However, firm has provided copies of operator’s manual of particle counter only, as evidence. Confirmation from FID is required for the Installational & Operation Qualification


of liquid particle counter & TOC analyzer. 3. Stability summary at 30 C and 65% RH for only one batch of 3,000/- vials submitted. Which is required to be as per WHO guidelines.

190. M/s Pakistan Pharmaceutical Products (Pvt) Ltd. D-122, Sindh Industrial Trading Estate, Karachi

Pioglit 15mg + 2mg Tablet

Tablet


Pioglitazone.. …..…. 15mg

Glimepiride.. …….. 2mg

(Anti-Hyperglycemic)

Form 5

Dy. No. Not mentioned / R&I date not mentioned (Covering letter dated 07/07/2010) Rs.8000/- (19/07/2010) Rs.12,000/- (15/05/2013) fee challans are duplicate Total Rs.20,000/-

14’s / Rs. 10 per tablet

Glibetic 15/2mg ICI Inspection report dated 13-02-2013 and 03-06-2014 considered to be operating at satisfactory level of GMP.

Evidence of approval of same formulation by stringent regulatory authority e.g., FDA, TGA, MHLW, EMA and Health Canada required.



Glitter 4mg Tablet

Tablet


Glimepiride ……..

Form 5

Dy. No Not mentioned / R&I dated not mentioned (Covering letter

Amaryl MHRA Amaryl Sanofi-Aventis Inspection report

Approved.


4mg


dated 20/07/2010) Rs.8000/- (22/07/2010) Rs.12,000/- (15/05/2013) fee challans are duplicate Total Rs.20,000/-

20’s As per PRC

dated 13-02-2013 and 03-06-2014 considered to be operating at satisfactory level of GMP.


Glitter 3mg Tablet

Tablet


Glimepiride …….. 3mg


Form 5

Dy. No. Not mentioned / R&I dated not mentioned (Dossier dated 20/07/2010) Rs.8000/- (22/07/2010) Rs.12,000/- (15/05/2013) fee challans are duplicate Total Rs.20,000/-

20’s / As per PRC

Amaryl MHRA Amaryl Sanofi-Aventis Inspection report dated 13-02-2013 and 03-06-2014 considered to be operating at satisfactory level of GMP.

Approved.


Glitter 2mg Tablet

Tablet



Form 5

Dy. No. Not mentioned / R&I dated not mentioned (Dossier dated 20/07/2010)

Amaryl MHRA Amaryl Sanofi-Aventis Inspection report dated 13-02-2013 and 03-06-2014

Approved.



Rs.8000/- (22/07/2010) Rs.12,000/- (15/05/2013) fee challans are duplicate Total Rs.20,000/-

20’s / As per PRC

considered to be operating at satisfactory level of GMP.


Glitter 1mg Tablet

Tablet




Form 5

Dy. No. Not mentioned / R&I dated not mentioned (Dossier dated 20/07/2010) Rs.8000/- (22/07/2010) Rs.12,000/- (15/05/2013) fee challans are duplicate Total Rs.20,000/-

20’s / As per PRC

Amaryl MHRA Amaryl Sanofi-Aventis Inspection report dated 13-02-2013 and 03-06-2014 considered to be operating at satisfactory level of GMP.

Approved.


6. Routine drug registration applications

Evaluator – II

S.No Name and address of manufacturer / Applicant




Decision

195. M/s Macter International (Pvt) Ltd. F-216, S.I.T.E, Karachi.

Affient 5mg TabletEach film coated tablet contains: Prasugrel HCl eq. to Prasugrel…………….5 mg (Inhibitor of platelet activation and

aggregation) (Manufacturer’s Spec.s)

Form 5

05‐7‐2010(54) Rs.15000/‐ 22‐5‐2013 Rs.5,000/‐

Rs. 8.42/Tab Rs. 118/14’s Rs.236/28’s

BNF: Efient(Lilly) Prasu (Amson) Satisfactory level of GMP compliance. (10-04-14) 1. Verification of

photocopy of differential fee (Rs. 5000/-) paid is required.

2. The Firm had applied on Form 5-D initially but has now submitted Form 5.

3. Approval of section / manufacturing facility of applied drug from licensing section is required. The Firm has submitted GMP insp. Report dated 10-04-14 which



mentions Tablet (General) Section.

196. -do- Affient 10mg TabletEach film coated tablet contains: Prasugrel HCl eq. to Prasugrel…………….10 mg (Inhibitor of platelet activation and

aggregation) (Manufacturer’s Spec.s)

Form 5

05‐7‐2010(46) Rs.15000/‐ 22‐5‐2013 Rs.5,000/‐

Rs. 14/Tab Rs. 96/14’s Rs.392/28’s

BNF: Efient(Lilly) Prasu (Amson) Satisfactory level of GMP compliance. (10-04-14) 1. Verification of

photocopy of differential fee (Rs. 5000/-) paid is required.



197. -do- Tamsyl Tablets Each Tablet contains: Etamsylate (B.P)….250mg (Antifibrinolytic, synthetic antihaemorrhagic and angioprotective) (Manufacturer’s Spec.s)

Form 5

05‐7‐2010(N/A) Rs.15000/‐ 22‐5‐2013 Rs.5,000/‐

Rs. 7.5/Tab Rs. 75/10’s Rs.150/20’s

Not confirmed Not confirmed Satisfactory level of GMP compliance. (10-04-14) 1. Verification of

photocopies of fee (Rs. 15000/- + Rs. 5000/-) paid is required.


3. International availability not confirmed in same strength.

4. Me-too status given as Dicynone of French Pharmaceuticals

Deferred for confirmation of me too status & approval in reference Stringent Regulatory Agencies. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan.


Group (Reg. No. 004229) needs confirmation.

198. -do- Tamsyl Tablets Each Tablet contains: Etamsylate (B.P)….500mg (Antifibrinolytic, synthetic antihaemorrhagic and angioprotective) (Manufacturer’s Spec.s)

Form 5

05‐7‐2010(N/A) Rs.15000/‐ 22‐5‐2013 Rs.5,000/‐

Rs. 15/Tab

Rs. 150/10’s Rs.300/20’s

BNF: Dicynene (Sanofi-Aventis) Cytoplex of M/s AGP Reg. No. 061420 (Me too status appeared in agenda as not confirmed erroneously) Satisfactory level of GMP compliance. (10-04-14) 1. Verification of



Deferred for confirmation of me too status. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan.

199. -do- Valsitan Tablets Each film coated tablet contains: Amlodipine (as besilate)…5mg Valsartan….160mg (Calcium Antagonist) (Manufacturer’s Spec.s)

Form 5

06‐7‐2010(N/A) Rs.8000/‐ 22‐5‐2013 Rs.12,000/‐

AS per PRC

BNF: Exforge (Novartis) Exforge (Novartis) Satisfactory level of GMP compliance. (10-04-14) 1. Verification of



200. -do- Valsitan Plus TabletsEach tablet contains: Amlodipine (as besilate)…10mg Valsartan….160mg (Calcium Antagonist)

Form 5

06‐7‐2010(N/A) Rs.8000/‐ 22‐5‐2013 Rs.12,000/‐

BNF: Exforge (Novartis) Exforge (Novartis)

Approved with change in brand name. Reference wil be sent to B &


(Manufacturer’s Spec.s) AS per PRC

Satisfactory level of GMP compliance. (10-04-14) 1. Verification of


A Division, DRAP for verification of photocopy of fee challan. If confirmed, then Chairman, RB will permit issuance of registration letter.

201. -do- Alozin Tablets Each film coated extended release tablet contains: Ranolazine…1000mg (anti‐ischemic And antianginal) (Manufacturer’s Spec.s)

Form 5

06‐7‐2010(N/A) Rs.8000/‐ 22‐5‐2013 Rs.12,000/‐

AS per PRC

FDA: Ranexa (Gilead) Ranola (Highnoon) Satisfactory level of GMP compliance. (10-04-14) 1. Verification of



202. -do- Tamsyl 2ml InjectionEach 2ml ampoule contains: Etamsylate……….250 mg (Antifibrinolytic synthetic antihaemorrhagic and angioprotective) (Manufacturer’s Spec.s)

Form 5-D

06‐7‐2010(N/A) Rs.15,000/‐ 22‐5‐2013 Rs.5,000/‐

AS per PRC/4’s,

100’s

Not confirmed Cytoplex of M/s AGP Reg. No. 061419 (Me too status appeared in agenda as not confirmed at that time) Satisfactory level of GMP compliance. (10-04-14) 1. Verification of



Deferred for confirmation of followings: 1. Installation and performance qualifications of TOC analyser & Liquid Particle Counter by area FID. 2. Approval in reference Stringent Regulatory Agencies. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan.


3. Approval of section / manufacturing facility of applied drug from licensing section is required. The Firm has submitted GMP insp. Report dated 10-04-14 which mentions Sterile Products (Liquid injections, Opthalmic/Otic drops).

4. International availability not confirmed.

5. Verification of Total Organic Testing Facility is required.

203. M/s. WelMark

Pharmaceuticals Plot # 122, Block-B, Phase-V Industrial Estate Hattar.

Rismek 3mg Tablets Each film coated tablet contains:- Risperidone(USP)….3mg (Antipsychotic) (USP Spec.s)

Form 5

12-07-2010 (17) Rs.8,000/

+Rs. 12000 (09-05-2013)

As Per PRC

BNF. Risperdal (Janssen) Benzisox (Highnoon) No conclusion of inspection report, recommendations of some corrections (24-05-14 routine GMP inspection) The Board considered the above inspection report & satisfied with the same.

Approved.

204. -do- Welfam 40mg Tablets Each tablet contains:- Famotidine (USP)…40mg (H2 receptor Blocker, Antipeptic ulcerate) (USP Spec.s)

Form 5

12-07-2010 (16) Rs.8,000/

+Rs. 12000 (09-05-2013)

BNF: Famotidine (Non-proprietary) Acicon (Barrett Hodgson)

Approved in uncoated Tablets.


As Per PRC/10’s

No conclusion of inspection report, recommendations of some corrections (24-05-14 routine GMP inspection) The Board considered the above inspection report & satisfied with the same. 1. BNF describes the

product as uncoated while the Firm has applied for the film coated formulation.

205. M/s Atco Laboratories Limited B-18, S.I.T.E, Karachi.

Combinol-D Sugar Free Syrup Each 5ml contains:- Dextromethorphan Hydrobromide (B.P)…10mg Ephedrine Hydrochloride (B.P)…7.5mg Chlorphenamine Maleate (B.P)…4mg Terpin Hydrate (USP)… 3.5 mg Ammonium Chloride (B.P)…90mg (Bronchodilator) (Manufacturer’s Spec.s)

Form 5

06-07-2010 Rs.8,000/ (N/A) +Rs. 12000 (22-

05-2013)

Rs. 38/- Per 120ml bottle

Not confirmed Combinol-D Syrup (Atco Laboratories) Good level of GMP (18-06-2014) 1. Verification of


2. Approval of section / manufacturing facility of applied drug from licensing section was asked. The Firm has submitted GMP insp. Report dated 18-06-14 which mentions Oral Liquid (Syrup/Suspension) section Non Antibiotic.

3. International



availability of formulation in SRA’s not confirmed.

4. Formulation contains Ephedrine Hydrochloride, a controlled drug substance.

206. M/s Nenza Pharmaceuticals, 33 A Industrial Estate Hayatabad Peshawar

NenKast 5mg Tablets Each Chewable Tablet contains:- Montulekast Sodium Equivalent to Montelukast(B.P)…5mg (Antiasthmatic) (Manufacturer’s Spec.s)

Form 5

16-07-2010 Rs.8,000/ (80)

+Rs. 12000 (23-05-2013)

As Per SRO/- 14’s

BNF: Singulair (MSD) Montiget (Getz) No conclusion regarding GMP of the Firm, some minor observations at which the management was agreed to rectify. (routine GMP 10-04-2014) The Board considered the above inspection report & satisfied with the same.

Approved.

207. -do- Nenmether DS Tablets Each Tablet contains:- Artemether…40mg Lumefantrine…240mg (Antimalarial) (USP Salmous Spec.s)

Form 5

16-07-2010 Rs.8,000/ (79)

+Rs. 12000 (23-05-2013)

As Per SRO/- 8’s

WHO approved formulation A-Fantrine 40/240 by M/s Atco No conclusion regarding GMP of the Firm, some minor observations at which the management was agreed to rectify. (routine GMP 10-04-2014) The Board considered the above inspection report & satisfied with the same.

Approved.


208. M/s PharmEvo (Private Limited

Plot #A-29, North West

Industrial Zone, Port Qasim,

Karachi-75020

Evorox 1.5g Injection (Powder for reconstitution) Each Vial contains:- Cefuroxime Sodium equivalent to Cefuroxime (USP) …1.5g (Antibiotic) (USP Spec.s)

Form 5 06-07-2010, Rs.

8000/- + Rs. 12,000 (22-05-

2013)

As per PRC

BNF: Zinacef (GSK) Zecef (Bosch) Good, GMP compliance (01-04-14) Provincial Drug Inspector. The firm later on submitted inspection report dated 20.03.2013 conducted by DRAP. The Board considered the above inspection report & satisfied with the same. 1. Verification of

copies of fee challans is required.

2. Evidence of approval of technical staff from licensing section is required. (The firm provided the technical staff approval but missed erroneously in agenda).

3. Firm has submitted inspection report of provincial drug inspector and has informed that they will submitt latest inspection report of FID when inspection report would be received.


209. M/s Maple Pharmaceuticals (Pvt.) Ltd., 147/23, Korangi

Defrinac Plus Tablets Each film coated tablet contains:- Dexibuprofen

Form 5-D 01-07-2010(11)Rs.8,000/-+Rs. 12,000 (25-

Form 5-D

Overall cGMP

Deferred for last reminder for correction in form 5-D


Industrial Area, Karachi.

(M.S)…300mg Pseudoephidrine Hydrochloride(B.P)…60mg (NSAID+Decongestant) (Manufacturer’s Spec.s)

07-2013)+Rs. 30,000/- (01-12-2014) Rs. As per PRC /3×10’s

measures are followed in the Firm (31-03-2014) 1. The Firm had

applied on Form 5, but after evaluation the Firm has deposited differential fee for application on Form 5-D. Form 5-D is incorrect.

2. Verification of fee of Rs. 12000/- is required.

3. Formulation contains controlled drug substance.

alongwith stability studies. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan.

210. -do- Fastofen Tablets Each film coated tablet contains:- Ibuprofen lysinate…342mg (NSAID) (Manufacturer’s Spec.s)

Form-5 05-07-2010(44)Rs.8,000/-+Rs. 12,000 (14-05-2013) Rs. 30,000/- (01-12-2014) Rs. As per PAC /30’s

Form 5-D

Overall cGMP measures are followed in the Firm (31-03-2014) 1. The Firm had

applied on Form 5, but after evaluation the Firm has deposited differential fee for application on Form 5-D. Form 5-D is incorrect.

2. Verification of fee of Rs. 12000/- is required.

Deferred for last reminder for correction in form 5-D alongwith stability studies. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan.

211. M/s Nabiqasim Industries (Pvt) Ltd. 17/24, Korangi Industrial Area, Karachi.

Misocot 50 mg Tablets Each tablet contains:- Diclofenac Sodium (B.P)…50mg Misoprostol…200mcg (NSAIDs) (Manufacturer’s Spec.s)

Form 5 01/07/10(Nil) Rs.8000/-+Rs.12000/- (14/05/13)

BNF: Arthrotec (Pharmacia) Arthrotec (Pfizer) Good GMP compliance (18-12-13)

Deferred for Product specific inspection by panel comprising of Director DTL, Karachi, DDG


As per PRC /10’s,20’s

1. Verification of

photocopies of fee submitted is required.

2. Other strength of the product Misocot 75 mg Tablets has already been deferred for Product specific inspection by panel comprising of Director DTL, DDG (E&M) and area FID

(E&M) and area FID. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan.

Evaluator – II

Applications checked by Evaluator IV (human)





Decision

212. M/s Pfizer Pakistan Limited. B-2, S.I.T.E., Karachi

Zetamax Tablet Each film coated tablet contains Azithromycin Dihydrate eq to Azithromycin USP ……….500mg Antibiotic

Form 5 23-07-2010 Dy. No. 264 Rs. 8000 + 12000 Rs 340/ 6’s

International: BNF: Azithromycin (Non-proprietary) Local: Azitor of Macter Int Pvt Limited Karachi According to

Approved.


Finished product specifications are USP

inspection report dated 16-05-2012, factory premises and manufacturing operations were found in line and good with GMP compliance standards at time of inspection. Latest inspection report is required. The firm later on submitted inspection report dated 09.09.2014 conducted by DRAP. The Board considered the above inspection report & satisfied with the same. According to BNF Azithromycin has been approved in UK as Azithromycin monohydrate hemi-ethanolate in Tablet dosage form.

213. -do- Zetamax Tablet Each film coated tablet contains Azithromycin Dihydrate eq to Azithromycin USP ……….250mg Antibiotic Finished product specifications are USP

Form 5 05-07-2010 Dy. No. 37 Rs. 8000 + 12000 Rs 240/ 6’s

International: BNF: Azithromycin (Non-proprietary) Local: Azitor of Macter Int Pvt Limited Karachi According to inspection report dated 16-05-2012, factory premises and manufacturing operations were found in line and good with GMP compliance standards at time of inspection. Latest inspection report is required. The firm later on submitted inspection

Approved.


report dated 09.09.2014 conducted by DRAP. The Board considered the above inspection report & satisfied with the same. According to BNF Azithromycin has been approved in UK as Azithromycin monohydrate hemi-ethanolate in Tablet dosage form.

214. M/s Genome Pharmaceuticals (Pvt) Limited., Plot No. 16/I- Phase IV, Industrial Estate, Hattar

Ovulin Tablet Each tablet contains Clomiphene Citrate USP …… 50mg Anti estrogen Finished product specifications are USP

Form 5 17-08-2010 Rs 20,000/- As per PRC

BNF: Clomid (Sanofi-Aventis) Ovi-F (Merck) Grant of GMP for Export recommended (27-12-13)


215. M/s Rotexmedica Pakistan (Pvt) Ltd., Plot no 206 & 207, Industrial triangle, Kahuta Road, Islamabad

Texpami Capsule Each capsule contains Pamidronate as disodium USP ………..100 mg (bone Resorption Inhibitor)

Finished product specifications are Manufacturer

Form 5 19-05-2010 Rs 8000 + 12000 10’s as per SRO

Not confirmed Aminomux Cap 100mg by M/s Seignior A compliance report was asked to be submitted for follow up inspection. (13-02-14) Firm has not given international availability. It is required as it is part of Form 5. Firm has replied reference of argentina. Latest satisfactory GMP inspection report is required. A

Deferred for confirmation of approval in reference Stringent Regulatory Agencies & latest GMP report.


compliance report was asked to be submitted for follow up inspection. (13-02-14)

216. M/s Macter International (Pvt.) Limited. F-216, S.I.T.E., Karachi.

Zincasa Syrup 10 mg/ 5 ml Each 5 ml contains Zinc Sulphate Monohydrate USP eq to elemental Zinc……10 mg Antidiarrheal Finished Product Specifications are Manufacturer

Form 5 20-08-2010 Dy. No. 151 Rs. 8000 + 12000 As per PRC

Me too Zegen Syrup 10 mg/5ml by Genera International available in India, China, Bangladesh According to inspection report dated 10-04-2014, firm was considered to be operating at satisfactory level of compliance with GMP guidelines. International availability in SRA’s not confirmed. USP mentions the formulation as Oral Solution with pH of 2.5to 4.5 while Manuf. Spec.s for this formulation has pH of 5 to 6.

Approved with USP specification (as formulation is WHO recommended).


Mclevo Infusion 250mg

Each 100 ml contains

Levofloxacin USP 250 mg

Broad Spectrum Antibacterial Agent

Finished Product Specifications are Manufacturer

Form 5

21-07-2010

Dy. No. 1371

Rs. 8000 + 12000

Rs 500

FDA has not approved strength of 2.5mg/ml. FDA approved 5ml/ml with Dextrose5%.

Firm has not submitted undertaking

(The firm had submitted the above undertaking but was erroneously missed in the agenda)

According to

Deferred for approval in reference Stringent Regulatory Agencies in same strength & volume along with confirmation of installation and operational qualifications of TOC analyser & Liquid Particle Counter by area FID.


inspection report dated 10-04-2014, firm was considered to be operating at satisfactory level of compliance with GMP guidelines.

International: FDA has not approved 2.5 mg/ml

Local: Bexus Inf 250mg/100ml by M/s Shaigan



Each 50 ml contains

Levofloxacin 250 mg



Form 5

21-07-2010

Dy. No. 1371

Rs. 8000 + 12000

Rs 400/ 50 ml



According to inspection report dated 10-04-2014, firm was considered to be operating at satisfactory level of compliance with GMP guidelines.

International: Levaquine 250mg/50 ml (FDA)

Local: Xeflox Inf 250mg/50ml by M/s Helix

Deferred for confirmation of installation and operational qualifications of TOC analyser & Liquid Particle Counter by area FID.

219. M/s Macter International (Pvt.) Limited. F-


Each 100 ml contains

Form 5

21-07-2010


Deferred for approval in reference Stringent


216, S.I.T.E., Karachi.

Levofloxacin 750 mg



Dy. No. 1371

Rs. 8000 + 12000

Rs 800/ 100 ml



International: FDA has not approved 7.5 mg/ml

Local: Bexus Inf 750mg/100ml by M/s Shaigan

Regulatory Agencies in same strength & volume along with confirmation of installation and operational qualification of TOC analyser & Liquid Particle Counter by area FID.



Each 20 ml contains

Levofloxacin 500 mg



Form 5

21-07-2010

Dy. No. 1373

Rs. 8000 + 12000

Rs 500/ 20 ml




International: Levaquine 500mg/20 ml (FDA)

Deferred for verification of me too status along with confirmation of installation and operational qualification of TOC analyser & Liquid Particle Counter by area FID.


Local: Me too status needs confirmation

221. M/s Macter International (Pvt.) Limited.

F-216, S.I.T.E., Karachi.

Kirin Tablet

Each film coated tablet contains

Aliskirin hemifumarate MS……150 mg

Hydrochlorothiazide USP …..12.5 mg

Non peptide, direct rennin inhibitor


Form 5

30-08-2010

Dy. No. 191

Rs. 8000

As per PRC

1 × 14’s

Me too Co-Kiren Tablet by Tabros Pharma

International Tekturna HCT tablet (USA)


Firm has not submitted undertaking.


Approved.



Mimin Tablet 200 mg


Rifaximin……..200 mg

Non systemic Antibiotic


Form 5

30-08-2010

Dy. No. 196

Rs. 8000

As per PRC

1 × 10’s

Me too Xerifax Tablet 200 mg

International Xifaxan Tablet 200 mg (FDA)

According to inspection report dated 10-04-2014, firm was considered to be operating at satisfactory level of compliance with

Approved.


GMP guidelines.





Mirin Capsule 50 mg

Each capsule contains

Diacerein MS …..50 mg

Antirheumatics/ Pain Management


Form 5

30-08-2010

Dy. No. 198

Rs. 8000 + 12000

As per PRC

Me too Diora Capsule 50 mg by Getz

International Diacerein Capsule 50 mg available in India. EMA approved Diacerein for rare disease (epidermolysis bullosa).




Firm has given assay limit for finished



product as 288-368 mg/capsule.

Firm has given assay for tablets while applied product is capsule.

The firm has submitted the correct assay method with correct limits.



Micam Injection 8 mg

Each vial contains

Lornoxicam…….8 mg

Analgesic & Anti inflammatory

Finished Product Specifications are

Form 5

30-08-2010

Dy. No. 200

Rs. 8000 + 12000

As per PRC

Firm has not provided reference of specifications of finished product.

The firm submitted Finished Product Specification as Manufacturer’s specifications

Firm has written Glenmark as reference to specifications of active raw material for description, identification, solubility and Aydin/ Turkey for assay of active raw material.

QC tests for injections have not been provided.

Me too Xefast tablet 8 mg by PharmEvo

International Xefo powder for injection 8

Deferred for confirmation of installation and operational qualification of TOC analyser & Liquid Particle Counter by area FID.


mg (EMA)

225. -do- Zincasa DS Syrup 20 mg/ 5 ml Each 5 ml contains Zinc Sulphate Monohydrate USP eq to elemental Zinc……20 mg Antidiarrheal Finished Product Specifications are Manufacturer

Form 5 20-08-2010 Dy. No. 151 Rs. 8000 + 12000 As per PRC

Me too Zegen Syrup 10 mg/5ml by Genera International available in India, China, Bangladesh According to inspection report dated 10-04-2014, firm was considered to be operating at satisfactory level of compliance with GMP guidelines. International availability in SRA’s not confirmed. USP mentions the formulation as Oral Solution with pH of 2.5to 4.5 while Manuf. Spec.s for this formulation has pH of 5 to 6.

Approved with USP specification as formulation is WHO recommended.

226. M/s Pharmatec Pakistan (Pvt.) Ltd.

D- 86/A., S.I.T.E., Karachi.

Alptec 0.25mg Tablet

Each tablet contains

Alprazolam USP ….0.25mg

Anxiolytic


Form 5

31-05-2013

Rs 60,000/-

3 × 10

International: Alprazolam 0.25mg (FDA)

Me too: Alloram 0.25 mg by M/s Global

According to inspection report dated 23-10- 2013, firm was considered to be operating at good level of compliance with GMP guidelines.

Deferred for confirmation of segregated manufacturing facility for Narcotic Drugs and Psychotropic substances.

227. M/s Benson Pharmaceuticals. Plot No 119, street No 8, I-10/3, Industrial area Islamabad.

Moxi Tablet Each film coated tablet contains Moxifloxacin (as hydrochloride) (USP...400mg


BNF: Avelox (Bayer) Local: Morax tab 400mg by M/s Global Firm is operating at

Deferred for provision of assay method of Finished Product.


(Fluroquinolone) (Manufacturer’s Spec.s)

satisfactory level of GMP compliance (15-04-14) Assay method had not been given in Finished Product specifications.

228. -do-

Piclo Tablet Each film coated tablet contains Piroxicam (as beta cyclodextrin)……………20 mg (NSAID) (Manufacturer’s Spec.s)


BNF: Brexidol(Chiesi) Local: Brexidol cap 20mg by M/s Genome Firm is operating at satisfactory level of GMP compliance (15-04-14) Originator’s formulation is uncoated while the Firm has applied Film coated formulation. Firm has not given active raw material specifications. Finished product specifications are incomplete and without reference. Assay, identification, dissolution methods have not been provided.

Deferred for correction in coating & speficication of active material & finished product.

229. M/s WnsFeild Pharmaceuticals Plot no. 122, Block B, Phase V, Industrial Estate, Hattar

Venlax tablet 37.5 mg Each extended release film coated tablet contains Venlafaxine (as HCl) ……..37.5 mg (Anti depressant) (B.P Spec.s)

Form 5 04-08-2010 Rs 20,000/- Pack of 20’s As fixed by Govt

BNF: Venlafaxine (Non-proprietary) Local: Zaxine (Araf Pharma) Grant of GMP Certificate for Export recommended (04-09-14)


230. -do- Venlax tablet 75mg Form 5 BNF: Venlafaxine Approved with


Each extended release film coated tablet contains Venlafaxine (as HCl) ……..75 mg (Anti depressant) (B.P Spec.s)

04-08-2010 Rs 20,000/- Pack of 2 × 7’s As fixed by Govt

(Non-proprietary) Local: Zaxine (Araf Pharma) Grant of GMP Certificate for Export recommended (04-09-14)

change in brand name.

231. -do- Venlax tablet Each film coated tablet contains Venlafaxine (as HCl) (USP)……..50 mg (Anti depressant) (BP Spec.s)

Form 5 04-08-2010 Rs 20,000/- Pack of 20’s As fixed by Govt

FDA: Venlafaxine (as HCl) by Teva Amfax (Amson) Grant of GMP Certificate for Export recommended (04-09-14)


232. -do- Artidoxin DS co-blister Tablet (i) 3Tablets of which Each coblister tablet contains Sulphadoxin USP …….. 500mg Pyrimethamine USP ……..25mg (USP Spec.s) (ii) 6Tablets of which Each tablet contains Artisunate……100mg (Antimalarial) Finished product specifications are (Manufacturer’s Spec.s)

Form 5 04-08-2010 Rs 20,000/- 2 × 10’s tab As fixed by Govt

International: Not confirmed. (Formulation is found WHO approved) Local:Fansi Plus (Wilshire) Grant of GMP Certificate for Export recommended (04-09-14) International availability in SRA’s not confirmed. Firm has provided reference from China. For verification of Facility (Co-blister Machine etc) Firm has submitted that they possesses the Chinese made blister machine which has the capability of blistering different size of tablets together I to one

Deferred for confirmation of co-blister facility by area FID.


blister. The machie is convertible from Alu Alu to Alu PVC and vice versa. The have given undertaking that they will procure the specific dye for the purpose if the product is registered.

233. -do- Artidoxin co-blister Tablet (i) 3Tablets of which Each coblister tablet contains Sulphadoxin USP …….. 500mg Pyrimethamine USP ……..25mg (USP Spec.s) (ii) 6Tablets of which Each tablet contains Artisunate……50mg (Antimalarial) Finished product specifications are(Manufacturer’s Spec.s)


International: Not confirmed. Local: Arteka of Hemis Grant of GMP Certificate for Export recommended (04-09-14) International availability in SRA’s not confirmed. Firm has provided reference from China. Me-too status needs confirmation. (Arteka of Hemis), Pricing of formulation has been fixed in 19th PRC. For verification of Facility (Co-blister Machine etc) Firm has submitted that they possesses the Chinese made blister machine which has the capability of blistering different size of tablets together I to one blister. The machie is convertible from Alu Alu to Alu PVC and vice versa. The have given undertaking that they will procure the specific dye for the purpose if the product is registered.

Deferred for confirmation WHO recommended formulation / Pack & verification of co-blister facility by area FID.


234. -do- Winprid Tablet Each film coated tablet contains:- Itopride HCl…..50mg Gastroprokinetic (Manufacturer’s Spec.s)


International: Ganaton Local:Ganaton (Abbot) Grant of GMP Certificate for Export recommended (04-09-14) Formulation is under review by the review committee.


235. M/s Qintar Pharmaceuticals, 14-A P.S.I.E., Lahore road, Sargodha

HEMA Chewable (Sugar Free) Tablets Each chewable tablet contains Mecobalamin (J.P)…500 mcg (Co enzyme type vitamin B12) (Manufacturer’s Spec.s)

Form 5 27-03-2010 Rs 8000 + 12000 Rs 178 for 20’s Rs 267 for 30’s Rs 890 for 100’s

International: Not confirmed Local: Hicobal 500mcg by M/s Himont Renewal of DML recommended (08-10-12) International availability not confirmed in SRAs. Firm has given reference of international availability from India. Formulation given is not of chewable Tablets Latest inspection report is required.

Deferred for confirmation of approval of same dosage form in reference Stringent Regulatory Agencies and clarification of formulation as not given for applied chewable dosage form and submission of latest GMP inspection report.

236. -do-

Gexin Tablets Each film coated tablet contains:- Gemifloxacin as mesylate………… 320 mg (Fluroquinolone) (Manufacturer’s Spec.s)

Form 5 27-03-2010 Rs 8000 + 12000 Rs 625 for 7’s

International: FDA Factive Local: Actigem tab 320mg by M/s Ferozsons Renewal of DML recommended (08-10-12) Latest inspection report is required.

Deferred for submission of latest GMP inspection report.

237. -do- Smart XR Tablets Form 5 International:ALLEGRA- Deferred for


Each film coated XR tablet contains Fexofenadine HCL (USP) as immediate Layer…..60 mg Pseudoephedrine HCL (USP) as extended release….. 120 mg (Histamine H1 receptor antagonist & adrenergic vasoconstrictor) Finished product specifications are USP

27-03-2010 Rs 8000 + 12000 Rs 120 for 10’s

D 12 HOUR ALLERGY AND CONGESTION (Sanofi) Local: Fexet D by M/s Getz Renewal of DML recommended (08-10-12) Formulations is specialized dosage form, Product specific inspection may be carried out for the product for verification of facility etc. Confirmation of section is required. Latest inspection report is required.

submission of latest GMP inspection report & product specific inspection by panel comprising of DDG, Lahore and area FID for verification of manufacturing & testing facilities of the applied formulation.

238. -do-

Rovax Tablet Each film coated tablet contains Rosuvastatin Calcium eq to Rosuvastatin….. ……..5mg (Hypolipidaemics) (Manufacturer’s Spec.s)

Form 5 27-03-2010 Rs 8000 + 12000 Rs 100 for 10’s

BNF: Crestor (AstraZeneca) Local: Rast 5mg by M/s Tabros Renewal of DML recommended (08-10-12) Latest inspection report is required.


239. -do-

Rovax Tablet Each film coated tablet contains Rosuvastatin Calcium eq to Rosuvastatin….. ……..10mg (Hypolipidaemics) (Manufacturer’s Spec.s)

Form 5 27-03-2010 Rs 8000 + 12000 Rs 180 for 10’s

BNF: Crestor (AstraZeneca) Local: Rast 5mg by M/s Tabros Renewal of DML recommended (08-10-12) Latest inspection report is required.


240. M/s Nenza Pharmaceuticals,

Flotin Tablet 20 mg Each tablet contains

Form 5 15-07-2010

Me too Floxac tablet 20 mg by Schazo

Approved.


Plot No. 33 A, Phase- V, Industrial Estate, Hayatabad, Peshawar.

Fluoxetin HCl USP eq to Fluoxetin…. 20 mg (Antidepressant) Finished product specifications are USP

8000 + 12000 As fixed by govt 1 × 10 pack

International Selfemra tablet 20 mg (FDA) No conclusion regarding GMP of the Firm, some minor observations at which the management was agreed to rectify. (Routine GMP 10-04-2014). The Board considered the above inspection report & satisfied with the same.

241. M/s Genix Pharma (Pvt.) Ltd. 44, 45- B, Korangi Creek Road, Karachi.

Triptan Tablet Each film coated tablet contains Frovatriptan (as Succinate monohydrate)….. …2.5 mg Anti migraine Finished product specifications are Manufacturer.

Form 5 D 10-08-2010(52) Rs 15000/-+ Rs. 12000/- (21-05-13)+Rs. 23000/- 21-11-2014 Rs. 200 per tablet Pack of 10’s for Rs 2000/-

International:Frova Tablet 2.5 mg (FDA) Local: Form 5-D Good GMP (30-04-2014) Verification of copy of Rs.12000/- fee challan is required. No authentic reference to clinical use & doses given in clinical part of dossier Stability studies conducted under Zone IV A conditions as per ICH/ WHO guidelines, Clinical data/ clinical trials are required. Reference of specifications/testing methods of finished product is required.

Deferred for rectification of following observations in the dossier: 1. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. 2. No authentic reference to clinical use & doses given in clinical part of dossier 3. Stability studies conducted under Zone IV A conditions as per ICH/ WHO guidelines, Clinical data/ clinical trials are required. 4. Reference of specifications/testing methods of finished


product is required.


Eltram Tablet Each film coated tablet contains Eltrambopag (as olamine)….. …50 mg Haematopoietic Finished product specifications are Manufacturer.

Form 5-D 10-08-2010 Rs 15000/-+ Rs. 12000/- (21-05-13) Rs. 200 per tablet Pack of 10’s for Rs 2000/- Pack of 20’s for Rs 4000/-

International: Promacta Tablet 50 mg (FDA) Local: Not confirmed. Good GMP (30-04-2014) Verification of copy of Rs.12000/- fee challan is required. Firm has requested to change Form 5-D to Form 5 as at the time of initial application, the product was new but now it has become me-too. Form 5 is required. Evidence of Me-too status is required.

Deferred for rectification of following observation in the dossier: 1. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. 2. Form 5 is required. 3. Evidence of Me-too status is required.


Eltram Tablet Each film coated tablet contains Eltrambopag (as olamine)….. …25 mg Haematopoietic Finished product specifications are Manufacturer.

Form 5 D 10-08-2010 Rs 15000/-/-+ Rs. 12000/- (21-05-13) Rs. 150 per tablet Pack of 10’s for Rs 1500/- Pack of 20’s for Rs 3000/-

International: Promacta Tablet 50 mg (FDA) Local: Good GMP (30-04-2014) Verification of copy of Rs.12000/- fee challan is required. Firm has requested to change Form 5-D to Form 5 as at the time of initial application, the product was new but now it has become me-too. Form 5 is required. Evidence of Me-too status is required.

Deferred for rectification of following observation in the dossier: 1. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan 2. Form 5 is required. 3. Evidence of Me-too status is required.



Art-M Tablet Each tablet contains Artesunate …….60 mg Pyronaridine Phosphate eq to Pyronaridine…180 mg Anti malarial Finished product specifications are Manufacturer.

Form 5 D 10-08-2010(52) Rs 15000/-+ Rs. 12000/- (21-05-13)+Rs. 23000/- 21-11-2014 Rs. 300 per tablet Pack of 10’s for Rs 3000/- Pack of 20’s for Rs 6000/- Pack of 30’s for Rs 9000/-

International: Local: Form 5-D Good GMP (30-04-2014) Verification of copy of Rs.12000/- fee challan is required. No authentic reference to clinical use & doses given in clinical part of dossier Stability studies conducted under Zone IV A conditions as per ICH/ WHO guidelines, Clinical data/ clinical trials are required. Reference of specifications/testing methods of finished product is required. Evidence of Availability in Stringent SRA’s is required.

Deferred for rectification of following observation in the dossier: 1. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. 2. No authentic reference to clinical use & doses given in clinical part of dossier 3. Stability studies conducted under Zone IV A conditions as per ICH/ WHO guidelines, Clinical data/ clinical trials are required. 4. Reference of specifications/testing methods of finished product is required. 5. Evidence of Availability in Stringent SRA’s is required.

245. M/s Helix Pharma (Pvt) Ltd., Hakimsons House, A/ 56, S.I.T.E., Karachi

Primavera/ Omni Plus/ Ristor/ Omnita Omitag/ OSB Capsule Each capsule contains Omeprazole…..20mg Sodium Bicarbonate …….1100mg (Strength has been corrected as 1100 mg which was typed as 110mg in the agenda copy) Proton Pump Inhibitor &

Form 5 30-08-2010 Dy No 203 Rs 8000+Rs. 12000/- (22-07-13) MRP of 10 capsules as per PRC

International: Zegerid (FDA) Local: Rapid (global) Satisfactory GMP compliance (11-08-14) Verification of copy of Rs.12000/- fee challan is required.



Antacid (Manufacturer’s Spec.s)

246. M/s AGP (Private) Limited. B-23, S.I.T.E., Karachi

Maxna Injection Each ml contains Tranexamic acid BP ……….100mg Anti Fibrinolytic Agent Finished product specifications are BP

Form 5 30-08-2010 Rs. 8000 + 12000 As fixed by DPC 5 × 10 ml ampoules

International: Local: Satisfactory GMP compliance (26-11-13) Verification of copy of fee challans is required. Verification of TOC analyzer & liquid particle counter is required. Confirmation of Me too status in 1g/10ml is required. Letter of approval of injection section is required. Inspection report dated 26-09-2012 mentions Injectable (Antibiotic, Analgesic, Spasmolytics etc) Section.

Deferred for rectification of following observations in the dossier: 1. Reference will be sent to B & A Division, DRAP for verification of photocopy of fee challan. 2. confirmation of installation and operational qualification for TOC analyzer & liquid particle counter by area FID. 3. Confirmation of Me too status in 1g/10ml is required. 4. Letter of approval of injection section is required.

247. M/s Bloom pharmaceuticals (Pvt) Ltd. Phase I & II Industrial Estate, Hattar

Surfen Plus Tablet Each film coated tablet Contains: Hyoscine N Butylbromide BP………… 10 mg Paracetamol BP…… 500mg Anticholinergic & Analgesic (B.P Spec.s)

Form 5 05-08-2010 Rs 20,000/- 10 × 10’s tab As per SRO

International: Local: Buscopan Plus Tablets NO conclusion , routine GMP inspection , Shortcomings have been improved (25-07-14) International availability has not been written. It is required as it is part of Form 5. Reference to finished product specifications has been given as B.P

Deferred for rectification of following observations in the dossier: 1. International availability (in Stringent Regulatory Agencies) required as part of Form 5. 2. Reference to finished product specifications has been given as B.P while the formulation is not included in B.P. 3. Undertaking on desired format has


while the formulation is not included in B.P. Undertaking on desired format has not been submitted.

not been submitted.

248. M/s Bloom Pharmaceuticals (Pvt) Ltd. Phase I & II Industrial Estate, Hattar

Amalar Suspension Each 5 ml contains Artemether…..15mg Lumefantrine…..90mg Antimalarial Finished product specifications are Manufacturer.

Form 5 05-08-2010 Rs 20,000/- As per SRO 30 ml & 60 ml

International: Local: Buscopan Plus Tablets NO conclusion , routine GMP inspection , Shortcomings have been improved (25-07-14) Firm has written that “we will surrender our already registered product Benol Capsule Reg No. 022525 in case of fast track registration of our this product Amalar Suspension.” No clarification has been given in reply. International availability has not been written. It is required as it is part of Form 5. Active raw material specifications have been given as B.P while these are not included in B.P. Undertaking on desired format has not been submitted.

Deferred for rectification of following observations in the dossier: 1. International availability has not been submitted. 2. Active raw material specifications have been given as B.P while these are not included in B.P. 3. Undertaking on desired format has not been submitted.

249. Rogen Pharmaceuticals.

Plot No. 30, St No. S-4

National Industrial

Olirag 10 mg Tablet


Olanzapine 10 mg

Form 5

19-07-2010

20,000

As per SRO

International: Olanzapine 52 mg (FDA)

Me too: Amprex tablet 5 mg by

Approved.


Zone (RCCI), Rawat, Islamabad.

(Tranquilizers, Sedative, Hypnotics)

USP Specifications

for 10’s Amarant

The firm has rectified the short-comings conveyed to him.



National Industrial Zone (RCCI), Rawat, Islamabad.

Olirag 5 mg Tablet


Olanzapine 5 mg

(Tranquilizers, Sedative, Hypnotics)

USP Specifications

Form 5

19-07-2010

20,000

As per SRO for 10’s

International: Olanzapine 5 mg (FDA)

Me too: Amprex tablet 5 mg by Amarant

Approved.




Rocep 250 mg Capsule


Ciprofloxacin HCL USP 250 mg

(Quinolone)


Form 5

19-07-2010

20,000


International: Not approved by reference DRAs

Local: Ciprocin cap 250mg by M/s Miracle

Deferred for review of formualation by Review Committee.




Rocep 500 mg Capsule


Ciprofloxacin HCL 500 mg

(Quinolone)


Form 5

19-07-2010

20,000



Local: Ciprocin cap 250mg by M/s Miracle



Plot No. 30, St

Sulrog Tablet 25 mg


Levosulpride 25 mg

Form 5

19-07-2010

20,000


Local: levopraid



No. S-4


(Antidepressant/ Gastroprokinetic)



tablet 25mg by M/s Pacific




Sulrog Tablet 50 mg


Levosulpride 50 mg


Finished product specifications are Manufacturer.

Form 5

19-07-2010

20,000



Local: levopraid tablet 50mg by M/s Pacific





Sulrog Tablet 100 mg


Levosulpride 100 mg



Form 5

19-07-2010

20,000








Mecrogen 500 mcg Tablet


Macobalamin……..500 mcg

Vitamin B12


Form 5

19-07-2010

20,000


International: Methycobal tablet (Japan)


Approved with sugar coating.


Evaluator – II

Applications of impot checked by Evaluator – IV





Decision

257. M/s. Novartis Pharma (Pvt) Ltd, Karachi. / Product License Holder:- M/s. Novartis Pharma Schweiz Ltd Monbijoustrasse Bern, Switzerland. Manufacturing Site:- M/s. Novartis Pharma SAS, rue la Chapelle, Huningue, France.

Sebivo Oral Solution 20mg/ml Each ml of oral solution contains: - Telbivudine…………20mg (Hepatitis B)

Form 5-A 11-11-2009 Diary No. 659 Rs.15000/- 12-02-2014 Rs.35000/- Total Rs.50,000/- Demanded Price/Pack Size Rs.3915/300ml

FDA: Tyzeka (Novartis) New Application N/A Following objections were raised on the applications: 1. Firm has not provided Studies like process validation, pharmaceutical development studies, validation of analytical methods. 2.Firm has not provided chromatographs for sample and reference of active ingredient, benzoic acid, degradation products in analytical procedures and stability studies. 3.Clinical trial data/ clinical data Firm had objected on these observations and regarding limited time

Approved `(The firm submitted the relevant portion of CTD showing the Process validation, validation of analytical method & chromatograms of sample and standard of : (i) API (ii) Benzoic acid (iii) Degradation products.

The referred CTD mentions same the manufacturing site as applied).


period provided for reply of these objections but now has submitted the reply of these observations. Assessment of reply reveals that the Firm has not submitted the validation reports regarding process and analytical methods in a prescribed manner viz. without contents like specificity, linearity, precision, accuracy, limit of detection, Range , Robustness etc. Further, the Firm has also not submitted the chromatograms of sample and standard of :

(i) API (ii) Benzoic Acid (iii) Degradation

products. 258. Applicant:

M/s. Mehran Dental, Karachi. M No. Al Noor Centre Randle Road, ADJ-ANKLESeriaHospital, Karachi Manufacturer: M/s. Laboratorios Zeyco S.A. DE C.V. CAMINO A SANTA ANA TEPETITLAN NO. 2230 COLONIA SANTA ANA TEPETITLAN 45230 ZAPOPAN JALISCO, Mexico.

FD Injection IV Each 1.8ml ampoule contains: - Lidocaine HCl…36.0mg Epinephrine…0.018mg Local Anesthetic /Adrenergic agonist


Form 5-A 17-02-2009 Diary No.153 Rs.15000/- 18-06-2013 Rs.85000/- Rs.1200 / 1 x 10 cartridge in each blister Total 5 blister in packet Total 50 Pieces of cartridges in Packet

International: Local: Sole agency agreement has been expired. GMP certificate of manufacturer has been expired. Firm has not provided original & legalized Certificate of Pharmaceutical Product with english translation. Firm has not provided long term stability studies under zone IV A conditions are ICH/ WHO guidelines. Chromatograms in analytical methods & stability studies have not been provided along with data. Firm gave reference of USP for finished

Deferred for rectification of following observations in the dossier: 1. Sole agency agreement has been expired. 2. GMP certificate of manufacturer has been expired. 3. Firm has not provided original & legalized Certificate of Pharmaceutical Product with english translation. 4. Firm has not provided long term stability studies under zone IV A conditions are ICH/ WHO guidelines. 5. Chromatograms in


product specifications while given assay method is not as same as given in USP 35. Firm has not provided active raw material specifications. Firm has not provided specifications of primary packaging material (glass vial). Undertaking on desired format has not been submitted.

analytical methods & stability studies have not been provided along with data. 6. Firm gave reference of USP for finished product specifications while given assay method is not as same as given in USP 35. 7. Firm has not provided active raw material specifications. 8. Firm has not provided specifications of primary packaging material (glass vial). 9. Undertaking on desired format has not been submitted.

259. Applicant: M/s. Haroon Brothers, 1/ A, KarimjeeBuilding, Opposite HBL Napier Rd Branch, Near Denso Hall, Karachi.

Manufacturer: M/s. Pharma Stulln GmbH Werksstrasse 3, D-92551 Stulln, Germany.

Mydriaticum Stulln UD Eye Drops Each ml contains: - Tropicamide Ph. Eur. ….…5mg Ophthalmic Preparation / Mydriatic & Cycloplegic

Finished product specifications are

Form 5-A 30-04-2009 Rs.15000 + Rs.85000 = Rs.100000/ Rs.30/ Per Vial (0.4ml), depending on pack size

Reply of the Firm needs further evaluation.

Deferred for evaluation of replies submitted by the firm.

260. Applicant: M/s. Haroon Brothers, 1/ A, KarimjeeBuilding, Opposite HBL Napier Rd Branch, Near Denso Hall, Karachi. Manufacturer: M/s. Penta

Blupan UD Eye Drops Each ml contains: - Sodium Hyaluronate Ph. Eur. …1.5057mg Dexpanthenol (Vitamin B5) USP….20.0000 mg Ophthalmic Preparation

Form 5-A 30-04-2009 Rs.15000 + Rs.85000 = Rs.100000/ Rs.36/ per vial (0.5ml)

Reply of the Firm needs further evaluation.

Deferred for evaluation of replies submitted by the firm.


Arzneimittel GmbH Werksstrasse 3, Germany.

Finished product specifications are

Evaluator – III






Decision

261. M/s Atco Laboratories (Pvt) Limited Karachi.

ADVOCORT Fatty Ointment 0.1% Each gram contains: Methylprednisolone aceponate…….1mg Synthetic corticosteroid Manufacturer

Form-5 Dy. No: 126 dated 14th October 2010 8,000/- Rs. 95/- per 5gm tube Rs. 176/- per 10gm tube Rs. 250/- per 15gm tube

Advantan Fatty Ointment of CSL Limited (TGA Approved) Advantan of Bayer Pakistan Karachi. Inspection of the firm was conducted on 18-06-14 by the area FID and GMP Compliance was found good.

Firm has submitted that they are in process of establishing the steroidal section facility. The firm has also submitted letter regarding approval of proposed layout plan for Ointment (Steroid) and Oral Liquid Section (General).

Deferred for confirmation of manufacturing facility for steroids.


262. -do- ADVOCORT Ointment 0.1% Each gram contains: Methylprednisolone aceponate…….1mg Synthetic corticosteroid Manufacturer

Form-5 Dy. No: 125 dated 14th October 2010 8,000/- Rs. 95/- per 5gm tube Rs. 176/- per 10gm tube Rs. 250/- per 15gm tube

Advantan Ointment of CSL Limited (TGA Approved) Advantan of Bayer Pakistan Karachi

Deferred for confirmation of manufacturing facility for steroids.

263. -do- ADVOCORT Lotion 0.1% Each ml contains: Methylprednisolone aceponate…….1mg Synthetic corticosteroid Manufacturer

Form-5D Dy. No: 127 dated 14th October 2010 15,000/- dated 14-10-10 35000/- dated 05-12-13 Rs. 225/- 30ml Rs. 330/- per 60ml

Advantan Lotion of CSL Limited (TGA Approved) Inspection of the firm was conducted on 18-06-14 by the area FID and GMP Compliance was found good.

a. Stability studies needs to be submitted as per ICH/ WHO guidelines.

b. Clinical trial data is required along with clinical justification.

Deferred for followings: 1. Confirmation of manufacturing facility for steroids. 2. Stability studies as per ICH/ WHO guidelines. 3. Clinical trial data along with clinical justification.


264. M/s Linear Pharma, Rawat Islamabad.

PYRETIC Effervescent Tablets 500mg Each tablet contains: Paracetamol….500mg Analgesic/ Antipyretic Manufacturer

Form-5 06-10-2010 Dy. No.9220 8,000/- 28-02-2014 Dy. No.595 12000/- As per SRO/ Pack of 100’s

Paracetamol effervescent tablet of Accord Health Care UK. Acetosol of Shigan Pharma Islamabad. Inspection of the firm was conducted by the area FID on 13-11-14 and the was complying the GMP

Approved.

265. -do- MEFQUINE Tablets 250mg Each tablet contains: Mefloquine Hydrochloride…..250mg Antimalarial Manufacturer


Lariam Tablet of Roche UK Meflogen of Genome Pharmaceuticals

Approved.

266. -do- PENTO Capsule 40mg Each capsule contains: Pantoprazole sodium 22.5 % pellets equivalent to Pantoprazole…..40mg PPI Manufacturer Source: Vision Pharmaceuticals Islamabad.


Not available in SRA’s Pentoloc of Aeries Pharma

Deferred for review of formulation.


267. M/s Innvotek Pharmaceuticals Islamabad.

LETRO Tablets Each film coated tablet contains: Letrozole……2.5mg Non steroidal aromatase Inhibitor USP

Form-5 Dy. No: 1037/ 20-10-10 20,000/- As per PRC/ Pack of 10’s

Femara of Novartis Femara of Novartis Karachi Inspection of the firm was conducted on 04-07-14 by the area FID and GMP compliance was found satisfactory.


268. -do- MILTEFO Capsules Each capsule contains: Miltefosine…..50mg Antiprotozoal Manufacturer

Form-5 Dy. No: 1036/ 20-10-10 20,000/- As per PRC/ Pack of 8x7’s

Impavido of Knight Theraps (USFDA) Fosin Capsules of Nimral Labs

Approved.

269. M/s Fedro Pharmaceutical Labs. Peshawar

RANIDOL Tablets 150mg Each film coated tablet contains: Ranitidine as hydrochloride……150mg H2 Blocker BP

Form-5 20-09-2010 Dy. No. 1148 20,000/- As per SRO 1x10’s

Ranitidine tablets of Aurobindo Pharma. Zantac of GSK

a. Evidence of approval of section from Drug Licensing division is not submitted.

b. Inspection of the Firm was conducted by the area FID on 23-07-14 and certain shortcomings were found, which are discussed with the management of which they agreed to rectify.

Deferred till rectifications of shortcomings as mentioned in GMP inspection report dated 23.07.2014.


(“drainage line found not cleaned properly in tablet section, three blistering and one stripping machines found kept in one room without segregation and advised to provided partition and AC facilities to control temperature and humidity.”)

270. -do- RANIDOL Tablets 300mg Each film coated tablet contains: Ranitidine as hydrochloride……300mg H2 Blocker BP


Ranitidine tablets of Aurobindo Pharma. Zantac of GSK


271. -do- FEKAST Tablets 4mg Each film coated tablet contains: Montelukast as sodium……4mg Leukotriene Receptor Antagonist Manufacturer


Not found in SRA’s, (applied strength is approved as chewable tablet.) Me too status needs confirmation


272. -do- FEKAST Tablets 5mg Each film coated tablet contains: Montelukast as sodium……5mg Leukotriene Receptor Antagonist

Form-5 20-09-2010 Dy. No. 1146 20,000/- As per

Not found in SRA’s, applied strength is approved as chewable tablet. Me too status needs confirmation



Manufacturer

SRO 2x7’s

273. -do- FEKAST Tablets 10mg Each film coated tablet contains: Montelukast as sodium……10mg Leukotriene Receptor Antagonist Manufacturer


Motelukast of Accord Healthcare Aerokast of Barrett & Hodgson (Pvt) Limited Karachi


274. -do- FINFLEX-S Tablets 50mg Each enteric coated tablet contains: Diclofenac Sodium BP…….50mg Antirehumatic BP


Voltral of Novartis Fastaid of Platinum Pharma Karachi

Master formulation submitted is of film coated tablets however applied product is enteric coated.

Deferred till rectifications of shortcomings as mentioned in GMP inspection report dated 23.07.2014 & rectification of following observation: Master formulation is of film coated tablets while applied product should be enteric coated.

275. -do- FINFLEX-S Tablets 75mg Each enteric coated tablet contains: Diclofenac Sodium BP…….75mg Antirehumatic BP


Diclofenac sodium of Sandoz (USFDA) Fastaid of Platinum Pharma Karachi

Master formulation submitted is of film coated tablets however applied product is enteric coated.

Deferred till rectifications of shortcomings as mentioned in GMP inspection report dated 23.07.2014 & rectification of following observation: Master formulation is of film coated tablets while


applied product should be enteric coated.

276. -do- FEDRACAM-BCD Tablets 20mg Each tablet contains: Piroxicam as Beta Cyclodextrin……20mg NSAID Manufacturer


Brexidol of Chesi (BNF) Brexin of Chiesi Karachi.

Master formulation needs rectification regarding quantity of API.

Deferred till rectifications of shortcomings as mentioned in GMP inspection report dated 23.07.2014 & rectification of following observation: Master formulation needs rectification regarding quantity of API.

277. -do- CERIGEX-L Tablet 5mg Each film coated tablet contains: Levocetirizine as dihydrochloride…..5mg Antihistamine Manufacturer

Form-5 20-09-2010 Dy. No. 1139 20,000/- As per SRO Pack of 10’s

Levocetirizine of Actavis UK Alergocit of Global Pharma Islamabad.

Deferred till rectifications of shortcomings as mentioned in GMP inspection report dated 23.07.2014

278. -do- DI- METHER Tablets Each tablet contains: Artemether ……40mg Lumefantrine….240mg Antimalarial

Form-5 20-09-2010 Dy. No. 1145 20,000/-

WHO recommended Formulation Artem DS of Hilton

Deferred till rectifications of shortcomings as mentioned in GMP inspection


USP (Salmus) As per SRO Pack of 10’s

report dated 23.07.2014

279. M/s Asian Continental (Pvt) Limited, Karachi

FEVEREN 6 Plus Suspension Each 5ml contains: Paracetamol……..250mg Analgesic and Antipyretic USP

Form-5 Dated: 08-10-2010 8,000/- Dated: 31-07-2013 12000/- As per SRO/ Pack of 1’s 90ml bottle

Calpol 6 Plus (BNF) Calpol 6 Plus GSK Karachi Inspection of the firm was conducted on 09-09-14 by the area FID and concluded that the firm is working at acceptable level of GMP compliance.

Approved.

280. -do- ATIZA Syrup 2.5mg/ 5ml Each 5ml contains Levocetirizine dihydrochloride……..2.5mg Antihistamine Manufacturer

Form-5 Dated: 12-10-2010 8,000/- Dated: 31-07-2013 12000/- As per SRO/ Pack of 1’s 90ml bottle

Xyzal Oral Solution (USFDA) T-Day of Novartis Karachi

Approved.

281. -do- FEVEREN Tablet 500mg Each tablet contains: Pracetamol……500mg Analgesic Manufacturer

Form-5 Dy. No: 1916/ 29-10-10 8,000/- As per

Panadol GSK USA Panadol GSK Karachi

Approved.


PRC

282. -do- FEVEREN Extra Tablet 500mg Each tablet contains: Pracetamol……500mg Caffiene…….65mg Analgesic

Form-5 Dy. No: Not provided 8,000/- dated 27-10-10 As per PRC

Panadol Extra GSK USA Panadol Extra GSK Karachi.

Approved.

283. M/s Linear Pharma, Rawat Islamabad

FACAL Tablet Each tablet contains: Alfacalcidol….0.25mg Elemental Calcium…..50mg Vitamin D supplement Manufacturer

Form-5 Dy. No: 9229 dated 06-10-10 20,000/- As per SRO/ Pack of 10’s

Not available in SRA’s Me too status needs confirmation. Inspection of the firm was conducted by the area FID on 13-11-14 and the was complying the GMP


284. -do- ALEND Tablets Each tablet contains: Alendronate as sodium…..10mg Biphosphonates Manufacturer


Alendronic acid of Accord HealthCare UK Alendrate of Global Pharma

Approved.


285. -do- DOMELATE-C Tablet Each tablet contains: Domperidone as meleate….15mg Cinnarizine……25mg Antidopaminergic/ Antihistamine Manufacturer

Form-5 Dy. No: 1148 dated 03-11-10 20,000/- As per SRO/ Pack of 2x10’s

Not available in SRA’s Me too status needs confirmation


286. -do- DIVAL Tablets Each delayed release tablet contains: Divalproex sodium…….500mg Antiepileptic USP


Depakote of Abbive Divarex of Medera Pharma

Approved.

287. -do- DIVAL Tablets Each delayed release tablet contains: Divalproex sodium…….250mg Antiepileptic USP


Depakote of Abbive Divarex of Medera Pharma

Approved.

288. -do- LINQUE Tablets Each film coated tablet contains: Quetiapine Fumarate equivalent to Quetiapine….200mg Hypnotic


Seroquel of AstraZeneca (USFDA) Dequit of Shaheen Pharma

Approved.

289. -do- LINQUE Tablets Each film coated tablet contains: Quetiapine Fumarate

Form-5 Dy. No: 1150 dated 03-11-10

Seroquel of AstraZeneca (USFDA) Dequit of

Approved.


equivalent to Quetiapine….400mg Hypnotic Manufacturer

20,000/- As per SRO/ Pack of 10’s

Shaheen Pharma

290. -do- ALMOVAL Tablets Each film coated tablet contains: Amlodipine as besylate……5mg Valsartan….80mg Antihypertensive Manufacturer


Exforge of Novartis (USFDA) Exforge of Novartis Karachi

Approved.

291. -do- AMEASAID Tablets Each sugar coated tablet contains: Flurbiprofen….100mg Antirheumatic Manufacturer


Froben Tablet of Abbot HealthCare UK Ansaid of Pfizer Karachi

Approved (As sugar coated approved in UK).

292. -do- ALDONATE Tablet Each film coated tablet contains: Methyldopa….250mg Antihypertensive Manufacturer


Aldomet of Aspen UK Aldomet of MSD

Approved.

293. -do- LINESTIN Tablet Each film coated tablet contains: Ebastine……10mg Antihistamine

Form-5 Dy. No: 1149 dated 03-11-10 20,000/- As per SRO/ Pack

Aerius of Dermagen Pharma Islamabad

Approved.


of 10’s

294. -do- L-FENAC Capsule Each capsule contains: Acitretin…..10mg Vitamin A Derivative


Acitretin Capsules of Genus Pharmaceuticals UK Neotigason of Roche Karachi

Approved.

295. -do- TOLFERID Tablet Each film coated tablet contains: Tolterodine tartrate…..2mg Urinary antispasmodic Manufacturer


Detrusitol Tablet of Pfizer UK Detrusitol Tablet of Pfizer Karachi

Approved.

296. -do- OFLOX Tablet Each film coated tablet contains: Ofloxacin……200mg Fluoroquinolone Manufacturer


Terivid of Sanofi UK Treivid of Sanofi Karachi

Approved.


297. -do- CITAL Tablet Each chewable tablet contains: Escitalopram as oxalate……10mg Antidepressant Manufacturer


Not available in SRA’s Me too status needs confirmation

Deferred for approval in reference Stringent Regulatory Agencies & me too status.

298. -do- LEVRINE Tablets Each film coated tablet contains: Alverine Citrate…..60mg Simethicone….300mg Antispasmodic Manufacturer


Not available in SRA’s Me too status needs confirmation.

Deferred for approval in reference Stringent Regulatory Agencies & me too status.

299. -do- TAMSIN Capsule Each capsule contains: Tamsulosin HCL as modified release pellets (0.2%) equivalent to Tamsulosin……0.4mg Alpha-1 Blocker Manufacturer Source: Vision Pharmaceuticals Islamabad


Flomax MR Capsules of Boehringer Inghelheim UK Tamsolin of Getz Karachi

Approved.

300. -do- LINAKSAT Tablets Each film coated tablet contains: Montelukast as sodium……10mg Antihistamine Manufacturer


Singulair of MSD Montiget of Getz Karachi

Approved.


301. -do- GEMNILOX Tablets Each film coated tablet contains: Gemifloxacin as mesylate…..320mg Quinolone Manufacturer


Factive of LG Life Sciences (USFDA) Factiflox of Envoy Pharma

Approved.

302. -do- LINPRIDE Tablets Each tablet contains: Amisulpride…..50mg Antipsycotic Manufacturer


Solian Tablet Solian Tablet of Sanofi Karachi

Approved.

303. -do- DOB-C Capsules Each capsule contains: Calcium dobisilate….500mg Vasotherapeutic


Not available in SRA’s Doxium of AGP Karachi

Deferred for review of formulation by the Review Committee.

304. M/s Caraway Pharmaceuticals, Islamabad.

ONDENLES Injection 8mg Each ml contains: Ondansetron hydrochloride dihydrate equivalent to Ondansetron……2mg 5HT-3 Antagonist USP

Form-5 Dy. No: 9773 dated 18th October 2010 20,000/- As per SRO

Zofran of GSK Zofran of GSK, Karachi The inspection of the firm was conducted on 24-09-12 by the panel of inspectors and they concluded that the firm is operating at good level of GMP

a. Evidence of availability of TOC and liquid particle counter is not provided by the firm.

b. Latest inspection report is required.

Deferred for the followings: 1. Confirmation of installation and operational qualifications of TOC analyser and liquid particle counter by FID. 2. Latest inspection


compliance. report is required.

305. -do- ONDENLES Tablet 8mg Each film coated tablet contains: Ondansetron hydrochloride dihydrate equivalent to Ondansetron……8mg 5HT-3 Antagonist USP

Form-5 Dy. No: 9774 dated 18th October 2010 20,000/- As per SRO

Zofran of GSK Zofran of GSK, Karachi

Latest inspection report is required.

Deferred for latest GMP status of the firm.

306. M/s Genix Pharma (Pvt) Limited, Karachi.

GRANI Tablet Each film coated tablet contains: Granisetron HCL equivalent to Granisetron…….1mg Antiemetic Manufacturer

Form-5 Dy. No: 1899 dated 29-10-10 8,000/- Rs. 3250/- Pack of 10’s Rs. 6500/- Pack of 20’s

Kytril Tablet of Roche Kytril Tablets of Roche Karachi Inspection of the firm was conducted on 30-04-14 by the area FID and GMP compliance is rated as GOOD

Approved.

307. -do- GRANI Syrup Each 5ml contains: Granisetron HCL equivalent to Granisetron…….1mg Antiemetic Manufacturer

Form-5 Dy. No: 1907 dated 29-10-10 8,000/- Rs. 210/- Pack of 30ml Rs. 420/- Pack of 60ml

Kytril Syrup of Roche Graniset Syrup of SJ & G Fazul Elahi Karachi

Approved.


Evaluator – III (Veterinary Cases)






Decision

308. M/s Noble Pharma, Mirpur Azad Kashmir

NOBI-LINCOL Powder Each 1gm contains: Lincomycin Sulphate…..100mg Colistin Sulphate……8,00,000IU Antibacterial Manufacturer

Form-5 Dy. No: 05 dated 02-10-10 20,000/- Decontrolled/ 100gm, 500gm and 1kg

Vety Lincon Powder of Leads Pharma Karachi.

Approved.

309. -do- TRIDOX-TD Oral Powder Each 1000gm contains: Doxycycline HCL……200gm Tylosin Tartrate…..100gm Bromohexine HCL…..5ogm Colistin sulphate…..48MIU

Form-5 Dy. No: 85 dated 08th November 2010 20,000/- Decontrolled/ 100gm, 500gm, and 1Kg

Pulmotin Water Soluble Powder of Attabak Pharma Islmabad.

Approved.


Evaluator – III (Import applications)






Decision

310. Applicant M/s Bajwa Sons, 129 Circular Road, Lohari Lahore Manufacturer Shanghai Transfusion Technology Co. Ltd. Add: No.500 You Dong Road, Minhang, Shanghai, 201100, P.R of China

Famous Brand Single Blood Bags Each 100ml of CPDA (Citrate Phosphate Dextrose Adenine Solution, Anticoagulant) contains: Citric acid monohydrate……0.299g Sodium citrate dihydrate…………2.63g Sodium biphosphate monohydrate……0.222g Dextrose monohydrate……..3.19g Adenine……….0.0275g

Form-5A Dy No: Not provided 15000/- dated 08-10-10 Rs 150/ Blood Bag of 250ml Rs 150/ Blood Bag of 450ml Rs 160/ Blood Bag of 500ml

a. Evidence of Balance fee is not submitted.

b. Stability studies as per Zone-IV-A conditions as per ICH/ WHO guidelines need to be submitted.

c. Original Legalized and valid COPP as per WHO format or original and legalized GMP certificate along with Free sale certificate from regulatory body of country of origin, needs to be submitted.

d. Clinical trial data is not

Deferred for the followings: 1. Evidence of Balance fee is not submitted.

2. Stability studies as per Zone-IV-A conditions as per ICH/ WHO guidelines need to be submitted.

3. Original Legalized and valid COPP as per WHO format or original and legalized GMP certificate along with Free sale certificate from regulatory body of country of origin, needs


Water for Injection….Qs Disposable

submitted. e. Packaging

material specification are not provided

to be submitted. 4. Clinical trial data is not submitted.

5. Packaging material specification has not been provided

311. Applicant M/s Bajwa Sons, 129 Circular Road, Lohari Lahore Manufacturer Shanghai Transfusion Technology Co. Ltd. Add: No.500 You Dong Road, Minhang, Shanghai, 201100, P.R of China

Famous Brand Double Blood Bags Each 100ml of CPDA (Citrate Phosphate Dextrose Adenine Solution, Anticoagulant) contains: Citric acid monohydrate……0.299g Sodium citrate dihydrate…………2.63g Sodium biphosphate monohydrate……0.222g Dextrose monohydrate……..3.19g Adenine……….0.0275g Water for Injection….Qs Disposable

Form-5A Dy No: 29 dated 08-10-10 15000/- dated 08-10-10 Rs 300/ Blood Bag of 450ml Rs 315/ Blood Bag of 500ml


b. Stability studies as per Zone-IV-A conditions as per ICH/ WHO guidelines need to be submitted.


d. Clinical trial data is not submitted.

e. Packaging material specification are not provided


2. Stability studies as per Zone-IV-A conditions as per ICH/ WHO guidelines need to be submitted.

3. Original Legalized and valid COPP as per WHO format or original and legalized GMP certificate along with Free sale certificate from regulatory body of country of origin, needs to be submitted.

4. Clinical trial data is not submitted.


312. Applicant M/s Bajwa Sons, 129 Circular Road, Lohari Lahore Manufacturer

Famous Brand triple Blood Bags Each 100ml of CPD (Citrate Phosphate Dextrose Solution,

Form-5A Dy No: Not provided 15000/- dated 08-10-10


b. Stability studies as per Zone-IV-A conditions as


2. Stability studies as per


Shanghai Transfusion Technology Co. Ltd. Add: No.500 You Dong Road, Minhang, Shanghai, 201100, P.R of China

Anticoagulant) contains: Citric acid monohydrate……0.299g Sodium citrate dihydrate…………2.63g Sodium biphosphate monohydrate……0.222g Dextrose monohydrate……..3.19g Water for Injection….Qs to 100ml Each 100ml of SAGM (Saline Adenine Glucose Mannitol, Red Blood Cell Preservative) contains: Dextrose monohydrate…..0.900g Sodium chloride…..0.877g Adenine…….0.0169g D-Mannitol…….0.525g Water for Injection….qs to 100ml Disposable

Rs 510/ Blood Bag of 450ml Rs 525/ Blood Bag of 500ml

per ICH/ WHO guidelines need to be submitted.




Zone-IV-A conditions as per ICH/ WHO guidelines need to be submitted.




313. Applicant M/s Bajwa Sons, 129 Circular Road, Lohari Lahore Manufacturer Shanghai

Famous Brand Quadruple Double Blood Bags Each 100ml of CPD (Citrate Phosphate Dextrose Solution,

Form-5A Dy No: Not provided 15000/- dated 08-10-10


b. Stability studies as per Zone-IV-A conditions as per ICH/


2. Stability studies as per Zone-IV-A


Transfusion Technology Co. Ltd. Add: No.500 You Dong Road, Minhang, Shanghai, 201100, P.R of China

Anticoagulant) contains: Citric acid monohydrate……0.299g Sodium citrate dihydrate…………2.63g Sodium biphosphate monohydrate……0.222g Dextrose monohydrate……..3.19g Water for Injection….Qs to 100ml Each 100ml of SAGM (Saline Adenine Glucose Mannitol, Red Blood Cell Preservative) contains: Dextrose monohydrate…..0.900g Sodium chloride…..0.877g Adenine…….0.0169g D-Mannitol…….0.525g Water for Injection….qs to 100ml Disposable

Rs 440/ Blood Bag of 450ml Rs 445/ Blood Bag of 500ml

WHO guidelines need to be submitted.




conditions as per ICH/ WHO guidelines need to be submitted.





Case No.07. Remaining drug registration applications of previously approved new sections

Evaluator – I

M/s Stallion Pharmaceuticals (Pvt) Ltd, Lahore have informed that their 04 products were deferred in 244th meeting of Registration Board held on 8th and 9th May, 2014 due to confirmation of manufacturing facility and that they are now under process of developing a dedicated Carbapenem facility and that the

04 deferred products may be considered of their approved manufacturing facility. The firm has requested consideration of the following 04 products on priority basis (according to 10 products per section policy).

S.N

Name and address of Manufacturer / Applicant





Decision

314. M/s. Stallion Pharmaceuticals (Pvt) Ltd, 581- Sunder Industrial Estate, Lahore New License 1.Capsule.(Penicillin) 2.Dry Powder Suspension (Penicillin) 3.Dry Powder Injection (Penicillin)

Vide letter No. F. 1-33/2009 – Lic dated 6th February, 2014

Fluclox Injection 500mg Dry Powder Injection Each vial contains:- Flucloxacillin Sodium (B.P) eq. to Flucloxacillin ……………….. 500mg (Penicillin) BP Specifications

Form-5 27-10-2014 1336 R&I Rs. 20,000/- Pack of one Rs. 90/- Pack of 5 Rs. 450/- Pack of 10 Rs. 900/-

FLOXAPEN Injection 500mg MHRA UK A-FLOX 500mg Injection Laderly N/A (New License)

Approved.

315. -do- Staclox Injection Dry Powder Injection

Form-5 27-10-2014 1337 R&I

AMPICLOX 250/250mg Injection MHRA

Approved.


Each vial contains:- Ampicillin Sodium (B.P) eq. to Ampicillin ……………….. 250mg Cloxacillin Sodium (B.P) eq. to Cloxacillin 250mg (Penicillin) Manufacturers Specifications

Rs. 20,000/- Pack of one Rs. 70/- Pack of 5 Rs. 350/- Pack of 10 Rs. 700/-

AMPICLOX 500mg Injection Gsk N/A (New License)

316. -do- Flustal Injection Dry Powder Injection Each vial contains:- Amoxicillin Sodium (B.P) eq. to Amoxicillin……..….. 250mg Flucloxacillin Sodium (B.P) eq. to Flucloxacillin ………………… 250mg (Penicillin) Manufacturers Specifications

Form-5 27-10-2014 1338 R&I Rs. 20,000/- Pack of one Rs. 144/- Pack of 5 Rs. 720/- Pack of 10 Rs. 1440/-

FLUMOX 250/250mg Inj EIPICO, Egypt Biflocin 500mg Inj Zam Zam Corp N/A (New License)

1) Evidence of approval of same formulation in Egypt has been provided instead of stringent regulatory authority e.g., FDA, TGA, MHLW, EMA and Health Canada.

Deferred for confirmation of approval in reference Stringent Reulatory Agencies.

317. -do- Amoxi Injection 500mg (BP) Dry Powder Injection Each Vial Contains: Amoxicillin Sodium ( BP) eq.

Form-5 25-10-2013 643 R&I Rs. 20,000/- Rs. 90.0 / 1’s,

Amoxil 500 mg Vial MHRA Amoxil 500 mg GSK, Pakistan N/A (New

Approved.


to Amoxicillin …… 500mg (Penicillin) BP Specifications

Rs. 900.0 / 10’s

License)

Evaluator – II

The Registration Board has been granting 10 products per section to newly approved sections. Following are the remaining products of the applicants as per above policy.

S/N

Name and address of manufacturer / Applicant

Brand Name


Composition



Type of Form

Initial date, diary




Me-too status


Decision

318. M/s Rogen Pharmaceuticals

Plot No. 30 Street No. # S-4 National

Industrial Zone Rawat Islamabad.

Semi Solid (Cream/Ointment) General Section

(No. F. 1-27/2009-Lic Dated 19-07-10

)

Efrog 13.9%Cream Each gram contains:- Eflornithine (as eflornithine Hydrochloride …139mg (Enzyme Inhibitor) (Manufacturer’s Spec.s)

Form 5

26/11/2014 Dy. No. 1907 Rs. 20000/-

As per SRO

BNF: Vaniqa (Almirall), but in 11.5% strength Vanika (Crystollite) 13.9 % , Depilus Cream (Atco) in 11.5% strength but no pricing The company may be issued cGMP Certificate for export purpose. (09-06-2014) 1. The product is

available in 11.5 %

Approved in 11.5 % strength.


strength as per BNF. In Pakistan product is available in both 13.9% and 11.5 % strengths but pricing of 11.5 % strength could not be traced. The Firm has submitted master formulation of both strength after evaluation of initial dossier and has requested to grant them registration of any one strength.

319. M/s Faas Pharmaceuticals (Pvt.) Limited F-

784/L S.I.T.E. Karachi

Sachet Section: F. 2-2/2009-Lic

dated 15-02-2013

Antisec Sachet Each Sachet contains:- Racecadotril (B.P)…10mg (Anti-Diarrheal) (Manufacturer’s Spec.s)

Form 5

29/10/2014 Dy. No. 117 Rs. 20000/-

As per SRO/1×10’s

BNF: Hidrasec (Abbott Healthcare) Not confirmed Satisfactory level of GMP compliance(18-03-14) 1. Me-too status needs

confirmation.

Deferred for confirmation of me too status otherwise the firm shall apply on form 5-D with fee & other codal formalities.

320. -do- Antisec Sachet Each Sachet contains:- Racecadotril (B.P)…15mg (Anti-Diarrheal) (Manufacturer’s Spec.s)

Form 5

29/10/2014 Dy. No. 116 Rs. 20000/-


Not confirmed Not confirmed Satisfactory level of GMP compliance(18-03-14) 1. International





321. -do- Antisec Sachet Each Sachet contains:- Racecadotril (B.P)…30mg (Anti-Diarrheal) (Manufacturer’s Spec.s)

Form 5

29/10/2014 Dy. No. 115 Rs. 20000/-


BNF: Hidrasec (Abbott Healthcare) Not confirmed Satisfactory level of GMP compliance(18-03-14) 1. Me-too status needs

confirmation.


322. -do- Uronol Sachet 3G Each Sachet contains:- Fosfomycin (as Tromethamine …3gm (Anti-bacterial) (Manufacturer’s Spec.s)

Form 5

29/10/2014 Dy. No. 114 Rs. 20000/-


Health Canada: Monurol (Triton Pharma Inc.) Not confirmed Satisfactory level of GMP compliance (18-03-14) 1. Me-too status needs

confirmation.


323. -do- Ostrolife Sachet Each Sachet contains:- Cholecalciferol (USP)…60,000IU (Vitamin) (Manufacturer’s Spec.s)

Form 5

29/10/2014 Dy. No. 276 Rs. 20000/-


Not confirmed Not confirmed Satisfactory level of GMP compliance(18-03-14) 1. International




324. -do- Oraltral Sachet (Orange Flavor) Each Sachet contains:- Sodium Chloride…3.5g Sodium Citrate Dihydrate…2.9g Potassium Chloride…1.5 Glucose Anhydrous…20g (Electrolytes) (Manufacturer’s

Form 5

29/10/2014 Dy. No. 271 Rs. 20000/-


Not confirmed Peditral (Searle) Satisfactory level of GMP compliance(18-03-14) 1. International

availability of formulation in SRA’s not confirmed. WHO formulation is sodium chloride 2.6 g,

Approved as the formulation is WHO approved.


Spec.s) potassium chloride 1.5 g, sodium citrate 2.9 g, anhydrous glucose 13.5 g

325. -do- Oraltral Sachet (Lemon and Lime Flavor) Each Sachet contains:- Sodium Chloride…3.5g Sodium Citrate Dihydrate…2.9g Potassium Chloride…1.5 Glucose Anhydrous…20g (Anti-Malarial) (B.P Spec.s)

Form 5

17/09/2014 Dy. No. 274 Rs. 20000/-


Not confirmed Peditral (Searle) Satisfactory level of GMP compliance(18-03-14) 1. International

availability of formulation in SRA’s not confirmed. WHO formulation is sodium chloride 2.6 g, potassium chloride 1.5 g, sodium citrate 2.9 g, anhydrous glucose 13.5 g.

Approved as the formulation is WHO approved.

326. -do- Neomecta Sachet Each Sachet contains:- Dioctahedral Smectite…3000mg (Anti-diarrhioeals) (Manufacturer’s Spec.s)

Form 5

17/09/2014 Dy. No. 275 Rs. 20000/-


Not confirmed Smecta (Atco) Satisfactory level of GMP compliance(18-03-14) 1. International



327. -do- Capsule Section: F. 2-2/2009-Lic

dated 15-02-2013

Itometic Capsule Each capsule contains: Itopride hydrochloride…150mg (as sustained release pellets) (Gastoprokinetic / antiemetic) (Manufacturer’s Spec.s)

Form 5

17/09/2014 Dy. No. 270 Rs. 20000/-


Not confirmed Ganaton OD (Abbott) Satisfactory level of GMP compliance(18-03-14) 1. Formulation is under

review by the Review Committee.

2. Fee for import of pellets, Legalized Copy of Valid GMP

Deferred for review of formulation alongwith the rectification of following observations: 1. Fee for import of pellets, Legalized Copy of Valid GMP certificate of manufacturer of


(Source of Pellets: M/s Titan Laboratories Private Limited Plot No. E27/1, E27/2, MIDC, Mahad Village Jite District, Raigad, Maharashtra, India)

certificate of manufacturer of Pellets; stability studies according to zone of Pakistan of Pellets are required.

Pellets; 2. stability studies according to zone of Pakistan of Pellets are required. .

328. -do- Azobact Capsule 250mg Each capsule contains: Azithromycine (As dihydrate) (USP)..250mg (Anti-Infective) (USP Spec.s)

Form 5

17/09/2014 Dy. No. 266 Rs. 20000/-


BNF : Zithromax (Pfizer) Azomax (Novartis) Satisfactory level of GMP compliance(18-03-14)

Approved.

329. -do- Pirotrin 20mg Capsule Each capsule contains: Piroxicam beta cyclodextrin eq. to Piroxicam……..20 mg (Analgesic / anti-rheumatic/ anti pyretic) (Manufacturer’s Spec.s)

Form 5

17/09/2014 Dy. No. 267 Rs. 20000/-


BNF : Feldene (Pfizer) Pirobet (Highnoon) Satisfactory level of GMP compliance(18-03-14)

Approved.

330. -do- Tamsol 0.4mg Capsule Each capsule contains:- Tamsulosin hydrochloride(as modified release pellets)…….0.4 mg (Anti BPH) (USP Spec.s) {Source: M/s Vision Pharmaceuticals, Plot No 224, Street No.

Form 5

17/09/2014 Dy. No. 268 Rs. 20000/-


BNF: Tamsulosin hydrochloride (Non-proprietary) Tamsolin (Getz) Satisfactory level of GMP compliance (18-03-14) 1. Certificate of

Analysis, stability studies according to zone of Pakistan of Pellets are required.

Approved. Firm will provide Certificate of Analysis and stability studies of pellets according to zone IV A and Chairman, RB will permit issuance of registration letter.


Evaluator – III






Decision

331. M/s Wenovo Pharmaceuticals, Taxila (Dry Powder Vial Injectable)

CLARITHREM Injection Each vial contains: Clarithromycin ….….500mg Macrolide BP

Form-5 Dy No: 864 dated 24-09-2014 20,000/- As fixed by Govt. Pack of 1’s

Klaricid of Abbott UK (Lyophilized Powder) Clariset of Mediate Pharma

Approved.

332. -do- LANSOP Injection 30mg Each vial contains: Lansoprazole……30mg PPI Manufacturer

Form-5 Dy No: 863 dated 24-09-2014 20,000/- As fixed by Govt.

Prevacid of Takeds Pharm (USFDA) Lyophilized Powder Lansit of SJ & G Fazul Elhahi Karachi

Approved.

01, I-10/3 , Industrial area, Islamabad}


Pack of 1’s

333. -do- PANTOWEN Injection Each vial contains: Pantoprazole as sodium…..40mg PPI Manufacturer


Protonix of Wyeth (USFDA) Lyophilized powder

Lesprot of Nabiqasim Karachi

Approved.

334. -do- AZINOV Injection Each vial contains: Azithromycin….500mg Macrolide Manufacturer


Zithromax of Pfizer (USFDA) Lyophilized Powder Azimycin of Medicina Pharma Lahore

Approved.

335. -do- (Capsule General)

WENOLOX Capsule Each capsule contains: Duloxetine as HCL enteric coated pellets (17%) eq. to Duloxetine…..30mg Antidepressant Manufacturer Source: Vision Pharma Islamabad

Form-5 Dy No: 1277 dated 24-10-2014 20,000/- As per policy of MOH 1x10’s

Cymbalta of EliLilly Netherlands Duxafit of Wnsfield Hattar

Approved.


336. -do-

WENOLOX Capsule Each capsule contains: Duloxetine as HCL enteric coated pellets (17%) eq. to Duloxetine…..60mg Antidepressant Manufacturer


Cymbalta of Eli Lilly Netherlands Duxafit of Wnsfield Hattar

Approved.

337. -do- GABANOV Capsules Each capsule contains: Gabapentin…..300mg Anticonvulsant USP


Gabapentin Capsules of Sandoz UK Nerogabin of Merck

Approved.

338. -do- GABANOV Capsules Each capsule contains: Gabapentin…..400mg Anticonvulsant USP


Gabapentin Arrow 400mg Hard Capsules of Actavis UK Nerogabin of Merck

Approved

339. -do- (Liquid Ampoule SVP)

TRAMANOV Injection Each 2ml ampoule contains: Tramadol HCL……100mg Synthetic opiate analogue Manufacturer

Form-5 Dy No: 1273 dated 23-10-2014 20,000/- As per policy of MOH Pack of 5’s & 10’s

Tramdol Injection of Beacon Pharma UK Lamadol of Brooks Karachi

Evidence of availability of TOC analyzer and liquid particle counter is required.

Deferred for confirmation of installation and operational qualifications of TOC analyser & liquid Particle Counter by Area FID.


340. -do- WENOFEN Injection Each 2ml of amber glass ampoule contains: Diclofenac Sodium…..75mg Lidocaine HCl…..20mg Analgesic, Local anesthetic Manufacturer

Form-5 Dy No: 1272 dated 23-10-2014 20,000/- As per policy of MOH Pack of 5’s & 10’s

Availability in SRA’s needs confirmation Dinopen of Global Pharma, Islamabad.

Evidence of availability of TOC analyzer and liquid particle counter is required.

Deferred for confirmation of installation and operational qualifications of TOC analyser & liquid Particle Counter by Area FID.

Evaluator – III (Veterinary applications)





Remarks by the Evaluator

Decision

341. M/s Noble Pharma, Mirpur Azad Kashmir Liquid Injection Section (Veterinary) Approved vide letter No. F.5-2/207 Lic dated: 18-02-13

Nobivec Injection 2% Each ml contains: Ivermectin……..20mg Antiparasitic BP

Form-5 Dy. No: 65 dated 20-07-14 20,000/- Decontrolled/ Pack of 50ml

Elvomec D/S of Elko Karachi Inspection of the firm was conducted by the area FID and firm was found GMP compliant.

Deferred for confirmation of installation and operational qualifications of liquid Particle Counter by Area FID.


342. -do- Nobivec Injection 1% Each ml contains: Ivermectin……..10mg Antiparasitic BP

Form-5 Dy. No: 66 dated 20-07-14 20,000/- Decontrolled/ Pack of 50ml

Actimec Injection of Selmore Pharmaceuticals Lahore.

Deferred for confirmation of installation and operational qualifications of liquid Particle Counter by Area FID.

Case No.08. Registration applications of Pregabalin deferred in previous meetings of Registration Board

Evaluator - I

Sr. No.

Name and address of Manufacturer / Applicant





Decision

343. M/S CCL Pharmaceutical (Pvt.) Ltd. 62-Industrial Estate , Kot Lakhpat, Lahore.

Achlin Capsule 25mg Capsule Each Capsule Contains: Pregabalin……25mg (Antiepileptics, other antiepileptics) Manufacturers specifications

Form 5 14-11-2005 Rs.8000/- Dy. No. Not mentioned 14-02-2014 Dy. No.596 Rs.12000/- 14’s/ As Per Brand Leader

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Panel inspection for the grant of GMP certificate

Approved.


conducted on 06/11/2013, 12/12/2013 & 18/12/2013. Capsule (General) section mentioned in Issuance of / Revalidation of DML vide letter No. F. 1-8/84-Lic (Vol. II)


Achlin Capsule 50mg Capsule Each Capsule Contains: Pregabalin……50mg (Antiepileptics, other antiepileptics) Manufacturers specifications

Form 5 14-11-2005 Rs.8000/- Dy. No. Not mentioned 14-02-2014 Dy. No.596 Rs.12000/- 14’s/ As Per Brand Leader

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Panel inspection for the grant of GMP certificate conducted on 06/11/2013, 12/12/2013 & 18/12/2013. Capsule (General) section mentioned in Issuance of / Revalidation of DML vide letter No. F. 1-8/84-Lic (Vol. II)

Approved.


Achlin Capsule 100mg Capsule Each Capsule Contains: Pregabalin……100

Form 5 14-11-2005 Rs.8000/- Dy. No. Not mentioned

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA

Approved.


mg (Antiepileptics, other antiepileptics) Manufacturers specifications

14-02-2014 Dy. No.596 Rs.12000/- 14’s/ As Per Brand Leader

ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Panel inspection for the grant of GMP certificate conducted on 06/11/2013, 12/12/2013 & 18/12/2013. Capsule (General) section mentioned in Issuance of / Revalidation of DML vide letter No. F. 1-8/84-Lic (Vol. II)

346. M/S NabiQasim (Pvt) Ltd. 17/24, Korangi Industrial Area, Karachi-Pakistan.

Preka Capsule 150mg Capsule Each Capsule Contains: Pregabalin……150mg (Anticonvulsant) Manufacturers Specifications

Form 5 24-04-2008 Rs.8000/- Dy. No. Not mentioned 09-09-2013 Rs.12000/- Dy. No. not mentioned duplicate dossier / 10’s, / Rs. 288/- 20’s / Rs. 547/- 30’s / 799/-

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Inspection report dated 18-12-2013. Capsule section mentioned in report and cGMP certificate.

Approved.

347. M/S NabiQasim (Pvt) Ltd. 17/24, Korangi Industrial Area, Karachi-

Preka Capsule 75mg Capsule

Form 5 24-04-2008 Rs.8000/-

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and

Approved.


Pakistan. Each Capsule Contains: Pregabalin……75mg (Anticonvulsant) Manufacturers Specifications

Dy. No. Not mentioned 09-09-2013 Rs.12000/- Dy. No. not mentioned duplicate dossier / 10’s / Rs.160/- 20’s / Rs. 304/- 30’s / Rs. 444/-

300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Inspection report dated 18-12-2013. Capsule section mentioned in report and cGMP certificate.



Form 5 24-04-2008 Rs.8000/- Dy. No. Not mentioned 09-09-2013 Rs.12000/- Dy. No. not mentioned duplicate dossier / 10’s / Rs.144/- 20’s / Rs. 273/- 30’s / Rs. 400/-

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Inspection report dated 18-12-2013. Capsule section mentioned in report and cGMP certificate.

Approved.



Form 5 24-04-2008 Rs.8000/- Dy. No. Not mentioned 09-09-2013 Rs.12000/- Dy. No. not mentioned duplicate dossier /

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton

Approved.


10’s / Rs.201/- 20’s / Rs. 382/- 30’s / Rs. 558/-

Inspection report dated 18-12-2013. Capsule section mentioned in report and cGMP certificate.

350. M/S Linz Pharmaceuticals (Pvt) Ltd., 31-G/H, Sector 15 Korangi Industrial Area, Karachi-Pakistan.

Pegab 300mg Capsule Capsule Each Capsule Contains: Pregabalin……300mg (Anticonvulsant Agent) Manufacturers specifications

Form 5 Covering letter not attached. Rs.8000/- Jul, 2008 Dy. No. Not mentioned 28-05-2014 Rs.12000/- Dy. No. 802 duplicate dossier / 14’s/ Rs.390/-

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Panel inspection dated 27-05-2014. Capsule section mentioned. Panel recommended grant of renewal.

Approved.

351. M/S Linz Pharmaceuticals (Pvt) Ltd., 31-G/H, Sector 15 Korangi Industrial Area, Karachi-Pakistan.

Pegab 100mg Capsule Capsule Each Capsule Contains: Pregabalin……100mg (Anticonvulsant Agent) Manufacturers specifications

Form 5 Covering letter not attached. Rs.8000/- Jul, 2008 Dy. No. Not mentioned 28-05-2014 Rs.12000/- Dy. No. Not mentioned 14’s/ Rs.291/-

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Panel inspection dated 27-05-2014. Capsule section mentioned. Panel recommended grant of renewal.

Approved.

352. M/S Linz Pegab 75mg Form 5 LYRICA Approved.


Pharmaceuticals (Pvt) Ltd., 31-G/H, Sector 15 Korangi Industrial Area, Karachi-Pakistan.

Capsule Capsule Each Capsule Contains: Pregabalin……75mg (Anticonvulsant Agent) Manufacturers specifications

Covering letter not attached. Rs.8000/- Jul, 2008 Dy. No. Not mentioned 28-05-2014 Rs.12000/- Dy. No. Not mentioned 14’s/ Rs.237/-

Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Panel inspection dated 27-05-2014. Capsule section mentioned. Panel recommended grant of renewal.

353. M/S Bosch 221, Bosch House , Sector 23, Korangi Industrial Area,Karachi.

Gablin 100mg Capsule Capsule Each Capsule Contains: Pregabalin……100mg (Anticonvulsant Agent) Manufacturers specifications

Form 5 Covering letter not attached. June, 2008 Rs.8000/- Dy. No. Not mentioned 28-05-2014 Rs.12000/- 803 R&I 14’s / Rs.291/-

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Inspection report dated 12-08-2014. Capsule section approved

Approved.


Gablin 75mg Capsule Capsule Each Capsule Contains: Pregabalin……75mg (Anticonvulsant Agent)

Form 5 Covering letter not attached. June, 2008 Rs.8000/- Dy. No. Not mentioned 28-05-2014 Rs.12000/-

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg)

Approved.


Manufacturers specifications

803 R&I 14’s/ Rs.237/-

Hilton Inspection report dated 12-08-2014. Capsule section approved


Gablin 300mg Capsule Capsule Each Capsule Contains: Pregabalin……300mg (Anticonvulsant Agent) Manufacturers specifications

Form 5 Covering letter not attached. June, 2008 Rs.8000/- Dy. No. 803 28-05-2014 Rs.12000/- 803 R&I 14’s/ Rs.390/-

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Inspection report dated 12-08-2014. Capsule section approved

Approved.

356. M/S Sami Pharmaceutical Pvt., Limited F-95, S.I.T.E. Karachi.

Pregy 50mg Capsule Capsule Each Capsule Contains: Pregabalin……50mg (Anticonvulsant) Manufacturer Specifications

Form 5 Rs.8000/- 22-12-2009 Dy. No. not mentioned Rs.12000/- fee challan is missing As per PRC duplicate dossier

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Panel inspection report dated 24-06-2014. Panel recommended grant of additional sections. Capsule section mentioned.

Approved.

357. M/S Sami Pharmaceutical Pvt., Limited F-95,

Pregy 75mg Capsule Capsule

Form 5 Rs.8000/- 22-12-2009


Approved.


S.I.T.E. Karachi. Each Capsule Contains: Pregabalin……75mg (Anticonvulsant) Manufacturer Specifications

Dy. No. not mentioned Rs.12000/- 29-07-2013 Dy. No. Not mentioned As per PRC duplicate dossier

300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Panel inspection report dated 24-06-2014. Panel recommended grant of additional sections. Capsule section mentioned.


Pregy 100mg Capsule Capsule Each Capsule Contains: Pregabalin……100mg (Anticonvulsant) Manufacturers specifications

Form 5 Rs.8000/- 22-12-2009 Dy. No. not mentioned Rs.12000/- 29-07-2013 Dy. No. Not mentioned As per PRC Duplicate dossier

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Panel inspection report dated 24-06-2014. Panel recommended grant of additional sections. Capsule section mentioned.

Approved.


Pregy 150mg Capsule Capsule Each Capsule Contains: Pregabalin……150mg

Form 5 Rs.8000/- 22-12-2009 Dy. No. not mentioned Rs.12000/- 29-07-2013 Dy. No. Not mentioned

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75,

Approved.


(Anticonvulsant) Manufacturers specifications

As per PRC Duplicate dossier

100, 150 and 300mg) Getz Panel inspection report dated 24-06-2014. Panel recommended grant of additional sections. Capsule section mentioned.

360. M/S AGP (Private) Limited, B-23, S.I.T.E., Karachi

Hi-Gab Capsules 75mg Capsule Each Capsule Contains: Pregabalin……75mg (Anti-Epileptic) Manufacturers specifications

Form 5 Rs.8000/- 17-07-2009 Dy. No. not mentioned Rs.12000/- 19-03-2014 Dy. No. Not mentioned 14’s / Rs.565/- Duplicate dossier

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 26/11/2013. Capsule section mentioned in FID report.

Approved.



Form 5 Rs.8000/- 17-07-2009 Dy. No. not mentioned Rs.12000/- 19-03-2014 Dy. No. Not mentioned 14’s / Rs.450/- duplicate dossier

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 26/11/2013.

Approved.


Capsule section mentioned in FID report.




LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA SYNGAB Capsules 200mg Atco Inspection report dated 26/11/2013. Capsule section mentioned in FID report.

Approved.




LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA Evidence of Me too status required Inspection report dated 26/11/2013. Capsule section mentioned in FID report.

1) Evidence of me too status required.

Deferred for confirmation of me too status.


Hi-Gab Capsules 300mg Capsule Each Capsule Contains: Pregabalin …… 300mg (Anti-Epileptic) Manufacturers

Form 5 Rs.8000/- 17-07-2009 Dy. No. not mentioned Rs.12000/- 19-03-2014 Dy. No. Not mentioned

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz

Approved.


specifications 14’s/Rs.1560/- duplicate dossier

Inspection report dated 26/11/2013. Capsule section mentioned in FID report.



Form 5 Rs.8000/- 17-07-2009 Dy. No. not mentioned Rs.12000/- 19-03-2014 Dy. No. Not mentioned 14’s/Rs.735/- duplicate dossier

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 26/11/2013. Capsule section mentioned in FID report.

Approved.




LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Inspection report dated 26/11/2013. Capsule section mentioned in FID report.

Approved.


Hi-Gab Capsules 150mg Capsule

Form 5 Rs.8000/- 17-07-2009


Approved.


Each Capsule Contains: Pregabalin……150mg (Anti-Epileptic) Manufacturers specifications

Dy. No. not mentioned Rs.12000/- 19-03-2014 Dy. No. Not mentioned 14’s/Rs.940/- duplicate dossier

300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 26/11/2013. Capsule section mentioned in FID report.

368. M/s Neutro Pharma (Pvt) Ltd., 9.5 Km, Sheikhupura Road, Lahore

Gabin Capsules 300mg Capsule Each Capsule Contains: Pregabalin……300mg (GABA Analogue) Manufacturers Specifications

Form 5 Rs.8000/- 17-08-2009 Dy. No. not mentioned Rs.12000/- 07-07-2014 Dy. No. 66 As per PRC

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Panel inspection to check GMP compliance conducted on 6th& 7th January, 2014.

Approved.

369. M/s Atco Laboratories Limited, B-18, S.I.T.E., Karachi

Syngab Capsules75mg Capsule Each Capsule Contains: Pregabalin……75mg (Anti Epileptic) Manufacturers Specifications

Form 5 Rs.8000/- 29-04-2008 Dy. No. not mentioned Rs.12000/- 08-04-2014 Dy. No. not mentioned As per leader price per 14’s

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 18-06-2014

Approved.



Syngab Capsules 150mg Capsule Each Capsule Contains: Pregabalin……150mg (Anti Epileptic) Manufacturers Specifications



Approved.


Syngab Capsules 300mg Capsule Each Capsule Contains: Pregabalin……300mg (Anti Epileptic) Manufacturers Specifications



Approved.

372. M/S Tabros Pharma

L-20/B, F.B. Industrial Area, Karachi.

Grelin Capsule 75mg Capsule Each Capsule Contains: Pregabalin……75mg (Anti-Epileptic.) Manufacturers specifications

Form 5 Rs.8000/- 30-06-2008 Dy. No. Not mentioned Rs.12000/- Dated 20-03-2014 Dy. No. not mentioned 14’s / Rs.1100/- (Rs. 78.57 per capsule) (duplicate dossier)

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 11/03/2014. Overall conditions noted improved as

Approved.


compared to last visit.




Form 5 Rs.8000/- 30-06-2008 Dy. No. Not mentioned Rs.12000/- Dated.20-03-2014 Dy. No. not mentioned 14’s/Rs.1300/- (duplicate dossier)

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 11/03/2014. Overall conditions noted improved as compared to last visit.

Approved.




Form 5 Rs.8000/- 30-06-2008 Dy. No. Not mentioned Rs.12000/- Dated.20-03-2014 Dy. No. not mentioned 14’s/Rs.1600/- (duplicate dossier)

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 11/03/2014. Overall conditions noted improved as compared to last visit.

Approved.


L-20/B, F.B. Industrial Area,

Grelin Capsule 300mg Capsule Each Capsule

Form 5 Rs.8000/- 30-06-2008 Dy. No. Not

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg)

Approved.


Karachi. Contains: Pregabalin……300mg (Anti-Epileptic.) Manufacturers specifications

mentioned Rs.12000/- Dated.20-03-2014 Dy. No. not mentioned 14’s/Rs.2600/- (duplicate dossier)

US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 11/03/2014. Overall conditions noted improved as compared to last visit.

376. M/S Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial Area Islamabad.

Foxril Capsule 75mg Capsule Each Capsule Contains: Pregabalin……75mg (Anticonvulsant.) Manufacturers specifications

Form 5 Rs.8000/- 15-07-2008 Dy. No. 186 Rs.12000/- Dated.08-07-2014 Dy. No. 1244 14’s / Rs. 16.95 / Capsule

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 12-04-2013. Good compliance. Capsule section mentioned in panel inspection report dated 02-12-2008.

Approved.


Foxril Capsule 100mg Capsule Each Capsule Contains: Pregabalin……100mg (Anticonvulsant.)

Form 5 Rs.8000/- 15-07-2008 Dy. No.176 Rs.12000/- Dated.08-07-2014 Dy. No. 1244

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg)

Approved.



14’s/Rs.20.85/Capsule

Getz Inspection report dated 12-04-2013. Good compliance. Capsule section mentioned in panel inspection report dated 02-12-2008.


Foxril Capsule 150mg Capsule Each Capsule Contains: Pregabalin……150mg (Anticonvulsant.) Manufacturers specifications

Form 5 Rs.8000/- 15-07-2008 Dy No.181 Rs.12000/- Dated.08-07-2014 Dy. No. 1244 Rs.33.90/Capsule 14’s

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 12-04-2013. Good compliance. Capsule section mentioned in panel inspection report dated 02-12-2008.

Approved.

379. M/S OBS Pakistan (Pvt.) Ltd. C-14, S.I.T.E., Manghopir Road Karachi-75700

Pregalin Capsule Capsule Each Capsule Contains: Pregabalin……150mg (Antiepileptics) Manufacturers specifications

Form 5 Rs.8000/- 18-10-2008 Not mentioned Rs.12000/- Dated.29-07-2013 duplicate dossier Dy. No. not mentioned 14’s/Rs.1300/-

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 06-03-

Approved.


2014. GMP satisfactory and capsule section mentioned in report.




LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 06-03-2014. GMP satisfactory and capsule section mentioned in report.

Approved.




LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 06-03-2014. GMP satisfactory and capsule section mentioned in report.

Approved.

382. M/S Glitz Pharma (Pvt.) Ltd; 265-Industrial Triangle, Kahuta Road

P-Gab 75 Tablet Each film coated

Form 5 Rs.8000/- 31-12-2008

Inspection report dated 18-03-2013. Satisfactory GMP

1) Firm had initially applied on Form 5 for

The request of the firm has not been acceded to by


Islamabad. tablet Contains: Pregabalin……75mg (Antiepileptics) Manufacturers specifications

Dy. No.561 Rs.12000/- Dated.08-07-2014 Dy. No. 1239 10x2=20’s /As Per SRO

and tablet section mentioned.

registration of Pregabalin 75mg tablet. Since the product is not me too, firm was asked to provide me too reference or application on Form 5D. Now, firm has requested to change the particulars of the file to Pregabalin Oral Solution 20mg/ml. Firm has also submitted that additional fee if any, will be deposited.

the Board & the Board rejected the application of P-Gab 75 Tablet

383. M/S Glitz Pharma (Pvt.) Ltd; 265-Industrial Triangle, Kahuta Road Islamabad.

P-Gab 100 Tablet Each tablet Contains: Pregabalin……100mg (Antiepileptics) Manufacturers specifications

Form 5 Rs.8000/- 31-12-2008 Dy. No.562 Rs.12000/- Dated.08-07-2014 Dy. No. 1235 10x2=20’s & 14’s /As Per SRO

Inspection report dated 18-03-2013. Satisfactory GMP and tablet and capsule section mentioned.

1) Firm had initially applied on Form 5 for registration of Pregabalin 100mg tablet. Since the product is not me too, firm was asked to provide me too reference or application on Form 5D. Now, firm has requested to change the particulars of the file to Pregabalin 300mg capsules. Firm has also

The request of the firm has not been acceded to by the Board & the Board rejected the application P-Gab 100, Tablet


submitted that additional fee if any, will be deposited.


P-Gab 50 Tablet Each tablet Contains: Pregabalin……50mg (Antiepileptics) Manufacturers specifications

Form 5 Rs.8000/- 31-12-2008 Dy. No. 560 Rs.12000/- Dated.08-07-2014 Dy. No. 1233 10x2=20’s /As Per SRO

Inspection report dated 18-03-2013. Satisfactory GMP and tablet section mentioned.

1) Firm had initially applied on Form 5 for registration of Pregabalin 100mg tablet. Since the product is not me too, firm was asked to provide me too reference or application on Form 5D. Now, firm has requested to change the particulars of the file to Pregabalin 200mg capsules. Firm has also submitted that additional fee if any, will be deposited.

The request of the firm has not been acceded to by the Board & the Board rejected the application of P-Gab 50, Tablet


P-Gab 150mg Tablet Each film coated tablet Contains: Pregabalin……150mg (Antiepileptics) Manufacturers specifications

Form 5 Rs.8000/- 31-12-2008 Dy. No.563 Rs.12000/- Dated.08-07-2014 Dy. No. 1234 10x2=20’s/As Per SRO

Inspection report dated 18-03-2013. Satisfactory GMP and tablet section mentioned.

1) Firm had initially applied on Form 5 for registration of Pregabalin 100mg tablet. Since the product is not me too, firm was asked to provide me too reference or application on Form 5D.

The request of the firm has not been acceded to by the Board & the Board rejected the application of P-Gab 150mg Tablet


Now, firm has requested to change the particulars of the file to Pregabalin 150mg capsules. Firm has also submitted that additional fee if any, will be deposited.


P-Gab 100 Capsule Each capsule Contains: Pregabalin……100mg (Antiepileptics) Manufacturers specifications

Form 5 Rs.8000/- 31-12-2008 Dy. No.559 Rs.12000/- Dated.08-07-2014 Dy. No. 1236 10x2=20’s & 14’s /As Per SRO and Rs. 625/- per 20’s

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 18-03-2013. Satisfactory GMP and tablet section mentioned.

Approved.



Form 5 Rs.8000/- 31-12-2008 Dy. No.557 Rs.12000/- Dated.08-07-2014 Dy. No. 1238 10x2=20’s & 14’s/As Per SRO and Rs. 345/- per 20’s

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 18-03-2013.

Approved.


Satisfactory GMP and tablet section mentioned.



Form 5 Rs.8000/- 31-12-2008 Dy. No.556 Rs.12000/- Dated.08-07-2014 Dy. No. 1237 10x2=20’s & 14’s/As Per SRO

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 18-03-2013. Satisfactory GMP and tablet section mentioned.

Approved.

389. M/S Global Pharmaceuticals (Pvt.) Ltd., Plot No. 204-205, Industrial Triangle, Kahuta Road, Islamabad.

Pert 50 mg Capsules Capsule Each capsule Contains: Pregabalin……50mg (Anticonvulsant) Manufacturers Specifications

Form 5 Rs.8000/- fee challan not attached Rs.12000/- Dated.05-06-2014 Dy. No. 566 R&I 14’s As Per SRO

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz cGMP certificate dated 21-11-2014. Capsule section mentioned in inspection report and GMP certificate dated 31-05-2012 and 21-11-2014.

1) Rs. 8,000/- fee challan (duly endorsed by Statistical Officer) has not been provided. However, copy of extracts from 214th meeting of Registration Board as evidence of fee submission.

Approved. Reference will be sent to B & A Division for verification of fee challan. In acse of non-confirmation, firm will deposit the fee (Rs.8000/-) and Chairman, RB will permit for issuance of registration letter.

390. M/S Global Pharmaceuticals (Pvt.) Ltd., Plot No.

Pert 75 mg Capsules Capsule

Form 5 Rs.8000/- fee

LYRICA Capsules (25, 50, 75, 100,

1) Rs. 8,000/- fee challan (duly

Approved. Reference will be sent to B &


204-205, Industrial Triangle, Kahuta Road, Islamabad.

Each capsule Contains: Pregabalin……75mg (Anticonvulsant) Manufacturers Specifications

challan not attached Rs.12000/- Dated.05-06-2014 Dy. No. 565 R&I 14’s As Per SRO

150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz cGMP certificate dated 21-11-2014. Capsule section mentioned in inspection report and GMP certificate dated 31-05-2012 and 21-11-2014.

endorsed by Statistical Officer) has not been provided. However, copy of extracts from 214th meeting of Registration Board as evidence of fee submission.

A Division for verification of fee challan. In acse of non-confirmation, firm will deposit the fee (Rs.8000/-) and Chairman, RB will permit for issuance of registration letter.

391. M/S Genome Pharmaceutical Private Limted, Factory 16/1-Phase IV, Industrial Estate, Hattar.

Pregabanome-150 Capsule Capsule Each Capsule Contains: Pregabalin……150mg (Gaba Analogue) Manufacturers specifications

Form 5 Rs.8000/- 09-08-2008 Dy. No.287 Rs.12000/- 16-06-2014 Dy. No. 258 As Per SRO 2x7’s (14)

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Panel inspection for grant of GMP dated 27-12-2013. Capsule General / Antibiotic mentioned.

Approved.


Pregabanome-75 Capsule Capsule Each Capsule Contains: Pregabalin……75mg

Form 5 Rs.8000/- 09-08-2008 Dy. No.288 Rs.12000/- 16-06-2014

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP

Approved.


(Gaba Analogue) Manufacturers specifications

Dy. No. 258 As Per SRO 2x7’s (14)

Capsules (25, 50, 75, 100 and 150mg) Hilton Panel inspection for grant of GMP dated 27-12-2013. Capsule General / Antibiotic mentioned.


Pregabanome-50 Capsule Capsule Each Capsule Contains: Pregabalin……50mg (Gaba Analogue) Manufacturers specifications

Form 5 Rs.8000/- 09-08-2008 Dy. No. 289 Rs. 12000/- 16-06-2014 Dy. No. 258 As Per SRO 2x7’s (14)

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Panel inspection for grant of GMP dated 27-12-2013. Capsule General / Antibiotic mentioned.

Approved.


Pregabanome-100Capsule Capsule Each Capsule Contains: Pregabalin……100mg (Gaba Analogue) Manufacturers specifications

Form 5 Rs.8000/- 09-08-2008 Dy. No.286 Rs.12000/- 16-06-2014 Dy. No. 258 As Per SRO 2x7’s (14)

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Panel inspection for grant of GMP dated 27-12-2013.

Approved.


Capsule General / Antibiotic mentioned.

395. M/s Noa Hemis Pharmaceuticals Plot No.154, Sector-23, Korangi Industrial Area,Karachi

Gabatil-75mg Capsule Each Capsule Contains: Pregabalin ……75mg (Anti epileptic) Manufacturers specifications

Form 5 Rs.8000/- 22-07-2008 Dy. No. not mentioned Rs.12000/- 19-06-2014 1609 R&I 10’s, 14’s/15% less then brand leader

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz DDG and FID inspection report dated 09-06-2014 GMP compliance considered good. Capsule section mentioned in GMP inspection reports.

Approved.

396. M/s Noa Hemis Pharmaceuticals Plot No.154, Sector-23, Korangi Industrial Area,Karachi

Gabatil-150mg Capsule Each Capsule Contains: Pregabalin ……150mg (Anti epileptic) Manufacturers specifications

Form 5 Rs.8000/- 22-07-2008 Dy. No. not mentioned Rs.12000/- 19-06-2014 1609 R&I 10’s, 14’s / 15% less then brand leader

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz DDG and FID inspection report dated 09-06-2014 GMP compliance considered good. Capsule section mentioned in GMP inspection reports.

Approved.

397. M/s Noa Hemis Gabatil-300mg Form 5 LYRICA Approved.


Pharmaceuticals Plot No.154, Sector-23, Korangi Industrial Area,Karachi

Capsule Each Capsule Contains: Pregabalin ……300mg (Anti epileptic) Manufacturers specifications

Rs.8000/- 22-07-2008 Dy. No. not mentioned Rs.12000/- 19-06-2014 1609 R&I 10’s, 14’s / 15% less then brand leader

Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz DDG and FID inspection report dated 09-06-2014 GMP compliance considered good. Capsule section mentioned in GMP inspection reports.

398. M/S Sharooq Pharmaceuticals (Pvt) Ltd. 21-KM Ferozepur Road, Lahore.

Gabmor Capsule Capsule Each Capsule Contains: Pregabalin……300mg (Antiepileptic) Manufacturers specifications

Form 5 Rs.8000/- 19-01-2009 Not mentioned Rs.12000/- Dated.19-06-2014 duplicate dossier Dy. No. 1286 14’s/As per PRC

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Panel inspection after non-compliance report and grant of GMP certificate dated 28-03-2014. GMP issued and capsule section mentioned.

Approved.

399. M/S Sharooq Pharmaceuticals (Pvt) Ltd. 21-KM Ferozepur Road,

Gabmor Capsule Capsule Each Capsule Contains:

Form 5 Rs.8000/- 19-01-2009 Not mentioned

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg)

Approved.


Lahore. Pregabalin……75mg (Antiepileptic) Manufacturers specifications

Rs.12000/- Dated.19-06-2014 duplicate dossier Dy. No. 1281 14’s,10’s/As per PRC

US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Panel inspection after non-compliance report and grant of GMP certificate dated 28-03-2014. GMP issued and capsule section mentioned.

400. M/S Sharooq Pharmaceuticals (Pvt) Ltd. 21-KM Ferozepur Road, Lahore.

Gabmor Capsule Capsule Each Capsule Contains: Pregabalin………………..…150mg (Antiepileptic) Manufacturers specifications

Form 5 Rs.8000/- 19-01-2009 Not mentioned Rs.12000/- Dated.19-06-2014 duplicate dossier Dy. No. 1282 14’s, 10’s/As per PRC

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Panel inspection after non-compliance report and grant of GMP certificate dated 28-03-2014. GMP issued and capsule section mentioned.

Approved.

401. M/s Rasco Pharma, 5.5Km Raiwind Road Lahore.

Pregab Capsule 300mg Capsule Each Capsule Contains: Pregabalin ….……300mg

Form 5 Rs.8000/- 25-07-2009 Dy. No. Not mentioned Rs.12000/-

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA

Approved.


(Anticonvulsant) Manufacturers specifications

20-06-2014 Dy. No. 1296 Rs.630/-, 1x14

Capsules (50, 75, 100, 150 and 300mg) Getz Panel inspection dated 03-06-2014 where panel recommended grant of renewal of DML. Capsule section mentioned in said report.


Pregab Capsule 150mg Capsule Each Capsule Contains: Pregabalin ……150mg (Anticonvulsant) Manufacturers specifications

Form 5 Rs.8000/- 25-07-2009 Dy. No. Not mentioned Rs.12000/- 20-06-2014 Dy. No. 1295 Rs.350/-, 1x14

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Panel inspection dated 03-06-2014 where panel recommended grant of renewal of DML. Capsule section mentioned in said report.

Approved.


Pregab Capsule 50mg Capsule Each Capsule Contains: Pregabalin ……50mg (Anticonvulsant)

Form 5 Rs.8000/- 25-07-2009 Dy. No. Not mentioned Rs.12000/- 20-06-2014 Dy. No. 1294

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg)

Approved.



Rs.175/-, 1x14 Getz Panel inspection dated 03-06-2014 where panel recommended grant of renewal of DML. Capsule section mentioned in said report.

404. M/s WnsFeild Pharmaceuticals, Plot#122, Block-A, Phase-V, Industrial Estate, Hattar

Lyricowin 75 Capsule Each capsule Contains: Pregabalin ……75mg (Anticonvulsants) Manufacturer’s specifications In agenda, erroneously dosage form with brand name written as Tablet instead of Capsule. The firm actually mentioned dosage form as capsule in form 5.

Form 5 Rs.8000/- 19-04-2009 Dy. No. Not mentioned Rs.12000/- 19-06-2014 Dy. No. 259 As per SRO

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Panel report dated 04-09-2014. Panel recommends grant of GMP and capsule section mentioned.

Approved. Reference will be sent to B & A Division for verification of fee challan for capsule dosage form. If confirmed, then Chairman, RB will permit for issuance of registration letter. Otherwise case will be placed before the Board for decision.

405. M/s Pakistan Pharmaceuticals Products (Pvt) Ltd. D-122, Sindh Industrial Trading Estate, Karachi.

Gablin 150mg Capsule Capsule Each capsule Contains: Pregabalin ……150mg (Anticonvulsants)

Form 5 Rs.8000/- 17-06-2009 (Challan submission date) Dy. No. Not mentioned Rs.12000/- 26-07-2013 Dy. No. not mentioned Covering letter

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report

Approved.


is not attached Rs.25/Capsule /not mentioned

dated 13-02-2013 and 03-06-2014 considered to be operating at satisfactory level of GMP.



Form 5 Rs.8000/- 17-06-2009 Dy. No. Not mentioned Rs.12000/- 26-07-2013 Dy. No. not mentioned Covering letter is not attached Rs.25/Capsule /not mentioned

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 13-02-2013 and 03-06-2014 considered to be operating at satisfactory level of GMP.

Approved.



Form 5 Rs.8000/- 17-06-2009 Dy. No. Not mentioned Rs.12000/- 26-07-2013 Dy. No. not mentioned Covering letter is not attached Rs.25/Capsule /not mentioned

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 13-02-2013 and 03-06-2014 considered to be operating at satisfactory level of GMP.

Approved.

408. M/s Danas Pharmaceuticals (Private) Limited,

Gabfast Capsule300mg Capsule

Form 5 Rs.8000/-


Approved.


Islamabad.

Each capsule Contains: Pregabalin ……300mg (Gaba analogue)

08-12-2009 Dy. No. 57 Rs.12000/- 05-06-2014 Dy. No. 555 10’s/As Per SRO

150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz cGMP certificate dated 28-01-2014. Capsule section mentioned.

409. M/s Danas Pharmaceuticals (Private) Limited, Islamabad.

Gabfast Capsule75mg Capsule Each capsule Contains: Pregabalin ……75mg (Gaba analogue)

Form 5 Rs.8000/- 08-12-2009 Dy. No. 55 Rs.12000/- 05-06-2014 Dy. No. 555 10’s/As Per SRO

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz cGMP certificate dated 28-01-2014. Capsule section mentioned.

Approved.

410. M/s Danas Pharmaceuticals (Private) Limited, Islamabad.

Gabfast Capsule150mg Capsule Each capsule Contains: Pregabalin ……150mg (Gaba analogue)

Form 5 Rs.8000/- 08-12-2009 Dy. No. 56 Rs.12000/- 05-06-2014 Dy. No. 555 10’s/As Per SRO

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz cGMP certificate dated 28-01-2014. Capsule

Approved.


section mentioned.


Pregy 25mg Capsule Capsule Each Capsule Contains: Pregabalin……25mg (Anticonvulsant) Manufacturer Specifications

Form 5 Rs.8000/- 07-09-2010 Dy. No. not mentioned Rs.12000/- 10-05-2013 duplicate dossier Dy. No. Not mentioned As per PRC

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Panel inspection report dated 24-06-2014. Panel recommended grant of additional sections. Capsule section mentioned.

Approved.

412. M/S Weather Folds Pharmaceuticals, Plot No.69/2, Phase-II, Industrial Area, Hattar, KPK

Gabalin 50mg Cap Capsule Each Capsule Contains: Pregabalin……50mg (Analgesic / Anticonvulsant Activity) Manufacturers specifications

Form 5 Rs.8000/- 29-12-2010 Dy. No. Not mentioned Rs.12000/- Dated.11-07-2014 Dy. No. 323 As per SRO

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Panel inspection report dated 04-09-2014. Panel recommended grant of GMP certificate. Capsule section approved.

Approved.

413. M/S Weather Folds Pharmaceuticals, Plot No.69/2,

Gabalin 100mg Cap Capsule

Form 5 Rs.8000/-


Approved.


Phase-II, Industrial Area, Hattar, KPK

Each Capsule Contains: Pregabalin……100mg (Analgesic / Anticonvulsant Activity) Manufacturers specifications

29-12-2010 Dy. No. Not mentioned Rs.12000/- Dated.11-07-2014 Dy. No. not mentioned As per SRO

150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Panel inspection report dated 04-09-2014. Panel recommended grant of GMP certificate. Capsule section approved.

414. M/S Lowitt Pharma (pvt.) Ltd. 24-Hayatabad Industrial Estate Peshawar.

P-Gablin 150Capsule Oral Capsule Each Capsule Contains: Pregabalin……150mg (Gaba Analogue, Anticonvulsant.Analgasic) Manufacturers specifications

Form 5 Rs.8000/- 22-03-2010 (Endorsement date) Dy. No. Not mentioned Rs.12000/- (for tablet) Dated 22-05-2014 Dy. No. Not mentioned Both pack size and price as Per SRO Duplicate Dossier

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Inspection report dated 21-08-2014. Overall firm in good working condition. Capsule section mentioned in inspection report and revised layout plan approval dated 13-12-2013.

1) Balance fee Rs. 12,000/- has been submitted for tablet dosage form.

Approved. Reference will be sent to B & A Division for verification of fee challan for capsule dosage form. In acse of non-confirmation, firm will deposit the fee (Rs.12000/-) and Chairman, RB will permit for issuance of registration letter.

415. M/S Lowitt Pharma (pvt.) Ltd. 24-Hayatabad Industrial Estate

P-Gablin 50Capsule Oral Capsule

Form 5 Rs.8000/- 22-03-2010


Approved.


Peshawar. Each Capsule Contains: Pregabalin……50mg (Gaba Analogue, Anticonvulsant.Analgasic) Manufacturers specifications

(Endorsement date) Dy. No. Not mentioned Rs.12000/- Dated. 22-05-2014 Dy. No. Not mentioned Both pack size and price as Per SRO Duplicate Dossier

300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Inspection report dated 21-08-2014. Overall firm in good working condition. Capsule section mentioned in inspection report and revised layout plan approval dated 13-12-2013.

416. M/S Lowitt Pharma (pvt.) Ltd. 24-Hayatabad Industrial Estate Peshawar.

P-Gablin 100Capsule Oral Capsule Each Capsule Contains: Pregabalin……100mg (Gaba Analogue, Anticonvulsant.Analgasic) Manufacturers specifications

Form 5 Rs.8000/- 22-03-2010 (Endorsement date) Dy. No. Not mentioned Rs.12000/- Dated.21-05-2014 Dy. No. Not mentioned Both pack size and price as Per SRO Duplicate Dossier

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA ZEEGAP Capsules (25, 50, 75, 100 and 150mg) Hilton Inspection report dated 21-08-2014. Overall firm in good working condition. Capsule section mentioned in inspection report and revised layout plan approval dated 13-12-2013.

Approved.

417. M/s Rogen P-Roglin 75mg Form 5 LYRICA Approved.


Pharmaceuticals Plot#30, S-4, National Industrial Zone, Rawat, Islamabad.

Capsule Capsule Each capsule Contains: Pregabalin ……75mg (Anti-epileptic) Manufacturers specifications

Rs.8000/- 02-06-2010 Dy. No. 4754 Rs. 12000/- 16-06-2014 Dy. No.735 10’s/As Per SRO

Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Panel inspection report dated 09-06-2014. Tablet / capsule section mentioned. General Capsule section mentioned on the report.

418. M/s Focus & Rulz Pharmaceuticals (Pvt) Ltd. Plot No.4, Industrial Triangle, Kahuta Road, Islamabad.

Pregab 75mg Capsule Capsule Each capsule Contains: Pregabalin ……75mg (Analgesic and Anticonvulsant) Manufacturers specifications

Form 5 Rs.8000/- 61 R&I 28-06-2010 Fee Rs.12000/- challans form is missing 14’s/As Per SRO

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Panel inspection report dated 27-03-2014. Capsule section approved.

Approved. Firm will provide verified challan of Rs.12000/- and Chairman will authorize issuance of registration letter.

419. M/s Focus & Rulz Pharmaceuticals (Pvt) Ltd. Plot No.4, Industrial Triangle, Kahuta Road, Islamabad.

Pregab 50mg Capsule Capsule Each capsule Contains: Pregabalin ……50mg (Analgesic and

Form 5 Rs.8000/- 62 R&I 28-06-2010 Fee Rs.12000/- challans form is missing

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and

Approved. Firm will provide verified challan of Rs.12000/- and Chairman will authorize issuance of registration letter.


Anticonvulsant) Manufacturers specifications

14’s/As Per SRO

300mg) Getz Panel inspection report dated 27-03-2014. Capsule section approved.

420. M/s Amarant Pharmaceuticals (Pvt) LTD 158-D, Toro Gadap Road, Super highway, Karachi.

Gabalin Capsule 50mg Capsule Each filled Capsule Contains: Pregabalin……50mg (Anticonvulsant) Manufacturers specifications

Form 5 Rs.8000/- 22-11-2010 Dy. No. not mentioned Rs.52,000/- (fast track) 19-11-2012 Dy. No. Not mentioned Rs.36/- capsule duplicate dossier

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 08-08-2014 observed that management is taking serious measures to rearrange and upgrade their whole manufacturing, quality control and storage facilities as per approved layout plan.

Approved.



Form 5 Rs.8000/- 22-11-2010 Dy. No. not mentioned Rs.52,000/- (fast track) 19-11-2012 Dy. No. Not mentioned Rs.71/- capsule

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report

Approved.


duplicate dossier dated 08-08-2014 observed that management is taking serious measures to rearrange and upgrade their whole manufacturing, quality control and storage facilities as per approved layout plan.



Form 5 Rs.8000/- 22-11-2010 Dy. No. not mentioned Rs.52,000/- (fast track) 18-11-2012 Dy. No. Not mentioned Rs.89/- capsule duplicate dossier

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 08-08-2014 observed that management is taking serious measures to rearrange and upgrade their whole manufacturing, quality control and storage facilities as per approved layout plan.

Approved.


Gabalin Capsule 150mg Capsule Each filled Capsule Contains: Pregabalin……150

Form 5 Rs.8000/- 22-11-2010 Dy. No. not mentioned

LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA

Approved.


mg (Anticonvulsant) Manufacturers specifications

Rs.52,000/- (fast track) 19-11-2012 Dy. No. Not mentioned Rs.107/- capsule duplicate dossier

GABICA Capsules (50, 75, 100, 150 and 300mg) Getz Inspection report dated 08-08-2014 observed that management is taking serious measures to rearrange and upgrade their whole manufacturing, quality control and storage facilities as per approved layout plan.

9. Contract manufacturing applications

Evaluator – II (Application checked by Evaluator - IV)





Decision

424. M/s Safe Pharmaceuticals (Pvt.) Ltd. Plot No. C-1-20,

Impulse Injection 500 mcg/ml Each 1 ml ampoule contains

Form 5 Not mentioned Rs 150,000 1 ml × 10’s

International: Methycobal Inj by M/s Eisai Co., Ltd. Tokyo

Deferred for rectification of following observation in the dossier:


Sector 6-B, North Karachi Industrial Area, Karachi For M/s Amarant Pharmaceuticals (Pvt.) Ltd. 158, D. Tore, Gadap Road, Super Highway, Karachi.

Mecobalamin (J.P)…..500 mcg (Co-enzyme type Vitamin B12) (Manufacturer’s Spec.s)

Me too:Elgin Inj by M/s Novartis According to inspection report dated 20-08-2014 of M/s Safe Pharmaceuticals; GMP compliance level of firm is rated as good. Only Form 5 of the application has been evaluated. Rest of the conditions of policy matters have not been evaluated . Verification fee challan is required. Evidence of TOC analyzer and liquid particle counter is required. Firm has replied that these are under the process of procurement.

1. Reference will be sent to B & A Division for verification of challan. 2. Confirmation of installation and operational qualifications for TOC analyzer and liquid particle counter by the area FID.

425. -do- Moxina Infusion 400 mg/ 250 ml Each vial (250 ml) contains Moxifloxacin (as HCl) (USP)…. 400 mg Quinolone (Manufacturer’s Spec.s)

Form 5 Not mentioned Rs 150,000 As per PAC

International: Avelox Inf (FDA) Me too: Moxiget Inf 400mg/250ml According to inspection report dated 20-08-2014 of M/s Safe Pharmaceuticals; GMP compliance level of firm is rated as good. Only Form 5 of the application has been evaluated. Rest of the conditions of policy matters have not been evaluated . Verification fee challan is required.

Deferred for rectification of following observation in the dossier: 1. Reference will be sent to B & A Division for verification of challan. 2. Confirmation of installation and operational qualifications for TOC analyzer and liquid particle counter by the area FID.


Evidence of TOC analyzer and liquid particle counter is required. Firm has replied that these are under the process of procurement.

426. -do-

Quvoxin Injection 500 mg/ 100 ml Each vial (100ml) contains Levofloxacin (USP)…. 500 mg Quinolone (Manufacturer’s Spec.s)


International: Levaquine 500mg/100ml (FDA) Me too: Raylox Inf 500mg/100ml by M/s Ray According to inspection report dated 20-08-2014 of M/s Safe Pharmaceuticals; GMP compliance level of firm is rated as good. Only Form 5 of the application has been evaluated. Rest of the conditions of policy matters have not been evaluated . Verification fee challan is required. Evidence of TOC analyzer and liquid particle counter is required. Firm has replied that these are under the process of procurement.

Deferred for rectification of following observation in the dossier: 1. Reference will be sent to B & A Division for verification of challan. 2. Confirmation of installation and operational qualifications for TOC analyzer and liquid particle counter by the area FID.

427. -do-

Amadrol Injection 100 mg/ 2 ml Each 2 ml contains Tramadol HCl (B.P) …..100 mg Non Narcotic analgesic (Manufacturer’s Spec.s)

Form 5 Not mentioned Rs 150,000 2 ml × 5’s As per PAC

International: Zamadol Inj 50mg/ml (100mg ampoule) in UK Me too: Tramadol Inj 50mg/ml by M/s Highnoon Latest GMP inspection report of contract giver is required.

Deferred for rectification of following observation in the dossier: 1. Reference will be sent to B & A Division for verification of challan. 2. Confirmation of installation and operational qualifications for TOC analyzer and liquid


According to inspection report dated 20-08-2014 of M/s Safe Pharmaceuticals; GMP compliance level of firm is rated as good. Only Form 5 of the application has been evaluated. Rest of the conditions of policy matters have not been evaluated . Verification fee challan is required. Evidence of TOC analyzer and liquid particle counter is required. Firm has replied that these are under the process of procurement.

particle counter by the area FID.

428. -do-

Amblum Injection Each ml ampoule contains Artemether……80 mg (Anti malarial) (Manufacturer’s Spec.s)

Form 5 Not mentioned Rs 150,000 1 × 5 ampoule As per PAC

International: Artem Inj in China Me too: Artem Inj by M/s Hilton According to inspection report dated 20-08-2014 of M/s Safe Pharmaceuticals; GMP compliance level of firm is rated as good. Only Form 5 of the application has been evaluated. Rest of the conditions of policy matters have not been evaluated . Verification fee challan is required. Formulation was Deferred in the light of recommendations by Malaria Control Programme in M-

Deferred in the light of recommendation of National Malaaria Control programme & for rectification of following observation in the dossier: 1. Reference will be sent to B & A Division for verification of challan. 2. Confirmation of installation and operational qualifications for TOC analyzer and liquid particle counter by the area FID.


245 of DRB.

429. M/s Caraway Pharmaceuticals Plot No. 12, street # N-3, National Industrial Zone, Rawat, Islamabad. For M/s Amarant Pharmaceuticals (Pvt.) Ltd. 158, D. Tore, Gadap Road, Super Highway, Karachi.

Amant- D Injection Each ml contains Cholecalciferol BP …..5 mg Vitamin Finished product specifications are B.P


International: Required Me too: Calciferol Inj by M/s Global Good level of GMP compliance (24-09-2012) Only Form 5 of the application has been evaluated. Rest of the conditions of policy matters have not been evaluated . Verification fee challan is required. International availability not confirmed in SRA’s. Letter of approval of injection section is required. Inspection report dated 24-09-12 mentions Ampoule and Vial sections. Labeling information has been given for malaria.

Deferred for rectification of following observation in the dossier: 1. Reference will be sent to B & A Division for verification of challan. 2. Confirmation of installation and operational qualifications for TOC analyzer and liquid particle counter by the area FID. 3. Evidence of approval in reference Stringent Regulatory Agencies. 4. Approval of manufacturing facility by Licensing section. 5. Correction in labeling as submitted label mentions the use of formulation in malaria.

430. -do-

Amta- Rose Injection Each ampoule (5ml) contains Iron Sucrose 420 mg eq to elemental Iron ….. 100mg Haematinic Finished product specifications are USP


International: Venofer Inj (FDA) Me too: Merofer JInj by M/s Bosch Good level of GMP compliance (24-09-2012) Only Form 5 of the application has been evaluated. Rest of the conditions of policy matters have not been evaluated . Verification fee challan is required. Initially on Form 5, firm mentioned quantity of active as

Deferred for rectification of following observation in the dossier: 1. Reference will be sent to B & A Division for verification of challan. 2. Confirmation of installation and operational qualifications for TOC analyzer and liquid particle counter by the area FID. 3. Initially on Form 5, firm mentioned quantity of active as 420 mg/ ampoule, in reply firm mentioned it as 1873 mg/ ampoule. Clarification is


420 mg/ ampoule, in reply firm mentioned it as 1873 mg/ ampoule. Clarification is required. No clarification is provided in second reply. Letter of approval of injection section is required. Not provided in second reply. Inspection report dated 24-09-12 mentions Ampoule and Vial sections. Evidence of TOC analyzer and liquid particle counter is required. Not provided in replies.

required. No clarification is provided in second reply. 4. Letter of approval of injection section is required. Not provided in second reply. Inspection report dated 24-09-12 mentions Ampoule and Vial sections.

Evaluator – III






Decision


431. Contract Giver M/s Dyson Research Labs, Lahore. Contract Acceptor M/s McOlson Research Laboratories, Sheikhupura.

OD-CEF Injection 500mg Each vial contains: Ceftriaxone sodium equivalent to Ceftriaxone…..500mg Cephalosporin USP

Form-5 Dy No: 2437 dated: 15-04-2013 1,42,000/- dated 15-04-13 8,000/- dated 18-05-09 As per SRO Pack of 1’s

Inspection of M/s McColson Research Labs conducted on 26-08-14 and 11-09-14 by the panel of inspectors and recommends the grant of renewal of DML to the firm

The applications have been evaluated as per Form-5. However the formalities as per contract manufacturing policy may be fulfilled by the concerned section before issuance of registration letter.

Approved. Firm will provide undertakings & agreement as per approved contract policy and Chairman will permit issuance of registration letter. Permission will be valid till 30.06.2015).

432. Contract Giver M/s McOlson Research Laboratories, Sheikhupura. Contract Acceptor M/s Dyson Research Labs, Lahore.

AZIBAC Suspension 200mg Each 5ml after reconstitution contains: Azithromycin dihydrate equivalent to Azithromycin USP…..200mg Macrolide Antibiotic USP

Form-5 Dy No: 2430 dated: 15-04-2013 50,000/- dated 15-04-13 1,00,000/- dated 14-05-13 As per SRO

Inspection of the M/s Dyson Research Labs Sheikhupura was conducted on 26-09-14 by the area FID and overall hygiene and condition is found good.


433. Contract Giver M/s Masfa Industries (Pvt) Limited, Lahore Contract Acceptor M/s McOlson Research Laboratories, Sheikhupura.

M-XIME Suspension 100mg/5ml Each 5ml contains: Cefixime trihydraye equivalent to Cefixime…..100mg Cephalosporin USP

Form-5 Dy No: 2430 dated: 15-04-2013 1,50,000/- As per SRO

Inspection of M/s McColson Research Labs conducted on 26-08-14 and 11-09-14 by the panel of inspectors and recommends the grant of renewal of DML to the

Approved. Firm will provide undertakings & agreement as per approved contract policy and Chairman will permit issuance of


firm

registration letter. Permission will be valid till 30.06.2015).

434. Contract Giver M/s Masfa Industries (Pvt) Limited, Lahore Contract Acceptor M/s McOlson Research Laboratories, Sheikhupura.

M-XIME Capsule 400mg Each capsule contains: Cefixime as Trihydrate…..400mg Cephalosporin USP

Form-5 Dy No: 2405 dated: 15-04-2013 1,50,000/- As per SRO Pack of 5’s

Inspection of M/s McColson Research Labs conducted on 26-08-14 and 11-09-14 by the panel of inspectors and recommends the grant of renewal of DML to the firm


435. Contract Giver M/s Arsons Pharmaceutical Industries, Lahore. Contract Acceptor M/s Friends Pharma (Pvt) Limited, Lahore for

MECOFOL Injection Each1ml ampoule contains: Mecobalamin……500mcg Co-Enzyme Vitamin B-12 IP

Form-5 Dy No: 2383 dated 12-04-13 1,50,000/- As per SRO Pack of 1’s

Inspection of M/s Friends Pharma Lahore was conducted by the panel of inspectors on 21-05-14 concluded the firm GMP compliant. Liquid Injection (general) section approval vided letter No. F.1-18/ 93-Lic (Vol-II) (M-227) dated 17-06-11.

Evidence of availability of TOC and liquid particle counter is not provided.

Deferred for confirmation of installation and operational qualifications for TOC analyser & Liquid Particle Counter by Area FID.


436. Contract Giver M/s M/s Unison Chemical Works Lahore. Contract Acceptor M/s English Pharmaceuticals Lahore

ESUN Injection 40mg Each vial contains: Sterilized Esomeprazole Sodium lyophilized equivalent to Esomeprazole…..40mg PPI Manufacturer

Form-5 Dy No: 3160 dated 17-05-13 1,50,000/- As per SRO

Nexium of AstraZeneca Nexium of BMS The inspection M/s English Pharmaceuticals Lahore was conducted on 14-11-2012 and 15-11-2012 by the area FID and found GMP complaint

a. Quantity of API in master formulation needs rectification.

b. Latest GMP Inspection report of M/s English Pharma is required.

Deferred for rectification of following observations: 1. Quantity of API in master formulation needs rectification. 2. Latest GMP Inspection report of M/s English Pharma is required.

437. Contract Giver M/s M/s Unison Chemical Works Lahore. Contract Acceptor M/s English Pharmaceuticals Lahore

U-MIP Injection 40mg Each vial contains: Sterilized Omeprazole Sodium lyophilized equivalent to Omeprazole…..40mg PPI Manufacturer

Form-5 Dy No: 3161 dated 17-05-13 1,50,000/- As per SRO

Losec Infusion of AstraZeneca Risek of Getz Pharma The inspection M/s English Pharmaceuticals Lahore was conducted on 14-11-2012 and 15-11-2012 by the area FID and found GMP complaint

a. Quantity of API in master formulation needs rectification


Deferred for rectification of following observations: 1. Quantity of API in master formulation needs rectification. 2. Latest GMP Inspection report of M/s English Pharma is required.

438. Contract Giver M/s Dyson Research Labs, Lahore. Contract Acceptor M/s English Pharmaceuticals Lahore

BEMOX Infusion Each 250ml contains: Moxifloxacin as hydrochloride…….400mg Fluoroquinolone Manufacturer

Form-5 Dy No: 2417 dated: 15-04-2013 1,50,000/- As per SRO

Avelox of Bayer HealthCare Inc Molox Infusion of CCL Pharma

a. Specifications of API needs to be submitted.

b. Under finished product specifications assay method needs to be submitted.

c. Evidence of facility of TOC analyzer and particle counter needs to be submitted.

Deferred for rectification of following observations: 1. Specifications of API needs to be submitted. 2. Under finished product specifications assay method needs to be


d. Latest GMP Inspection report of M/s English Pharma is required.

submitted.3. Confirmation of installation and operational qualifications for TOC analyzer and particle counter. 4. Latest GMP Inspection report of M/s English Pharma is required.


DYPENEM Injection 500mg Each vial contains: Meropenem trihydrate equivalent to Meropenem……500mg Penicillin Antibiotic Manufacturer

Form-5 Dy No: 2411 dated: 15-04-2013 50,000/-dated 15-04-13 100,000 dated 14-05-13 As per SRO

Meronem of AstraZeneca Demonem of Rotex Medica

a. Evidence of approval of manufacturing facility for applied product needs to be submitted


Deferred for rectification of following observations: 1. Evidence of approval of manufacturing facility for applied product needs to be submitted

2. Latest GMP Inspection report of M/s English Pharma is required.


DYPENEM Injection 1g Each vial contains: Meropenem trihydrate equivalent to Meropenem……1g Penicillin Antibiotic Manufacturer

Form-5 Dy No: 2412 dated: 15-04-2013 50,000/-dated 15-04 -13 100,000 dated 14-

Meronem of AstraZeneca Demonem of Rotex Medica

a. Evidence of approval of manufacturing facility for applied product needs to be submitted

b. Latest GMP Inspection report of M/s English Pharma

Deferred for rectification of following observations: 1. Evidence of approval of manufacturing facility for applied product needs to be


05-13 As per SRO

is required. submitted2. Latest GMP Inspection report of M/s English Pharma is required.

Case No.10. Replies of deferred applications

Evaluator – I

Case No. a: -

The following two products, namely Effiflox 125mg/5ml and Effiflox 250mg/5ml, of M/s Sami Pharmaceuticals (Pvt) Ltd., Karachi were deferred in the 242nd meeting of the Registration Board held on 24th – 25th February, 2014 for confirmation of approved dosage form (dry powder suspension or solution) by stringent regulatory bodies.

2. The firm has now submitted that they have prepared the drugs against LEVAQUIN of M/s Janssen Pharma – USA as oral solution and in parallel conducted accelerated stability studies. The firm has also submitted revised Form – 5 and requested the Board to grant registration as oral solution. 3. It is pertinent to mention that evidence of approval of 250mg / 5ml strength by stringent regulatory agencies was not submitted by the firm instead comments of some local prescribers in favor of the same have been submitted.



1.Type of Form 2. Type of application 3. Demanded Price / Pack size 4. Initial date, diary. 5. Date on which fee becomes complete according to type of application /or Form

1.Finished Product Specification 2. Facility where drug has to be manufactured with status whether approved by CLB or not 3. Last GMP inspection report with date & status.

Decision in 242nd Meeting of Registration Board

Decision


441. M/s Sami Pharmaceuticals (Pvt) Ltd., F-95, Off. Hub River Road, S.I.T.E., Karachi.

1. EFFIFLOX 125 mg/5ml 2. Dry powder suspension 3. Each 5ml of reconstituted suspension contains: Levofloxacin Hemihydrate MS eq. to Levofloxacin …………….. 125mg 4. Fluroquinolone.

1. Form-5 2. Fast track 3. As per PAC, 60ml. 4. 20/04/2011, 264 (R&I) 5. 24/04/2013 Rs.60,000/-

1. Manufacturers specification. 2. Dry powder suspension General Antibiotic available as per inspection report dated 02/05.2013. 3. cGMP report dated 02/05/2013 is provided wherein good level of GMP compliance is reported.

Deferred for confirmation of approved dosage form (dry powder suspension or solution) by stringent regulatory bodies.

The Board did not accede the request of firm for change in dosage form & deferred the instant application for review of formulation by Incharge, PEC..

442. M/s Sami Pharmaceuticals (Pvt) Ltd., F-95, Off. Hub River Road, S.I.T.E., Karachi.

1. EFFIFLOX 250 mg/5ml 2. Dry powder suspension 3. Each 5ml of reconstituted suspension contains: Levofloxacin Hemihydrate MS eq. to Levofloxacin …………….. 250mg 4. Fluroquinolone.

1. Form-5 2. Fast track 3. As per PAC, 60ml. 4. 20/04/2011, 263 (R&I) 5. 24/04/2013 Rs.60,000/-

1. Manufacturers specification. 2. Dry powder suspension General Antibiotic available as per inspection report dated 02/05.2013. 3. cGMP report dated 02/05/2013 is provided wherein good level of GMP compliance is reported.

Deferred for confirmation of approved dosage form (dry powder suspension or solution) by stringent regulatory bodies.

The Board did not acceed the request of firm for change in dosage form & deferred the instant application for review of formulation by Incharge, PEC.


Case No. b:

Following registration application of M/s Arson Pharmaceutical Industries (Pvt) Ltd., Lahore was deferred in the 243rd meeting of the Registration Board for status of license in light of inspection report dated 15-04-2013.

2. The firm has now submitted copy of panel inspection report dated 08/05/2014 for renewal of Drug Manufacturing License and Grant of additional section (Tablet Psychotropic). The panel in its aforesaid report reached on the following recommendations:

a. Recommend the renewal of Drug Manufacturing License of the firm M/s Arson Pharmaceutical Industries (Pvt) Ltd., Multan Road Lahore.

b. Recommend the grant of license to the additional tablet Psychotropic Section.

3. The firm has also submitted a copy of certificate of current Good Manufacturing Practices dated 19-08-2014 wherein it is reported that firm is found complying with cGMP in terms of process control, maintenance of equipment and area, documentation etc. as per provisions of Drugs Act, 1976 and rules framed there under.

443. M/s Arsons Pharmaceutical Industries (Pvt) Ltd. 22 Km Multan Road off 4 Km Defence Road, Lahore Anomaly Case: Capsule (General Antibiotic) Vide letter No. F. 1-14/95 – Lic (Vol I) (M – 227) dated 13th June, 2011

DOXICYCLINE 100mg Capsules Capsule Each Capsule contains:- Doxycycline as Hyclate…..100 mg Tetracycline

As Per SRO 10 x 10’s

Form-5 28-09-2012 2280 R&I Rs.20,000/-

Vibramycin 100mg Capsules US FDA DOTUR 100mg Capsule Novartis

Deferred for status of lisence in light of inspection report dated 15-04-2013

Decision: The Board approved the registration of application.


Case No. c: -

Following registration application of M/s A’raf (Pvt) Ltd., Lahore was deferred in the 242nd meeting of the Registration Board for expert opinion of Dr.Rizwan Taj, PIMS and Brig Jehangeer Saleem. Now, the firm has informed that same product is already registered in the 214th meeting of the Registration Board having registration No. 062765 to the firm M/s Schazoo Zaka.

2. In light of above, firm has requested for registration of their product and to change it to XR.

444. M/s A’RAF (Pvt) Ltd. (Former M/s Remedy Pharmaceutical Pvt Limited), 23 Km Raiwind Road Lahore.

1. Zaxine SR 150mg tablets 2. Sustained release film coated tablet 3. Each tablet contains: Venlafaxine as Hydrochloride ……. 150mg 4. Serotonin and Noradrenaline Reuptake Inhibitors.

1. Form-5 D 2. Fast track 3. Rs. 1100/- per 14’s 4. 30/07/2013, 9209 (R&I) 5. Rs.60,000/- Rs. 90,000/-

1. B.P. specifications. 2. General Tablet section available as per inspection report dated 19/01/2012. 3. GMP report dated 19/01/2012 attached. The formulation is found available in UK

Deferred for expert opinion of Dr.Rizwan Taj, PIMS; Brig Jehangeer Saleem

Decision: The Board approved the registration of the product & acceded to the request of the firm for change in nomenclature from SR to XR.


Evaluator - I

S/N


Brand Name


Composition



Type of Form

Initial date, diary





Me-too status


Decision

445. M/s. P.D.H. Pharmaceuticals, Lahore

Pyrox-B Tablets Each tablet contains:- Piroxicam Beta Cyclodextrin equivalent to Piroxicam …. 20mg (NSAID) Manufacturers specifications

Form-5 Fast Track 28/8/2013 9991 R&I 28/8/2013 (Rs. 60,000/-) Rs.265.22 per 2x10’s

Deferred for final reminder for completion of Form 5 1. An undertaking / commitment regarding the submission of following, as per decision of the Registration Board, may be submitted: a) Label claim and prescribing information being same as approved by reference drug agencies e.g., FDA, TGA, MHLW, EMA and Health Canada.

Brexidol, Cheisi, BNF Brexin 20mg, Cheisi Inspection report dated 30/09/2014 provided. Firm showed improvement regarding previous shortcomings / observations.

Approved.


2. Several observations have been made by the area FID in the inspection report dated 05/03/2014 regarding validation of HVAC, frequency of In Process testing, differential pressure maintenance, old machinery like fluid bed dryer, mixer, granulator to be replaced with latest version etc.

446. M/s. P.D.H Pharmaceuticals (Pvt) Ltd., 19 Km, Ferozpur Road, Lahore.

Giostatin 10mg Tablets Each film coated tablet contains:- Rosuvastatin Calcium equivalent to Rosuvastatin …………….. 10mg Statins Manufacturers specifications

Form 5 Fast Track 12/4/2013 798 R&I 13/11/2013 (Rs. 60,000/-) Rs.250/10’s

Deferred for final reminder for completion of Form 5 1. An undertaking / commitment regarding the submission of following, as per decision of the Registration Board, may be submitted: a) Label claim and prescribing information being same as approved by reference drug agencies e.g., FDA, TGA, MHLW, EMA and Health Canada. 2. Several observations

Crestor 10mg, FDA Rosutrol 10mg, Pfizer Inspection report dated 30/09/2014 provided. Firm showed improvement regarding previous shortcomings / observations.

Approved.


have been made by the area FID in the inspection report dated 05/03/2014 regarding validation of HVAC, frequency of In Process testing, differential pressure maintenance, old machinery like fluid bed dryer, mixer, granulator to be replaced with latest version etc.


Esogerd 20mg Capsule Enteric coated pellets Each capsule contains:- Esomeprazole Magnesium trihydrate enteric coated pellets equivalent to Esomeprazole …………..… 20mg Anti-ulcer Manufacturers specifications Source: M/s Vision Pharmaceuticals, Islamabad

Form 5 Fast Track 12/11/2013 788 R&I 12/11/2013 (Rs. 60,000/-) Rs.231/ 2x7’s

Deferred for final reminder for completion of Form 5 1. An undertaking / commitment regarding the submission of following, as per decision of the Registration Board, may be submitted: a) Label claim and prescribing information being same as approved by reference drug agencies e.g., FDA, TGA, MHLW, EMA and Health Canada. 2. Several observations

Nexium 20mg Capsules, FDA Nexum 20mg, Capsules Inspection report dated 30/09/2014 provided. Firm showed improvement regarding previous shortcomings / observations. FID mentioned that automatic capsule filling machine should be provided in capsule filling area.

Approved.


have been made by the area FID in the inspection report dated 05/03/2014 regarding validation of HVAC, frequency of In Process testing, differential pressuremaintenance, old machinery like fluid bed dryer, mixer, granulator to be replaced with latest version etc.


Esogerd 40mg Capsule Enteric coated pellets Each capsule contains:- Esomeprazole Magnesium trihydrate enteric coated pellets equivalent to Esomeprazole ……………… 40mg Anti-ulcer Manufacturers specifications Source: M/s Vision Pharmaceuticals, Islamabad

Form 5 Fast Track 12/11/2013 788 R&I 12/11/2013 (Rs. 60,000/-) Rs.360/ 2x7’s

Deferred for final reminder for completion of Form 5 1. An undertaking / commitment regarding the submission of following, as per decision of the Registration Board, may be submitted: a) Label claim and prescribing information being same as approved by reference drug agencies e.g., FDA, TGA, MHLW, EMA and Health Canada.

Nexium 40mg Capsules, FDA Nexum 40mg, Capsules Inspection report dated 30/09/2014 provided. Firm showed improvement regarding previous shortcomings / observations. FID mentioned that automatic capsule filling machine should be provided in capsule filling area.

Approved.


2. Several observations have been made by the area FID in the inspection report dated 05/03/2014 regarding validation of HVAC, frequency of In Process testing, differential pressure maintenance, old machinery like fluid bed dryer, mixer, granulator to be replaced with latest version etc.

449. M/s Zanctok Pharmaceutical Laboratories, F/5 S.I.T.E Area, Hyderabad

Genelor Syrup Each 5ml Contains: Desloratadine……………….2.5mg Antihistamine Manufacturers specifications

Form5 Routine 23/07/2010 Dy. No. 1411 Rs. 8000/- 13-05-2013 Rs. 12000/- 60ml,120ml/As per PRC

Deferred for confirmation of me too status

Firm has informed that due to typographic error the strength was typed as 5mg/10ml and that they have corrected the strength to 2.5mg/5ml. A revised Form-5 has been submitted by the firm.

Clarinex 0.5mg/ml, Syrup, FDA

Desora 0.5mg/ml Syrup, Continental Pharma

Approved.



Relevo Sachet 20mg

Each sachet contains:

Piroxicam beta-cyclodextrin 191.2 mg eq. to Piroxicam ………… 20mg


NSAIDs


Deferred for evidence of approval of same formulation by reference drug agencies e.g., FDA, TGA, MHLW, EMA and Health Canada.

BREXIN PULVER 20mg powder Torrex-Chiesi Pharma,Austria

BREXIN 20mg granules for oral solution (Sachet) Promedica, Italy

Deferred for evaluation of stability data & expert opinion by the following: 1. Dr.Abid Farooki, PIMS 2.Brig.Mushtaq, MH 3.Dr.fareedullah Zimri, NIRM


Gastocon Liquid Sachet

Each 10ml sachet contains:

Sodium alginate (BP) 500 mg

Sodium bicarbonate (BP) 267mg

Calcium carbonate (BP)…. 160 mg

(BP Specifications)

Reflux suppressant / Antacid


Deferred for: 1) Evidence of approval of same formulation by reference drug agencies e.g., FDA, TGA, MHLW, EMA and Health Canada. 2) Stability data.

Now following reference in terms of evidence of international availability has been submitted: GAVISCON Liquid Sachet MHRA

Deferred for evaluation of stability data & expert opinion by the following: 1.Brig.Amjad Salamat 2.Dr.Najam, Shifa 3.Prof.Umer, RMC

452. M/s GlaxoSmithKline Pakistan limted, F-268 S.I.T.E., Karachi

Panadol Sinus Caplets Caplets Each Caplet Contains: Paracetamol…500mg Phenylephrine Hcl. 5.00mg

Form 5-D (Fast Track) Rs.8,000/- 09-12-2010 Dy. No. not mentioned Rs.60,000/- 20-03-2013 Dy. No. not

Registration Board referred Panadol sinus Caplets to Pharmaceutical Evaluation Cell for scrutinization in light of check list approved by

BENYLIN COLD & SINUS 500/5mg Health Canada Inspection dated 07-01-2014, 21-01-2014 & 19-02-2014. Well maintained / retained unit

Deferred for evaluation of stability data which should be performed at the applicant’s site & expert opinion by the following: 1.Brig.Aslam


mentioned Rs.82,000/- 19-11-2013 Dy. No. not mentioned Rs.300/-100’s

Registration Board.

reported. Tablet section mentioned in report. 1. In terms of Prescribing information (PI), Patient Information Leaflet (PIL) and Summary of product characteristics (SmPC) as approved by Drug regulatory agencies or authorities of country of origin or FDA, EMA, TGA, etc., firm has submitted international data sheet for the product. 2. Data of stability studies conducted on three pilot batches at 25C/60%RH, 30C/60%RH, 30C/75%RH and 40C/75%RH. However, it is pertinent to mention that the batches were manufactured in Sydney, Australia as the raw material and pharmaceutical development was carried out in firms R&D center in Australia.

2.Dr.Shazli Manzor 3.Dr.Rehana Kauser, PIMS


Evaluator – II

S/N


Brand Name


Composition



Type of Form

Initial date, diary





Me-too status


Decision

453. M/s Herbion Pakistan (Pvt) Ltd., Kahuta Road, industrial Triangle, Humak, Rawalpindi- Islamabad.

LacNovex / LaxNovex / ConstiNovex 3.35g Syrup Each 5ml contains:- Lactulose (BP)………3.35g (Laxative) (B.P Spec.s) {Source of Lactulose: M/s Fresenius Kabi Austria GmbH EstermannstraBe 17 4020 Linz}

Form 5

26-02-2014 Dy.No.208 Rs.20,000+

Rs.80,000/-(05-09-2014)

Rs.170.00/

120ml

Deferred for confirmation of 1. Source & Fee. 2. Testing facility by DDG DRAP and FID (M-243)

BNF 61 (Lactulose (Non-proprietary) DUPHALAC(HIGHNOON LABORATORIES LTD.) Grant of DML recommended (23-24th January 2014)

Approved. Firm will provide legalized GMP of source of lactulose and Chairman, RB will permit issuance of registration letter.


1. The firm has deposited fee of Rs. 80,000/- and requested for fixation of source i.e. M/s Fresenius Kabi Austria GmbH EstermannstraBe 17 4020 Linz.

2. Valid and legalized GMP Certificate of Source, COA and stability studies according to zone IV-a of lactulose are required.

(The firm has submitted COA & Stability studies)

3. Confirmation of testing facility by DDG DRAP and FID. (The inspection report by area FID & DDG dated 02.12.2014 confirms the testing facility).


454. -do- MonteNovex / AzmaNovex / LeukoNovex 5mg Chewable Tablets Each chewable tablet contains:- Montelukast Sodium BP eq. to Montelukast…5mg (Antiasthmatic Agent (Leukotriene Receptor antagonist) (Manufacturer’s Spec.s)

Form 5

24-02-2014 Dy.No.201

Rs.20,000

Rs.400.00/

14’s

Deferred for correction in master formulation.

BNF 61: (Singulair (MSD) Aerokast (Barrett Hodgson) Grant of DML recommended (23-24th January 2014) 1. The firm has

corrected master formulation.

Approved.

455. -do-

MonteNovex / AzmaNovex / LeukoNovex 10mg Chewable Tablets Each chewable tablet contains:- Montelukast Sodium BP eq. to Montelukast……….10mg (Antiasthmatic Agent (Leukotriene Receptor antagonist) (Manufacturer’s Spec.s)

Form 5

24-02-2014 Dy.No.197 Rs.20,000

Rs.460.00/

14’s

Deferred for correction in master formulation and confirmation of international availability

Not confirmed Aerokast (Barrett hodgson) not in chewable dosage form Grant of DML recommended (23-24th January 2014) 1. The firm has

corrected master formulation.

2. Reference of International availability has been given from India and Bangladesh.

3. Reference of

Rejected on the grounds that the efficacy & safety of the said formulation has not been established in chewable dosage form.


5mg chewable tablets has been given from Health Canada. Formulation is in film coated dosage form in Health Canada.

456. -do- Neemplast Plaster Contains:- Acrinol…………10.4% (Disinfectant and Antiseptic) (Manufacturer’s)

Form 5 17-03-2014 Dy.No.251 Rs.20,000

Rs. 25/

19×72mm (10 strips)

Rs. 35/19×72mm

(20 strips) Rs.

160/19×72mm (100 strips)

Rs. 720/19×72mm

(500 strips)

Deferred for confirmation of me too status and international availability.

Not confirmed Saniplast (Uniferoz Karachi) Grant of DML recommended (23-24th January 2014) 1. The firm has

provided reference of Saniplast of Uniferoz for both international availability and me-too status.

2. International availability not confirmed in stringent DRS’s.

3. Discussion is requested from honorable

Deferred for verification that the said formulation is registered in which category in the reference Stringent Regulatory Agencies whether as an OTC or Pharmaceutical.


Drug Registration Board about the status of formulation that whether it is a drug or HOTC product.

S/N


Brand Name


Composition



Type of Form

Initial date, diary





Me-too status


Decision

457. M/s. Simz Pharmaceuticals (Pvt) Ltd, 574-575 Sundar Industrial Estate, Raiwind Road Lahore.

Ibusim DS 200mg Liquid Suspension Each 5ml contains:- Ibuprofen (B.P)…..200mg (Antirheumatic, anti-inflammatory) (B.P Spec.s)

Form-5 Rs.20,000/-10-2-2014 Rs.60.00/90ml

Deferred for confirmation of international availability. (M-244)

Health Canada: Advil Pediatric Drops Brufen DS (Abbot) GMP compliant (22-11-2013)

1. The product was deferred because the Firm had not provided

Approved.


the International availability especially in FDA, EMA, Health Canada, TGA & MHLW for same generic, dosage form & strength with reference is required. Firm had provided Dolan Fp Forte from Phillipine. Later on same formulation was approved in M-245 for M/s Titles Pharma Karachi because international availability was confirmed. The Firm has requested to consider their application for registration.

458. M/s. Cibex (Private) Ltd. F-405, SITE, Karachi

Batema-F Syrup Each 15ml contains: Iron Protein Succinylate 800mg equivalent to elemental iron…40mg Folic Acid…5mg (Anti-Anaemic) (Manufacturer’s Spec.s)

Form-5 30-04-2014 (611) Rs.20,000/- As per SRO/60ml, 120ml

Deferred for confirmation of Me-Too & International (especially in Stringent Regulatory Agencies) registration Status. (M-245)

Not confirmed Sucrofer-F Syrup (Nexpharm) Grant of DML recommended (22-10-2013)

1. The Firm has

submitted that the product is already available locally manufactured

Approved


by CCL under the license of Nexpharm and the product is although not available in SRA,s but DRAP has granted registration to several companies. The Firm has requested for product registration.

459. -do- Cimora 20mg Capsule Each Capsule contains: Esomeprazole Magnesium Trihydrate enteric coated pellets equivalent to Esomeprazole…20mg (Anti-Ulcerant) (Manufacturer’s Spec.s)

Form-5 30-04-2014 (625) Rs.20,000/- As per SRO/14 Capsules

Deferred for rectification of following observation: 1. Fee for import. 2. Legalized and Valid GMP 3. Certificate of Analysis

4. Stability Studies according to zone assigned to Pakistan. (M-245)

BNF: Nexium (AstraZeneca) C-ESO (Crown Pharmaceuticals) Grant of DML recommended (22-10-2013)

1. The Firm has submitted documents for source of pellets, M/s Surge Lab (Pvt. ) Ltd. 10th K.M Faisalabad Road , Sheikhupura.

2. cGMP certificate has been issued to M/s Surge for

Approved


Evaluator – III

Cases deferred in M-245 meeting




Decision in 245th of Registration Board.


Decision

Enteric coated Pellets/Granules and Taste Masked Granules/ Pellets.

3. Approval by CLB for manufacturing of Esomeprazole enteric coated pellets by M/s Surge submitted.


460. M/s Cibex (Pvt) Limited Karachi.

KATAFEN Rapid Gel 1% Each gram contains:- Diclofenac diethylamine….10mg Anti-Rheumatic Manufacturer

Form-5 Dated 30/04/14 Dy No: 602 20,000/- Pack of 1’s, 20gm & 50gm/ As per PRC

Deferred for submission of finished product specifications

The firm has submitted the finished product specifications of applied product.

Approved.

461. -do- MYBINA Plus Ointment Each gram contains:- Polymyxin B sulphate….5000IU Bacitracin…500IU Neomycin…3.5mg Lidocaine….40mg Antibacterial Manufacturer

Form-5 Dated 30/04/14 Dy No: 605 20,000/- Pack of 1’s, 20gm tube/ As per PRC

Deferred for rectification of following observations: Under finished product specifications assay method is not submitted.

The firm has submitted the assay method under finished product specifications of applied product.

Approved.

462. M/s.Shawan Pharmaceuticals, Plot #37, Road: NS-1, National Industrial Zone, Rawat Islamabad.

DEXPRO Tablet 300mg Each film coated Tablet contains: Dexibuprofen ….. 300mg NSAID Manufacturer

Form 5 Fast Track Dy. No.5246 dated 16-08-2013 Rs.60,000/- As per SRO Pack of 10’s

Deferred for review committee for review of formulation

Seractil of Genus (BNF-61) Dexib of Tabros Pharma Karachi Inspection of the firm was conducted on 23 July 2013 and GMP compliance is found GOOD

Approved.

Cases deferred in M-242 meeting





Decision in 242nd of Registration Board.


Decision

463. M/s Medwell Pharmaceuticals, Lawrencepur

BETADINE Scrub Each 5ml contains: Povidone-Iodine…….7.5% Disinfectant BP

Form-5 Dy.No: 6382 dated: 07-10-2013 60,000/- As per SRO/ 50ml, 60ml and 450ml bottle

Deferred as the firm has not completed the requisite documentation per Form-5

Pyodine of Brookes Pharma Karachi The inspection of firm was carried out on 01-04-2014 by the area FID and GMP compliance was found good.

Approved.


Veterinary cases




Decision in 242nd of Registration Board.


Decision

464. M/s Jfrin Pharmaceuticals, Lasbella Balochistan

JF COLAMINE Oral Powder Each 100gm contains: Tylosin Tartrate…..100mg Doxycycline HCL…..200mg Phenyl Butazone….12gm Bromohexine HCL….05gm Colistin Sulphate…..500MIU Antibiotic Manufacturer

Form-5 Dy.No: 866 dated: 24-07-2013 60,000/- Decontrolled/ Jar of 100, 500, 1000gm

Deferred as the firm has not completed the requisite documentation per Form-5

Broncofas of Zakfas Pharmaceuticals

Rejected as the formulation contains banned drug that is Phenyl Butazone.


Case No. 11. NEW APPLICATIONS IN LEIU OF REJECTED ONES

Evaluator - III

Two products of M/s Hiranis Pharmaceuticals are rejected in the 243rd meeting of Registration Board as the safety and efficacy has not been established in the stringent SRA’s. The firm has submitted new applications in lieu of the rejected products. The detail is tabulated below:

Sr. No.

Products Discussed in M-243

Decision in M-243 New Products applied

1. Acebro Capsule (Acebrophylline 100mg)

Rejected as safety and efficacy of formulation has not been established in stringent regulatory authorities.

Fungisaf Capsule (Fluconazole 150mg)

2. Acebro syrup (Acebrophylline 50mg/ 5ml)

Rejected as safety and efficacy of formulation has not been established in stringent regulatory authorities.

Levopearl oral suspension 125mg/5ml (Levofloxacin)


The detail of new products is follows:






Decision

465. M/s Hiranis Pharmaceuticals Karachi

FUNGISAF Capsule 150mg Each capsule contains Fluconazole…..150mg Triazole Antifungal Manufacturer

Form-5 Dy No: 807 dated 28-07-14 20,000/- As per PRC

Diflucan Pfizer Inc

Diflucan of Pfizer Karachi

Approved.

466. -do- LEVOPEARL Oral Solution Each 5ml contains: Levofloxacin (USP)….125mg/ 5ml Quinolone Manufacturer

Form-5 Dy. No: 2067 dated:16-12-2013 20,000/- As per PRC

Levaquin Oral Solution of Janssen (USFDA)

The product was initially considered as dry oral suspension in 243rd meeting of Registration Board and deferred with following decision: “Deferred for confirmation of formulation” The firm then revised the formulation as Oral Solution which was product again

The Board did not accede to the request of firm for change in dosage form & deferred the instant application for review of formulation by Incharge,


considered in 244th meeting of Registration Board and deferred with decision: “Deferred as the Registration Board has already granted ten products in liquid syrup section (general)” The firm has now requested to consider applied formulation in lieu of the rejected product (Acebro syrup (Acebrophylline 50mg/ 5ml) in 243rd meeting of RB

PEC.


Item No. VI Miscellaneous Cases - Pharmaceutical Evaluation & Registration Division.

Registration-I

Case No.01. Drugs deferred by Registration Board for expert opinion.

a. Strefen Lozenges - M/s. Reckitt Benckiser Healthcare International, Karachi.

Following drugs deferred for expert opinion. Accordingly product was referred to expert

for views. Comments are as under:-

S. No. Name of Indenter/ Manufacturer

Name of drug (s)/ Composition

& Therapeutic Group

Demanded Price/Pack

Shelf Life Date of application receiving

& fee. 1. M/s. Reckitt Benckiser

Healthcare International, Karachi. / M/s. Notting Site, Nottingham, Nottinghamshire, United Kingdom.

Strefen Lozenge Each one lozenge contains:- Flurbiprofen BP……………..8.75mg

Price not mentioned.

03 years 04-06-2012 Rs.15000 + Rs.35000 = Rs.50,000/-

Dr. M.Ehsan-ul-Haq, MBBS, DTCD, FCPS, (Physician (Medicine), Federal Govt. Services Hospital, Islamabad.

Prof. Dr. Ejaz Hussain Malik, Nishtar Medical Institution, Multan.

Brig. (R) Prof. Dr. Muzammil Hasan Najmi, Chairman, Department of Pharmacology/Associate Dean, Basic Sciences Division, Foundation University, Medical College, Rawalpindi.

The drug Strefen Lozenge containing flurbiprofen BP 8.75 can be useful addition to the list of pharmaceutical available in the country. Since the amount of the active principle is quite small. It is les likely to cause untoward dose-related side effects. The lozenge formulation of this compound is already in use in the world market. However the therapeutic efficacy and the

I have gone through the literature of Flurbiprofen. The only is good and sample and recommended for registration.

Awaited.


social acceptance in our population can only be accessed when it is used in our country. The drug is intended for local use and has small amount of the active principle and thus is expected to be cost effective.

Decision: Registration Board approved registration of Strefen Lozenge as per detail

mentioned in the case. The approval is subject to inspection of manufacturer abroad as per

import policy, verification of storage facilities and price fixation / calculation by the pricing

Division etc.

b. AminoFluid ® Infusion Solution 1000ml - M/s Otsuka Pakistan Ltd., Distt. Lasbella

Registration Board in its 238th meeting deferred following products for expert opinion.

Accordingly products were referred for views. Comments are as under:-

S. No.

Name of Indenter/

Manufacturer


& Therapeutic Group

Demanded Price/Pack

Shelf Life

Date of application receiving

& fee. 1. M/s Otsuka

Pakistan Ltd., Distt. Lasbella. / M/s. PT. Otsuka Indonesia, Lawang, Malang. Indonesia.

AminoFluid ® Infusion Solution 1000ml Each 150ml contains:- L-Leucine…...………………2.100g L-Isoleucine……………...…1.200g L-Valine..………………...…1.200g L-Lysine hydrochloride…….1.965g (L-Lysine Equivalent)….....(1.573g) L-Threonine...........................0.855g L-Tryptophen……………….0.300g L-Methionine.………………0.585g L-Cystoine………………….0.150g L-Phenylalanine…………….1.050g L-Tyrosine..………………...0.075g L-Arginine………………….1.575g L-Histidine………………….0.750g L-Alanine…………………...1.200g L-Proline….………………...0.750g LSerine ……………………..0.450g Gylcine……...........................0.885g

Rs.4201/Per 1000ml Soft

bags.

02 years

27-09-2012 Rs.50,000/-


L-Aspartic acid……………..0.150g L-Glutamic acid….................0.150g Dipostassium phosphate…....0.458g Water for injection ad….........150ml (Clinical Parrenteral Nutrition).

2. M/s Otsuka Pakistan Ltd., Distt. Lasbella. / M/s. PT. Otsuka Indonesia, Lawang, Malang. Indonesia.

Kidmin ® Injection Each 1000ml contains:- L-Leucine………………….…14.0g L-Isoleucine………………...…9.0g L-Valine……………………...10.0g L-Lysine acetate………………7.1g (free base)…………………..(5.05g) L-Threonine…...........................3.5g L-Tryptophan……………….....2.5g L-MEthionine…………………3.0g L-Phenylalanine…………….....5.0g L-Cysteine….…………………1.0g L-Tyrosin……………………...0.5g L-Arginine…..………………...4.5g L-Histidine………………...…..3.5g L-Alanine………………...……2.5g L-Proline…………………...….3.0g L-Serine……………………….3.0g L-Aspartic acid..........................1.0g L-Glutamic acid……………….1.0g (Clinical Parentertal Nutrition).

Rs.1708/ Per 200ml

bag

02 years

18-10-2012 Rs.15000 + Rs.35000 = Rs.50,000/-

3. M/s Otsuka Pakistan Ltd., Distt. Lasbella. / M/s. PT. Otsuka Indonesia, Lawang, Malang. Indonesia.

Amiparen ® Injection Each 500ml contains:- L-Leucine…...………………..7.00g L-Isoleucine……………….....4.00g L-Valine……………………...4.00g Lysine Acetate……………….7.40g (L-Lysine equivalent)…....…(5.25g) L-Threonine………………….2.85g L-Tryptophan...........................1.00g L-Methionine...........................1.95g L-Phenylalanine……………...3.50g L-Cysteine…………………...0.50g Total free amino acids……50.00g Essential amino acids (E)…..29.55g Nonessential amino acids (N)20.45g Total nitrogen………………..7.84g L-Tyrosine…...........................0.25g L-Arginine...…………………5.25g L-Histidine…………………...2.50g L-Alanine…………………….4.00g L-Proline…..…………………2.50g

Rs.2512/ Per 500ml

Bag

02 years

24-09-2012 Rs.15000 + Rs.35000 = Rs.50,000/-


L-Serine…...…………………1.50g Aminoacetic acid………….…2.95g L-Aspartic Acid.......................0.50g L-Glutamic acid.......................0.50g Water for injection……ad 500mL (Clinical Parenteral Nutrition).

In charge Intensive Care Unit (ICU),

Pakistan Institute of Medical Sciences, Islamabad.

In charge Intensive Care Unit (ICU),

Military Hospital, Rawalpindi.

I have evaluated the data provided by Otsuka Pakistan Limited concerning AminoFluid ® 1000ml dual chamber soft bags, Kidmin ® Injection 200ml soft bag and Amiparen ® Injection 500ml soft bag. I have found that the scientific data supports the therapeutic efficacy and favorable safety profile. I recommended that this drug be registered according to the drug authority regulations.

Awaited

Decision: Brig. Aslam Khan, Member Registration Board / Incharge Intensive Care Unit (ICU), Military Hospital, Rawalpindi also recommended the appled formulations. Thus Registration Board approved registration of AminoFluid ® Infusion Solution 1000ml, Kidmin ® Injection and Amiparen ® Injection as per detail mentioned in the case. The approval is subject to inspection of manufacturer abroad as per import policy, verification of storage facilities and price fixation / calculation by the pricing Division etc. c. Propilen Surgical Suture with Needle - M/s. Nishat Surgical Hyderabad

Registration Board in its 243rd meeting deferred following products for expert opinion.


S. No.

Name of Indenter/

Manufacturer


& Therapeutic Group

Demanded Price/Pack

Shelf Life

Date of application receiving &

fee. 1. M/s. Nishat

Surgical Hyderabad Sindh Pakistan manufactured by M/s. Dogsan

Propilen Surgical Suture with Needle

As per PRC 05 years

26-03-2012 Rs.100,000/-


Tibbi Malzeme Sanayi A.S. Trabzon Turkey.

2. -do- Silk Non Absorbable Surgical Sutures

As per PRC 05 years

26-03-2012 Rs.100,000/-

3. -do- Pegelak and Pegelak Rapid

Synthetic Absorbable Surgical Sutures with Needle

As per PRC 05 years

26-03-2012 Rs.100,000/-

4. -do- Tektel Non Absorbable

Surgical Sutures with Needle As per PRC 05

years 26-03-2012 Rs.100,000/-

5. -do- Pedesente Synthetic

Absorbable Surgical Sutures with Needle

As per PRC 05 years

26-03-2012 Rs.100,000/-

6. -do- Pegesorb and Pegesorb Rapid

Synthetic Absorbable Surgical Sutures with Needle

As per PRC 05 years

26-03-2012 Rs.100,000/-

Professor Tanwir Khaliq, Professor of Surgery, Department of General Surgery, Pakistan Institute of Medical Sciences, Islamabad.

Dr. I.U Baig, FCPS FRCS, Consultant Surgeon & HOD, Federal Government Polyclinic, Islamabad.

Lt. Col. Dr. Farhan Ahmad Majeed, Surgeon, Combined Military Hospital, Rawalpindi

We have used the surgical sutures in our procedures. The tissue penetration, needle, suture strength, pliability and knotting quality have been found satisfactory.

Samples of sutures supplied by M/s. Nishat Surgical Hyderabad Sindh Pakistan manufactured by M/s. Dogsan Tibbi Malzeme Sanayi A.S. Trabzon Turkey were used/tested by me and by my surgeons at FGPC and our observations regarding the surgical sutures are : 1.Sterile packing is good. 2.Tensile strength of sutures of their appropriate types and sizes is good. 3.Needle anchorage is fine. 4.Needle quality is good. 5.Tissue reaction to sutures is according to standard.

Surgical sutures of M/s. Nishat Surgical Hyderabad Sindh Pakistan are of unsatisfactory quality, specially size of needle is dispropertmat with thread size (dia).


6.No allergic reaction to suture material. 7.No postoperative infections nooted. In light of above observations I recommend sutures namely; Propilen, Silk, Pegalak and Pegalak Rapi, Tektel, Pedesente and Pegesorb and Pegesorb Rapid.

Decision: Registration Board deferred the case due to the comments of Lt. Col. Dr.

Farhan Ahmad Majeed, Surgeon, Combined Military Hospital, Rawalpindi as he

mentioned “unsatisfactory quality, specially size of needle is dispropertmat with thread size

(dia)”. The Board decided to send these observations of Lt. Col. Dr. Farhan Ahmad Majeed

to the following experts for further pratical evaluation:

Col. Dr.Bilal Umair, Surgeon, CMH. Dr.Mamoon Rasheed, Surgeon, Shifa Int Hospital, Islamabad.

d. Azarga Eye Drop Suspension 5ml - M/s. Ali Gohar & Co. (Pvt) Ltd., Karachi



S. No.

Name of Indenter/

Manufacturer


& Therapeutic Group

Demanded Price/Pack

Shelf Life


fee. 1. Applicant:

M/s. Ali Gohar & Co. (Pvt) Ltd., Karachi. / Manufacturer: M/s. S.A. Alcon-Couvreur N.V. Rijksweg 14, 2870 Puurs, Belgium.

Azarga Eye Drop Suspension 5ml Each ml contains:- Brinzolamide......10mg Timolol...............4mg (Beta Blocking agents). Finished product specifications are Manufacturer.

Rs.1400/ 5ml Eye

Drops packs

24 months

02-03-2010 Rs.50, 000/-


Prof. Dr. M. Daud Khan, Principal & Dean, Pak International Medical College, Hayatabad, Peshawar.

Prof.Dr. Ali Raza, Head of Eye Department, RMC and Allied Hospitals, Rawalpindi.

Maj. Gen. Mazhar Ishaq, Commandant, Armed Forces Institute of Opthalmology, The Mall, Rawalpindi.

Alcon International is the leading international pharmaceutical company dealing with Ophthalmic drugs and devices. Alcon drugs are known for quality, safety and efficacy. Azarga Eye Drops, which is a combination of a beta blocker and carbonic anhydrase inhibitor. It is registered by FDA and has many studies in support of its safety, efficacy and effectiveness. The price seems to be reasonably comparable to other anti-glaucoma drugs. I therefore recommend that the drug may kindly be registered in Pakistan.

I have reviewed the literature & references relating to the above mentioned product with regard to its safety, efficacy & cost effectiveness. Azarga (Brinzolamide, Timolol) is most comfortable Eye Drops preferred by patient then Dorzolomide/Timolol combination. I have gone through all references which have been published in renowned International Medical Journals on regular intervals. As you all know that Glaucoma is a second leading cause of irreversible blindness worldwide & as well as in Pakistan & patient has to use lifelong. So it needs excellent tolerability & efficacy both. We need this product in Pakistan for the preservation of sight and prevention of blindness with Glaucoma. I always trust the quality of innovative products & Brands. I highly recommend this drug for registration & made available in Pakistan.

Azarga (Brinzolamide, Timolol) is already being used internationally for the management of Glaucoma & all references given by them have been published in peer reviewed international Medical Journals on regular basis. It has a very good efficacy and is well tolerated by the patients.

Therefore in the light of data provided I recommend this drug for registration in Pakistan.

Decision: Registration Board approved registration of Azarga Eye Drop Suspension

5ml as per detail mentioned in the case. The approval is subject to inspection of

manufacturer abroad as per import policy, verification of storage facilities and price

fixation / calculation by the pricing Division etc.


e. Hidrasec 10mg, 30mg Sachet and and Hidrasec Capsule 100mg



S. No.

Name of Indenter/ Manufacturer


& Therapeutic Group

Demanded Price/Pack

Shelf Life


fee. 1. M/s. Abbott

Laboratories (Pakistan) Limited, Karachi. / M/s. Laboratoires SOPHARTEX 21 Rue du Pressoir Vernouillet, France.

Hidrasec 10mg Sachet Each sachet contains:- Racecadotril……10mg (Anti-Diarrheal).

Rs.1046.30/Per 16 Sachets

24 months

29-04-2013 Rs.100,000/-

2. M/s. Abbott Laboratories (Pakistan) Limited, Karachi. / M/s. Laboratoires SOPHARTEX 21 Rue du Pressoir Vernouillet, France.

Hidrasec 30mg Sachet Each sachet contains:- Racecadotril….30mg (Anti-Diarrheal).

Rs.1046.30/Per 16 Sachets

24 months

29-04-2013 Rs.100,000/-

3. M/s. Abbott Laboratories (Pakistan) Limited, Karachi. / M/s. Laboratoires SOPHARTEX 21 Rue du Pressoir Vernouillet, France.

Hidrasec 100mg Capsules Each capsule contains:- Racecadotril….100mg (Anti-Diarrheal).

Rs.654/ Per 10

Capsules

24 months

29-04-2013 Rs.100,000/-

Prof.Dr. Rauf Niazi, Head of Unit-2 Pakistan Institute of Medical Sciences, Islamabad.

Prof.Dr. Syed Irfan Ahmed, Professor of Medicine, RMC & Allied Hospitals, Benazir Bhutto Hospital, Murree Road, Rawalpindi.

Brig.Amjad Salamat, Military Hospital, Rawalpindi.

I strongly recommend registration of that Raceadotril (acetorphan), Capsules and

Hidrasec is recommended for registration for the treatment

Awaited.


Sachets, however if the price of the drug can be brought down, keeping in mind the economic status of our population these drugs would be very useful addition, to present drugs, available to treat acute secretory diarrhea and reduce morbidity of this common condition. I highly recommend registration of the drug, on fast track basis.

of diarrhea in conjunction with ORS. However it should not be used to treat infections. Even in Cholera, which requires antibiotics and intravenous saline, it should be used with caution as severe fluid depletion can be a “Pre-renal” cause of renal failure. Hidrasec has a renal mode excretion. Also no studies have been conducted comparing its safety profile with Zinc or probiotics. Hence it can not be claimed superior to these modes of treatment.

Decision: Registration Board deferred the case for evaluation of clinical data by the

following experts:

Brig.Amjad Salamat MH, Rawalpindi. Prof.Syed Irfan, BBH. Prof.Rauf Niazi, PIMS.

Case No. 02. Registration of solvents for Oncodex (Docetaxel) Injection - M/s. PharmEvo (Pvt) Ltd, Karachi.

Drug Registration Board in 236th meeting held on 20th November, 2012 approved the

registration of following drugs in the name of M/s. PharmEvo (Pvt) Ltd, Karachi manufactured

by M/s. Jiangsu Aosaikang Pharmaceutical Co., Ltd., 699-Kejian Road, Jiangning Science Park,

Nanjing, China subject to inspection of manufacturer abroad:-

S. No. Name of drug (s) & composition. 1. Oncodex 20mg Injection.

Each vial contains:- Docetaxel……………20mg.

2. Oncodex 40mg Injection.


Each vial contains:- Docetaxel……………40mg.

3. Oncodex 80mg Injection. Each vial contains:- Docetaxel……………80mg.

4. Oncotaxel 100mg Injection. Each vial contains:- Paclitaxel……………100mg.

In compliance of Drug Registration Board’s decision, inspection of the manufacturer

M/s. Jiangsu Aosaikang Pharmaceutical Co., Ltd., 699-Kejian Road, Jiangning Science Park,

Nanjing, China has been carried out by the nominated panel comprising Dr. Obaidullah, Deputy

Director General (Registration) and Mr. Abdullah, Deputy Drugs Controller (RRR), Drug

Regulatory Authority of Pakistan. M/s. PharmEvo (Pvt) Ltd, Karachi was advised to submit

separate solvent application for each product. The panel of inspector has recommended the

registration of the above said products. The storage facility of the importer has already been

verified by the area FID.

In response to our latter M/s. PharmEvo (Pvt) Ltd, Karachi have informed that same

solvent with same composition is being used in all three strengths of docetaxel range with final

concentration of the diluted solution equivalent to 10mg/ml. Below is a self-explanatory chart

depicting the fill range, approximate extractable volume and final concentration of the product

i.e. 10mg/ml:-

PRODCUT NAME

DILUENT 13% (W/W)

ETHANOL IN WATER FOR INJECTION

FILL RANGE (ML)

APPROXIMATE EXTRACTABLE

VOLUME OF DILUENT WHEN

ENTIRE CONTENTS ARE

WITHDRAWN (ML)

CONCENTRATION OF THE INITIAL

DILUTED SOLUTION

(MG/ML DOCETAXEL)

DOCETAXEL 20MG INJECTION

3.88 – 3.08 ml 1.8 ml 10mg/ml


3.60 – 3.86 ml 3.66 ml 10mg/ml


6.96 – 7.70 ml 7.1 ml 10mg/ml


M/s. PharmEvo (Pvt) Ltd, Karachi was again advised to submit separate solvent

application for each strength. In response, M/s. PharmEvo (Pvt) Ltd, Karachi has submitted

separate solvent application for each three strengths.

Decision: Registration Board approved the request of the firm for registration of the

solvents for already registered Docetaxel range of products.

Case No.03. Drugs deferred by Registration Board for submission of documents.

a. Caflam 50mg Sachets - M/s. Novartis Pharma, Karachi.

Drug Registration Board deferred the following applications for registration of drugs in

its 243rd meeting and decided as mentioned against each. Accordingly, firm was advised to

provide the same information and the firm has submitted the required information as follows:-

S.# Name of Manufacturer /

Importer.

Name of Drug (s) Composition &

Therapeutic Group.

Demanded

Price & Pack Size.

Shelf Life

Decision Reply of the firm.

1. M/s. Novartis Pharma (Pakistan) Limited, Karachi / M/s. Mipharm S.p.A., Milan, Italy.

Caflam 50mg Sachets Each sachet contains:- Diclofenac potassium……50mg (Non-steroidal anti-inflammatory drug (NSAID) Analgesic.

Rs.198/ Per packs

of 9’s Rs.22/Per

Sachet

02 years

Deferred for submission of COPP from regulatory authority of Italy

The firm has provided COPP of Italy attested by Pakistan Embassy.

Decision: Registration Board approved registration of Caflam 50mg Sachets as per

detail mentioned in the case. The approval is subject to inspection of manufacturer abroad

as per import policy, verification of storage facilities and price fixation / calculation by the

pricing Division etc.


b. Fluimucil A 600mg Effervescent Tablets - M/s. Angelini Pharmaceuticals (Pvt) Ltd.,

Lahore.

Drug Registration Board in its 244th meeting held on 22-23rd July, 2014 considered and

deferred the application of “Fluimucil A 600mg Effervescent Tablets (Acetylcysteine

600mg)” applied by M/s. Angelini Pharmaceuticals (Pvt) Ltd., Lahore imported from M/s.

Zambon Switzerland Ltd., Cadempino, Switzerland for submission of safety and efficacy data of

the drug along with complete clinical trial data of the formulation.

Name of Importer / Manufacturer.

Name of Drug (s) Composition & Therapeutic Group.

Demanded

Price & Pack Size.

Shelf Life

M/s. Angelini Pharmaceuticals (Pvt) Ltd., Lahore /

M/s. Zambon Switzerland Ltd., Cadempino, Switzerland.

Fluimucil A 600mg Effervescent Tablets. Each tablets contains:- Acetylcysteine........600mg. (Mucolytics).

Rs.561.41/Per packs of 10 effervescent

tablets.

Rs.56.14/Per effervescent

tablets.

03 years

Accordingly, M/s. Angelini Pharmaceuticals (Pvt) Ltd., Lahore was advised to provide

the same. The firm has submitted the documents safety and efficacy data, which needs

deliberation by the Board.

Decision: Registration Board deferred the case for evaluation of clinical data by the following experts:

Brig. Aslam Khan, Member registration Board Abdul Lateef Shaikh, Director Pharmacy, AKUH, Karachi. Dr.Shazli Manzoor, Pulmonologist, Quaid-e-Azam Int Hospital, Islamabad.


Case No. 04. Registration of imported – Inspections of manufacturing units abroad

thereof.

a. Withdrawal of registration applications - M/s. Barrett Hodgson Pakistan (Private)

Limited, Karachi.

Drug Registration Board in its 228th meeting held on 12th - 13th October, 2010 approved

the registration of following drugs in the name of M/s. Barrett Hodgson Pakistan (Private)

Limited, Karachi manufactured by M/s. Yangtze River Pharmaceutical (Group) Jiangsu, China,

subject to inspection of manufacturer abroad:-

S. No. Name of Drug (s) Composition. 1. PacliBar Injection 30mg.

Each 5ml vial contains:- Paclitaxel………30mg USP Specs.

2. PacliBar Injection 100mg. Each 16.7ml vial contains:- Paclitaxel………100mg USP Specs.

Dr. Muhammad Khalid Khan, Director, DTL, KPK / Member Drug Registration Board

and Mrs. Rohi Obaid, DDC, DRAP, Karachi was nominated for inspection of M/s. Yangtze

River Pharmaceutical (Group) Jiangsu, China. Accordingly, M/s. Barrett Hodgson Pakistan

(Private) Limited, Karachi was informed for arranging the inspection.

In response, M/s. Barrett Hodgson Pakistan (Private) Limited, Karachi have informed

that their principal M/s. Yangtze River Pharmaceutical (Group) Jiangsu, China is no more

interested in getting these products registered in Pakistan due to much delay in the process.

Therefore, the firm has requested for withdrawing the cases for registration of the above

mentioned products.

Decision: Registration Board acceded to request of the firm about withdrawl of above

registration applications.


b. Registration of imported drugs – Comments of panel of inspectors.

Drug Registration Board in its 236th meeting held on 20th November, 2012 approved the

registration of following drugs for import in the name of M/s. Sind Medical Stores, Karachi

manufactured by M/s. Boryung Pharmaceutical Co. Ltd., Singil-dong, Wonnam-dong, Chongro-

ku, Seoul, Korea, subject to inspection of manufacturer abroad:-

S. No. Name of Drug (s) & Composition.

Fee deposited.

Price approved by the Price Advisory Committee.

1. A.D. Mycin Injection 10mg.

Each 5ml vial contains:- Doxorubicin HCI…….10mg.

Rs.100,000 Rs.430.00/Per vial.

2. A.D. Mycin Injection 50mg. Each 25ml vial contains:- Doxorubicin HCI…….50mg.

Rs.100,000 Rs.1716.00/Per vial.

3. E.P. Mycin Injection 10mg. Each 5ml vial contains:- Epirubicin HCI……10mg.

Rs.100,000 Rs.670.00Per vial.

4. E.P. Mycin Injection 50mg. Each 25ml vial contains:- Epirubicin HCI…....50mg.

Rs.100,000 Rs.2500.00/Per vial.

5. Neotabine Injection 1gm. Each vial contains:- Gemcitabine HCI….1.14gm.

Rs.100,000 Rs.8330.00/Per vial.

6. Neotabine Injection 200mg. Each vial contains:- Gemcitabine HCI….228mg.

Rs.100,000 Rs.1675.00/Per vial.

In compliance, inspection of the manufacturer abroad M/s. Boryung Pharmaceutical Co. Ltd.,

Singil-dong, Wonnam-dong, Chongro-ku, Seoul, Korea, has been carried out by the nominated

panel comprising Dr. Saifur-Rehman Khattak, Director, CDL, Karachi and Mr. Salateen Waseem

Philip, ADC (Licensing), Drug Regulatory Authority of Pakistan, Islamabad.


The panel of inspectors has recommended the registration of the above said products with the

remarks that registration of the applied products is recommended however import to Pakistan

should be allowed only after confirmation of successful execution of the desired improvement.

The storage facility of the importer has already been verified by the Area FID.

With reference to the inspection report Dr. Saifur-Rehman Khattak, Director, CDL, Karachi

and Mr. Salateen Waseem Philip, ADC (Licensing), Drug Regulatory Authority of Pakistan,

Islamabad were requested to inform about type of short coming pointed out whether these are

critical in nature affecting the quality of the product or suggestive / advisory nature for further

processing the case.

In response, Dr. Saifur-Rehman Khattak, Director, CDL, Karachi have informed that the firm

was thoroughly inspected for facilities regarding the production, quality control and storage of

their products (Anti-Cancer Injections) intended for registration in Pakistan. The risk based

assessment of the facilities of the firm identified a number of critical, major and minor

observations which can adversely affect the quality of the products intended for registration in

Pakistan. They has further clarified that the observation No.1,2,4,6 and 10 are the critical

observations which need be rectified in any stance along with the other stated observations

before importing these products in Pakistan.

The panel informed that the certain observations are very critical and can affect the quality of

the product which is very serious threat for the patients to whom use these products. It should be

the duty of the panel of experts should gave the clear recommendation in light of observation, in

light of these serious observations the panel also recommended these products in final

recommendation, which is not understandable.

Decision: Registration Board discussed the inspection report in detail and keeping in

view nature of the observations being critical rejected the following applications of M/s.

Sind Medical Stores, Karachi manufactured by M/s. Boryung Pharmaceutical Co. Ltd.,

Singil-dong, Wonnam-dong, Chongro-ku, Seoul, Korea;

S. No. Name of Drug (s) & Composition.




3. E.P. Mycin Injection 10mg. Each 5ml vial contains:- Epirubicin HCI……10mg.

4. E.P. Mycin Injection 50mg. Each 25ml vial contains:- Epirubicin HCI…....50mg.

5. Neotabine Injection 1gm. Each vial contains:- Gemcitabine HCI….1.14gm.

6. Neotabine Injection 200mg. Each vial contains:- Gemcitabine HCI….228mg.

c. Registration of imported drug – Issuance of registration letter after inspection of

manufacturer abroad.

i. M/s. Laderly Bio-Tech Pharma, Karachi

Drug Registration Board in its 244th meeting held on 22-23rd July, 2014 approved the

registration of following drugs in the name of M/s. Laderly Bio-Tech Pharma, Karachi,

manufactured by M/s. CSPC Pharmaceutical Co., Ltd., No. 188 Gongnong Road, Shijiazhuang

City, P R China, subject to inspection of manufacturer abroad, verification of storage facilities

and price fixation / calculation etc as per policy:-

S.#

Name of drug (s)/Composition. Fee deposited. Prices approved by the Price

Recommendatory Committee

1. Meropeon Injection 0.5gm. Each vial contains: - Meropenem USP…… 0.5gm.

Rs.100000 Rs.600/Per vial

2. Meropeon Injection 1gm. Each vial contains: - Meropenem USP …… 1gm.

Rs.100000 Rs.1100/Per vial.


Inspection of the manufacturer abroad M/s. CSPC Zhongnuo Pharmaceutical

(Shijiazhuang) Co., Ltd., 188 Gongnong Road, Shijiazhuang City, Hebei Province, China has

already been carried out by the nominated panel comprising Dr. Obaidullah, Deputy Director

General (Registration) and Mr. Abdullah, Deputy Drugs Controller (RRR), Drug Regulatory

Authority of Pakistan. The panel of inspectors has recommended the registration of the above

said products.

Decision: Registration Board considered the inspection report of the panel and

approved the registration of above products.

ii. M/s. Pak China International, Karachi.

Drug Registration Board in its 245th meeting held on 29-30th September, 2014 approved

the registration of following drug in the name of M/s. Pak China International, Karachi

manufacture by M/s. Zheijing Chimin Pharmaceutical Co. Ltd, 888 Beiyuan Road, Huangyan,

Zhejiang, P.R. China and exported by M/s. Ningbo Tisun Biochemi Company Ltd. Ningbo,

China subject to inspection of manufacturer abroad, verification of storage facilities and price

fixation / calculation etc as per policy:-

S.#

Name of drug (s)/Composition.

1. Sodium Ringer Lactate Injection. Each 500ml bottle contains:- Sodium Chloride….......................3.0gm. Sodium Lactate, Anhydrous……1.55gm. Potassium Chloride .....................0.15gm. Calcium Chloride............................0.1gm.

Inspection of the manufacturer abroad M/s. Zheijing Chimin Pharmaceutical Co. Ltd, 888

Beiyuan Road, Huangyan, Zhejiang, P.R. China has already been carried out by the nominated

panel comprising Dr. Obaidullah, Deputy Director General (Registration) and Mr. Abdullah,

Deputy Drugs Controller (RRR), Drug Regulatory Authority of Pakistan. The panel of inspectors

has recommended the registration of the above said product.


Decision: Registration Board considered the inspection report of the panel and

approved the registration of above products.

Case No. 05. Change of manufacturing site of imported registered drug.

a. Duac Gel (Reg. No.043090) - M/s. GlaxoSmithKline Pakistan Limited, Karachi.

M/s. GlaxoSmithKline Pakistan Limited, Karachi have requested to approve the change

of source of manufacturing & supply of their registered imported drug “Duac Gel (Reg.

No.043090)” from M/s. Stiefel Laboratories, Ireland to M/s. Glaxo Operations UK Limited,

Barnard Castle, UK.

The firm has deposited fee Rs.50000/- and submitted following supporting documents:-

i) Original legalized CPP from new source. ii) Supporting letter from endorsing source change. iii) Copy of initial registration letter. iv) Copy of transfer of registration letter in the name of M/s. GSK Pakistan Ltd.,

Karachi. M/s. GlaxoSmithKline Pakistan Limited, Karachi was advised to submit the balance fee

as per revised “Schedule-F” for change of source of Duac Gel (Reg. No.043090) and status of

registration with EMA, US-FDA, Japan & Australia.

In response, M/s. GlaxoSmithKline Pakistan Limited, Karachi has submitted required fee

as per revised fee structure given in SRO 1117 (I) 2012.

The firm M/s. GlaxoSmithKline Pakistan Limited, Karachi has submitted legalized

Certificate of Pharmaceutical Product of “Duac Gel” issued by Australian Regulatory Authority.

The firm has submitted the all document and required fee as per approved policy of the

Drug Registration Board.

Decision: Registration Board approved request of M/s. GlaxoSmithKline Pakistan

Limited, Karachi for change in manufacturing site of Duac Gel (Reg. No.043090) from M/s.

Stiefel Laboratories, Ireland to M/s. Glaxo Operations UK Limited, Barnard Castle, UK.


Case No.06 Transfer of registered drugs.

a. M/s. Getz Pharma (Pvt) Limited, Karachi.

M/s. Getz Pharma (Pvt) Limited, Karachi have requested for transfer of registration of the

under-mentioned registered imported drugs from the name of previous importer M/s. Abbott

Laboratories (Pakistan) Limited, Karachi to their name as a result of agreement between M/s.

AbbVie Inc & M/s. Getz Pharma (Pvt) Limited, Karachi: -

S. No. Reg. No. Name of Drugs. Name of Manufacturer.

1. 015532 Survanta Suspension 8ml. M/s. Abbvie Inc., North Chicago, IL 60064, USA.

2. 059025 Survanta Suspension 4ml. -do-

3. 011081 Forane Liquid for Inhalation 100ml.

Manufactured by:- M/s. Aescia Queenborough Limited, U.K. Marketing Authorization Holder:- M/s. Abbvie Limited, U.K.

4. 027374 Sevorane Volatile Liquid for Inhalation 250ml.

-do-

M/s. Getz Pharma (Pvt) Limited, Karachi have deposited required fee

Rs.100000x4=400000/- and submitted the following documents:-

i) Legalized CoPP / GMP Certificate of Survanta Suspension 4ml. ii) Legalized CoPP of Forane Liquid for Inhalation 100ml.

iii) Legalized GMP Certificate of Forane Liquid for Inhalation 100ml. iv) Legalized CoPP of Sevorane Volatile Liquid for Inhalation 250ml. v) Legalized GMP Certificate of Sevorane Volatile Liquid for Inhalation 250ml. vi) Legalized Termination letter from M/s. AbbVie. vii) Legalized Authorization letter from M/s. AbbVie viii) No Objection Certificate from M/s. Abbott Laboratories (Pakistan) Limited,

Karachi. ix) Registration applications on Form-5-A.

x) Copy of NOC for CRF.

Decision: Registration Board decided as follows:

Cancellation of above registrations from M/s. Abbott Laboratories (Pakistan) Limited, Karachi.

Grant of above registrations in name of M/s. Getz Pharma (Pvt) Limited, Karachi. Chairman, Registration Board will permit issuance of registration letter after evaluation / completion of Form 5A as per check list approved by Registration


Board, comments of Cost & Pricing Division about MRP of the drug and compliance of Import Policy for Finished Drugs.

b. Xenetix 350mg/ml Solution for Injection - M/s. A & Z Health Services, Rawalpindi

M/s. A & Z Health Services, Rawalpindi have requested for transfer of registration of a

registered drug “Xenetix 350mg/ml Solution for Injection (Reg. No.027353)” manufactured by

M/s. Guerbet France from the name of previous agent M/s. Digital Imaging Systems (Pvt) Ltd.,

Lahore to their name for finish import. They have deposited fee Rs.15000/- and submitted their

distribution agreement and previous agent dismissal notice. Since NOC of the former agent M/s.

Digital Imaging Systems (Pvt) Ltd., Lahore was not available. Therefore, as per practice in

vogue M/s. Digital Imaging Systems (Pvt) Ltd., Lahore were asked on 25th May 2009 either to

submit their NOC in this regard or provide their fresh agency agreement (if any) with the

manufacturer abroad. Thereafter a reminder was issued on 01-07-2009 but they did not respond.

Then a show cause notice was issued to them on 29th July 2009 to submit reply within 15 days

but they did not respond at all. Copy of this notice was also endorsed to DDG (E&M) Lahore to

ensure delivery to M/s. Digital Imaging Systems (Pvt) Ltd., Lahore. In response, Federal

Inspector of Drugs, Lahore, Mr. Asim Rauf has informed that despite personal visit of Drugs

Controller Officers to M/s. Digital Imaging Systems (Pvt) Ltd., Lahore on 03-03-2010 and

written reminder thereafter, the firm did not respond to the queries sought.

M/s. A & Z Health Services, Rawalpindi was advised to deposit balance fee as per

revised fee Schedule-F. In response, the firm have deposited the balance fee Rs.35000/-.

The firm has applied for the renewal neither on time nor after the expiry of the time till to

date. Therefore, the registration is not valid and cannot be transferred.

Decision: Registration Board did not accede to request of firm as registration of the

drug is not valid.

Case No. 07. Transfer of registrations and change of manufacturing site - M/s. Abbott Laboratories (Pakistan) Limited, Karachi

M/s. Abbott Laboratories (Pakistan) Limited, Karachi have requested for transfer of

registration of the under-mentioned registered imported drugs from the name of previous

importer M/s. Highnoon Laboratories Ltd., Lahore to their name due to an International


Acquisition of the Pharmaceutical Section of Solvay with all associated companies has been

acquired by the Abbott group since February 15, 2010: -

S# Reg. No. Name of Drugs. Existing Name of Manufacturer.

New Name of Manufacturer.

1. 018552 Physiotens 0.2mg Tablets.

M/s. Eli Lilly S.A., Spain.

Manufactured by: M/s. Rottendrof Pharma GmbH, Germany. Packed by: - M/s. Abbott Healthcare SAS, France.


-do- -do-


-do- -do-

They have deposited required fee and following supporting documents: -

i) Original NOC of the previous importer M/s. Highnoon Laboratories Ltd., Lahore. ii) Copy of the acknowledgement of last renewal of registration of the products

applied by the previous importer M/s. Highnoon Laboratories Ltd., Lahore. iii) Copies of acknowledgement of receipt issued by the German National authority

BfArM & a notification submitted by the Solvay to the Germany authority for the change in manufacturer name to M/s. Rottendrof Pharma GmbH, Germany.

iv) Copy of NOC for CRF.

Drug Registration Board in its 239th meeting held on 12th September, 2013 approved the

transfer of registration of Physiotens Tablet from M/s. Highnoon to M/s. Abbott Laboratories

(Pakistan) Ltd. Karachi along-with the change in manufacturing site from M/s. Eli Lilly S.A.,

Spain to M/s. Rottendrof Pharma GmbH, Germany, while the packaging site of the finished

products will be M/s. Abbott Healthcare SAS, France. The Board advised to provide site master

file of both sites and panel will inspect the manufacturing sites as well to comply the provisions

of import policy. The Board authorized its chairman to accord approval for issuance of letter

after compliance of aforementioned provisions.

As per decision of the Drug Registration Board M/s. Abbott Laboratories (Pakistan)

Limited, Karachi have submitted site master files of both sites attested by an authorized person

of the company.


M/s. Abbott Laboratories (Pakistan) Limited, Karachi was again advised to submit the

Form-5 (A), legalized CoPP’s of both Germany and French sources.

In response, M/s. Abbott Laboratories (Pakistan) Limited, Karachi have submitted Form

5(A) and following documents for an intermediate International Change of Manufacturing from

M/s. Rottendrof Pharma GmbH, Germany to M/s. Abbott Healthcare SAS, France:-

i) CoPP of the M/s. Abbott Healthcare SAS, France legalized by Pakistan Embassy.

ii) GMP of the regulatory authority for the manufacturing site legalized by Pakistan Embassy.

iii) Justification of Change.

M/s. Abbott Laboratories (Pakistan) Limited, Karachi have also submitted that both

manufacturing and release site will be M/s. Abbott Healthcare SAS, France.

This case was discussed in 239th meeting of the Drug Registration Board for the change

of manufacturing site from M/s. Eli Lilly S.A., Spain to M/s. Rottendrof Pharma GmbH,

Germany & packaging at M/s. Abbott Healthcare SAS, France. Meanwhile the firm requested

that all the manufacturing and packaging steps will be carried out at “M/s. Abbott Healthcare

SAS, France” and for which they have submitted documents as per SOP. Under the Drugs Act,

1976 there is no provision for transfer of registration from one company to another.

Decision: Registration Board referred above formulations for c onsideration of Review

Committee.

Case No.08 Change in name of manufacturer.

a. Rocaltrol Capsules 0.25mcg and 0.5mcg - M/s. Martin Dow Limited, Karachi.

M/s. Martin Dow Limited, Karachi has requested to approve the change of

manufacturer name of their following registered imported drugs as follows:-

S# Reg. No. Name of Drug (s) Current Name of Manufacturer.

New Proposed Name of Manufacturer.

1. 015557 Rocaltrol Capsules 0.25mcg.

M/s. R.P Scherer GmbH, Germany.

M/s. Catalent Germany Eberbach GmbH,


Gammelsbacher Strasse 2 69412 Eberbach / Baden, Germany.

2. 015556 Rocaltrol Capsules 0.5mcg.

-do- -do-

The firm have deposited required fee Rs.100000x2=200000/- and submitted following

supporting documents:-

i) Copy of registration letter. ii) Copy of transfer of registration letter. iii) Copy of change in manufacturing site. iv) Copy of NOC for CRF clearance. v) Original and legalized CoPP as per WHO format.

M/s. Martin Dow Limited, Karachi was advised to provide CoPP issued from German

authority as the above said products are being manufactured in Germany and Certificate of Swiss

Medica is irrelevant.

In response, M/s. Martin Dow Limited, Karachi have submitted that Rocaltrol Capsules

0.25mcg & 0.5mcg are imported in finished form from M/s. F. Hoffmann-La Roche Ltd.,

Switzerland, under contract manufacturing arrangement with M/s. R.P Scherer GmbH,

Germany. M/s. F. Hoffmann-La Roche Ltd., Switzerland holds marketing authorization for

Rocaltrol range and M/s. R.P Scherer GmbH, Germany is just a contract manufacturer of

Rocaltrol. M/s. R.P Scherer GmbH, Germany does not hold marketing authorization of Rocaltrol

in Germany as such German authorities cannot issue CoPP for the product not marketed by the

company in Germany.

The firm has further submitted that they have submitted CoPP of Rocaltrol Capsules

0.25mcg & 0.5mcg issued from Swiss authorities, as the finish product is supplied from

Switzerland which indicates M/s. R.P Scherer (new name Catalaent) as manufacturing site.

The firm has also informed that only the name of manufacturer of Rocaltrol Capsules is

changed from “R.P. Scherer GmbH & Co. KG” to “Catalent Germany Eberbach GmbH”. The

physical address of the facility, the manufacturing process and quality controls for the capsules

as well as the personnel producing & testing of the capsules remains unchanged.


The manufacturing site of the product “Rocaltrol Capsules” is located in Germany but the

firm has submitted CoPP of Swiss Medica and not of German Authorities. The same was asked

them but they have not provided the same. The CoPP of country of origin is mandatory for such

approval.

Decision: The Board deferred the case and advised the firm to submit the legalized document issued by German regulatory authorities for following confirmations:

Above referred products are being contract manufactured at Catalent Germany Eberbach GmbH.

It is only change of title / name of the firm and rest of facilities including address is same as of previous manufacturer.

Case No.09 Exemption from the Drugs (Labeling & Packing) Rules, 1976.

a. Kytril (Granisetron) Ampoule 3mg/3ml, Reg. No.020691 - M/s. Roche Pakistan Limited, Karachi.

M/s. Roche Pakistan Limited, Karachi have informed that “Kytril Ampoule 3mg/3ml

(Reg. No.020691)” was registered in the name of M/s. SmithKline & French Pakistan Limited,

Karachi on February 10, 1998 and the registration was subsequently transferred to M/s. Roche

Pakistan Limited, Karachi on July 25, 2001 after the global acquisition of this brand by their

principal M/s. F. Hoffmann La-Roche Basel, Switzerland. Due to the low volumes of the imports

/ sales, (approx 2000 packs / anum) M/s. Roche Pakistan Limited had applied for exemption

from the Drugs (Labeling & Packing) Rules 1986 and the exemption was granted on November

10, 2004. Furthermore, for necessary compliance to the Drugs (Labeling & Packing) Rules 1986,

i.e. (after imports of the consignment) the information, i.e. Pak Reg. No., Price and Urdu

instructions are being overprinted on the secondary carton using an ink-jet printer.

Recently M/s. Roche Pakistan Limited, Karachi have imported a consignment of “Kytril

Ampoules” in Islamabad, (1000 packs) and have been advised by the concerned ADC to paste

stickers for compliance to the Drugs (Labeling & Packing) Rules 1986 on the individual

ampoules of the 5’s pack. Following find few facts which would reveal that individual ampoule

sticker pasting would be detrimental to the 5’s pack and the product:-


i) It’s a Neo-top secondary carton, (5’s pack) with perforated seal, and if open once the temper evident seal / integrity of the pack would be compromised.

ii) Pasting of stickers is not possible due to the limited space available on the 3ml ampoule as the sticker would mask the primary label, hiding the critical information on the primary label, (ampoule photo attached).

iii) There would be high risk of ampoule breakage during the excessive handling of the pack after opening it and while carrying out the manual process of sticker pasting.

Considering the above mentioned facts M/s. Roche Pakistan Limited, Karachi have

requested for an exemption of overprinting of the primary label (ampoule), since the secondary

label (carton) is being duly complied with the requirement of the Drugs (Labeling & Packing)

Rules 1986 by ink-jet printing.

M/s. Roche Pakistan Limited, Karachi have deposited required fee Rs.5000/- and

submitted following supporting documents:-

i) Copy of transfer of registration letter. ii) Copy of initial registration letter. iii) Copy of letter exemption from Drugs (Labeling & Packing) Rules 1986. iv) Copy of last renewal status. v) Copy of labels.

Kytril Ampoules (Reg. No.020691) is an 5HT3-antagonist used as antienetic, available in

3ml ampoule, which cannot be allowed to sell without complying full requirement of the Drugs

(Labeling & Packing) Rules 1986.

Decision: The Board after detailed deliberations decided that M/s Roche Pakistan Ltd,

Karachi may be permitted for ink-ject printing of Urdu version only of the ampules of

Kytril Ampoules (Reg. No. 020691) in any licensed manufacturing unit having facility for

this purpose. The firm will provide NOC of any licensed manufacturing unit and case will

be processed for approval for issuance of letter. The firm will comply the rest of the

labeling requirements under the Drugs (Labeling & Packaging) Rules, 1986 before import.


Case No.10 Extension in shelf life of registered drugs.

a. Alimta 100mg Injection, Regn. No.066174 and Alimta 500mg Injection, Regn. No.043068.

M/s. Eli-Lilly Pakistan (Private) Limited, Karachi have requested to approve the

extension of shelf life of their following registered imported drugs from 24 months to 36 months.

As the current stability studies conducted on this product confirms that the product is well stable

when tested at 36 months time interval:-

S. No. Reg. No. Name of Product.

1. 066174 Alimta 100mg Injection.

2. 043068 Alimta 500mg Injection.

The firm has deposited required fee Rs.5000x2=10,000/- and submitted following

supporting documents:-

i) Copy of registration letter of Alimta 100mg Injection. ii) Original CoPP of Alimta 100mg Injection attested by Pakistan Embassy having

approved shelf life of 36 months.

iii) Copy of registration letter of Alimta 500mg Injection. iv) Copy of the acknowledgement of last renewal of registration of Alimta 500mg

Injection. v) Original CoPP of Alimta 500mg Injection attested by Pakistan Embassy having

approved shelf life of 36 months. vi) Copies of Stability Studies.

M/s. Eli-Lilly Pakistan (Private) Limited, Karachi was advised to clarify whether

stability data conducted for Zone-IV is approved by US-FDA or otherwise. In response, M/s. Eli-

Lilly Pakistan (Private) Limited, Karachi have submitted that previously provided stability data

was conducted for Zone-IV and approved by FDA. They have further submitted that original

CPPs issued by the FDA mentioning 36 months shelf life. These CPPs issued by the FDA

specifically for Pakistan for Alimta 100mg & 500mg on the basis of submitted Zone-IV stability

data. Therefore, Zone IV stability data should be considered as approved by the FDA.

As per practice in vogue views of following experts regarding extension of shelf lives of

the products has been obtained:-


S. No. Name of Expert.

Opinion

1. Prof. Dr. Zafar Iqbal, Chairman, Department of Pharmacy, University of Peshawar, Peshawar.

Recommended

2. Dr. Farzana Chowdhary, Director, Department of Pharmacy, University of Veterinary & Animal Sciences, Lahore.

Extension in shelf-lives is recommended on condition that they will be available only in hospitals / institutions specialized for the treatment of cancer.

3. Jamil Anwar,

Director, Drugs Testing Laboratory, Punjab, Lahore.

Recommended

M/s. Eli-Lilly Pakistan (Private) Limited, Karachi was advised to clarify as these

“Pemetrexed” containing products are meant for malignant pleural mesotheliona, which indicate

it is a specialized product for tertiary care institution. The one of the expert indicate these

products should be available only in hospitals / institutions specialized for the treatment of

cancer. Therefore, you are advice to inform this office about mode of sale whether it is selling to

institution / hospitals or also available in retail out lets as well.

In response, M/s. Eli-Lilly Pakistan (Private) Limited, Karachi have confirm that Alimta

(pemetrexed) is indicated for Nonsquamous Non-Small Cell Lung Cancer-NSCLC and

malignant Pleural Mesothelioma. Alimta 500mg and 100mg formulations are registered in

Pakistan since 2006 and 2010 respectively. They would like to inform that at the time of

registration, no restrictions were imposed on the availability of Alimta. They have authorized

their distributor to provide Alimta to hospitals / institutions specialized for the treatment of

Cancer based on tenders / orders and to the very selective licensed outlets in Pakistan.

Decision: Registration Board after deliberations approved the request of the firm for

increase in shelf life.


Case No.11. Resemblance of brand name – Personal hearing thereof.

M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore have informed about resemblance of

brand name of imported drug “OZOL-40 Infusion (Reg. No.044854)” imported by M/s. United

International, Karachi with the brand name of their already registered locally manufactured drug

“O-Zole Capsules 40mg (Reg. No.043642)”. M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore

submitted that they are facing problems in marketing the product, time and again, and it will be

even more aggravated if the situation continues. Therefore they have humbly requested to take a

check on the situation and to strictly instruct M/s. United International, Karachi to change their

brand name as early as possible, so that they could continue marketing their product smoothly

and without apprehensions.

Accordingly, M/s. United International, Karachi was advised to propose at least three

distinguished alternate names of their drug other than the existing name. Also, submit an

undertaking that the new proposed brands do not have resemblance with any already registered

drug.

In response, M/s. United International, Karachi have submitted that they had been

granted the registration of product “OZOL-40 Infusion (Reg. No.044854)” on 9th February,

2007, i.e. more than seven years before and the said product is already being marketed by them

for more than seven years, therefore, their product is strongly recognized and accepted by their

prevailing customers in the market with the said name since they have incurred substantial

marketing expenditures to create awareness among the customers about the product with the said

brand name. They have therefore requested to consider the additional fact that the nature of the

products being traded by them and that by M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore is

different, meaning that the product traded by them is an Injection whereas the product traded by

M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore is a capsule. M/s. United International,

Karachi has requested to continue trading of the said product with the same brand name, keeping

in view the these facts.

Registration Board took serious note of firm for not complying the instructions for

change of brand name. The Board decided to suspend the import of “OZOL-40 Infusion (Reg.

No.044854)” imported by M/s. United International, Karachi immediately and call the firm’s

representative in next meeting for personal hearing.


Accordingly, the importer M/s. United International, Karachi has been advised to suspend

the import of “OZOL-40 Infusion (Reg. No.044854)” imported by them immediately, till the

change of name of the product and called for personal hearing in this meeting.

Decision: The representative of the firm did not appear before the Board and informed

that they are willing to change the name of their product in light of the directions of the

Board. The Board accepts the request of the firm and authorized its Chairman for decision

on the change of name request of the firm.

Case No.12. Veterinary drugs deferred by Registration Board for expert opinion.

Registration Board in its 243rd meeting held on 08th -09th May, 2014 referred all

veterinary applications to a committed comprises of Dr. Muhammad Arshad, Member

Registration Board, Dr. Muhammad Ashraf, UVAS, Lahore and Head of Pharmacology

Department Arid University Rawalpindi for expert opinion. The recommendations of expert are

as under:-

S. No. Name of Importer/ Manufacturer.

Name of Drug (s)/Composition. Recommendations of Dr.

Muhammad Ashraf, UVAS,

Lahore

Recommendations of Dr. Muhammad Arshad, Member

R.B

Recommendations of Head of

Pharmacology Department

Arid University

Rawalpindi 1. M/s. Ghazi Brothers,

Karachi-75350 / Product License Holder:- M/s. Agrovet Market S.A., San Luis, Lima, Peru. Manufacturer Under Product License Holder:- M/s. Pharmadix Corp. S.A.C. Urbanizacion La Aurora-Ate Lima 3-Peru.

Metri-CEF 3 Intrauterine Suspension Each 30ml contains:- Cephalexin monohydrate (Base)……………….....600mg Neomycin sulfate (Base)…………………1.02gm Cloxacillin benzathine...1.50gm Vitamin A……….....30.000 IU

Recommended He endorsed the recommendations of Dr. Muhammad Ashraf.

Dr. Mazhar ul Haq Wrote to this office “I am unable to put my opinion on said drugs due to certain unavoidable reasons.


2. M/s. Ghazi Brothers, Karachi-75350 / Product License Holder:- M/s. Agrovet Market S.A., San Luis, Lima, Peru. Manufacturer Under Product License Holder:- M/s. Pharmadix Corp. S.A.C. Urbanizacion La Aurora-Ate Lima 3-Peru.

Catofos B9 + B12 Injectable Solution Each ml contains:- Butaphosphan…………100mg Vitamin B9 (Folic Acid)..15mg Vitamin B12 (Cyanocobalamin)…….0.05mg (Vitamin and Mineral).

Recommended

3. M/s. Ghazi Brothers, Karachi. / M/s. Vetanco S.A. Buenos Aires, Argentina.

Ketoxilen Injection Each 100ml contains:- Oxytetracycline………...20gm Ketoprofen………………3gm (Antibiotic/Anti-inflammatory).

Recommended

4. M/s. Ghazi Brothers, Karachi. / M/s. Cheilbio Co. Ltd., Moknae-Dong, Ansan-Si, Gyeonggi-Do, Korea.

Geslong Injection Each ml of solution contains:- Metoclopramide HCI……5mg (Antiemetic/ Gastroprokinetic).

Recommended


Cheil Tonocomp Injection Each ml of solution contains:- Toldimfos sodium……200mg

Recommended


Seletoco Injection Each ml of solution contains:- Vitamin E acetate……..100mg Sodium Selenite…………1mg (Nutritional additive).

Recommended

7. M/s. Ghazi Brothers, Karachi. / M/s. Cheilbio Co. Ltd.,

Procillin-LA Injection Each ml contains:- Pencillin G

Recommended


Moknae-Dong, Ansan-Si, Gyeonggi-Do, Korea.

Benzathine ………1,00,000 IU Penicillin G Procaine…………1,00,000 IU Dihydrostreptomycin sulfate…200mg (Antibacterial).

8. M/s. Ghazi Brothers, Karachi. / M/s. Cheilbio Co. Ltd.Gyeonggi-Do, Korea.

Oxyneo Powder Each 1 Kg contains:- Oxytetracycline Quaternary Ammonium Salts………110gm Neomycin sulfate…...…110gm (Antibiotic).

Potential of misuse on feed additive & drug interaction.

9. M/s. Ghazi Brothers, Karachi. / M/s. Cheilbio Co. Ltd.Gyeonggi-Do, Korea.

Oxyone Powder Each 1 Kg contains:- Oxytetracycline Quaternary Ammonium Salts……….200g (Antibiotic).

Potential of misuse on feed additive & drug interaction.

10. M/s. Ghazi Brothers, Karachi. / M/s. Hebei Yuanzheng Pharmaceutical Co. Ltd., Shijiazhuang City, Hebei Province, China.

Cefquin Suspension for Injection Each ml contains:- Cefquinome (as sulfate)..25mg (Antibiotic).

Recommended


Isomedium Powder for parental administration Each sachet contains:- Isometamedium chloride hydrochloride…………..…1g (Antiprotozoal).

Recommended


Oxybiotic LA 30% Solution for Injection Each ml contains:- Oxytetracycline (as dihydrate)…………….300mg (Antibiotic).

Recommended


Bupaquone Solution for Injection Each ml contains:- Buparvaqone…………...50mg (Antiprotozoal).

Recommended

14. M/s. Orient Animal Health (Pvt) Ltd., Karachi. / M/s. Univet Ireland Ltd. Tullyvin, Cootehill, Co. Cavan, Ireland.

Unimox LA Injection Each ml contains:- Amoxicillin (as Amoxicillin Trihydrate) Ph. Eur…...150mg (Antibacterial).

Recommended -



Unicycline LA Injection Each ml contains:- Oxytetracycline (as Oxytetracycline Dihydrate Ph. Eur)…………………...200mg (Antibacterial).

Recommended (Stability Study of

zone IV not provided)


Multivit Injection Each 1 ml contains:- Vitamin B1…………….10mg Vitamin B2………...……5mg Vitamin B6…….………..3mg Vitamin B12………....0.05mg Nicotinamide………..…35mg D-Panthenol…….……...25mg Vitamin A…………15,000 IU Vitamin D3………....1,000 IU Vitamin E…………........10mg (Multivitamins).

Recommended COPP of Ireland not provided.

17. M/s. Orient Animal Health (Pvt) Ltd. Karachi. / M/s. V.M.D. N.V, Hoge Mauw, Arendonk-Belgium.

Promycin-1000 Injectable Solution Each ml contains:- Colistin Sulphate………..1,000,000 IU (Polypeptide Antibiotic).

Recommended (Mnf. In France then packaging in Belgium; COPP of France)

18. M/s. Orient Animal Health (Pvt) Ltd., Karachi. / M/s. V.M.D. N.V, Hoge Mauw, Arendonk-Belgium.

Promycin-4800 Water Soluble Powder Each gram contains:- Colistin Sulphate…4,800,000 IU (Polypeptide Antibiotic).

Recommended (Mnf. In France then packaging in Belgium; COPP of France)

19. M/s. Marush (Pvt) Ltd., Lahore. / M/s. Univet Ltd. Tullyvin, Cootehill, Co. Cavan, Ireland.

Ubroloxin ® Intramammary Suspension Each 1 injector with 10g (12ml) contains:- Cefalexin monohydrate...................200mg Kanamycin monosulfate……………133mg (Corresponds to 100,000 I.U). (Pharmaceuticals).

Recommended

20. M/s. U.M. Enterprises, Karachi-74900/ M/s. Qilu Animal Health Products Co. Ltd., Jinan, Shandong,

Flumeglu 5gm Injection Each 100ml contains:- Flunixin Meglumine equivalent to 5.0g of Flunixin. (Non-steriod, Ant-

Recommended


China.

inflammatory drug).

21. M/s. U.M. Enterprises, Karachi-74900/ M/s. Qilu Animal Health Products Co. Ltd., Jinan, Shandong, China.

Cefent 1gm Injection Each 25ml vial contains:- Ceftiofur Sodium equivalent to 1.0g Ceftiofur. (B.Lactum Antibiotics).

Recommended


Cefent 4gm Injection Each 100ml vial contains:- Ceftiofur Sodium equivalent to 4.0g Ceftiofur. (B.Lactum Antibiotics).

Recommended


Ceftihyde 5gm Injection Each 100ml contains:- Ceftiofur Hydrochloride equivalent to 5.0g Ceftiofur. (B.Lactum Antibiotics).

Recommended

24. M/s. Siddiqui Pharma (Pvt) Ltd., Multan. / M/s. KBNP, INC, Dugok-ri, Sinam, Yesan, Chungnam, Korea.

Ciroxin 10% Oral Solution Each Liter contains:- Ciprofloxacin…………100g (Antibiotics).

Recommended


Kenoxin 10% Oral Solution Each Liter contains:- Enrofloxacin……100g (Antibiotics).

Recommended


Noroxin 200 Oral Solution Each Liter contains:- Norfloxacin…………200g (Antibiotics).

Recommended

27. M/s. Mustafa Brothers Faisalabad. / M/s. Laboratorio Centrovet Santiago, Chile.

Cefalexine Injectable Suspension 15% Each 10ml contains: - Cefalexine ….150/ml (Beta lactam Antibiotic)

Recommended

28. M/s. Mustafa Brothers Faisalabad. / M/s. Laboratorio Centrovet Santiago, Chile.

Ceftiofur Hydrochloride Injectable Suspension 5% Contains: Ceftiofur Hydrochloride…………...50mg

Recommended


(Antibiotic)

29. M/s. Ghazi Brothers, Karachi. / M/s. CEVASA S.A. Buenos Aires, Argentina.

Sulfyvit Water Soluble Powder Each 100gm contains:- Sodium sulfaquinoxaline………..15gm Sodium sulfamethazine………….14gm Sodium sulfadimethoxine………...2gm Trimethoprim …………...6gm Prednisolone………...0.004gm Vitamin A……....…300,000IU Vitamin E……………..200 IU Vitamin D3……..…..60.000IU Vitamin C……………….2gm Vitamin K3……………..1gm Excipients……..…………..q.s (Antibiotic, steroids Vitamin).

More chances of their misuse, drug interaction and development of resistance. It is better to have separate products for specific purpose. Need experimental verification for such combination,

30. M/s. Fartal Pharmaceuticals, Karachi. / M/s. Laboratorios Microsules Uruguay S.A. Canelones, Uruguay.

Ivermic M.O. Injectable Suspension Each ml contains:- Ivermectin………..……1,000g Zinc Sulphate 7H20…...0,043g Magnesum Chloride 6H20…………………...0,650g Copper Chloride 2H20…………………...0,004g Magnesium Hypophosphite 6H20…………………..2,670g Potassium Iodide……...0.030g Vitamin B12…………..0,010g Histidine HCI…………0,420g Valine……….………..0,420g Arginine HCI………….0,510g Methionine……………0,420g Threonine……………..0,500g Sodium monobasic glutamate……………....0,840g (Endectocide, organic

More chances of their misuse, drug interaction and development of resistance. It is better to have separate products for specific purpose.

31. M/s. International Chempharma (Pakistan) Lahore. /

CTC Plus Water Soluble Powder Contains:-

More chances of their misuse, drug


M/s. Biopharmachemie Co Ltd TangNhon Phu Vietnam.

Chlortetracycline……5500mg Vitamin A……………2400IU Potassium Chloride…..760mg Vitamin B12………...280mcg Lysine…………………60mg (Antibiotic)

interaction and development of resistance. It is better to have separate products for specific purpose.

32. M/s. Better Traders International, Faisalabad. / M/s. Kepro B.V. Maagdenburgstraat, Holland.

Thiacol 10% Oral Solution Each ml contains:- Thiamphenicol……….100mg (Broad Spectrum Antimicrobial Agent).

Recommended

33. M/s. Ani Cure Veterinary Services, Rawalpindi. / M/s. Interchemie Werken ”De Adelaar” B.V. Metaalweg, CG Venray, Holland.

Nemovit Water Soluble Powder Each gm contains: - Neomycin Sulpahte……………..…40mg Oxytetracycline HCl…...60mg Vitamin A……………7500IU Vitamin D3, Cholecalciferol………..1500IU Vitamin E, a-tocopherol acetate…………………....5mg Vitamin B1….thiamine hydrochloride……….....…1mg Vitamin B2, riboflavine………….….....2mg Vitamin B6, pyridoxine hydrochloride………….....2mg Vitamin B12, cyanocobalamin……….....7.5µ Vitamin C, Ascorbic acid..25mg Ca-pantothenate……….7.5mg Vitamin K3, menadione sodium bisulfite………….5mg Nicotinamide…………….5mg Folic Acid…………..…300µg DL-Methionine…………30mg L-Lysine hydrochloride…………...50mg

More chances of their misuse, drug interaction and development of resistance. It is better to have separate products for specific purpose.

34. M/s. Ani Cure Veterinary Services, Rawalpindi. / M/s. Interchemie Werken ”De Adelaar” B.V. Metaalweg, CG

Aliseryl Water Soluble Powder Each gm contains: - Erythromycin thiocyanate…………..…35mg Oxytetracycline HCl…...50mg Streptomycin Sulphate…35mg

More chances of their misuse, drug interaction and development of resistance. It


Venray, Holland.

Colistin Sulphate……….…..200,000IU Vitamin A, retinol acetate…………………3000IU Vitamin D3, cholecalciferol………1500IU Vitamin E, a-tocopherol acetate…….……………..2mg Vitamin B1, thiamine hydrochloride…………….2mg Vitamin B2, riboflavine…..4mg Vitamin B6, pyridoxine hydrochloride…………….2mg Vitamin B12, cyanocobalamin………..10µg Vitamin C, Ascorbic Acid..20mg Ca-pantothenate…………10mg Vitamin K3, menadione sodium bisulfite…………………..2mg Nicotinamide……….…..20mg Inositol……………….….1mg

is better to have separate products for specific purpose.

35. M/s. Seignior Pharma Karachi./ M/s. Instituto Rosenbusch S.A. de Biologia Experimental Agropecuaria, San Jose 1469 (1136) Buenos Aires, Argentina.

Ceftiofur LPU Injectable Each 100ml vial contains: - Ceftiofur HCL…………50mg Excipients…………..…100ml (Antibiotic)

Recommended

36. M/s. Seignior Pharma, Karachi. / M/s. Instituto Rosenbusch S.A. de Biologia Experimental Agropecuaria, San Jose 1469 (1136) Buenos Aires, Argentina.

Florfenicol 30% Rosenbusch Injectable Each 100ml vial contains:- Florfenicol………...…...30gm Excipients q.s……....…100ml (Antibiotic)

Recommended

37. M/s. Bio-Labs (Pvt) Ltd., Islamabad.

Bio-Enrocol-A Liquid Each 100ml contains:- Enrofloxacin………...…..10% Colistin Sulphate………..3.5% Amantadine…………….....4%

Contains “Amantadine” which is antiviral drug for flu and may have drug interaction and


(Antibiotic, Anti-viral).

resistance problem so should not be used in these combinations.

38. M/s. Bio-Labs (Pvt) Ltd., Islamabad.

Coliflox 20% Liquid Each 100ml contains:- Enrofloxacin……………20gm Colistin Sulphate…50,000,000 i.u. (Quinolones).

Recommended

39. M/s. Leads Pharma (Pvt) Ltd., Islamabad.

Virex CRD Powder Contains:- Tylosin Tartrate……….....10% Doxycycline HCI…….…..22% Colistin Sulphate……….…4% Amantadine HCI………….3% (Antibiotic).

Contains “Amantadine” which is antiviral drug for flu and may have drug interaction and resistance problem so should not be used in these combinations.

40. M/s. Elko Organization (Pvt) Ltd., Karachi.

Fe-Zole SC 5% Oral Suspension Each ml contains:- Fenbendazole………..….50mg Elemental Selenium…....1.6mg Elemental Cobalt.............10mg (Anthelmintic).

Recommended

41. Noble Pharma Mirpur Azad Kashmir.

ENTRO-5 Powder Each 1000gm contains:- Tylosin Tartrate BP……..10% Doxycycline Hyclate USP20% Colistin Sulphate…...450 MIU Bromhexine HCI………0.5% Neomycin SO4…………3.6% (Antibacterial).

Drug which are “Me too” like drugs with minor modifications which may or may not be considered.

42. M/s. Mallard Pharmaceuticals (Pvt)

Centrum Liquid Each 100ml contains:-

Drug which are “Me too” like


Ltd., Multan.

Enrofloxacin HCI…...7500mg Sulphamethoxypyridazine…………………………7500mg Sulphamethazine……5000mg Trimethoprim………2500mg (Antibiotic).

drugs with minor

modifications which may or

may not be considered.

43. M/s. Intervac (Pvt) Ltd, Sheikhupura Road, Sheikhpura.

Tilmodox Liquid Each 100ml contains:- Tilmicosin Phosphate….15gm Doxycycline HCI………15gm (Antibiotic).

Tissue resistance.

44. M/s. Intervac (Pvt) Limited, Lahore.

Amprobit Liquid Each liter contains:- Amprolium HCI………250gm Ethopabate……………..16gm (Anticoccidial).

Recommended

45. M/s. Attabak Pharmaceutical, Islamabad.

Tylothrodox Powder Each 1000gm contains:- Doxycycline HCl……..…100g Tylosin tartrate …………..50g Amantadine HCl ………...40g Erythromycin thiocyanate..60g (Antibacterial, Antiviral).


46. M/s. Attabak Pharmaceutical, Islamabad.

Spiralinc-B Powder Each 100gm powder contains:- Lincomycin HCI…………..5g Spectinomycin HCI……..7.5g Spiramycin adipate...........2.5g Bromhexine HCI………...0.5g (Antibacterials).

Recommended

47. M/s. D-Maarson Pharmaceuticals, Rawat, Islamabad.

CRD-555 Water Soluble Powder Each 1000g contains:- Doxycycline HCl ............200g Tylosin tartrate ………....100g Colistin sulphate……500MIU

Drug which are “Me too” like drugs with minor modifications which may or


Amantadine HCl ………..40g

may not be considered.

48. M/s. Symans Pharmaceuticals (Pvt) Ltd. Lahore.

SPZ-Plus Feed Additive Oral Each 100gm contains:- Procaine Penicillin B.P…1200mg Streptomycine Sulphate B.P……………………3600mg Zinc Bacitracin B.P…5200mg Colistin Sulphate B.P.500 MIU (Antimicobial).

Recommended

49. M/s. Symans Pharmaceuticals (Pvt) Ltd. Lahore.

Cipro Plus Solution Each Liter Contains:- Ciprofloxacin…………200gm Colistin Sulphate……400MIU Amantadine…………….40gm (Antibiotics).


50. M/s. Jfrin Pharmaceutical Laboratories, Hub, Balochistan.

Jfpidox Oral Powder Each Kg contains:- Tylosin Tartrate………100gm Doxycycline Hcl……...200gm Phyenylbutazone….……12gm Bromhexine Hcl…...........5gm Colistine Sulphate….500 MIU (Antibacterial/Antibiotic).

Drug which are “Me too” like drugs with minor modifications which may or may not be considered.

51. M/s. Biogen Pharma. 8th Km Rawat Chak Beli Road, Rawat.

Amcocin Liquid Each 100ml contains:- Enrofloxacin………….…10% Colistin Sulphate…………3% Amantadine HCI…………4% (Antibiotic)



52. M/s. Biogen Pharma.

8th Km Rawat Chak Beli Road, Rawat.

Doxytylodine Powder Each 1000gm contains:- Tylosin Tartrate BP…..200gm Doxycycline HCI BP…100gm Amantadine HCI……….40gm


53. M/s. Biogen Pharma, Rawat.

Advantage Water Soluble Powder Each 1000gm contains:- Tylosin Tartrate BP..…200gm Doxycycline HCI BP….40gm Amantadine HCI……...100gm Colistin Sulphate…5000 MIU (Antibiotic/ Antibacterial/Antiviral).


54. M/s. Wimits Pharmaceuticals, Plot No.129, Sunder Industrial Estate (P.I.E) Raiwind Road, Lahore.

Wimtox Injection Each ml of liquid injection contains:- Novaminsulfon………....40mg Etilefrin B.P …………...0.2mg Calcium Gluconate B.P.100mg Magnesium Gluconate B.P …………………….10mg Sodium Salicylate B.P …7mg Nicotinamide B.P …….0.3mg Caffeine B.P ………..…10mg Boric Acid B.P ……..…10mg (Analgesic and Antipyretic) Finished product specifications are Manufacturer.

Recommended


Stop Spray Each 100ml of aerosol contains:- Deltamethrin BP……...0.500g (Insecticide)

Recommended

56. M/s. Wimits Pharmaceuticals,

Defender Spray Each 30g of aerosol contains:-

Recommended


Plot No.129, Sunder Industrial Estate (P.I.E) Raiwind Road, Lahore.

Neomycin Sulfate BP...150mg Clostebol Acetate….....150 mg (Antiseptic)


Methra Spray Each 100ml of aerosol contains:- Permethrin ……………..0.5 g (Insecticide)

Recommended

58. M/s. D-Maarson Pharmaceuticals, Plot # 17, Street # SS-2, National Industrial Zone Rawat, Islamabad.

NOVA DM INJECTION Liquid Injection Each 100ml contains:- Novaminsulfon………..…..4g Etilefrin………………...0.02g Calcium Gluconate………10g Magnesium Gluconate…...1.0g Sodium salicylate……..0.700g Nicotinamide…………....0.3g Caffeine……………….…1.0g Boric acid………………..1.0g (Analgesic, Antipyretic)

Recommended

Decision: Registration Board deferred the case for the recommendations of Expert

Committee on Veterinary Drugs.

Case No.13. Directions from Drug Appellate Board regarding Nitrofurans.

Drugs Appellate Board in its 140th Sitting held on 20-08-2013 in the appeal of M/s.

Selmore Pharmaceuticals (Pvt.) Ltd., Lahore regarding rejection of their product “URO-

Pessaries” decided as follows:-

i) That the said formulation shall be referred to two veterinary experts, by the defendants, namely: (i) Vice Chancellor, University of Veterinary and Animal Sciences, Lahore, and (ii) A veterinary expert from Army, to be named by Brig. Akbar Waheed, Member, Drugs Appellate Board, for their expert opinion.

ii) The Chairman, Drugs Appellate Board was authorized to take decision on the aforesaid Appeal in the light of the recommendations of the experts.


iii) That the fate of other drug(s) / brand(s) of the same formulation available in the market shall also be decided by the Registration Board in the light of the recommendations of the experts and the provisions of law / rules, under intimation to the Drugs Appellate Board.

Accordingly, opinion of following experts regarding registration of product has been

obtained, which are as follows:-

S. No. Name of Expert. Recommendations.

1. Prof. Dr. Muhammad Ashraf, Dean, Faculty of Bio-Sciences, University of Veterinary & Animal Sciences, Lahore

URO-Pessaries having combination of Chlorotetracycline, Furazolidone and Metronidazole is not recommended for approval in animals.

2. Ltd. Col. Iftikhar Ahmad Anjum, for DGRV&F, QMG Branch RV&F Directorate, GHQ, Rawalpindi.

In order to proceed further, following steps be taken up before the product is registered:- a) A fair trial on animals after cultural sensitivity test, at least on 50 animals which can be provided by Military Farms located at Lahore or Okara. b) Deliberate and authentic recording of readings and fair evaluation be ensured. c) Post treatment cultural sensitively in an aseptic environment.

The Drugs Appellate Board in its 142nd Sitting held on 20-06-2014 keeping in view the

fact that Nitrofurans are recognized by FDA as mutagens / carcinogens, decided to dismiss the

appeal with the directions to the respondent Registration Board to decide the fact of similar

formulations accordingly. As per record, there is only one product “Utacare Pessary” (Reg.

No.035062) is registered in the name of M/s. Nawan Laboratories (Pvt) Ltd., Karachi.

Decision: In compliance to decision of Drugs Appellate Board, Registrstion Board

decided to issue the show cause notice to M/s. Nawan Laboratories (Pvt.) Karachi for

cancellation of registration of Utacare Pessary, (Reg. No.035062). Registration Board

authorized its Chairman for issuance of show cause notice for any other such me too drug.


Case No.14 Registration of imported veterinary drugs - Correction in minutes.

The Drug Registration Board in its 237th meeting held on 26-02-2013 approved the

registration of following imported veterinary drugs in the name of M/s. Mustafa Brothers,

Faisalabad, manufactured by M/s. Veyx-Pharma B.V, Forellenwegm SJ Raamsdonksveer, The

Netherlands, subject to inspection of manufacturer abroad, verification of storage facilities as per

policy. The firm has deposited the required fee;

S# Name of Drug (s) /Composition. Decontrolled / Pack Size.

Shelf Life

1. Masti Veyxym ® Suspension for Intramammary. Each 10gm contains:- All-rac-aTocopheryl acetate (Vitamin E acetate)……120.00mg. Vitamin A concentrate 100.000 IU. Chymotrypsin………2400 FIP-U. Trypsin……………..240 FIP-U. Papain…………………6-FIP-U.

Tube of 10ml 02 years

2. Veyxyl ® LA 20% Solution. Each 1ml contains:- Amoxicillin trihydrate…229.60mg (equivalent to 200.00mg Amoxicillin).

50ml 100ml

03 years

The applicant M/s. Mustafa Brothers, Faisalabad has requested for issuance of

registration letter of the above said drugs. M/s. Mustafa Brothers, Faisalabad was advised to

provide legalized (CoPP) of M/s. Vexy-Pharma B.V., Forellenweg 16, NL-4941 SJ

Raamsdonksveer, issued by Netherlands as the manufacturing site is located in Netherlands duly

endorsed by the Pakistan Embassy/Consulate office in the country of export.

In response, M/s. Mustafa Brothers, Faisalabad have informed that the production of

“Masti Veyxym ® Suspension for Intramammary & Veyxyl ® LA 20% Solution” is performed

in the Netherlands (as contract manufacturer) by M/s. Vexy-Pharma B.V, the Netherlands for

their principal company M/s. Vexy-Pharma GmbH, Germany. However, this production site only

produces bulk (unlabeled bottles / injections) that is shipped subsequently to their site in


Germany M/s. Vexy-Pharma GmbH for finalization the production. At the German site,

the secondary packaging takes place and final batch release is performed. The firm M/s. Vexy-

Pharma GmbH (Germany) is the marketing authorization holder and consequently responsible

for the overall quality, the safety and the efficacy of the products.

The firm has disclosed that the products referred above are being manufactured in bulk at

“M/s. Vexy-Pharma B.V, The Netherlands” then these will be labeled and packed at M/s. Vexy-

Pharma GmbH, Germany. Now it is clear the firm will import these drugs from Germany.

Therefore, it needs amendment in minutes i.e. name of manufacturer is mentioned from

Netherlands in the minutes of 237th meeting of the Registration Board.

Decision: Registration Board approved correction in minutes of 237th meeting for

name of manufacturer as M/s. Vexy-Pharma GmbH, Germany for the following products.

S# Name of Drug (s) /Composition. Decontrolled / Pack Size.

Shelf Life

1. Masti Veyxym ® Suspension for Intramammary. Each 10gm contains:- All-rac-aTocopheryl acetate (Vitamin E acetate)……120.00mg. Vitamin A concentrate 100.000 IU. Chymotrypsin………2400 FIP-U. Trypsin……………..240 FIP-U. Papain…………………6-FIP-U.

Tube of 10ml 02 years

2. Veyxyl ® LA 20% Solution. Each 1ml contains:- Amoxicillin trihydrate…229.60mg (equivalent to 200.00mg Amoxicillin).

50ml 100ml

03 years

Case No.15 Registration of veterinary drug.

Drug Registration Board in its 236th meeting held on 20th November, 2012 approved the

registration of following imported veterinary drugs in the name of M/s. Vet Line International,

Lahore manufactured by M/s. Bela-Pharm GmbH & Co.KG Lohner Strasse 19 49377 Vechta,

Germany, subject to inspection of manufacturer abroad, verification of storage facilities as per


policy. The firm has deposited the required fee.

# No. Name of Drug (s) /Composition. Decontrolled / Pack Size.

Shelf Life.

1. Neomycinsulfat Powder. Each gm powder contains:- Neomycin Sulphate……..1000mg.

100gm. 500gm.

1kg. 5kg.

3 years

2. Belacol 100% Pulver Each gm powder contains:- Colistin Sulphate……….1000mg.

100gm. 250gm.

1kg. & 2.5kg

3 years

The storage facility of the importer has also already been verified by the Area FID. The

applicant M/s. Vet Line International, Lahore has requested for issuance of registration letter of

the above said drugs. During processing of case for issuance of registration letter, it was

observed that these products are 100% API and under the Drug Act 1976 the drugs which are

ready to use are registered under the Section 7 of the Act. Then it was deliberated to get opinion

of experts. Accordingly, views of the following experts regarding use of products above in pure

form “100 API” with special reference to efficacy, safety, toxicity and residual effects in food

producing animal has been obtained, which are as follows:-

S.# Name of Expert. Opinion 1. Dr. Muhammad Ovais Omer,

Chairman, Department of Pharmacology & Toxicology, University of Veterinary and Animal Sciences, Lahore.

i) Based on the pharmacological properties, Neomycinsulfat is a recommended drug for treatment of enteric infections in calves, pigs and chickens. ii) Based on the pharmacological properties, Colistin Sulphate is a recommended drug for treatment of Salmonella, E. coli, Campylobacter, Pullorum, Paratyphoid infections, Colibacillosis and Diarrhoea by E.coli in different animal species.

2. Brig. Zahid Hussain Abid,

Director Rem & Vet., QMG Branch RV & F Dte, General Headquarters,

As regards efficacy, safety, toxicity and residual effects in food producing animal, viz a viz both the products are concerned, in puts of the experts from University of Veterinary and Animal


Rawalpindi.

Sciences, Lahore would be more valuable and pertinent. However, it is suggested that a trial may be conducted at least on 200 animals for establishment of all above factors. In this regard Army Veterinary School can be assigned this task.

3. Dr. Farzana Chowdhary, Director, Department of Pharmacy, University of Veterinary & Animal Sciences, Lahore.

1. Neomycinsulfat – this drug contains 100mg Neomycin Sulphate in 1gm indicating that it is a pure API and not a veterinary finished dosage form. According to the Drugs Act, 1976 APIs do not require registration and can only be imported by manufacturers possessing a valid Drug Manufacturing License (Formulation) and registration of the finished drug of which it is an ingredient. 2. Belacol 100% Pulver contains Colistin Sulphate 1000mg per 1gm (1000mg) powder and does not contain any adjuvant or excepient which is indicative of the fact that it is a pure API and not a finished dosage form for veterinary use. Only finished dosage forms require registration under the Drugs Act, 1976, whereas, APIs can be imported only by those who hold a valid DML (Formulation) and registration of finished drug containing that API.

Decision: Registration Board deferred the case for the recommendations of Expert

Committee on Veterinary Drugs and list of all such products registered earlier by the

DRAP.

Case No.16. Correction of composition of registered veterinary drug-Neurozoc Injection Regn. No. 074072.

M/s. Hilton Pharma (Private) Limited, Karachi have requested for correction of

composition of their registered veterinary “Neurozoc Injection (Reg. No.074072)”. They have

informed that they want to apply below composition as “each 1ml contains, pack size of 100ml”

but by typographically mistake it was mentioned in application dossier as “each 100ml contains,

pack size 100ml”. The registration letter received for following composition “each 100ml

contains, pack size 250ml & 500ml”. They have therefore requested for correction of


composition from “each 100ml contains” to “each 1ml contains” and also change in pack size

from 250ml & 500ml to “100ml”:-

Approved composition Revised composition. Neurozoc Injection. Each 100ml contains:- Novaminsulfon …………….. .100mg. Etilefrin……………………. 0.50mg. Calcium gluconate …………250mg. Magnesium gluconate ……… 25mg. Sodium salicylate ………….17.5mg. Nicotinamide ………………0.75mg. Caffeine………………………. 25mg. Boric acid………………………25mg.

Neurozoc Injection. Each ml contains:- Novaminsulfon …………….. .100mg. Etilefrin……………………. 0.50mg. Calcium gluconate …………250mg. Magnesium gluconate ……… 25mg. Sodium salicylate ………….17.5mg. Nicotinamide ………………0.75mg. Caffeine………………………. 25mg. Boric acid………………………25mg.

M/s. Hilton Pharma (Private) Limited, Karachi have deposited required fee Rs.20000/-

and submitted following supporting documents:-

i) Copy of registration letter. ii) Copy of old Form-5. iii) New Stability data. iv) Copy of new Form-5. Decision: Registration Board deferred the case for the recommendations of Expert

Committee on Veterinary Drugs.

Case No. 17. Cancellation of registration of drugs and stoppage of production.

Drug Registration Board in its 240th meeting held on 07-11-2013 considered the

inspection report of M/s. Avicenna Laboratories (Pvt) Ltd.,14 Km, Sheikhupura, Faisalabad

Road, Bikhi, District Sheikhupura dated 04-03-2013 conducted by the area FID, wherein the FID

has reported that the firm has registration of following (10) injectable products including

(Penicillin and Steroids) but the Injectable Section is not approved as yet by Licensing Section

and the Registration Section has granted the registration of the same:-

S. No. Reg. No. Name of Drug (s) / composition. 1. 035001 Gentacen 100 Injectable Solution.

Each ml Contains: - Gentamycin Sulphate (eq to 100mg


Gentamycin base). 2. 035002 Moxicol Injectable Suspension.

Each ml contains: - Amoxycillin Trihydrate 100mg. Colistin Sulphate 250,000 IU.

3. 035003 Avimox Injectable Suspension. Each ml contains: - Amoxycillin base (as trihydrate) 150mg.

4. 035004 Tylocen-200 Injectable Solution. Each ml contains: - Tylosin Sulphate 200mg.

5. 035005 Avoxy LA Injectable Suspension. Each ml contains: - Oxytetracycline HCl…200mg.

6. 035006 Dexon-5 Injectable Solution. Each ml contains: - Dexamethasone 5mg.

7. 035127 Oxytocen Injectable Solution. Each ml contains: - Oxytocin 10 I.U.

8. 043166 Predexon Injectable Suspension. Each ml contains:- Dexamethasone ……… 2.5mg. Prednisolon ………….. 7.5mg.

9. 043167 Lincospec Injectable Solution. Each ml contains:- Spectinomycin Sulphate 100mg base. Lincomycin Hydrochloride 50mg base.

10. 043168 Avigen-F20 Injectable Solution. Each ml contains:- Gentamycin Sulphate ……. 10mg. Flumequine ……………… 20mg.

The Drug Registration Board decided that the production of the firm for above mentioned

products should immediately be stopped till the complete investigation of the matter and issue a

show cause notice to the firm for explanation of reasons in their defense. Then place the case

before the Board for further deliberations.

Accordingly, a show cause notice was issued to the firm.

In response to the show cause notice the firm has submitted following documents:-


i) Approval of layout plan. ii) Copies of registration letters.

iii) Copy of layout plan. M/s. Avicenna Laboratories (Pvt) Ltd., Sheikhupura was again advised to provide proof

of approval of the Injectable Section and also provide proof of renewal of registration of drugs

above said drugs. The firm have submitted copies of the acknowledgement of last renewal of

registration of above said products and also submitted that on April 15, 2014 the panel

constituted by the Director QA, inspected their Oral Powder, Liquid, Vaccine and Injectable

Sections. The report will be submitted in coming board meeting. The firm have further submitted

that they also want to shift all Penicillin products into toll manufacturing.

DDC (RRR) was also requested to confirm renewal status of the above products. DDC

(RRR) have confirmed the renewal of the drugs.

The Chairman, CLB also resumption of production to the firm only in veterinary oral

powder and veterinary oral liquid sections.

Decision: Registration Board after detailed deliberations canceled the registrations of

following products of M/s. Avicenna Laboratories (Pvt) Ltd., Sheikhupura as the firm do

not have the approved manufacturing facility for these products;

S. No. Reg. No. Name of Drug (s) / composition. 1. 035001 Gentacen 100 Injectable Solution.

Each ml Contains: - Gentamycin Sulphate (eq to 100mg Gentamycin base).

2. 035002 Moxicol Injectable Suspension. Each ml contains: - Amoxycillin Trihydrate 100mg. Colistin Sulphate 250,000 IU.

3. 035003 Avimox Injectable Suspension. Each ml contains: - Amoxycillin base (as trihydrate) 150mg.

4. 035004 Tylocen-200 Injectable Solution. Each ml contains: - Tylosin Sulphate 200mg.

5. 035005 Avoxy LA Injectable Suspension. Each ml contains: - Oxytetracycline HCl…200mg.


6. 035006 Dexon-5 Injectable Solution. Each ml contains: - Dexamethasone 5mg.

7. 035127 Oxytocen Injectable Solution. Each ml contains: - Oxytocin 10 I.U.

8. 043166 Predexon Injectable Suspension. Each ml contains:- Dexamethasone ……… 2.5mg. Prednisolon ………….. 7.5mg.

9. 043167 Lincospec Injectable Solution. Each ml contains:- Spectinomycin Sulphate 100mg base. Lincomycin Hydrochloride 50mg base.

10. 043168 Avigen-F20 Injectable Solution. Each ml contains:- Gentamycin Sulphate ……. 10mg. Flumequine ……………… 20mg.

Case No.18. Registration of Magnesium Sulphate 15% in veterinary products.

Drug Registration Board in its 243rd meeting held on 08-09th May, 2014 considered and

approved the registration of following drug for import in the name of M/s. BN Pharmaceuticals,

Lahore manufactured by M/s. Laboratories Chaix et Du Marais Lavoisier Head Quarter Paris

France subject to price fixation / calculation:-

Name of drug (s)/Composition. Demanded Price /Pack.

Sulphate De Magnesium Lavoisier (1.5G/10ML) 15% (I.V) Injectable. Each ampoule contains: - Magnesium as Sulphate. 1.5g/10ml (15%).

Rs.450/Per ampoule. Rs.4500/Per 10 ampoules.

Meanwhile, the firm M/s. BN Pharmaceuticals, Lahore have submitted the references in

support of above mentioned product which is already under process of registration. The firm has

also submitted the list of countries-organizations in which this product is registered / sponsored

at this time along with the report of WHO Drug Information volume-21/2.2007 WHO Geneva.


The Magnesium Sulphate 15% is not approved by any of the reference authorities i.e.

EMA, USFDA, TGA or PDMC, except France.

Decision: Registration Board referred the case to Review Committee for formulation

review.

Registration-II

Case No.19 Registration of drugs deferred by Registration Board.

a. Cases deferred for expert opinions.

i. Lurisa Tablet 40mg and 80mg – M/S Helix Pharma, Karachi.

Registration Board in 242nd meeting deferred following products for expert opinion. Accordingly

products were referred to expert for views. Comments are as under.

S. No

Name of drug(s) & Composition Proposed Pack size

Demanded Price

1 Lurisa Tablets Each film coated tablet contains: Lurasidone HCl………..….40 mg (Antipsychotic for Treatment of Schizophrenia)

10’s, 20’s, 30’s

As per PRC

2 Lurisa Oral Tablets Each tablet contains: Lurasidone HCl…….80 mg (Antipsychotic for Treatment of Schizophrenia)

10’s, 20’s, 30’s

As per PRC

Brig. Saleem Jehangeer

Armed Forces Institute of Mental Health,

Rawalpindi

Prof. Dr. Rizwan Taj

Psychiatrist,

Pakistan Institute of Medical Sciences,

Islamabad

Dr. Nadeem Abbas

Fauji Foundation Medical Centre,

Rawalpindi

Brig for Comdt (Farrukh Hayat Khan) stated that Maj. Gen Salim Jehangir, Commandant of Armed Forces Institute of Mental Health is not avail due

I have study documents and fee that this medication should be available in Pakistan.

It is a new salt which has shown promising result as compared to

Although Lurasidone salt is not available / introduced in Pakistan, In the light of above mentioned facts & data provided, the drugs Lurasidone (Lurisa) 40mg &


to official commitments

other products in the market it side effect profile is better also.

I am recommending its availability in Pakistan

Lurasidone (Lurisa) 80mg are recommended for Registration Board

Decision: Registration Board discussed and agreed to above expert opinions. However, the Board advised firm to provide data for stability studies conducted under zone IV-A conditions as per ICH / WHO guidelines for consideration of Registration Board.

ii. Roflumilast 500mcg Tablet.

Registration Board in its various meetings deferred registration of Roflumilast 500mcg Tablet of

various firms for expert opinion. Accordingly products were referred to expert for views. Comments are

as under.

S. No

Name of firm(s) Name of drug(s), Composition & Registration Board Meeting

Proposed Pack size

Demanded Price

1. M/s Macter International Karachi

Milast Tablet Each film coated tablet contains: Roflumilast …………… 500 mcg (Phosphodiesterase 4 inhibitors) ( M-242 )

Per tab.

Rs.17.36/-

2. M/s Hiranis Pharma, Karachi

Roflu Tablet Each film coated tablet contains: Roflumilast…………..500mcg (Inhibitor of the enzyme PDE-4) ( M-243 )

10’s 14’s

Rs.270/- Rs.378/-

3. M/s Helix Pharma, Karachi

Raspro 500mcg Tablet Each tablet contains: Roflumilast…………...500 mcg (Anti-Inflammatory) ( M-243 )

10’s As per PRC

Brig. Dr. Aslam Khan, Consultant Pulmonologist, Military Hospital, Rawalpindi

Dr. Rehana Kauser, Consultant Pulmonologist, Pakistan Institute of Mecial Sciences, Islamabad

Dr. Shazli Manzoor Quaid-e-Azam International Hospital, Islamabad


Regarding expert opinion on efficacy, safety, quality and cost effectiveness of Roflumilast in the management of COPD

Roflumilast is a Phosphodiesterase-4 Enzyme Inhibitor. FDA and EMEA has approved this drug as an adjunct to bronchodilator therapy in the maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis given for the purpose of preventing exacerbations Roflumilast significantly improved prebronchodilator FEV1 and decreased the rate of moderate to severe exacerbations in a 52 week, randomized trial of 3091 patients with COPD . Compared to placebo, roflumilast decreased exacerbations (17 percent [95%, CI 8-25]). The use of a once daily oral medication in COPD is enticing; however, the medication should be used as a maintenance therapy to prevent exacerbations rather than to improve other COPD outcomes It is a safe drug which is contraindicated only in moderate or severe hepatic impairment (Child-Pugh class B or C) In view of the above I recommend this drug for registration at an affordable

Regarding expert opinion on efficacy, safety, quality and cost effectiveness of Roflumilast in the management of COPD. FDA and EMEA approved this drug for use in COPD management in severe and very severe COPD. This drug reduce Exacerbations rate in COPD also included in GOLD guidelines However certain studies reported no much beneficial role in the COPD patients. Clinical Studies have also demonstrated higher pharmacological activity and better tolerability of as compared to earlier PDE-4 inhibitors. In my honest opinion this drug may be helpful in the management of COPD in combination with other drugs so it should be cost effective and affordable to the patients.

Regarding expert opinion on efficacy, safety, quality and cost effectiveness of Roflumilast. In this connection I would recommend that Roflumilast (PDE4 inhibitor), is an FDA and EMEA approved drug with established role in the management of COPD. This has been proven to reduce COPD exacerbations in various clinical trials and also included in GOLD guidelines 2014. Clinical Studies have also demonstrated higher pharmacological activity and better tolerability of Roflumilast as compared to earlier PDE-4 inhibitors. Therefore, Roflumilast 500mcg orally once a day if made available in Pakistan especially from Macter platform due to quality and cost effectiveness concern; it can held in reducing suffering due to exacerbations of COPD.


price.

Decision: Registration Board discussed and agreed to above expert opinions. However, the Board advised firm to provide data for stability studies conducted under zone IV-A conditions as per ICH / WHO guidelines for consideration of Registration Board.

iii. Cocard Plus 75/75MG Tablet – M/S Helix Pharma, Karachi.

Registration Board in 237th meeting approved following product of M/s Helix Pharma,

Karachi subject to reason mentioned in last column. Accordingly provided data was referred to

expert for views. Comments are as under.

S. No


Demanded Price

Decision

1 Cocard Plus 75/75mg Tablet Each tablet contains: Clopidogrel bisulfate eq. to clopidogrel……….75 mg Aspirin as enteric coated pellets………….…75 mg (Anti coagulant anti platelet)

10’s As per PRC

Approved subject to confirmation of Bilayered tablet manufacturing facility

Dr. Amanullah Khan, Director, Drug Testing Laboratory, Government of Baluchistan, Quetta

Mr. Abdul Razzaq, Director, Drug Testing Laboratory, Government of Sindh, Karachi

Mr. Muhammad Jamil Anwar, Director, Drug Testing Laboratory, Government of Punjab, Lahore

COCARD PLUS 75/81MG TABLET dissolution profile is different from the originator brand (OGREL PLUS 81 TABLET OF M/S BOSCH PHARMA, Karachi) and scientifically the dissolution method applied is incorrect

Tablet COCARD PLUS is a bilayered film coated (Antiplatelets) having 02 years shelf life is indicated in different kind of CV diseases.

The comparative dissolution profile of M/s Helix Pharma

COCARD PLUS 75/81MG TABLET It is observed that necessary equipment, particularly Bilayered Tableting Machine is available for manufacturing of Cocard Plus 75mg /81mg Tablet. The accelerated stability studies for


because they use separate tablet of Cocard for acid and buffer stages rather replacing the buffer medium from acid to buffer stage, hence on scientific grounds of dissolution profile the product COCARD PLUS 75/81MG TABLET is not recommended.

Products “ COCARD PLUS Tablets” with originator Brand “ OGREL PLUS 81 TABLETS” by M/s Bosch Pharmaceuticals, Karachi” was thoroughly checked & evaluated.

The stability profile shows that stability studies was carried out, and there was no significant physical and chemical changes when product was kept at 40o

C + 2o C /75% RH + 5%, provided proof of climatic chamber, also complies the other tests performed such as weight variation, Assay, disintegration time, dissolution and other aspects that meets the required quality specifications.

The data provided also reflects that manufacturing method / equipments / instruments are properly validated and calibrated.

The last panel inspection was conducted on 28-06-2013 & for verification of bilayered tablets manufacturing facilities was conducted 06-12-2013 wherein they stated that the firm has good facilities provided for manufacturing and quality control and GMP Compliance was found good / satisfactory.

The data provided is sufficient regarding raw material specification &

the product has been carried out with the concluded results of active ingredient within the limits and also shows that no significant physical and chemical change occurred during accelerated stability study carried out for six months. The Dissolution Profile of the product Batch TF001 has been studied in acidic and buffer stage and observed satisfactory. The comparative study with the other brand “Ogrel Plus 81mg Tablets of M/s Bosch Pharma, Karachi was also carried out with the acceptable results. In the light of above and as per data / information provide the drug “Cocard Plus 75mg /81mg (Clopidogrel 75mg + Aspirin 81mg) Tablet is recommended for registration.


finished product specification & analytical procedures, labeling, packing is also available.

So In the light of above mentioned facts & data provided the drug COCARD PLUS Tablets is recommended for registration.

It is to mention here that following is correct formulation submitted by the firm and same has

been evaluated by experts. However, erroneously wrong formulation has been mentioned in

agenda and minutes of 245th Registration Board meeting:-

Cocard Plus 75/81mg Tablet Each tablet contains: Clopidogrel bisulfate eq. to clopidogrel…….75 mg Aspirin as enteric coated pellets………….…81 mg (Anti coagulant anti platelet)

Decision: Registration Board decided to forward comments of Director DTL, Quetta to the manufacturer for clarification.

iv. Dexlansoprazole - M/s OBS Pakistan, Karachi

Registration Board in its 235th meeting deferred following products of M/s OBS Pakistan,

Karachi for reason mentioned in last column.

Name of Drug & Composition Pack Demanded MRP

Decision

Kapdex 30mg Capsule Each capsule contains:- Dexlansoprazole ………..30mg (Anti ulcerants)

14’s Rs.840.00 Deferred. Not me- too product. May be referred to expert committee for new molecule


Kapdex 60mg Capsule Each capsule contains:- Dexlansoprazole ……...60mg (Anti ulcerants)

14’s Rs.1260.00 Deferred. Not me- too product. May be referred to expert committee for new molecule

Registration Board in 245th meeting discussed same formulation and agreed to expert

opinions and advised the firms to provide data for stability studies conducted under zone IV-A

conditions as per ICH / WHO guidelines for consideration of Registration Board.

M/s OBS Pakistan, Karachi has deposited remaining fee (Rs.50000/-) and requested to consider

their above formulations.

Decision: Keeping in view decision of 245th meeting of registration board regarding same

formulation, the advised firm to provide data for stability studies conducted under zone

IV-A conditions as per ICH / WHO guidelines for consideration of Registration Board.

b. Cases for registration of Tramadol.

Registration Board in its 236th meeting held on 20th November, 2012 had decided

that since Nalbuphine and Tramadol are not controlled drugs as per INCB regulation. So the

Board will not consider these cases in light of controlled drug guidelines. However to avoid

misuse potential, their procurement and manufacturing record shall be strictly maintained and

submitted in quadruplicate under Rule 30 (6) of Drugs (Licensing, Registering and Advertising)

Rules, 1976 to the E&M (Evaluation of Monitoring) Department of DRAP.

In light of above decision for registration of Tramadol containing product of

following firm was pending for decision. Firm has deposited the remaining fee @ Rs.12000/- as

per revised schedule for fees. Details are as under:-

S. No. Name of firm Name of Drug(s) Pack MRP Decision

1. M/s Safe Pharmaceutic

Magadol Drops Each ml contains:-

10ml As per PAC 225th RB


als, Karachi

Tramadol HCl ………2.5mg (Non Narcotic Analgesic)

Deferred for confirmation of facility

2. -do-

Magadol Capsule Each capsule contains:- Tramadol HCl ………50mg (Non Narcotic Analgesic)

1x10’s As per PAC -do-

Decision: Registration Board deferred the case for evaluation of registration

application as per approved check list.

c. Registration of Agomelatine Tablet 25mg.

Registration Board in its 227th meetings deferred following products of M/s Nabiqasim

Industries, Karachi and M/s PharmaEvo, Karachi for confirmation of formulation, application on

Form 5D, fee Rs.15, 000.

M/s Nabiqasim Industries, Karachi


Modton Tablet 25mg Each film coated tablet contains:- Agomelatine ……25mg (Antidepressant)

10’s Rs.1500.00

M/s PharmEvo, Karachi.


Agloda 25mg Tablet Each tablet contains:- Agomelatine ……..25mg (Anti depressant)

10’s 14’s 28’s

Rs.2690/- Rs.3750/- Rs.7500/-


Later on scrutiny of registration data reveals that the above formulation is already approved by

the Registration Board in its 236th meeting in favour of M/s Servier Research and Pharmaceuticals

(Pakistan) Ltd, Lahore under the brand name “ Valdoxan 25mg Tablets”

M/s PharmEvo has deposited remaining fee @ Rs.5,000/- and M/s Nabiqasim Industries,

Karachi has also deposited fee @ Rs.15,000/- (dated 10-08-2010) + Rs.52,000/- (dated 24-

01-2013) + Rs.5,000/- (dated 06-05-2013)


applications as per approved check list.

d. Kaizen Pharmaceutical (Pvt.) Ltd , Karachi i. Calcium citrate + Vitamin D.

Registration Board in its 237th meeting deferred following registration application of M/s

Kaizen Pharmaceuticals (Pvt.) Ltd, Karachi for reason mentioned in last column.


Demanded Price

Date of application, Diary No. &

Form

Decision

Calvit-D Sachet Each sachet contains: Calcium citrate maleate…………..2500mg Vitamin D……….400 IU (Calcium and Vitamin supplement/replacement preparation)

10’s 20’s

As per PRC 28-01-2013 Dy.No.60 Form-5

Rs.20,000/-

Deferred for submission of application on form-5D with balance fee

Now firm has stated that same formulation is already registered in favour of M/s Maple

Pharmaceuticals, Karachi with the brand name “Calcivit Sachet” Reg. No.076051 in 234th

meeting of Registration Board.




ii. Alfacalcidol + Calcium carbonate

Registration Board in its 237th meeting deferred following registration application of M/s

Kaizen Pharmaceuticals (Pvt.) Ltd, Karachi for reason mentioned in last column.


Demanded Price

Date of application, Diary No. &

Form

Decision

Alfakal Tablet Each tablet contains: Alfacalcidol ………....0.5 mcg Calcium carbonate….1000 mg (Calcium and Vitamin Analogue)

10’s 20’s 30’s

As per PRC 28-01 -2013 65

Form-5 Rs.60,000/-

Deferred for Clarification regarding dosage of calcium

Now firm has stated that same formulation is available / marketed by M/s SchazooZaka

(Pvt.) Ltd, Lahore with the brand name “Bone-Care C Tablet” vide Reg. No.062790.



e. Sodium Polystyrene– M/s PharmaEvo, Karachi.

Registration Board in its 227th meeting deferred following product of M/s PharmaEvo,

Karachi for expert opinion.

S. No


Demanded Price

Date of application, Diary No. & Form

Decision

1 Klenar Sachet Each sachet contains:- Sodium Polystyrene Sulphonate …………..…15000mg (Potassium removing resin)

15’s 30’s

Rs.3000.00 Rs.6000.00

02-11-2009 2229

Form-5 Rs.8000/-

Deferred for expert

opinion

Now M/s PharmEvo have deposited remaining fee @ Rs.42,000/- being new formulation.


Decision: Registration Board deferred the case for evaluation of registration application as per approved check list. Moreover, the product will be referred to Prof. Dr. Ghias Butt, PIMS, Islamabad; Syed Ather Hussain, Head of Nephrology, Agha Khan University Hospital, Karachi and Uzma Bano, FFH, Rawalpindi for expert opinion.

f. Macter International, Karachi

Following products of M/s Macter International, Karachi was deferred by Registration

Board in 214th meeting for confirmation of atomic absorption spectrophotometer.


Mactosin Suspension Each 5ml contains:- Ossien Mineral Complex (Hydroxy Apatite) 800mg equivalent to Calcium …………. 130mg Phosphorous …………… 68.8mg Residual Mineral Salts ….57.5mg Collagen …………………87.5mg Other Proteins …………20mg Trace elements F1,mg,Zn,Fe,Ni,Cu)

60ml Rs.100.00

Mactosin Tablets Each tablet contains:- Ossien Mineral Complex (Hydroxy Apatite) 250mg equivalent to Calcium ….53.5mg Phosphorous …….24.8mg Residual Mineral Salts ….7.5mg Collagen …………………87.5mg Other Proteins ………… Trace elements F1,Mg,Zn,Fe,Ni,Cu)

Per tablet Rs.5.33

Later on scrutiny of registration data reveals typographic error in above formulation.

Correct formulation as applied by the firm are as under:-

Correct Formulation

Mactosin Tablets


Each tablet contains:- Ossien Mineral Complex (Hydroxy Apatite) 800mg equivalent to Calcium …………. 130mg Phosphorous …………… 68.8mg Residual Mineral Salts ….57.5mg Collagen …………………67.5mg Other Proteins …………..…20mg Trace elements F1,mg,Zn,Fe,Ni,Cu) Mactosin Suspension Each 5ml contains:- Ossien Mineral Complex (Hydroxy Apatite) 250mg equivalent to Calcium ………….53.5mg Phosphorous …….24.8mg Residual Mineral Salts ….7.5mg Collagen …………………87.5mg Other Proteins ………… 20mg Trace elements F1,Mg,Zn,Fe,Ni,Cu)

Federal Inspector of Drug, Karachi in inspection dated 27.09.2012 confirmed atomic

absorption in the Quality Control Laboratory of the firm.

Decision: Registration Board approved correct formulation for registration.

g. M/s Bosch Pharmaceuticals, Karachi.

Registration Board in 228th & 244th meeting deferred following products of M/s Bosch

Pharmaceuticals, Karachi reason mentioned in last column.

S. No. Name of drug(s) & Composition Proposed Pack size

Demanded Price

Decision

1. Calamox Chewable Tablet 200mg Each chewable tablet contains:- Amoxycillin as Trihydrate ..200mg Clavulanic Acid as Potassium ……….….28.50mg

Not mentioned

Not mentioned

Deferred for confirmation of international availability & expert opinion


(Antibiotics) 2. Calamox Chewable Tablet 400mg

Each chewable tablet contains:- Amoxycillin as Trihydrate ..400mg Clavulanic Acid as Potassium ………………….57 mg (Antibiotics)

Not mentioned

Not mentioned

-Do-

3. Calamox Dispersible Tablet 375mg Each Dispersible tablet contains:- Amoxycillin as Trihydrate ..250mg Clavulanic Acid as Potassium ………………...125mg (Antibiotics)

Not mentioned

Not mentioned

-Do-

4. Calamox ES Oral Suspension Each ml contains: Amoxycillin as Trihydrate……….600 mg Clavulanic acid as potassium salt…… 42.9 gm (ntibiotic / antibacterial for microbial diseases)

75ml 125ml 200ml

Rs.225.00 Rs.375.00 Rs.600.00

Deferred for confirmation of me too status

5. Calamox-XR Tablet Each extended release tablet contains: Amoxycillin as trihydrate ……….…...1 gm Clavulanic acid as potassium…………… 62.5 mg (Antibiotic / antibacterial for microbial diseases)

6’s 14’s 28’s

Rs.180.00 Rs.420.00 Rs.840.00

Deferred for confirmation of me too status.

Now firm has stated as under:-

For products at S. No.1 – 3

Remaining fee @ Rs.35,000/- for each product Application of Form-5-D

For products at S. No.4 – 5

Remaining fee @ Rs.23,000/- for each product Application of Form-5-D

Decision: Registration Board advised firm to provide data for stability studies conducted under zone IV-A conditions as per ICH / WHO guidelines for consideration of Registration Board.


Case No.20 De-Registration of registered drugs.

M/s Tabros Pharma, Karachi have requested for de-registration of their registered drugs,

as per following details:-

S. No. Name of drug(s) Reg. No. Reason / Justification 1. Tabromide Capsule 2mg

Each capsule contains:- Loperamide HCl …….2mg

014296 Due to some unavoidable circumstances and unfeasibility in the market

2. Evac 100mg Tablets Each chewable coated tablet contains:- Alpha Tocopherol Acetate J.P ……………100mg

021801 -do-


021802 -do-


021803 -do-


021804 -do-

6. Pyrazol 500mg Tablet Each tablet contains:- Pyrazolone Magnesium 500mg

014346 -do-

Decision: Registration Board deferred the case for presentation before the Board.


Case No.21 Grant of Registration – Mentioning of two MRPs for a formulation.

Registration Board in its 242nd meeting approved following registration in favour of M/s

The Searle Company Ltd, Karachi and accordingly registration letter was issued as per following

details.

S. No Reg. No. Name of Drug(s) & Composition

Packing MRP

1 076280 Peditral-R (Bubble Gum Flavor) Powder (Low Osmolar Formulation) Each sachet contains:- Pre-cooked Rice Powder…...6g Sodium Chloride ……….0.35g Potassium Chloride ……0.30g Sodium Citrate ………..0.58g (Manufacturer’s Specifications)

10’s Sachet Rs.100.00

2 076281 Peditral-R (Mango Flavor) Powder (Low Osmolar Formulation) Each sachet contains:- Pre-cooked Rice Powder…...6g Sodium Chloride ……….0.35g Potassium Chloride ……0.30g Sodium Citrate ………..0.58g (Manufacturer’s Specifications)


3 076282 Peditral-R (Orange Flavor) Powder (Low Osmolar Formulation) Each sachet contains:- Pre-cooked Rice Powder…...6g Sodium Chloride ……….0.35g Potassium Chloride ……0.30g Sodium Citrate ………..0.58g (Manufacturer’s Specifications)


Later on firm has stated that basically they have filed for pack size of 10’s in registration

dossier including Costing, pack proposed labeling & design but only in Form-5 pack size 20’s

were also mentioned by mistake. Being brand leader they have demanded the MRP Rs.200/- for

10 sachets. While minutes of meeting 242nd of RB shows only pack size of 20’s instead of

10’s.Firm has also submitted that Drug Pricing Committee in its 15th meeting dated 12-04-2011

has already fixed MRP Rs.140/- for pack size of 10’s for same formulation.


Case was referred to Evaluation Cell and they explained that firm has applied for both

packs / prices i.e Rs.200/20’s & Rs.200/10’s in the same dossier.

Decision: Registration Board referred to Cost & Pricing Division, DRAP for their opinion on the case. Case No.22 Transfer of registered drugs:

a. Transfer of registration from import to local manufacturing:

M/s The Searle Company Ltd, Karachi have requested for transfer of registration

of following drugs from import to local manufacturing at their own facility i.e M/s The Searle

Company Ltd, F-319, S.I.T.E, Karachi

S. No. Reg. No. Name of drug (s)

1 010172 Tramal – 100 Injection

(Tramadol) 2. 023317 Tramal SR100mg Tablet

(Tramadol) As per SOP, supporting documents were sent for expert opinion to three (03) experts and

now two (02) experts out of three (03) has sent their opinion. Details of comments of experts are

as under:-

Prof. Nadeem Irfan Bukhari, Faculty of Pharmacy, University of the Punjab, Lahore

Director, Drug Testing Laboratory, Government of Bluchistan, Quetta

Director, Drug Testing Laboratory, Government of Punjab, Lahore

The report sent for the above subject shows the results of ongoing real time stability studies of Tramal SR Tablets and Tramal 100mg/2ml Injection. It is understood that the case has been filed for the transfer of registration from

After thorough review of the stability data and validation of analytical methods of the products of Tramal SR Tablets 100mg and Tramal Injection 100mg/2ml Injection is recommended.

Awaited


import to local manufacturing at their local facility. My opinion / comments are as follows:- The data provided on tablet formulation indicated that the strength (assay) of tramadol HCl , dissolution test and the physical characteristics were within the limits and specifications after the real time one year and accelerated studies. The data given on the injection formulation showed that the tramadol was stable in this formulation during real time as well as in the accelerated stability study. The data on real time and accelerated study reflected some variations which were minor and within the acceptable limits. The HPLC method developed for each formulations was linear, precise and accurate, through LOQ and LOD was not provided. Meanwhile the drug peaks were shown to be resolved well without interference. Furthermore, the drug peaks seem to be responsive to the changes in concentrations of the tramadol HCl in the samples. Keeping the general reflection, the data on the stability and HPLC method of Tramal SR Tablets 100mg and Tramal Injection 100mg/2ml Injetion seem to be appropriate.

In this regard the undersigned scientifically and logically comments as under:- Stability Studies: The stability studies of both Tramal 100 Injection as well as Tramal SR 100mg Tablets have been carried out against ICH guidelines. The results of ongoing real time stability studies showing all physical parameters and assay of Tramadol HCl is well within the specified limits. Also, at accelerated condition the stability data is found satisfactory. The data given on Tramadol SR Tablets specified that the dissolution test, assay of Tramadol and physical characteristics of the formulation is within the limits in ongoing stability studies (real time and accelerated). Validation data The validation studies of both products have been evaluated the results are found satisfactory. Therefore keeping in view the present data provided by the firm for both their products, the undersigned


is of the opinion to recommend the registration of Tramal -100 Injection (Tramadol) 100mg/2ml (Reg. No.010172 and Tramal SR 100mg Tablets (Tramadol) (Reg. No.023317) in favour of the firm.

As per practice in vogue cases for transfer of registration from import to local

manufacturting are considered at same terms and condition including MRP. Cost & Pricing

Divison was also consulted, who confirmed to proceed as per previous practice. Form 5 has

already been evaluated by PEC as per check list approved by Registration Board.

Decision: Registration Board decided as follows: Cancellation of registrations of Tramal – 100 Injection, Registration No. 010172 and

Tramal SR100mg Tablet, Registration No. 023317 from M/s Serale Pharmaceuticals, Karcahi.

Grant of registrations of Tramal – 100 Injection, Registration No. 010172 and Tramal SR100mg Tablet, Registration No. 023317 in name of M/s The Searle Company Ltd, F-319, S.I.T.E, Karachi for local manufacturing.

b. Transfer of registrations from M/s Macter International, Karachi to M/s Ray

Pharma, Karachi.

M/s Ray Pharma, Karachi have requested for transfer of registration of following drugs

from M/s Macter International, Karachi to their name. Registration dossiers were evaluated by

Incharge PEC and DDC (R-II) as per check list approved by the Registration Board and firm has

also rectified shortcomings and following recommendations were framed.

S. No.

Reg. No. Name of Drug(s) Recommendations

01 000482 Genticyn Ear / Eye Drops

May be approved subject to confirmation of renewal status

02 004298 Genticyn HC Ear / Eye Drops

Referred to Review Committee or may be discussed in Registration Board due to the reason that these formulations have not been found approved in SRA’s (reference drug agencies)


03 000497 Genticyn Cream 0.1% w/w

May be approved subject to confirmation of renewal status

04 000483 Genticyn HC Cream Referred to Review Committee or may be discussed in Registration Board due to the reason that these formulations have not been found approved in SRA’s (reference drug agencies)

05 010186 Genticyn B Cream -do-

06 007701 Multigesic Cream May be approved subject to confirmation of renewal status

Renewal status of products are as follows:-

S. No.

Reg. No. Name of Drug(s) Initial date Aplication receiving date

Renewal status

01 000483 Genticyn HC Cream 06-09-2006 Application received after expiry date and grace period 24-02-2012

Registraion is not valid

02 010186 Genticyn B Cream -do- -do- -do- 03 007701 Multigesic Cream -do- -do- -do- 04 000482 Genticyn Ear / Eye Drops 24-08-1978

Trasnfer of regn date 18-06-2007

07-06-2012 Registraion is valid upto 17-06-2017

05 004298 Genticyn HC Ear / Eye Drops

-do- -do- -do-

06 000497 Genticyn Cream 0.1%

w/w 06-09-2006 Application

received after expiry date and grace period 24-02-2012

Registraion is not valid


Cancellation of registrations of Genticyn Ear / Eye Drops, Regn No. 010186 from M/s. Macter International, Karachi.

Grant of registrations of Genticyn Ear / Eye Drops, Regn No. 010186 in name of M/s. Ray Pharma, Karachi. Chairman, Registration Board will permit issuance of


registration letter after comments of Cost & Price Division.1 Genticyn HC Ear / Eye Drops, Registration No. 004298 referred to review

committee as it’s not found approved in SRA’s (reference drug agencies). Registrations of Genticyn HC Cream, Genticyn B Cream, Multigesic Cream and

Genticyn Cream 0.1% w/w are not valid.

c. Transfer of registration from M/s Macter Pharmaceutical (Pvt.) Ltd, Karachi to M/s Macter International (Pvt.) Ltd, Karachi.

M/s Macter International (Pvt.) Ltd, Karachi has requested for transfer of their following

registered drug from previous name i.e M/s Macter Pharmaceutical (Pvt.) Ltd, Karachi to new

name i.e M/s Macter International (Pvt.) Ltd, Karachi.

Sr. No.

Registration No. Brand

Name(s) Formulation/Generic

Name Date of

Registration Renewal Status

1. 011206

Relaxin Tablets 3mg

Bromazepam 06-06-1990

Valid up to 05-06-2015

Central Licensing Board in its 238th meeting held on 19-11-2014 approved Tablet

(Psychotropic) / Narcotic) Section as segregated section.

Decision: Registration Board approved registration of Relaxin Tablets 3mg in name of

M/s Macter International (Pvt.) Ltd, Karachi.

Case No.23 Change of Contract Manufacturer – M/s B. Braun Pakistan (Pvt.) Ltd, Karachi

M/s B. Braun Pakistan (Pvt.) Ltd, Karachi was granted approval for transfer of

registration from Import to Local manufacturing by contract manufacturing at M/s Mac & Rains

Pharmaceuticals (Pvt.) Ltd, Lahore. Now firm has requested for change of contract

manufacturing from M/s Mac & Rains Pharmaceuticals (Pvt.) Ltd, Lahore to M/s Frontier

Dextrose Ltd, Hattar as the M/s Mac & Rains were unable to manufacture their medicine due to

hiring of their plant by M/s Searle Pakistan.

Applicant Contract manufacturer

Reg. No. Name of drug(s) & Composition Date of application, Diary No. & Form

Category

1. M/s B. Braun

M/s Frontier Dextrose Ltd,

053854 B. Braun-RL Infusion Each 100ml contains:-

03-06-2014 537

Import to local


Pakistan (Pvt.) Ltd, Karachi

Haripur Sodium Chloride …..0.600gm Sodium Lactate …..…0.32gm Potassium Chloride…0.040gm Calcium Chloride 2H2O …...0.027gm

Form-5 Rs.50,000/-

contract

2. -do- -do- 053855 B. Braun-RLD Infusion Each 100ml contains:- Sodium Chloride …..0.600gm Sodium Lactate …..…0.32gm Potassium Chloride…0.040gm Calcium Chloride 2H2O …...0.027gm Dextrose Anhydrous for Parenteral …………5.5gm

03-06-2014 538

Form-5 Rs.50,000/-

Import to local

contract

3. -do- -do- 053848 B. Braun – Paeds Infusion Each 100ml contains:- Sodium Chloride …..0.45gm Dextrose Anhydrous for Parenteral use………5.0gm

03-06-2014 543

Form-5 Rs.50,000/-

Import to local

contract

4. -do- -do- 053849 B. Braun – DS ½ Infusion Each 100ml contains:- Sodium Chloride …..0.45gm Dextrose Anhydrous for Parenteral use………5.00gm

03-06-2014 536

Form-5 Rs.50,000/-

Import to local

contract

5. -do- -do- 053850 B. Braun – DS Infusion Each 100ml contains:- Sodium Chloride …..0.9gm Dextrose Anhydrous for Parenteral use………5.00gm

03-06-2014 541

Form-5 Rs.50,000/-

Import to local

contract

6. -do- -do- 053851 B. Braun – G5 Infusion Each 100ml contains:- Dextrose Anhydrous for Parenteral use………5.00gm

03-06-2014 535

Form-5 Rs.50,000/-

Import to local

contract

7. -do- -do- 053852 B. Braun – G10 Infusion Each 100ml contains:- Dextrose Anhydrous for Parenteral use………10.00gm

03-06-2014 539

Form-5 Rs.50,000/-

Import to local

contract


8. -do- -do- 053856 B. Braun - Mannitol Infusion Each 100ml contains:- Mannitol ………..17.5gm Sorbitol for Parenteral use…………….…2.5gm

03-06-2014 540

Form-5 Rs.50,000/-

Import to local

contract

9. -do- -do- 053853 B. Braun - NS Infusion Each 100ml contains:- Sodium Chloride ……0.90gm

03-06-2014 542

Form-5 Rs.50,000/-

Import to local

contract

The above case was deferred in 245th meeting of Registration Board for confirmation of TOC

analyzer and particle counter in M/s Frontier Dextrose Ltd, Hattar. Federal Inspector of Drugs, DRAP,

Peshawar has reported that that he has checked physically the installation of TOC analyzer and particle

counter in the said firm’s laboratory on 17-11-2014.

Decision: Registration Board acceded to request of M/s B. Braun Pakistan (Pvt.) Ltd, Karachi for change of contract manufacturer for above products to M/s Frontier Dextrose Ltd, Hattar at same terms and conditions. This permission will be valid till 30.06.2015. Case No: 24 Change of contract manufacturer-M/s Excell Health Care Laboratories

(Pvt.) Ltd, Karachi. Following products of M/s Excell Health Care Laboratories (Pvt.) Ltd, Karachi

were registered for bulk import from M/s ACTAVIS UK Ltd, United Kingdom and local

repacking at M/s Elko Organization, Karachi.

S. No. Name of product(s) Reg. No.

1. Cyclogest Pessaries 200mg (Progesterone Pessaries)

033181

2. Cyclogest Pessaries 400mg (Progesterone Pessaries)

033182

Now the firm has requested for change of contract manufacturer for above mentioned

product (bulk import and local repacking) from M/s Elko Organization, Karachi to M/s Apex

Pharmaceuticals (Pvt.) Ltd, D-21-A1, S.I.T.E, Super Highway, Karachi. Firm has deposited fee

@ Rs.10, 0000/- for each product for the purpose.


Registration Board in 241st meeting discussed and decided as under:-

The Board deliberated that reapacking is the part of manufacturing and in this case final quality control release will be granted by local manufacturer, which will be M/s Apex Pharmaceuticals (Pvt.) Ltd, D-21-A1, S.I.T.E, Super Highway, Karachi. Thus Board constituted a panel comprising of Director DTL, Peshawar, Director CDL Karachi and area FID to inspect the premesis for confirmation of repacking and quality control facilities of the firm. The Board also advised the panel to confirm that status of imported products whether in pessaries, blister etc. Registration Board will decide the case in light of report of the panel.

Accordingly panel inspected the premises of M/s Apex Pharmaceuticals, Karachi

and concluded as under:-

During inspection, it was observed that management has provided adequate facilities for repacking of above named products and quality control that are being imported from M/s Actavis, United Kingdom in form of strips and management is intended to repack 15 pessaries in one pack. A room with controlled temperature is also reserved for proper placement of bulk and repacked products. Based on the observations made, people met, record reviewed and repacking & QC facilities provided by the management, panel recommends the transfer of the above name products from M/s Elko Organization, Karachi to M/s Apex Pharmaceuticals (Pvt.) Ltd, D-21-A1, S.I.T.E, Super Highway, Karachi

Decision: Registration Board acceded to request of M/s Excell Health Care Laboratories (Pvt.) Ltd, Karachi for change of contract manufacturer for repacking and quality control release of above products to M/s Apex Pharmaceuticals (Pvt.) Ltd, D-21-A1, S.I.T.E, Super Highway, Karachi. However the firm will provide legalized COPP at WHO format for both products and authorized its Chairman for issuance of letter. Permission is at the same terms and conditions will be valid till 30.06.2015.

Case No.25 Issuance of duplicate registration letter.

M/s Johnson & Johnson, Karachi have requested for issuance of duplicate registration of

their following drugs:-

S. No. Reg. No. Name of Drug(s) 1. 009078 Daktarin Oral Gel 2. 009084 Daktacort Cream 3. 009083 Sibelium Capsule 4. 009082 Vermox Tablet 500mg


Firm has furnished following documents to support their request:-

a) Copy of entry in roznamcha from concerned policy station b) Fee @ Rs.5000/- for each product for the purpose.

Decision: Registration Board deferred the case for confirmation of renewal status.

Case No.26 Grant of Registration for export purpose - Contract Manufacturing.

Following firm has requested for registration of drug for export purpose only,

on basis of contract manufacturing.

Contract giver Contract manufacturer

Name of Drug(s) & Composition Date of application, Diary No. &

Form M/s Medisure Labs, Karachi

M/s Cirin Pharma, Hattar

Rumaclav Tablet 625mg Each tablet contains:- Amoxicillin as Trihydrate ……500mg Clavulanic Acid as Potassium…125mg

31-12 -2013 Form-5

Rs.50,000/-

Decision: Registration Board approved grant of above registration on contract manufacturing basis for export purpose only. In order to boost export, The Board also authorized Chairman for grant of registration for export purpose on contract manufacturing basis excluding controlled drugs and new drug as per contract manufacting policy. Case No.27 Grant of Registration for export purpose – Controlled Drug.

M/s Pharmatec Pakistan (Pvt.) Ltd, Karachi has requested for registration of following

drug for export purpose only:-

S. No.

Date of application Diary No. & Form

Name of drug(s) & Composition

Information required & reply of firm

30-09-2014 753 Form-5 Rs.20,000/-

Flu-Gone C&F Tablet Each tablet contains:- Paracetamol ...600mg Pseudoephedrine HCl…………60mg

Application on Form 5 with required fee as per relevant SRO

NOC for CRF clearance Copy of approved section from CLB

Copy of last inspection report An undertaking that applied registration


Chlorpheniramine Maleate …….4mg

is exclusively for export purpose and will not be sold in Pakistan.

If formulation / product is not registered in Pakistan, then export order from importing country (Registered in Pakistan)

Above formulation is registered for local manufacturing as per following details:-

Applied formulations Registered in Pakistan Manufacturer Flu-Gone C&F Tablet Each tablet contains:- Paracetamol …….....600mg Pseudoephedrine HCl..60mg Chlorpheniramine Maleate..4mg

Reltus C&F Tab(Reg. No.024908) Epinol-CF Tab (Reg. No.023982)

M/s Pharmatec M/s CCL, Lahore

Decision: Registration Board discussed that applied drug contains Pseudoephedrine, which is a precursor chemical and segregated section is required only for Narcotic Drugs and Psychotropic substances as per Central Licensing Board decision. Thus applied formulation registered for export purpose only. Case No.28 Change in flavour – Gastrolyte Rice (Reg.No.070436) – M/s Sanofi Aventis Pakistan Ltd, Karachi. M/s Sanofi Aventis Pakistan Ltd, Karachi has informed that their product

Gastrolyte Rice (Reg. No.070436) is registered in Apricot flavor. Now firm has requested for

change of flavor from Apricot to Raspberry.

Firm has submitted for information to support their request.

O6 months accelerated stability data Undertaking Specification & Control Method Copy of Registration letter Fee @ Rs.5,000/- for the purpose.

Decision: Registration Board approved the request. However, Incharge, PEC will evaluate the stability data and Chairman, Registration Board will authorize issuance of permission letter on the basis of these recommendations.


Case No.29 Change of manufacturing site from Contract to own facility.

Following products of M/s Medisure Labs (Pvt.) Ltd, Karachi were initially registered for

import as per following details and then permitted for local contract manufacturing from M/s

Indus Pharma, Karachi which are valid till 30.06.2015. Now M/s Medisure Labs (Pvt.) Ltd,

Karachi has informed that they have developed facility for Liquid Injectables (Ampoules &

Vials) at their own premises 17/24, Korangi Industrial Area Karachi and requested to permit

manufacturing of products at this facility.

S. No. Reg. No. Name of Drug(s) Date of Registration

1. 015566 Rosiden Injection Each 1ml ampoule contains:- Piroxicam …………….20mg

23-08-1994

2. 014084 Neurocoline 250mg/2ml Injection Each 2ml contains:- Citicoline …………….250mg

01-11-1993

Registration dossiers were evaluated by Incharge PEC and DDC (R-II) as per check list

approved by the Registration Board and firm has also rectified shortcomings. It is pertinent to

mention that citicoline is under consideration of Review Committee.

Decision: Registration Board approved request of M/s Medisure Labs (Pvt.) Ltd,

Karachi for manufacturing of Rosiden Injection, Registration No.015566 at its own

premesis. However, request of Neurocoline 250mg/2ml Injection, Registration No.014084

will be considered after recommendation of Review Committee and decision of the Board

on Citicoline.

Case No.30 Correction in Minutes:

a. M/s Amarant Pharma, Karachi

Registration Board in 245th meeting approved following registration in favour

of M/s Amarant Pharma, Karachi. Registration letter could not be issued due to following

mistake in minutes. Existing and correct formulation are as under:-


Name of Drug(s) & Composition Correct Composition Amprexa-F Tablet 12/25mg Each tablet contains:- Olanzapine ………..……12mg Fluoxetine HCl …….……25mg

Amprexa-F Capsule 12/25mg Each capsule contains:- Olanzapine ……..………12mg Fluoxetine HCl ………..…25mg

Decision: Registration Board approved the correction as Amprexa-F Capsule 12/25mg

instead of tablets.

Case No.31 Registration of Drugs for export purpose-Not me too Drugs.

Following firms have requested for registration of following drugs for export

purpose only which are not me-too. Details are as under:-

S. No.

Name of Company

Name of product(s) Date of application, Diary No. & Form

Export Order

1. M/s Genix

Pharma, Karachi

Sofos Tablet Each film coated tablet contains:- Sofosbuvir MS ....400mg

23-11-2014 769

Rs.20,000/-

Original Export Order from Afghanistan

2. -do- Sofopas Tablet Each film coated tablet contains:- Ledipasvir MS ……90mg Sofosbuvir MS .......400mg

23-11-2014 770

Rs.20,000/-

Original Export Order from Afghanistan

3. M/s Tabros

Pharma, Karachi

Vibrenta 400mg Tablet Each film coated tablet contains:- Sofosbuvir MS ....400mg

19-11-2014 767

Rs.20,000/-

Copy of Export Order from Afghanistan

4. M/s Getz Pharma, Karachi

Azvira 400mg Tablet Each film coated tablet contains:- Sofosbuvir ....400mg

05-12-2014 771

Rs.20,000/-

Not provided


Decision: Mr.A Q Javed Iqbal, Director QA &LT opined that for export purpose only

those formulations should be registered, which are already registered in Pakistan. For new

formulations (which are not registered in Pakistan), manufacturers should first conduct

stability studies and then registration for export purpose be granted. Prof. Muzammil H

Najmi also endorsed it. Registration Board after deliberation decided that inorder to

facilitate export of quality drugs (non-me too drugs), export registration will be granted

and manufacturer will comply following conditions before export of drug:



Registration Board approved above products for registration for export purpose only

with aforementioned conditions. These conditions will also be applicable to products approved for exports (Sofosbuvir) by Chairman, registration Board


Registration-III Case No.32

Registration Board in its 229th meeting approved the following product of M/s Global

Pharmaceutical, Islamabad.

S.No. Name and Composition of

Product Pack size Demanded

Price 1. Tamsol-D Tablets

Each film coated tablet contains:- Tamsulosin Hydrochloride 0.4 mg (as modified – release tablets) Dutasteride………………0.5 mg

10’s As Per SRO Fee

Rs:8,000/=

The Registration Board reconsidered the decision of 229th meeting which is as follows:

“Decision: Registration Board after considering the technical opinion by its members decided to ask the manufacturer to appear before Registration Board for presentation of his opinion regarding efficacy of the above drug formulation. The Board further ordered that till final decision, the registration of above product would remain suspended under section 7(11) (ad) of Drug Act, 1976.”

Decision: Registration Board discussed the case and decided to issue show cause notice

to M/s Global Pharmaceutical, Islamabad for cancellation of registration.

Case No.33

M/s. Amgomed, Islamabad has requested to transfer of the following drug from being

imported for local manufacturing on contract basis by M/s. Bio-Lab (Pvt) Limited, Islamabad:-

S.No.

Reg. No.

Name and Composition of Product

Pack size Demanded Price

1 053821 Amgozole Injection

Each vial contains:- Omeprazole Sodium ≡ Omeprazole……40 mg

Per vial As Per SRO


(Proton Pump Inhibitor)

The dossier has been submitted along with fee amounting Rs.50,000 and has been evaluated

with the collaboration of the Incharge Evaluation Cell as per check list.

Decision: Registration Board approved request of M/s. Amgomed, Islamabad for contract manufacturing of Amgozole Injection, Registration No. 053821 from M/s. Bio-Lab (Pvt) Limited, Islamabad. This permission will be valid till 30.06.2015. Case No. 34.

M/s. Quaper (Pvt) Limited, Sargodha has requested to transfer the manufacturing site from

M/s. Fassgen Pharmaceuticals, Hattar to M/s. Mediate Pharmaceuticals, Karachi on contract

basis:-

1. From Fassgen Hattar

To Mediat

e Karachi

054069 Cefein 250 Injection IV Each vial contains:- Ceftriaxone Sodium ≡ Ceftriaxone……..250 mg (Cephalosporin)

2. Fassgen

Mediate

054077 Cefein 500 Injection IV Each vial contains:- Ceftriaxone Sodium ≡ Ceftriaxone……..500 mg (Cephalosporin)

3. Fassgen

Mediate

054073 Cefein 250 Injection IV Each vial contains:- Ceftriaxone Sodium ≡ Ceftriaxone……..1g (Cephalosporin)

4. Fassgen

Mediate 054067 Rayxime 400 mg Capsule Each capsule contains:- Cefixime Trihydrate ≡ Cefixime…………400 mg (Cephalosporin)


The dossiers have been submitted along with fee of Rs:50,000/each and have been evaluated

with the collaboration of the Incharge Evaluation Cell as per check list.

Decision: Registration Board approved the request of M/s. Quaper (Pvt) Ltd., Sargodha for change in contract manufacturer of above products from M/s. Fassgen Pharma to M/s. Mediate Pharma, Karachi. Permission is at already approved terms and conditions.

Case No.35 Registration Board in 242nd meeting approved the registration of following drug

of M/s. Olive Laboratories, Rawat.

S.No

Existing name with approved Composition

Correct formulation/Nomenclature

1. 1. Hepatavir 300 mg Tablets 2.Tablets 3. Each film coated Tablet contains: Tenofovir Disoproxil Fumarate ….30 mg 4. Anti-retroviral / Nucleoside and Nucleotide Reverse Transcriptase Inhibitors

1. Hepatavir 300 mg Tablets 2.Tablets 3. Each film coated Tablet contains: Tenofovir Disoproxil Fumarate…300 mg 4. Anti-retroviral / Nucleoside and Nucleotide Reverse Transcriptase Inhibitors

The Evaluation Cell stated that the firm had correctly applied for Tenofovir Disoproxil

Fumarate 300 mg film coated tablet but inadvertently incorporated as 30mg in agenda and

minutes of 242nd meeting. The abovementioned inadvertent typographical error of the strength

needs rectification as Tenofovir Disoproxil Fumarate 300 mg.

Decision: Registration Board approved the correction as Tenofovir Disoproxil Fumarate 300mg Tablet.

5. Fassgen

Mediate

054065 Rayxime 100 mg Dry Suspension Each 5ml contains:- Cefixime Trihydrate ≡ Cefixime…………100 mg (Cephalosporin)


Case No.36

Registration Board in 244th meeting deferred the following registration applications of M/s.

Welwink Pharmaceutical, Gujranwala for manufacturing by M/s. Weather Fold Pharmaceuticals,

Hattar on contract basis in view of required GMP inspection as mentioned below:

M/s Welwink Pharmaceuticals. G.T Road, Industrial Estate, Gujranwala Cantt. Gujranwala Manufacturing on Contract basis by M/s Weather Folds Pharmaceuticals. Plot 69/2, Phase-2, Industrial Estate, Hattar

Acticef 500 mg Powder for reconstitution of IM Injection Each Vial contains:- Ceftriaxone Sodium ≡ Ceftriaxone ……500 mg (Cephalosporin Antibiotic) (USP Specs)

Form 5 18-07-2012 Dy No 7333 21-05-2013 Rs. 150,000/- As Per SRO 1‟s vial

FDA. (Rocephin (Roche) SPORCEF(LOWITT PHARMACEUTICALS (PVT) LTD) Advised for further improvement in different sections. (22-03-2014)

Deferred for GMP inspection of contract manufacturer by panel comprising of Dr. Muzammal H. Najmi, Director QA & LT and Area FID. Contract giver will be inspected by Area FID as last inspection report is more than 01 year old

-do- Acticef 250 mg Powder for reconstitution of IM Injection Each Vial contains:- Ceftriaxone Sodium ≡ Ceftriaxone…….250 mg (Cephalosporin Antibiotic)

Form 5 18-07-2012 Dy No 7336 21-05-2013 Rs. 150,000/- As Per SRO/1‟s vial

SPORCEF(LOWITT PHARMACEUTICALS (PVT) LTD) Advised for further improvement in different sections. (22-03-2014)


-do- Acticef 250mg Powder for reconstitution of IV Injection

Form 5 18-07-2012 Dy No

BNF. (Rocephin (Roche) SPORCEF(LOWITT

Deferred for GMP inspection of contract


Each Vial contains:- Ceftriaxone Sodium ≡ Ceftriaxone ………250 mg (Cephalosporin Antibiotic) USP Specs

7338 21-05-2013 Rs. 150,000/- As Per SRO 1‟s vial

PHARMACEUTICALS (PVT) LTD) Advised for further improvement in different sections. (22-03-2014)

manufacturer by panel comprising of Dr. Muzammal H. Najmi, Director QA & LT and Area FID. Contract giver will be inspected by Area FID as last inspection report is more than 01 year old

Weather Fold Pharmaceuticals Hattar for M/s Welwink Pharmaceuticals, Gujranwala

Acticef Injection 500mg (IV) Each vial contains: Ceftriaxone sodium ≡ Ceftriaxone …500mg (Cephalosporin Antibiotic) USP Specs

Form 5 18-07-12 Dy No 7341 Rs 8000/- 21-05-13 Dy No 3283 1,42,000/- As per SRO/ Pack of 1‟s

Rociphen of Gentech USA Rociphen of Roche Karachi Inspection of the M/s Weather Folds Pharmaceuticals, Hattar was conducted by the area FID on 22/03/14 and advised firm for further improvements in different sections


-do- Acticef Injection 1gm (I.M.) Each vial contains: Ceftriaxone sodium ≡ Ceftriaxone …….1g Cephalosporin Antibiotic USP specs

Form 5 18-07-12 Dy No 7334 Rs 8000/- 21-05-13 Dy No 3283 1,42,000/- As per SRO/ Pack of 1‟s

Rociphen of Gentech USA Rociphen of Roche Karachi

Deferred for GMP inspection of contract manufacturer by panel comprising of Dr. Muzammal H. Najmi, Director QA & LT and Area FID. Contract giver will be inspected by


Area FID as last inspection report is more than 01 year old

-do- Acticef Injection 1gm( I.V) Each vial contains Ceftriaxone sodium ≡ Ceftriaxone …….1gm Cephalosporin Antibiotic USP Specs

Form 5 18-07-12 Dy No 7339 Rs 8000/- 21-05-13 Dy No 3283 Rs 1,42,000/- As per SRO/ Pack of 1‟s

Rociphen of Gentech USA Rociphen of Roche Karachi


M/s Weather Folds Pharmaceuticals. Plot 69/2, Phase-2, Industrial Estate, Hattar For M/s Welwink Pharmaceuticals. G.T Road, Industrial Estate, Gujranwala Cantt. Gujranwala

Maxoxim 200 mg/5ml Dry powder suspension Each 5 ml contains: Cefixime Trihydrate USP ≡ Cefixime ……200 mg (Cephalosporin antibiotics) USP Specs

Form 5 18-07-2012 Dy No 7330 Rs. 150,000/- As per SRO

International: Suprax for suspension 200mg/5ml (FDA) Local: Biozil Dry Suspension 200 mg/5 ml by M/s BioLabs According to report of inspection dated 22-10-2014 of M/s Weather f old, firm is advised to rectify shortcomings in various sections. According to report of inspection dated 13-06-2013 of M/s Welwink, inspection book was not available at time of inspection and firm was once again directed to submit their validation data of areas and processes before starting of their production.



-do- Maxoxim 100 mg/5ml

Dry Powder Suspension Each 5 ml contains: Cefixime Trihydrate USP ≡ Cefixime ………100 mg (Cephalosporin antibiotics) USP Specs

1.Form 5 2.18-07-2012 Dy No 7335 3. 21-05-2013 Rs. 150,000/-

-do- -do-

-do- Maxoxim 400 mg Capsule Each capsule contains: Cefixime trihydrate ≡ Cefixime …….. 400 mg (Cephalosporin antibiotics) Finished product Manufacturing specifications

1.Form 5 2.18-07-2012 Dy No 7335 3. 21-05-2013 Rs. 150,000/-

-do- -do-

The panel of Central Licensing Board inspected Weather Fold Pharmaceuticals, on 18-11-

2014 and recommended the Renewal of DML. The Federal Inspector of Drugs Lahore also

inspected the M/s. Welwink Pharmaceutical Gujranwala and stated that the firm possesses the

relevant facility of quality control.

Decision: Registration Board approved the request of M/s. Welwink Pharmaceuticals for contract manufacturing of above products by M/s. Weather Ford Pharmaceuticals, Hattar. Permission will be valid till 30.06.2015.

Case No.37

Registration Board in 245th meeting considered the following new molecule of M/s. Global

Pharmaceutical, Islamabad

Dlanz 30mg Capsules Each capsule contains:- Dexlansoprazole …. 30 mg (Proton Pump Inhibitor)

30‘s

As Per SRO

Registration Board discussed and agreed to above expert opinions. However, the Board advised firm to provide data for stability studies conducted under zone IV-


A conditions as per ICH / WHO guidelines for consideration of Registration Board.

Dlanz 60mg Capsules Each capsule contains:- Dexlansoprazole …. 60 mg (Proton Pump Inhibitor)

30‘s

As Per SRO

-do-

Zaprin SR 15mg Capsules Each capsule contains:- Cyclobenzaprine HCl (USP) ≡ Cyclobenzaprine ……15 mg (Skeletal Muscle Relaxant)

60‘s

As Per SRO

-do-

Now the firm has submitted the stability report of quality control for period of 12, 9, 6, 3

(months) and initial QC about Dexlansoprazole. Moreover, Cyclobenzaprine has been already

approved in favour of CCL, Lahore in 242nd meeting of DRB. The firm has requested to grant of

registration of above mentioned drugs in view of the relevant explanation.

Decision: Registration Board approved the products. However, the Board advised concerned P E & R Division and Incharge, PEC to evaluate submitted stability studies of Zone IVA of Dexlansoprazole 30 & 60mg Capsule. Registration Board authorized its Chairman for subsequent approval for issuance of registration letter.

Registration Board approved Cyclobenzaprine HCl 15mg Capsule, being me too product. Case No.38

Registration Board in 245th meeting deferred the following application of M/s. Global

Pharmaceuticals Islamabad for evaluation of dossier with the collaboration of Evaluation Cell as

per check list:-

Anarob Infusion Each 100 ml contains:- Metronidazole B.P…500 mg

026985

1x100 ml

M/s. Mac & Rains

Pharmaceuticals,

M/s. Vision Pharmaceuticals,

Ofloquin Infusion Each 100 ml contains: Ofloxacin HCl

026980

1x100 ml

-do- -do-


≡ Ofloxacin….. 200 mg Nafcin Injection Each 100 ml contains: Ciprofloxacin Lactate ≡ Ciprofloxacin…..200 mg

026979

100 ml

-do- -do-

The dossiers have been evaluated with the collaboration of Incharge Evaluation Cell as per

check list.

Decision: Registration Board approved request of M/s Global Pharmaceuticals, Islamabad for change of contract manufacturer of above products from the M/s. Mac & Rains Pharmaceuticals to M/sVision Pharmaceuticals, Islamabad. Permission is at same terms and conditions. Case No.39

M/s. Vision Pharmaceutical, Kahuta Road, Islamabad has requested for transfer of

registration of following drugs from M/s. Vision Pharmaceutical, I-10/3, Islamabad. Previously,

these products were contract manufactured by m/s Mac & Rains Pharmaceuticals, Lahore:-

Levovis IV Infusion Each 100 ml contains:- Levofloxacin hemihydrate ≡ Levofloxacin……… 500ml

032160 1x100mlM/s. Mac &

Rains Pharmaceuticals,

M/s. Vision Pharmaceuticals,

Medicip IV infusion Each 100 ml contains:- Ciprofloxacin lactate ≡ Ciprofloxacin ......200 mg

030701 1x100ml -do- -do-

M/s. Vision Pharmaceutical, Kahuta Road, Islamabad has developed the relevant

manufacturing facilities and submitted complete dossier along with fee amounting

Rs:50000/dossier. The dossiers have been evaluated with the collaboration of Incharge of the

Evaluation Cell as per check list.



Cancellation of above registrations from M/s. Vision Pharmaceuticals, I-10/3, Islamabad.

Grant of above registrations in name of M/s. Vision Pharmaceutical, Kahuta Road, Islamabad. Chairman, Registration Board will permit issuance of registration letter after comments of Cost & Pricing Division about MRP of the drug.

Case No.40 M/s. Metro Pharmaceutical, Islamabad has requested for correction of nomenclature and label

claim of the following drugs as mentioned below:-

Existing /approved formulation Correct

formulation/Nomenclature Reg No.

Myzinc Syrup Each 5ml contains:- Zinc Sulfate Monohydrate…. 20 mg (USP Specs)

Myzinc Syrup Each 5ml contains:- Zinc Sulphate Monohydrate ≡ Zinc (element)……..…. 20 mg (USP Specs)

075253

The management has deposited fee of Rs:5000/- for this purpose. It is pointed out that the

strength of the API is calculated on the basis of content of zinc element.

Decision: Registration Board approved the correction as Zinc Sulphate Monohydrate equivalent to Zinc (element) 20mg/5ml syrup.

Registration-IV

Case No.41 M/s. Genome Pharmaceutical, Hattar has requested for correction in formulation of

following drugs. Initially these drugs were registered on 2nd August, 2003 and 4th February,

2006 with M/s. Silver Oak Corporation Hattar. The management was changed and the unit was

renamed and registrations of the products approved for Silver Oak Corporation Hattar were

transferred in favour of M/s. Genome Pharmaceuticals. It is pointed out that at the time of

transfer of registration of the products, the brand name was also changed but the strengths of


active pharmaceutical ingredient in the below-mentioned formulations were inadvertently typed

as:

S.No

Previous name / Formulation

Existing name / Incorrect Formulation

Reg No.

1.

Tick-Nil Tablets Each tablet contains:- Cetirizine 2HCl…..10 mg

Citgen Tablets Each tablet contains:- Cetirizine Dihydrate….10 mg

030815

2.

Solifen Tablets Each tablet contains:- Ketoprofen…………100 mg

Proket Tablets Each tablet contains:- Ketoprofen………30 mg

042511

It is pointed out that it was inadvertently written as Cetirizine Dihydrate 10 mg per tablet

while transferring the registration from M/s. Silver Oak to M/s. Genome. Similarly, the strength

of Ketoprofen was wrongly mentioned as 30mg/tablet. The correct formulation is mentioned

below in the right column of table.

S.No

Existing name with Composition

Correct Formulation/ Nomenclature

Reg No.

1. Citgen Tablet Each tablet contains:- Cetirizine Dihydrate…..…..10mg

Citgen Tablet Each film coated tablet contains:- Cetirizine Dihydrochloride… 10 mg

030815

2. Proket Tablet Each tablet contains:- Ketoprofen……30mg

Proket Tablet Each film coated tablet contains:- Ketoprofen……… 100 mg

042511

Decision: Registration Board approved the correction as Cetirizine Dihydrochloride 10mg film coated tablet and Ketoprofen 100mg film coated tablet of the above mentioned products.


Case No.42 Registration Board approved the application of M/s. Genome Pharmaceuticals, Hattar for

Tablets containing combination of Domperidone Maleate and Cinnarizine in Drug Registration

meeting 214th as mentioned below:-

1. Approved formulations in

214th meeting The formulation issued in the Registration letter)

2. Domenome Tablets Each tablet contains:- Domperidone Maleate…19.48 mg Cinnarizine………20.40mg

Zinom Tablets Each tablet contains:- Domperidone Maleate......19.10 mg Cinnarizine ...........25mg (Genome’s Specs)

It is pointed out that Domperidone Maleate and Cinnarizine were inadvertently approved as

19.48 mg and 20.4mg respectively. Moreover, the certificate of registration also contained

typographical error regarding Domperidone maleate 19.10mg and Cinnarizine 25mg. The firm

provided the copy of the dossier and requested to correct the Minutes of 214th meeting as well as

the typographical error of the respective formulation along with the correction in certificate of

registration as mentioned below.

Reg No Correct formulation /Nomenclature

053580 Domenome Tablets Each tablet contains:- Domperidone Maleate……19.1mg ≡ Domperidone…………..15 mg Cinnarizine………………..20 mg (Approved formulations in 214th meeting )

Decision: Registration Board deferred and referred above formulations to Review

Committee.


Case No.43 Registration Board in 243rd meeting approved the registration of following drug of M/s.

Wnsfeild Pharmaceutical Hattar.

S.No

Existing name with Composition Correct formulation/Nomenclature

1. 1. Alfa-Block 2. Capsule 3. Each capsule contains:- Tamsulosin Hydrochloride SR pellets……50mg 4. (Selective Alpha-a Adrenergic Blocking Agents)

1. Alfa-Block Capsule 2. Each capsule contains:- 3.Tamsulosin Hydrochloride SR pellets 0.2%w/w ≡ Tamsulosin HCl……….0.4mg 4. (USP Specification)

Now the firm has informed that the strength of Tamsulosin HCl pellets is incorrectly

mentioned as 50 mg per capsule. Incharge Evaluation Cell stated that above mentioned error had

been pointed to the firm and it was rectified subsequently and prior to the 243-Meeting. But the

agenda and minutes of 243rd meeting could not be amended. The management has requested for

the appropriate correction and issuance of the certificate of registration accordingly.

Decision: Registration Board approved the correction as Tamsulosin Hydrochloride SR pellets 0.2%w/w equivalent to Tamsulosin Hydrochloride 0.4mg/Capsule. Case No.44

M/s. Wisdom Pharmaceuticals Industries, Peshawar requested for issuance of registration

letter of Zoramid (Domperidone) Suspension which was approved in 243rd meeting of

Registration Board with the following formulation:-

Zoramid Suspension Each 5ml contains:- Domperidone Maleate eq. to Domperidone….5mg

The registration letter was not issued due to inappropriate active pharmaceutical ingredient

and the ambiguous label claim. With reference to Motilium Suspension (brand leader Johnson &

Johnson) and BNF 66 it is evident that Suspension contains Domperidone 5mg/5ml instead of

Domperidone maleate equivalent to Domperidone 5mg/5ml.


The management was informed that the inappropriate description of active pharmaceuticals

ingredient and label claim needs verification by the Incharge Pharmaceutical Evaluation Cell

because the dossier was evaluated by the PEC and the management has to apply formally for this

rectification.

Mr. Tahir CEO M/s. Wisdom Pharmaceuticals, Peshawar verbally informed, “The

management corrected the formulation and claim of Zormid Suspension and submitted the same

to the PEC before the commencement of DRB meeting-243rd. The correction was neither

incorporated in agenda nor in the relevant minutes and the ambiguity prevailed the approved

minutes”. Instead of proceeding in the proper way, ironically, Mr. Tahir CEO wrote in the letter

No.WPI/DRAP/40/14 dated 11-11-2014, “but due to unknown reason registration letter of our

product has not been issued till to date it is requested to issue registration letter of our product as

soon as possible. If the registration letter is not issued up to 30-11-2014 the case will be sent to

the Honourable Wafaqi Mohtasib (Ombudsman) of Pakistan Islamabad.,” Moreover, the

management forwarded the copies to Honourable Wafaqi Mohtasib (Ombudsman) of Pakistan,

C.E.O DRAP and Director PE&R without waiting for the response of the department according

to the stipulated period of 30-11-2014.

Resultantly the Incharge Evaluation Cell was asked to verify the in appropriation in

formulation and the proclaimed rectifications of Wisdom Pharmaceuticals. The Evaluation Cell

confirmed from the record that stance of firm is true i.e.Wisdom Pharmaceuticals has corrected

the composition as per reference product but the same could not be reproduced into the agenda

and minutes of 243rd meeting of DRB.

Decision: Registration Board deferred the formulation and referred the case to Review Committee in conformity of decision of 244th meeting.

Case No. 45

Registration Board in 227th meeting held on 26th & 27th August, 2010 deferred the following

registration application of M/s Cherwel Pharmaceuticals, Hattar for manufacturing on basis of

contract till the finalization of contract policy:-

1. M/s. Cherwel

PharmaceuticCherzone 250 mg Injection

I.V Per vial

As Per SRO

3-10-2009

Deferred tillthe


als, Hattar Manufacturing on Contract

basis by M/s.Wise Pharma,

Islamabad

Each vial contains:- Ceftriaxone Sodium ≡ Ceftriaxone…….…….250

mg (Cephalosporin)

finalization ofcontract policy

2. -do- Cherzone 500 mg Injection I.V

Each vial contains:- Ceftriaxone Sodium ≡ Ceftriaxone…….…….500

mg (Cephalosporin)

Per vial

As Per SRO

-do- -do-

3. -do- Cherzone 1 g Injection Each vial contains:- Ceftriaxone Sodium ≡ Ceftriaxone ………….1 g (Cephalosporin)

Per vial

As Per SRO

-do- -do-

4. -do- Getxime 400 mg Capsules Each capsule contains:- Cefixime Trihydrate ≡ Cefixime………….….400

mg (Cephalosporin)

5’s As Per SRO

-do- -do-

5. -do- Getxime 100 mg Dry Suspension

Each 5 ml contains:- Cefixime Trihydrate ≡ Cefixime

…..…….….100mg (Cephalosporin)

30ml As Per SRO

-do- -do-

6. -do- Getxime200mg Dry Suspension

Each 5 ml contains:- Cefixime Trihydrate ≡Cefixime …..…….….200

mg (Cephalosporin)

30ml As Per SRO

-do- -do-


7. -do- Welpime 500mg Injection Each vial contains:- Cefepime HCl with L-

Aginine ≡ Cefepime (anhydrous) 500mg (Cephalosporin)

Per vial

As Per SRO

-do- -do-

8. -do- Welpime 1gm Injection Each vial contains:- Cefepime HCl with L-

Aginine ≡ Cefepime (anhydrous) 1 g (Cephalosporin)

Per vial

As Per SRO

-do- -do-

9. -do- Biset 1 g Injection Each vial contains:- Cefoperazone Sodium ≡ Cefoperazone.…… 500 mg Sulbactam Sodium ≡ Sulbactam…………. 500

mg (Cephalosporin)

Per vial

As Per SRO

-do- -do-

10. -do- Biset 2g Injection Each vial contains:- Cefoperazone Sodium ≡ Cefoperazone……… 1g Sulbactam Sodium ≡ Sulbactam…………… 1g (Cephalosporin)

Per vial

As Per SRO

-do- -do-

Now contract manufacturing policy has been finalized and the management of the firm has

deposited the fee of Rs. 50,000/each and requested to change the manufacturer from M/s. Wise

Pharmaceuticals Rawat to M/s. Bloom Pharmaceuticals, Hattar and also to change the brand

name of some product. The Dossiers have been evaluated with the collaboration of Incharge

Evaluation Cell as per check list.

Decision: Registration Board registered above products of M/s. Cherwell Pharmaceuticals, Hattar on contract manufacturing basis from M/s. Bloom Pharmaceuticals, Hattar. Permission will be valid till 30.06.2015


Case No.46 M/s. Maxi Care International, Lahore has requested for transfer of following drug from

import for local manufacturing on contract basis by M/s. Welwrd Pharmaceuticals Hattar:-

S.No.

Reg. No.


Pack size Demanded Price

1 059263 PE-40 Lyophilized Injection

Each vial contains:- Pantoprazole Sodium ≡Pantoprazole……… 40 mg (Proton Pump Inhibitor)

Per vial Rs.250.00

They have submitted the complete dossier along with fee of Rs. 50,000/- for this purpose.

The dossier has been evaluated by the Incharge Evaluation Cell as per check list.

Decision: Registration Board approved request of Maxi Care International, Lahore for contract manufacturing of above product from M/s. Welwrd Pharmaceuticals, Hattar. Permission is at same terms and conditions except that firm will not claim the product as lyophilized. Case No.47 M/s. Aries Pharmaceuticals, Peshawar has requested for registration of following drugs for the export only:-

S.No.


1 Xanek Tablets Each tablet contains:- Alprazolam……….0.5 mg (USP Spec)

2 Lexonil Tablets Each tablet contains:- Bromazepam…………3 mg (Aries Specs)

The management of the firm provide the complete dossier, Fee of Rs,20000/- original export

order and requested for registration of drugs for export purpose only. The dossiers have been

evaluated accordingly.

Decision: Registration Board approved grant of registration of above mentioned products for the purpose of export only.


Case No. 48

Registration Board in 243rd meeting deferred the following application of M/s. Genome

Pharmaceuticals, Hattar for opinion of experts but the panel of experts has not been proposed :-

1. M/s. Genome

Pharmaceutical, Hattar.

Genozal Tablets Each tablet contains:- Balsalazide Disodium Dihydrate………750 mg (Genome Spec) (Anti-inflammatory drug)

10’s As Per SRO

Deferred for expert opinion.

2. -do- Rebon-X Tablets Each film coated tablet contains:- Strontium citrate………680 mg (Bone stabilizer)

10’s As Per SRO

Deferred due to Methylene Chloride.

Inspection report nil

Form 5/ file partially signed.

Now the case is again included in the agenda for constitution of panel of expert for expert

opinion. The dossier has been evaluated and rectified by the Evaluation Cell as per check list.

Decision: Registration Board referred above products to following panel for expert evaluation:

Genozal Tablets (Balsalazide Disodium Dihydrate………750 mg) o Brig Dr. Aslam Khan, Member Registration Board. o Dr. Rauf Niazi, PIMS, Islamabad. o Dr.Irfan Ahmad, BBH, Rawalpindi

Rebon-X Tablets (Strontium citrate………680 mg) o Mr. Abdul Latif Sheikh, AKUH. o Prof Dr. Rafi-uz-Zaman, Member Registration Board. o Prof. Dr. Zafar Iqbal, University of Peshawar


Case No. 49 M/s. Swat Pharmaceutical, Swat has requested to transfer the manufacturing site from

M/s. Medera Pharmaceuticals (toll manufacturer) to their own manufacturing unit in view of the

existence of the manufacturing facility:

1. Baxib 250mg Tablets Each film coated tablet contains:- Ciprofloxacin HCl ≡ Ciprofloxacin……....250 mg (Quinolone)

030449

2. Baxib 500mg Tablets Each film coated tablet contains:- Ciprofloxacin HCl ≡ Ciprofloxacin……....500 mg (Quinolone)

030450

3. Baxib 750 mg Tablets Each film coated tablet contains:- Ciprofloxacin HCl ≡ Ciprofloxacin……....750 mg (Quinolone)

030451

4. Sanlevo 250 mg Tablets Each film coated tablet contains:- Levofloxacin Hemihydrate ≡ Levofloxacin…………….250 mg (Quinolone)

029883

5. Sanlevo 500 mg Tablets Each film coated tablet contains:- Levofloxacin Hemihydrate ≡ Levofloxacin…………….500 mg (Quinolone)

029884

The management of the firm has deposited the fee of Rs. 20,000/each and requested to

transfer the above mentioned drugs to their own manufacturing site M/s. Swat Pharmaceutical,

Swat. The Dossiers have been evaluated with the collaboration of incharge Evaluation Cell as

per check list.

Decision: Registration Board approved request of M/s. Swat Pharmaceuticals, Swat for manufacturing of the above products at its own facility. Permission is at same terms and conditions.


Case No. 50 M/s. Usawa Pharmaceutical, Rislapur has requested to transfer the manufacturing site

from M/s. Caraway Pharmaceuticals (toll manufacturer) to their own manufacturing unit in view

of the existence of the manufacturing facility:

1. Afixim 400 mg Capsule

Each capsule contains:- Cefixime Trihydrate ≡ Cefixime……………… 400 mg

060248

2. Durixil Capsule 500 mg Each capsule contains:- Cefadroxil Monohydrate ≡ Cefadroxil……………… 500 mg

060249

The management of the firm has deposited the fee of Rs. 20,000/each and requested to

transfer the above mentioned drugs to their own manufacturing site M/s. Usawa Pharmaceutical,

Rislapurt. The Dossiers have been evaluated with the collaboration of Incharge Evaluation Cell

as per check list.

Decision: Registration Board approved request of M/s. Usawa Pharmaceuticals,

Risalpur for manufacturing of the above products at its own facility. Permission is at same terms and conditions.

Case No. 51

Registration Board in 228th meeting and 238th meeting deferred the following drugs of

M/s. Genome Pharmaceuticals, Hattar for the reasons mentioned below:

1. Perilone Tablets

Each tablet contains:- Paliperidone……….1.5 mg (Ant-psychotropic)(Genome Spec)

10’s As Per SRO

Deferred for expert opinion being a new chemical entities.

(M-228

2. Lanso-SR Capsules Each SR capsule contains:- Dexlansoprazole enteric coated Pellets

14’s As Per SRO

Deferred till submission of application on FORM 5-D along


≡ Dexlansoprazole….30 mg (Proton Pump Inhibitor)

with prerequisite fee (M-238)

Now the firm has informed that the same formulations and same strength has been registered

by the Registration Board in favour of Pharmatec. The firm deposited the differential fee and

dossiers have been evaluated by the collaboration of Evaluation Cell as per check list.

Decision: Registration Board approved Lanso-SR Capsules. However, the Board advised concerned P E & R Division and Incharge, PEC to evaluate submitted stability studies of Zone IVA of Dexlansoprazole 60mg Capsule. Registration Board authorized its Chairman for subsequent approval for issuance of registration letter.

Registration Board approved Tablets Paliperidone 1.5mg Case No.52

The following anomaly cases drugs of M/s. Wnsfeild Pharmaceuticals, Hattar were deferred

in 245th meeting as mentioned below:-

1. Somac 40 mg Injection

Each vial contains:- Pantoprazole Sodium Sesquihydrate ≡ Pantoprazole…..40 mg (Proton pump inhibitor)

Per vial

As per SRO 29-1-13

As per SRO

29-1-13

Registration Board deferred above

products for scrutinization of

registration application as per check list.

2. Winomax 500 mg injection Each vial contains:- Azithromycin monohydrate ≡ Azithromycin ……..40 mg (Anti-infective)

Per vial

As per SRO 29-1-13

As per SRO

29-1-13

-do-

3. Lantex 30 mg injection Each vial contains:- Lansoprazole sodium ≡ Lansoprazole ……..30 mg (Proton pump inhibitor)

Per vial

As per SRO 29-1-13

As per SRO

29-1-13

-do-

4. Kalwin 500 mg Injection Each vial contains:- Clarithromycin

Per vial

As per SR

As per SRO

29-1-13

-do-


≡ Clarithromycin …..500 mg (Proton pump inhibitor)

O 29-1-13

The dossiers have been evaluated by with the collaboration of Evaluation Cell as per check

list and the term lyophilized will not be claimed by the manufacturer.

Decision: Registration Board approved the registration of above mentioned products. Case No.53 The following anomaly cases of M/s. Welmark Pharmaceuticals, Hattar were deferred in 237th

meeting of the Drug Registration Board as mentioned below:-

1. M/s. Welmark

Pharmaceuticals, Hattar

New Section

Carimark 500 mg Injection Each vial contains:- Clarithromycin ≡ Clarithromycin …500 mg (Macrolide)

Per vial

As per

SRO

16-08-11

Deferred for clarification weather Lyophilization procedure is mandatory/required for such formulation or not.

2. -do- Ezi-mark 500 mg Injection Each injection contains:- Azithromycin dihydrate ≡ Azithromycin ….500 mg (Macrolide)

Per vial

As Per

SRO

19-8-2011

do

Now the firm has removed the word Lyophilized from the formulation and the dossiers have

been evaluated with the collaboration of Evaluation Cell as per check list.

Decision: Registration Board approved the registration of above mentioned products.


Case No.54. The following registration application of M/s. Navegal Pharmaceuticals, Hattar were considered

in 225th meeting and approved on the ground that the firm develop new separate Psychotropic

Section. The registration letter was not issued.

1. Zocin 25 mg Tablets

Each tablet contains:- Pentazocine HCl ≡ Pentazocine base.. 25 mg (Benzomarphan derivative)

10x10’s REs.2.50 per tablet

Approved

2. Fenotal 30mg Tablets Each tablet contains:- Phenobarbital……. 30 mg (Barbiturate)

2x15’s Rs.2.70 per tablet

Approved

3. Buprex 0.2mg Tablets Each tablet contains:- Buprenorphine HCl ≡ Buprenorphine base0.2 mg (Thebaine derivative)

50’s Rs.0.68 per tablet

Approved

4. Gytil 3 mg Tablets Each tablet contains:- Bromazepam……3 mg (Benzodiazepine)


Approved

5. Gytil 6mg Tablets Each tablet contains:- Bromazepam……6 mg (Benzodiazepine)


Approved

6. Xafil 0.25mg Tablets Each tablet contains:- Alprazolam………0.25 mg (Benzodiazepine)


Approved

7. Xafil 0.5mg Tablets Each tablet contains:- Alprazolam……… 0.5 mg (Benzodiazepine)


Approved

8. Xafil 1mg Tablets Each tablet contains:- Alprazolam………1 mg (Benzodiazepine)


Approved

9. Xolpi 10mg Tablets Each tablet contains:- Zolpidem

2x10’s Rs.16.00 Approved


Hemitartrate….10mg (Imidazopyridine)

10. Dilamid 1mg Tablets Each tablet contains:- Lormetazepam ………1mg(Short Acting Benzodiazepine)

100’s Rs.1.70 per tablet

Approved

Now the firm deposited the differential fee of Rs:12000/- each and complete the dossiers.

The dossiers have been evaluated with the collaboration of Evaluation Cell as per check list.

Decision: Registration Board approved the registration of above mentioned products.

Registration-V

Case No.55: M/S. CCL Pharmaceuticals (Pvt.) Ltd, Lahore- Export Registrations.

M/s. CCL Pharmaceuticals (Pvt.) Ltd; Lahore has requested for registration of following

products for export purpose only:-

S. No Name of Products

1. Cef-OD Chewable Tablet 100mg Each chewable tablet contains:- Cefixime trihydrate equivalent to Cefixime ……………………….. 100mg

2. Bicarb Capsule 600mg Each capsule contains:- Sodium Bicarbonate ………………… 600mg

The above mentioned products are not available locally. However, product at Sr. No. 1 is

FDA approved and product at Sr. 2 is available in Sri-Lanka. The firm has submitted the

following documents:-

a. Fee of Rs. 20000/- for this purpose. b. Form-5. c. Under taking stamp paper. d. Copy of GMP inspection. e. CRF clearance certificate. f. Export orders.


Decision: Registration Board approved the products with following conditions:



Case No. 56: M/s. Wilshire Labs Lahore - Case deferred for expert opinion

Registration Board in its 237th deferred the following registration application of M/s.

Wilshire Laboratories, Lahore for expert opinion by Brig.(R).Prof. Dr. Muzammil Hasan Najmi,

member Registration Board and submission of differential fee. Initially the case was deferred for

expert opinion and two experts have already been given their opinions as follows. Now

Brig.(R).Prof. Dr. Muzammil Hasan Najmi has also give expert opinion:-

Name of Product Pack Size. MRP Tripoli 400 mg & 800 mg Each tablet contains:- Metaxalone….400 mg & 800 mg

10’s 100’s 500’s

15% less brand leader

S. No. Name of Expert Opinion

1. Prof. Dr.

Mohammad Hanif

Head Deptt. of

Medicine,

Rawalpindi

Medical College,

Rwp.

The mode of action of this drug has not been clearly identified, absolute bioavailability is not known. Impact of age, gender, hepatic and renal disease on the pharmacokinetics, carcinogenic potential, safety in pregnancy, safety and effectiveness in children under age of 12 has not determined. Leucopenia and haemolytic anemia are among the side effects. The drug is not cost-effective. “Tripoli tablets cannot be recommended for registration for the adjunctive treatment of acute, painful, musculo-skeletal conditions”

2. Dr. Mughees

Sherani, Agha

khan Hospital

Karachi

“I have personal experience of writing this medication as this is an FDA approved medication and is available in the United State by the name of “Skelaxin”. Before moving to Pakistan in 2002, I was practicing in Midland Texas, USA and use to prescribe this medication”. “It is used as an adjunctive treatment of acute, painful musculoskeletal conditions and provides earlier relief.” “It major side effects include drowsiness. It should be given with caution in older patients and in patients with chronic disease,


especially in liver and kidney diseases.” “I think this medication can be approved as this has long track record without major complications or problems.”

3. Brig.(R).Prof. Dr.

Muzammil Hasan

Najmi

“Metaxalone is a skeletal muscle relaxant used in treatment of painful muscle spasm/sprains. The exact mechanism of action of the drug is not known but it produce generalized CNS depression, which is also responsible for its side effects. It has significant interactions with other centrally acting drugs like benzodiazepines and antidepressants. It is considered to be unsafe in elderly. Safety in pregnancy and location has bot been determined. The drug is available in USA. Metaxalone may be registered as a prescription drug to be marketed with precautions as outlined above”.

The firm has also deposited remaining fee of Rs. 35,000/- for this purpose.

Decision: Registration Board discussed and agreed to above expert opinions.

However, the Board advised firm to provide data for stability studies conducted under zone


Case No.57 : M/s. Highnoon Labs, Lahore- Case deferred for submission of clinical data

The Registration Board in its 245th meeting deferred the following product of M/s.

Highnoon Labs; Lahore for submission of safety and efficacy data of the drugs along with

complete clinical trial data of these formulations:-

Sr.No. Product Name with

composition Pack size Demanded

price Date of submission and fee

Remarks

1. Ebernet 1% Cream Each gram contains:- Eberconazole (as nitrate)….10mg (anti fungal)

10gm Rs.320.00 21-06-2011 Rs. 8000/- 27-06-2011 Rs. 7000/- 10-7-2013 135000/- (Total: Rs. 150000/-) Form-5D

Not available in FDA, EMA, Australia and Japan.


In compliance to the decision of registration board, M/s. Highnoon Labs; Lahore has

submitted clinical trial data of the above mentioned product.

Decision: Board deferred above products for expert opinion of following experts on

submitted clinical studies data:

Dr.Fareed ur Rehman, FFH, Rawalpindi. Dr.Afaq, PIMS, Islamabad. Mr.Abdul Lateef Shaikh, AKUH

Case No.58 : Permission for Contract Manufacturing due to renovation.

M/s. Highnoon Laboratories Ltd; Lahore has applied for contract manufacturing of their

following products on toll manufacturing basis through M/s. Titlis Pharma, Lahore. Due to

continuous improvement and capacity enhancement program of their manufacturing plant, they

have planned for renovation/up gradation of their granulation-I area while granulation-II area

will remain operational. Therefore they have applied for contract manufacturing of the products

manufactured in granulation-I to avoid shortage of these products:-

S. No. Name of Drug(s) Reg. No. 1. Cyrocin Tablet 250mg

Ciprofloxacin 011406

2. Cyrocin Tablet 500mg Ciprofloxacin

011407

3. Hilin Capsule 100mg Pregabalin

048917


048834


048916


047833

7. Oxaquin Tablet 400mg Moxifloxacin

043660

8. Aria Tablet 1mg Ketotfen (Fumarate)

014742

9. Inhibitol Capsule 30mg Lansoprazole (pellets)

020613

10. Neupentin Capsule 100mg Gabapentin

035763

11. Neupentin Capsule 300mg Gabapentin

035764


12. Voxiquin Tablet 250mg Levofloxacin Hemihydrate

038991

13. Voxiquin Tablet 500mg Levofloxacin Hemihydrate

038992

14. Senegy-OD Tablet 10mg Loratidine

017672

They have deposited fee of Rs. 50,000/- for each product and have furnished application

dossiers along with toll agreement.

It is submitted that in total there are 83 registered in tablet and capsule sections, however

firm has applied for 14 products only i.e. for products of granulation-I area. Orders are solicited,

whether such cases can be processed as per new toll policy.

Decision: Registration Board deferred the case and advised firm to provide complete

renovation plan with time frame for consideration of the Board. Form-5 will be checked as

per check list approved by Registration Board.

Case No. 59: M/s. Phamrawise Labs (pvt.) Ltd; Lahore - Transfer of registration due to

change of name of the firm without change in manufacturing site.

The name of M/s. Fakma Pharma, Lahore was changed from M/s. Fakma Pharma, Lahore

to M/s. Pharmawise Labs (Pvt.) Ltd; Lahore in 2000 on their request. The firm had requested that

either to change all letters regarding registrations with new name or issue a letter to reflect the

said change in each of the registration letter. However, they had not deposited any fee for this

purpose. The case was presented in Board meeting No. 164th on 30-07-2001 and the Registration

Board had decided as under:-

“The request of the firm was not acceded to and the firm was directed to deposit the

requisite fee of Rs. 8000/- for each product for transfer of registration in the new name”.

It is submitted that as per practice in vogue, in case a company changes their name / title apply

for transfer of registration from previous name to new name with full registration fee. However,

the owner of the firm has the view that there is no provision in law for transfer of registration on

same premises.


The case was also referred to Law Division for comments. Law Division in their reply

referred to the case of change of name of M/s. Breeze Pharma, Islamabad to M/s. ICI, Pakistan

Ltd; due to change in management. The issue was as to whether M/s. ICI Pakistan Ltd; require a

fresh license for manufacturing of drugs on leased premises or license of M/s. Breeze Pharma,

Islamabad would be a valid one for manufacturing of drugs.

In this regard, Law Division was of the opinion that license issued by competent

authority was issued to drug manufacturing facility/plant/premises and inspection was done for

drug manufacturing facility, plants, its premises and also of the qualifications of the management

under rule 15, 16 of Drug (Licensing Registering & Advertising) Rules 1976. It would therefore,

be wrong to state that license was issued to the premises and not the management. Law Division

has further referred to Section 196 of the Companies ordinance 1984 which states that business

of a company is run and managed by the Directors of a company. Therefore, lease agreement

between Breeze Pharma, & M/s. ICI amounts to transfer of license which is un-authorized under

the said rules.. It is also been suggested that referring Division (DRAP) shall suitable amend the

rules, so that such like complications due to silent position of rules can be averted in future.

Decision: Registration Board decided to seek opinion of Legal Affairs Division, DRAP in

the matter.

Case No. 60: M/s Servier Research & Pharmaceuticals (Pakistan) (Pvt.) Ltd; Lahore- Case deferred for confirmation of registration in France

Registration Board in its 245th meeting deferred the following products of M/s. Servier

Research and Pharmaceuticals (Pakistan) Limited Lahore till confirmation of registration status

of Nartrilam 5 and 10 mg tablets in France:-

S. No.

Name of Drug(s) with formulation

Pack size

Demanded price

Fee & form

1 Natrilam 10mg Tablets Each tablet contains:- Indapamide SR…..1.5mg AmlodapineBesilate…..10mg (Antihypertensive diuretic + Calcium antagonist)

30‘s Rs.72.52/Tablet

20-6-2012 Rs.8000/- 30-04-13 Rs. 130,000/- Total Fee Rs. 150,000/- Form 5-D


2 Natrilam 5 mg Tablets Each tablet contains:- Indapamide SR…..1.5mg Amlodapineas Besilate…..5mg (Antihypertensive diuretic + Calcium antagonist)

30‘s Rs.36.26/Tablet

05-04-2011 Rs.8000/- 30-04-13 Rs. 130,000/- Total Fee Rs. 150,000/- Form 5-D

The management of the firm has provided legalized free certificate of the products in France and have requested to grant them registration of above mentioned products.

Decision: Board decided to defer the product for expert opinion of following experts on

clinical studies data:

Brig(R). Dr. Muzamil H. Najmi, Member Registration Board Dr. Shahid Nawaz, PIMS, Islamabad. Brig. Dr. Sohail Aziz, AFIC, Rawalpindi.

Case No. 61: M/s. English Pharma, Lahore- Case Deffred For Expert Opinion

Registration Board in its 243rd meeting deferred the following product of M/s. English

Pharma, Lahore for expert opinion of Prof. Dr. Ghias Butt; Prof. Mumtaz Ahmad, Benazir

Bhutto hospital and Prof. Muzamil Tahir, Sh Zayed Hospital, Lahore:-

S. No. Name of Drug(s) 1. Ucholin 10mg Tablet

Each tablet contains:- Bethanechol Chloride equivalent to Bethanechol ……………. 10mg

Two experts have provided their opinion as under:-

Name of expert Comments Prof. Ghias-ud-Din Butt, PIMS, Islamabad

Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum non obstructive (functional) urinary retention and for neurogesic atony of the urinary bladder with retention. It works by helping the bladder muscle to squeeze better, thereby improving your ability to urinate. Because of the selective action of bethanechol, nicotinic symptoms of cholinergic stimulation are usually absent or minimal when orally or subcutaneously administered in therapecutic doses, while muscarinic effects are prominent. Special care is required if this drug is given to patients receiving


ganglion blocking compounds because a critical fall in blood pressure may occur. Usually, severe abdominal symptoms appear before there is such a fall in the blood pressure. Safety and effectiveness in pediatric patients have not been established. Price is a matter of regulator authorities but considering the effectiveness of Molecule or patients Bethanechol HCl availability in Pakistan must be assured at affordable price. The maximum price should not exceed Rs. 30 for 10mg tablet.

Prof. Dr. Mumtaz Ahmad Benazir Bhutto Shaheed Hospital, Rawalpindi

This medicine is used to treat certain bladder problems such as the inability to urinate or empty the bladder completely due to certain causes (e.g surgery, bladder muscle problems). It works by helping the bladder muscle to squeeze better, thereby improving your ability to urinate. Synthetic choline ester with effects similar to those of acetylcholine (ADh). Acts directly on postsynaptic receptor, and since it is not hydrolyzed by cholinesterase, its actions are more prolonged than those of Ach. Dosage must be individualized, depending on the type and severity of the condition to be treated. Preferably gives the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur. Due to non availability of local brand price is at a high and different prices are charged by patients in different areas. I therefore recommended the immediate allocation of local manufacturing of the drug so that the patients can also benefit from it. There also have been incidents reported for high rates and over charging of drug due the smuggled version of the drug.

Decision: Registration Board discussed and agreed to above expert opinions.

However, the Board advised firm to provide data for stability studies conducted under zone


Case No. 62: Case deferred for confirmation of storage facilities

Registration Board in its 245th meeting deferred the following product of M/s. Rasco

Pharma, Lahore for further deliberation on storage condition of the Misoprostol API. Chairman,

Registration Board advised members and stakeholders to forward their scientific comments on

storage condition of the Misoprostol API for consideration of Registration Board:-


Name of Drug(s) Form & demanded MRP. Competitor & specification Aerotec-75 Tablet (Inner core is enteric coated with outer core as immediate release) Each tablet contains:- Diclofenac Sodium ….. 75mg Misoprostol …….. 200mcg NSAID + mucosal protective

1. Form 5 2. Fast Track 3. As per SRO/blister of 2×10 tablets 4. 29.06.2011/Rs.8000 5.21.05.2013/Rs.52000/4237

Arthrotec (Pfizer) Manufacturers‘s Specs

The firm has now provided assessment report (EMA) of misoprostol API which is reproduced as under:-

Misoprostol, as described in the Ph.Eur., is an only liquid which is very unstable and difficult to be process into a drug product in liquid form. The stability of misoprostol is significantly enhanced when it is dispersed in hypromellose. Hence, misoprostol dispersed in hypromellose is used as an intermediate in the manufacture of misoprostol tablet. The dispersion consists of a powder that can be stored at 5+3 °C, whereas the actual active substance is an oily liquid that needs to be stored at -20 °C.

The certificate of analysis of the misoprostol API of the firm shows that the product is Misoprostol 1% HMPC dispersion (White to off-white powder) and it is to be stored at 2-8 °C.

The panel of inspectors has already been recommended the storage facility of the firm for above mentioned product. They have requested to grant them registration of above mentioned products.

A panel of inspectors comprising DDG (E & M), Lahore & area FID inspected the firm on

18-06-2014 for verification of manufacturing and storage facilities for misoprostol raw material.

The panel had recommended as under:-

“the management had provided cold cabinet to maintain temperature range from 2 to 8 C° at the

time of inspection. The panel member physically inspected the cabinet and found that the

conditions for storage were maintained. The overall sanitation and hygienic in this area was

satisfactory. SOPs for handling the raw material during sampling and dispensing were

available. The panel was satisfied with storage and production facilities at the time of inspection

to manufacture the Aerotec-75 Tablet”.


Decision: Keeping in view discussion regarding requirement of storage facility for Misoprostol and inspection report of the firm, the Board approved the product (Misoprostol with 1% dispersion HPMC) and with change in brand name.

RRR Section

Case No. 63: Applications for Re-Registration of drugs

Following firms have applied for registration of drug as they failed to apply for renewal of

registration in time:-

M/s. Ambrosia Pharmaceuticals, Islamabad S.

No. Reg. No.

Name of Drugs with composition

Date of Initial Reg.

Renewal Application

Due Date

Application Receiving Date for Re-Reg.

Documents Provided

by the firm

1. 035357 Ambrocillin 250mg Tablets Each tablets contains:- Amoxicillin (as Trihydrate)…….250mg

18-12-2004 17-12-2009 17-10-2012 (i). Form-5 (ii). Initial Reg. Letter (iii). CRF

NOC (iv). Fee

Rs.20,000/- 2. 035358 Ambrocillin 500mg

Tablets Each tablets contains:- Amoxicillin (as Trihydrate)…….500mg

-do- -do- -do- -do-

3. 041411 Micozole N Ointment Contains:- Miconazole Nitrate……………2%

04-10-2005 03-10-2010 -do- -do-

4. 041412 Isozole Vag Cream Contains:- Isoconazole Nitrate…………..1%

-do- -do- -do- -do-

5. 041414 Sexatin N Cream Each gm cream contains:-

-do- -do- -do- -do-


Bufexamac………50mg Neomycin Sulphate……….2500IU Nystatin……100,000IU

6. 042917 Monorate Ointment Contains:- Mometasone Furoate…….0.1% w/w

-do- -do-

M/s. Woodward Pakistan (Private) LTD., Karachi. S.

No. Reg. No.



Renewal Application

Due Date


Documents Provided

by the firm

1. 055717 Bactizith 500mg Capsule Each capsule contains:- Azithromycin (as Dihydrate)……..500mg (USP Specification)

07-04-2009 06-04-2014 24-06-2014 (i). Form-5 (ii). Initial Reg. Letter (iii). Fee

Rs.20,000/- M/s. Macter International Limited, Karachi.

S. No.

Reg. No.



Renewal Application

Due Date


Documents Provided

by the firm

1. 000483 Genticyn HC Cream Each gm contains:- Gentamicin Sulphate Hydrocotisone Acetate

06.9.2006 05.9.2011 24-11-2014 (i). Form-5 (ii). Initial Reg. Letter (iii). CRF

NOC (iv). Fee

Rs.20,000/- 2. 010186 Genticyn B Cream

Each gm contains:- Gentamicin Sulphate Betamethasone Valerate

-do- -do- -do- -do-

3. 007701 Multigesic Cream Each gm contains:- Diethylamine Salicylate

-do- -do- -do- -do-

4. 000497 Genticyn Cream Each gm contains:-

-do- -do- -do- -do-


Gentamicin Sulphate

Decision: Registration Board decided to defer the case till opinion of stake holders in the matter as decided in Item No. IV(c).


Item No. VII Registration of Biological Drugs – Biological Evaluation & Research Division

Case No. 01. Expert Committee for Biological Drugs

The Drug Registration Board in its 241st Meeting decided to strength the expert

committees on biological drugs for the technical evaluation of biological drugs. The earlier

committee was not functional due to resignation of 01 member and absence of another member

due to tour abroad. The proposal of constitutions of new expert committees on biological drugs

was floated with draft notifications for separate expert committees for human and veterinary

biological drugs and were processed as per law with the approval of Federal Government.

However, the Law, Justice and Human Rights Divisions raised certain queries/ legal aspects

regarding composition of committees and role of secretariat officers in the committees, which

needed to be rectified before the notifications are finalized. The notifications were re-visited and

necessary amendments were made in consultation with the Law, Justice and Human Rights

Division. The process of official notification of expert committees is in final stages. However,

due to non functional ECBD, no fresh cases can be placed before the Registration Board.

However, miscellaneous cases of already registered biological drugs are placed before the Board

for its consideration in this meeting.

Decision: Registration Board noted the information.

Case No. 02. Change of manufacturing site for already registered drugs of M/s. R.G. Pharmaceutica (Pvt), Ltd., Karachi.

M/s R.G. Pharmaceutica (Pvt) Ltd., Karachi has submitted the following

applications for change in manufacturing site of their already registered drugs;

S.# Product & Registration No.

Existing Manufacturing site

New Manufacturing Site

1. Ferti-C 5000IU Chorionic gonadotrophin for Injection (Reg. No070931)

Livzon (Group) Pharmaceutical Zhohai, Guangdong, China

Livzon (Group) Pharmaceutical Factory. Address: No.38, Chuangye Road North, Liangang Industrial Zone, Zhuhai, Guangdong, China.

2. Ferti-C 1000IU Chorionic gonadotrophin for


Livzon (Group) Pharmaceutical Factory. Address: No.38, Chuangye Road


Injection (Reg. No 070930)

North, Liangang Industrial Zone, Zhuhai, Guangdong, China.

3. Ferti-M 150IU Menotropin for Injection (Reg. No 070929)



4. Ferti-M 75IU Menotropin for Injection (Reg. No 070928)

Livzon (Group) Pharmaceutical, Zhohai, Guangdong, China


As per SOP defined by the Drug Registration Board in its 240th Meeting, the firm has provided following documents;

1. Application with required fee as per SRO (Rs.100, 000/- per product). 2. Copy of registration letter and last renewal status. 3. NOC for CRF clearance (Not required for Importer) 4. Original legalized CoPP, having address of new manufacturing site.

The source is from China, which falls under category, where the inspection abroad is mandatory. Decision: Registration Board approved the request of the firm. Inspection of the foreign manufacturer shall be conducted as per Import Policy. The Board authorized its Chairman for issuance of letter for change in manufacturing site on the recommendation of inspection report if it is of recommendation. If inspection report is of not recommendation, then case will be placed before Registration Board. Case No. 03. Request for change of importer and manufacturing site for already

registered drugs by m/s. Avior Pharmaceuticals (Pvt) Ltd., Karachi.

M/s. Avior Pharmaceuticals (Pvt) Ltd., Karachi has submitted applications for transfer of

products from M/s Global Pharmaceuticals (Pvt) Ltd. The firm has also informed that the

manufacturing site is also changed by the foreign principal. The details are as under: -




1. Tropin 2000iu Inj Each vial contains: -Recombinant Human Erythropoietin

M/s Harbin Pharmaceutical Group of Bioengineering Co. Ltd., Harbin China

M/s Harbin Pharmaceutical Group Bioengineering Co., Ltd., No.99 Zhuhai Road Limin Development Zone Hulan District, Harbin,


2000iu Reg No. 062218

Heilongjiang Province, P.R. of China

2. Tropin 4000iu Inj Each vial contains: -Recombinant Human Erythropoietin 4000iu Reg No. 62219

M/s Harbin Pharmaceutical Group of Bioengineering Co. Ltd. China

M/s Harbin Pharmaceutical Group Bioengineering Co., Ltd., No.99 Zhuhai Road Limin Development Zone Hulan District, Harbin, Heilongjiang Province, P.R. of China

Tropin 6000iu Inj Each vial contains: -Recombinant Human Erythropoietin 6000iu Reg No.066152



4. Auspogen 300ug per vial Recombinant Human G.CSF Reg No. 062217



5. Refron 3 MIU Inj Each vial contains Recombinant Human Interferon Alpha 2b 3MIU Reg No. 047665



M/s Avior Pharmaceuticals (Pvt) Ltd, Karachi has provided following documents as per SOP defined by the Drug Registration Board in its 240th Meeting;

i) Application on Form 5 A along with fee as defined under SRO (Rs. 100,000 per product).

ii) Copy of registration letters and last renewal status. iii) NOC for CRF clearance (Not applicable to importers) iv) Termination letter (Original) of previous importer M/s. Global

Pharmaceuticals (Pvt) Ltd v) Authority letter/sole agent letter (original) from manufacturer in favour of

M/s Avior Pharmaceuticals (Pvt) Karachi. vi) No objection letter from Global Pharmaceuticals in favor of M/s. Avior

Pharmaceuticals for transfer of Registration. vii) Original and legalized CoPP of all above products. viii) Site Master file.

The source is from China, which falls under category, where the inspection abroad is mandatory.


Decision: Registration Board approved the request of the firm. Inspection of the foreign manufacturer shall be conducted as per Import Policy. The Board authorized its Chairman for issuance of letter for change in manufacturing site on the recommendation of inspection report if it is of recommendation. If inspection report is of not recommendation, then case will be placed before Registration Board. Case No. 04. Change of manufacturing site for already registered drugs of M/s.

Pharmaevo (Pvt) Ltd, Karachi.

M/s. PharmaEvo (Pvt) Ltd., Karachi has submitted application for change of

manufacturing site of their already registered drugs. The details are as under: -

Product / Registration

No. Previous Name of

Manufacturing Site New Name of Manufacturing

site EPOSINO 4000IU/ML Each pre-filled syringe contains: - Recombinant Human Erythropoietin…4000IU (Reg No. 045690)

Sandong Kexing Bioproducts Co., Ltd., China

Shandong Kexing Bioproducts Co., Ltd. No.2666, Chuangye Road, Mingshui development Zone, Zhangqiu, Shandong, China.

EPOSINO 2000IU/ML Each pre-filled syringe contains: - Recombinant Human Erythropoietin…2000IU Erythropoietin Reg No. (045689)

Sandong Kexing Bioproducts Co., Ltd., China

Shandong Kexing Bioproducts Co., Ltd. No.2666, Chuangye Road, Mingshui development Zone, Zhangqiu, Shandong, China.

M/s PharmaEvo (Pvt) Ltd, Karachi has provided following documents to support their request as per SOP decided by the DRB in its 240th Meeting:-

1. Application with required fee as per SRO (Rs.100, 000/- per product). 2. Copy of registration letter and last renewal status. 3. NOC for CRF clearance. 4. Original legalized CoPP for new manufacturing site. 5. Site Master file

The source is from China, which falls under category, where the inspection abroad is mandatory. Decision: Registration Board approved the request of the firm. Inspection of the foreign manufacturer shall be conducted as per Import Policy. The Board authorized its Chairman for issuance of letter for change in manufacturing site on the recommendation of inspection


report if it is of recommendation. If inspection report is of not recommendation, then case will be placed before Registration Board.

Case No. 05. Change of manufacturing site for already registered drugs by M/s. Roche

Pakistan, Ltd, Karachi.

M/s. Roche Pakistan Ltd., Karachi has submitted application for change of manufacturing

site. The details are as under: -

Product / Registration

No. Previous Name of

Manufacturing Site New Name of Manufacturing

site Avastin 100mg/4ml injection Each ml contains: Bevacizumab 25mg Reg No. 043004

M/s F. Hoffmann- La Roche Ltd., Basel, Switzerland

M/s F. Hoffmann La-Roche Ltd., Wurmisweg 4303, Kaiseraugst, Switzerland.

Avastin 400mg/16ml injection Each ml contains: Bevacizumab 25mg Reg No. 043005

M/s F. Hoffmann- La Roche Ltd., Basel, Switzerland

M/s F. Hoffmann La-Roche Ltd., Wurmisweg 4303, Kaiseraugst, Switzerland.

M/s Roche Pakistan Ltd, Karachi has provided following documents to support their claim:-

1. Application on Form 5-A with required fee as per SRO (Rs.50, 000/- per product). 2. Copy of registration letter and last renewal status. 3. NOC for CRF clearance (Not required for Importer) 4. Original CoPP provided for new manufacturing site, however the CoPP is not

notarized and legalized from Embassy of Pakistan 5. Site Master file

The drugs is used for Matastatic Carcinoma of the Colon are rectum breast cancer and other types of cancers. The site falls under category of Stringent Regulatory Authorities. It is proposed that the request of the firm may be approved with condition that change of site letter shall be issued after submission of legalized CoPP through permission from Chairman Registration Board. Decision: Registration Board approved request of the firm. The firm will provide legalized CoPP of the product and authorized its Chairman for issuance of letter in light of Import Policy for Finished Drugs.


Case No. 06. Request for exemption of printing of registration and MRP on vial M/s. Popular International (Pvt) Limited, Karachi

M/s Popular International (Pvt) Ltd., Karachi has submitted the following requests for

exemption of printing of Registration Number & MRP on inner vials as exemption for Urdu

Version granted to them vide letter No. F.1-19/95-Reg-I (Pt) dated 11th July, 2007. The firm has

informed that their principal print lot number, date of manufacturing and date of expiry on each

vial and outer box and finally print registration number on each box before shipment whereas

MRP is printed locally by us on outer box. However due to limited space on the inner vial the

principal cannot print registration and MRP. Further the company has informed that laser

printing may denature the products. The details of their request are as under: -

S.# Product Name Registration No.

Generic Name

1. KOATE – DVI 007965 Antihemophilic Factor – VIII(Human)

2. HyperRAB S/D 007972 Rabies Immune Globulin (Human)

3. HyperHEP B S/D 012835 & 007971

Hepatitis B Immune Globulin (Human)

4. PLASBUMIN UMAN ALBUMIN

007967 059249

Albumin (human)

5. IMMUNORHO 059296 059297

Rho (D) Immune Globulin (Human)

6. GAMMARAAS 031350 Intravenous Immune Globulin (Human)

Decision: Registration Board decided to call firm,s representative in its forthcoming meeting for presentation of their case along with labeling/ printing status/ evidence of similar products available in the market.


Case No. 07 Request for additional pack size by M/s. Snam Pharma, Lahore

M/s Snam Pharma, Lahore has requested to approve additional pack against their

already registered products. The firm has deposited an amount of Rs.5,000/- as prescribed fee for

each product. The detail is as under with justification: -

S.# Product Name Regn No.

Existing pack size

Additional Pack

Justification

1. Biocan R Injection ad us vet

057167 10x5ml. 5x20ml

(1m1)x20 single dose

The single dose of Biocan R is necessary as it will be used in single dog vaccination, and it is demanded by the market.

2. Ornipet lyof.ad.us.vet 059171 200doses. 500 doses. 1000 doses. 2500 doses. 10x200 doses10x500 doses10x1000 doses 10x2500 doses

5000 x 10 doses

Large dose pack size in poultry is convenient in the large poultry formers and dose of 5000 bird packing is demanded by the market.

3. Ornibron lyof.ad.us.vet

057169 10x200 doses10x500 doses10x100 doses10x2500 doses

5000 x 10 doses

Large dose pack size in poultry is convenient in the large poultry formers and dose of 5000 bird packing is demanded by the market.

4. Orniprim lyof.ad.us.vet

057170 10x200 doses10x500 doses10x100 doses10x2500 doses

5000 x 10 doses

Large dose pack size in poultry is convenient in the large poultry farmers and dose of 5000 bird packing is demanded by the market.

5. Ornibur intermediate lyof.ad.us.vet

059172 500 doses 1000 doses 1000 doses 2000 doses 5000 doses 10x500 doses10x1000 doses 10x2000

2500 x 10 doses.

Large dose pack size in poultry is convenient in the large poultry farmers and dose of 2500 bird packing is demanded by the market.


doses 10x5000 doses

Decision: Registration Board deferred the request and advised the firm to provide legalized CoPP of the product for confirmation of availability of applied packs.

Case No. 08 Request for additional pack size by M/s Marush (Pvt) Ltd, Lahore

M/s Marush (Pvt) Ltd, Lahore with the request to approve additional pack against

their already registered products. The firm has deposited an amount of Rs.5,000/- prescribed fee.

The detail is as under with justification: -

S.# Product Name Regn No.

Existing pack size

Additional Pack Justification

1. CEVAC TRANSMUNE IBD VACCINE

039910 1000 doses. 2000 vial 4000 vial 8000 vial

More recently market trends and demand of formers have changed due to initiation of multiple large sized commercial farms and integrated units which, demands medium and bigger packs keeping in view their convenience and economy in usage. To demonstrate the benefits for users regarding introduction of additional packs a detailed study as per DRA’s format.

Decision: Registration Board deferred the request and advised the firm to provide legalized CoPP of the product for confirmation of availability of applied packs.


Case No. 09 Withdrawal of applications for registration of finished drugs by M/s. Sami Pharmaceuticals, Karachi. M/s Sami Pharmaceuticals (Pvt) Ltd, Karachi has requested for surrender of

applications for registration of finished drugs to be imported from M/s Xiamen Amoytop Biotech

Co. Ltd, Xiamen, Fujian, P.R. China. These drugs were considered favourable in meeting No. M-

225 dated 15.05.2010 and registration for the same were to be granted after satisfactory

inspection of the manufacturer’s facility abroad which could not be done till to date. However,

the firm was voluntarily withdrawn these long outstanding applications and will have no

objection if registrations for the same are granted either to M/s Xiamen Amoytop Biotech Co.

Ltd and/or to any other party so authorized by them. The details of withdrawn applications are

as under: -

Sl.# Name of company Drug name with composition

MRP Shelf life Remarks

1. M/s Sami Pharmaceutical(Pvt) Ltd, Karachi./M/s Xiamen Amoytop Biotech Co., Ltd., Xiamen, Fujian, P.R. China

Relkin 1.5mg Injection Each vial contains: - Oprelvekin Recombinant Human Interleukin-11 (rHulL-11)…..1.5mg (Immunostimulants)

As per latest decision taken by PAC

24 months Approved

2. M/s Sami Pharmaceutical(Pvt) Ltd, Karachi./M/s Xiamen Amoytop Biotech Co., Ltd., Xiamen, Fujian, P.R. China

Relkin 3mg Injection Each vial contains: - Oprelvekin Recombinant Human Interleukin-11 (rHulL-11)…..3mg (immunostimulants)

As per latest decision taken by PAC

24 months Approved

Decision: The request of the firm was acceded to and the Board rejected the above registration applications.


Case No. 10 Grant of registration of solution for injection - M/s. Macter International Limited, Karachi

M/s. Macter International Limited, Karachi has requested for registration of

solution for injection for local manufacturing. The firm has deposited an amount of Rs. 50,000/-.

The composition detail is as under: -

Name of Company Raw Material Quantity/0.6Ml M/s Macter International Limited, Karachi

Sodium Chloride 3mg Glycine 0.225mg Polysorbate 80 0.06mg Water for Injection Qs to 0.6mL

The solvent is required to be co-packed with the product free of cost. The case of manufacturing

of locally manufactured biological product was decided in the 244th Meeting of the Drug

Registration Board including lyophilized pegylated interferon products of the company which is

under implementation process.

Request of the company for grant of registration of solvent is submitted for the approval of Registration Board. Decision: The request of the firm for grant of registration of solvent was approved. Case No. 11. Change of manufacturing site for already registered drugs by M/s. Hospital

Services & Sales, Karachi and change of brand name.

M/s Hospital Services & Sales, Karachi has submitted the applications for change of

manufacture site and brand name of their already registered vaccine for below mentioned

product;

Sl.No. Reg. No.

Previous Brand Name and composition.

Proposed Brand Name

Existing Manufacturing Site

New proposed manufacturing site

1. 053813 EASYFIVE – Pentavalent Vaccine Each dose 0.5ml contains: - Diphtheria Toxoid: 20Lf (30IU) Tetanus Toxoid:

EASYFIVE – TT Pentavalent Vaccine Each dose 0.5ml contains: - Diphtheria Toxoid: 20Lf (30IU) Tetanus Toxoid: 7.5Lf(40IU in guinea pig and 60 IU in

M/s. Panacea Biotech Ltd., New Delhi, India.

M/s. Panacea Biotech Limited, Malpur, Baddi, Distt. Solan (H.P.) 173 205, Inda.


7.5Lf(40IU in guinea pig and 60 IU in mice) Pertussis Vaccine: 12OU (4IU) r-Hepatitis B surface antigen (HBsAg): 10mcg Haemophilus type b conjugate vaccine: 10mcg.

mice) Pertussis Vaccine: 12OU (4IU) r-Hepatitis B surface antigen (HBsAg): 10mcg Haemophilus type b conjugate vaccine: 10mcg.

M/s Hospital Services & Sales, Karachi has provided following documents to support their request:-

1. Application on Form 5-A with required fee as per SRO (Rs.100, 000/- per product).

2. Copy of registration letter and last renewal status. 3. NOC for CRF clearance (Not required for Importer) 4. Original CoPP provided for new manufacturing site. 5. Site Master file 6. The firm has also provided evidence of WHO prequalification of EASYFIVE –

TT vaccine. Decision: Request of the firm for grant of registration of solvent exclusively to be used with EASYFIVE – Pentavalent Vaccine, Regn No. 053813 was approved. Case No. 12. Case of import of interferon from Cuba instead of China by M/s. Macter

International (Pvt) Ltd., Karachi.

The case was discussed in the 244th Meeting of Drug Registration Board. The decision of the

case was as below:

Decision: Registration Board discussed the matter in detail and advised investigation officer to further clarify following points:

a) On which documents the firm obtained clearance of Heberon Alfa R-2-b Registration No.047675 from DRAP, Karachi along with dates of invoice, airway bill/BL, LC date and other relevant information.

b) After grant of approval of change of source, what is legal status of renewal application submitted by the firm from previous source?


c) What is the status of recall of stocks, the legal course of holding/restricting the stocks from sale was followed or otherwise, after “not to dispose of order” on Form-1 dated 28.10.2013?

The decision of the Board was communicated to DDG (E&M) with request to clarify the points

raised by the Drug Registration Board. In response to Directorate of Biological’s letter dated 5th

November, 2014. The Deputy Director General (E&M), DRAP, Karachi has stated that.

a) The documents on which the firm obtained clearance of Heberon Alpha R 2-b, Registration No. 047675 from DRAP, Karachi are follows: -

i. Attested invoices. ii. Copy of Airway bill/Bill of lading.

iii. Copy of L.C. dated 23.05.2013 as swift of M/s. Meezan Bank, Karachi Pakistan.

b) The lyophilized source from Cuba; Product name: Heberon Alpha 3MIU injection (interferon Alpha 2b3 MIU) Registration No. 022820 vide letter No.F. 3-6/98-Reg-II (M-137).

2. The liquid source from china product name: Heberon Alpha 3 MIU (Interferon R 2-b 3MIU) Registration No. 047675 vide letter No.F.3-1/2008-Reg-I (M-212).

3. The legal status with justification as I understand is the change of dosage form for

another Registration No.047675 which becomes legal as source was changed only for

Registration No. 047675 of the same product. The first source relates to the Heberon Alpha

3MIU (Interferon R 2-b 3MIU) (Registration No. 022820) but the change of source from Cuba to

China is for Heberon Alpha 3MIU (Inteferon R 2-b 3MIU) (Registration No. 047675) in liquid

form. T he former dosage form was lyophilized. Hence, it is concluded that M/s. Changchun

Heber Biological Technology Co. Ltd., China is the sister concern of M/s. Heber Biotech S.A.

La Havana, Cuba the basic approved site and the product release authority of both the sources

Cuba and China is same. Hence, there is no product Safety, Quality, Efficacy and Economic

value related issued found. As the lot was released by NCLB, Islamabad also the importer (M/s.

Macter International Pvt. Ltd.) applied for the renewal of the said product on form 5-B of the

rule 26 of the Drug renewal for registration on 18.07.2013 and also deposited the required fee

under SRO 1117(I)/2012 which is pending with RRR section, DRAP. Therefore there is no harm

to allow them to market the aforesaid lot in favour of the importer in public interest so required

as protected under rule 27 of the Drugs (Licensing, Registering & Advertising) Rules, 1976

(copies of both the application for registration renewal are enclosed.


As far as the grant of approval of change of source is also valid under rule 26 of

the Drugs renewal for registration dosage form of which is physically different as described

above. On the other hand, the legal status of renewal application submitted by the firm from

previous source is also legal as there is no legal embargo if the previous source is rejuvenated by

the applicant that is valid under SRO 145(I)/1976 if pending with the board concerned and

1117(i)/2012.

(i) The status of recall of stocks is laying hold in the cold storage area of the importer.

(ii) The legal course of holding/restriction of the stocks were followed by the firm. Through, they are now not bound to sell after the expiration of the period of the order on Form-I dated 28.10.2013 which is only for the period of 14 days by the undersigned.

Conclusion: After having sufficient documents evidences for both the sources of same product, having

different registration for different sources and renewal also pending though applied well in time

under rules, suffice the need of legal protection to import from the either source being the

custodian of two registrations originally and subsequently renewed as per law enacted under

condition of registration under Drug Act 1976.

The intention of the importer depicts that the change of source of one registration from Cuba to

China is positive for the adequate / free availability of life saving drugs in public interest.

Concluding all pros and corns of this investigation the contention and intention of the importer

was found positive professional approach and no evidence was found to contravene the Drugs

Act 1976 and rules prevails thereunder.

Hence the DDG (E&M) has recommended to allow the importer M/s Macter International (Pvt)

LTd, to make this life saving drug available and restriction as imposed after lot release may also

be withdrawn.

Decision: Registration Board discussed that the firm has violated the Drug Act, 1976 and rules framed there under and decided to issue show cause notice to the company, as why not the consignment be re-exported or legal action be taken as per procedure, after giving opportunity of personal hearing to the firm in the next meeting.


Case No. 13. Import of Insulatard Penfill Syringe from the previous source by M/s Novo Nordisk Pharma (Pvt) , Cl i f ton Karachi .

The case of the firm was discussed in 244th Meeting of Drug Registration Board. The

case details are as below: -

M/s Novo Nardisk has applied for the change of source of their registered product namely Insulatard Penfill 100iu/ml 5x3ml (Registration No.010341). The decision of the Registration Board in its 242nd meeting is as follows: -

S.No. Product & Regn.No.

API Manufacture Site

Existing secondary packaged import site

Proposed secondary packaged import site

1 Insulatard Penfill ® 100 IU/ml 5x3 ml (R.No. 010341)

Novo Nordisk A/S Novo Alle DK-2880 Bagsvaerd Denmark

Novo Nordisk A/S Novo Alle DK-2880 Bagsvaerd Denmark

Novo Nordisk Production S.A.S. 5 bis, rue Edmond Poillot 28000 Chartres France

Past Decision: The Board approved the new EMA approved site mentioned above for import

of the above mentioned products subject to COPP from new site.

Accordingly the change of source letter was issued to the firm on 7th April, 2014 clearly

mentioning that the previous source of import stands cancelled. The Assistant Drugs Controller,

Karachi has informed that M/s Novo Nordisk, Karachi has imported Insulatard Penfil 100IU/M

(Reg NO. 010341) from Denmark on 20th May, 2014 which is the earlier source of import. The

ADC, Karachi was requested to submit complete case along with his recommendations. The

ADC Karachi has stated that he is of the opinion to revoke the orders of sales restrictions as the

safety, quality and economic value of drug in question. The officer has also stated that sale of the

drug may be allowed in the public interest so required.

It is submitted that the source of import was cancelled by the Drug Registration Board vide letter

No. 2-1/2014-DDC (BD)(M-242), dated 7th April, 2014. Under section 23 subsection 1(a) (vii)

“no person shall himself or by any other person on his behalf export, import or manufacture for

sale or sell any drug which is not registered or is not in accordance with the conditions of

registration”. The firm has violated the Drugs Act, 1976.


The case of the firm was decided as under: -

“DECISION: Registration Board approved request of the firm. However the Board advised firm to provide/submit copy of L/C (original or duly certified) for establishing the fact that the import order was placed well before the date of grant of change of manufacture site by DRAP and authorized its Chairman for permission to issue the letter for sale of drug”.

The firm was asked to provide the documents as per decision of the Drug Registration Board, however, the company has provided following documents: -

i) Signed distribution Agreement between Novo Nordisk A/S Novo Alle 2880 Bagsveard Denmark and Novo Nordisk Pharma (Pvt) Ltd, 113, Shahrah-e-Iran, Mian Clifton Karachi by indicating that in place of L/C the term of payment is 360 days from the date of invoice, which is also mentioned on custom invoice.

ii) Customs Invoice. The firm informed that they have not established L/C as per their own system. The case was submitted to the Chairman Registration Board for decision. The Chairman has desired to place the case before the Drug Registration Board for decision. Decision: Registration Board discussed that the firm has violated the Drug Act, 1976 and rules framed there under and decided to issue show cause notice to the company for not providing the copy of L/C with opportunity of personal hearing, as per procedure of Drug Registration Board. Case No. 14. Deferred case of 241st meeting for Poulvac ® SE Vaccine by M/s. Hi-tech

Pharmaceutical, Lahore. The following case of M/s. Hi-Tech Pharmaceutical, Lahore was deferred in 241st Meeting of Drug

Registration Board reasons mentioned in the last column below: -

Sl.# Applicant Name and Specs ECBD Committee

Recommendation Decision

6. M/s Hi-Tech Pharmaceutical, Lahore Manufactured by: M/s Pfizer

Poulvac ® SE Vaccine Each 0.5ml dose contains: - Salmonella enteritidis Phase Type

Recommended

More data is required

Deferred for clarification from the application regarding


Animal Health (Pfizer Inc), 2000 Rockford Road, Charles City, Iova, USA

4….RP…> 1.0/dose at release. Salmoella enteritidis Phase Type 8…RP….>1.0/dose at release. Salmonella enteritidis Phase Type 13a…RP…> 1.0/dose at release 37% Formaldehyde. Solution…..0.0006ml White oil….0.1995ml Arlacel-83…0.1105ml Tween-80…0.001105ml Saline….q.s to 0.3ml (For Veterinary Use)

use of formalin concentration and review by already constituted committee and veterinary expert of ECBD.

The firm has submitted application to Animal Husbandry Commissioner Dr. Qurban Ali and

submitted clarification to Director Biological Drugs, DRAP, Islamabad. Clarification submitted to

DRAP and comments of Animal Husbandry Commissioner are tabulated below: -

Clarification submitted by the firm to DRAP Comments of Animal Husbandry Commissioner

For inactivation, formalin is added to the total volume of the bacterial suspension, not over 1%

Source of formalin brand used holds 37% formaldehyde solution, of this 37% branded formaldehyde stock solution, maximum upto 1% of formalin is used in total volume of the bacterial suspension.

Dose of Poulvac SE is 0.3mL/bird and each dose contains 0.0006mL i.e. 0.2% of 37% formaldehyde solution.

“Formalin is used to produce inactive bactervaccines. For this purpose, 37% formalindehygas is added to water to produce reagecommonly known as formaline, which is thused in a very small concentration (as is used the subject product “Poulvac SE” at the rate 1% to the total volume of bacterial suspensionTherefore, 37% formaldehyde solution formalin at the rate of 1% is part of normprocedure to produce such inactivated vaccines”

Decision: Registration Board referred the case to Expert Committee on Biological Drugs (Vet) for its consideration.


Case No. 15. Change of manufacturing site for already registered drugs of M/s. Pfizer Pakistan, Karachi.

M/s Pfizer Pakistan, Karachi had submitted the following application along with prescribed Fee Rs. 50,000/- for the product as well as CoPP from new manufacturing site. The details are as under: -




1. Prevenar 13 Suspension for injection (Reg # 066110)

Baxter Pharmaceutical Solutions LLC 927 South City Curry Pike, Bloomington IN, USA

Pfizer Ireland Pharmaceuticals Grange Castle Business Park, Clondalkin, Dublin 22 Ireland.

M/s Pfizer Pakistan Ltd, Karachi has provided following documents to support their claim:-

1. Application with required fee as per SRO (Rs.50, 000/- per product) being the innovative.

2. Copy of registration letter and last renewal status. 3. NOC for CRF clearance. 4. Original legalized CoPP for new manufacturing site. 5. GMP of manufacturing site. 6. Site Master file

Decision: The request of the company was acceded by the Board as per CoPP issued by the

EMA.

Case No. 16

M/s Novo Nordisk, Karachi had requested for registration of Histidine solvent in

Prefilled Syringe for already registered drugs NovoSeven 50KIU (1mg) Powder for solution for

Injection (Reg No. 066157) each vial contains: Eptacog alfa (activated)1mg and NovoSeven

100KIU (2mg) Powder for Solution for Injection (Reg No. 66158) alongwith Hisitidine 2ml each

vial contains Eptacog alfa (Activated) 2mg. The firm has deposited an amount of Rs. 50,000/- for

each product. The composition detail is as under: -

Name of Company Raw Material Quantity/0.6mL Novo Nordisk, Karachi Powder and solvent 01mg/vial


for solution for injection

(50KIU/vial)

Novo Nordisk, Karachi Powder and solvent for injection for injection

02mg/vial (1000KIU/vial

Decision: Registration Board deferred the case for confirmation of status of solvent in CoPP.

Case No. 17. Extension in exemption for the biological drugs imported from M/s Ferring Germany.

Atco Laboratories Limited, Karachi have submitted that they are importing

following Biological drugs from M/s Ferring Pharmaceutical, Germany since 1994 that are in the

process of shifting their manufacturing facility and it would not be possible for them during this

period to incorporate all requirements according to their local labeling rules on the packaging

material. As these products are rare/ already in the market and patient needs them, therefore, M/s

Atco Laboratories Limited, Karachi has requested for extension in exemption in Labeling and

Packing Rules for the Biological Imported Drugs for at least twenty months are more: -

Sl. # Reg. No.

Name of Drug(s)

Exemption requested Quantity

1. 016110 Decapeptyl 0.1mg injection

i) Generic Name not in bracket. ii) Drug registration number to be printed

locally. iii) MRP to be printed locally. iv) Urdu instruction to be printed locally. v) Pharmaceutical specification. vi)

924 units.

2. 016111 Decapeptyl 3.75mg injection

-do- 2638 units.

3. 032143 Menogon Injection

-do- 6106 units.

4. 016153 Glypressin 1mg Injection

-do- 3438 units.


This case has been discussed in 243 Meeting of Drug Registration Board and deferred for confirmation of pharmacological group. The firm has provided the pharmacological group as per following details: - Sl. # Product name Generic Name Pharmacological Group

1. Decapeptyl 0.1mg injection Triptorelin Acetate Eq. to 95.6UG Triptorelin/ml

Triptorelin is synthetic form of Gonaderelin. Triptorelin causes an increase in the amount of FSH and LH release from the Pituitary gland.

2. Decapeptyl 3.75mg injection Triptorelin Acetate Corresponding to 3.75mg/Single Dose

Triptorelin is synthetic form of Gonaderelin. Triptorelin causes an increase in the amount of FSH and LH release from the Pituitary gland.

3. Menogon Injection Menotrophin 75IU Gonadotrophic Hormone (used in infertility).

4. Glypressin 1mg Injection 1mg Terlipressin Acetate Pentahydrate In 11mg Dry Substance

Terlinpressin is an analog of vasopressin used for Bleeding of esophageal varices, spactic shock and hepato-renal syndrome.

Decision: Registration Board acceded to the request of the firm for relaxation for the Urdu version at the time of import for the products referred above subject to local printing at the licensed premises of M/s. Atco Laboratories Ltd. Karachi for one year. The firm will comply with all the rest of conditions as per rules for labeling, before importing to Pakistan.

Case No. 18. Change of manufacturing name for already registered drug of M/s. Allmed Laboratories, Karachi

M/s Allmed Laboratories, Karachi has submitted the following application for change of

name of manufacturer along with CoPP from new manufacturer as well as fee of Rs. 50,000. The

detail is as under: -


Existing name of manufacturer

New Manufacturer name

1. ATG – Fresenius S Concentrate for solution for

M/s Fresenius Biotech GmbH Germany

M/s Neovii Biotech GmbH, AM Haag 6-7, 82166 Grafelfing


infusion. Each ml contains:- Rabbit Immunoglobulin 20mg (Reg No. 033134)

Germany,

M/s Allmed Laboratories, Ltd, Karachi has provided following documents to support their claim:-

1. Application with required fee as per SRO (Rs.50, 000/- per product). 2. Copy of registration letter and last renewal status. 3. NOC for CRF clearance (Not required for Importer) 4. Original legalized CoPP for new manufacturing site.

Decision: The request of the firm was approved as per CoPP provided by the firm.

Case No. 19. Change of name of manufacturing site for already registered drug of M/s. Wyeth Pakistan Limited, Karachi.

M/s Wyeth Pakistan Limited, Karachi has submitted the following application for change of

name of manufacture site for their already registered product along with copy of CoPP from new

manufacturer as well as fee of Rs. 100,000/-. The detail is as under: -


Existing name of manufacturer

New Manufacturer name

1. Premarin 0.3mg tablet Conjugated Estropgens USP (Desiccated with Lactose at 4.29%)…0.3mg.

M/s. Wyeth Medica Ireland Little Connell New bridge Country Kildare, Ireland

Pfizer Ireland Pharmaceuticals Little Connell New Bridge Country Kildare, Ireland.

1. Application with required fee as per SRO (Rs.100,000/- per product). 2. Copy of registration letter and last renewal status. 3. NOC for CRF clearance. 4. Original legalized CoPP for new name of manufacturer. 5. GMP of manufacturing site. 6. Site Master file

Decision: The request of the company was approved as per CoPP.


Case No. 20. Extension in shelf life of Poliomyelitis Vaccine of M/s. Hospital Services & Sales, Karachi.

M/s. Hospital Services & Sales, Karachi has submitted the following application for extension in shelf life of already registered drug from 24 months to 36 months: -

Sl. No.

Name of Drug with Registration No. Existing Shelf Life Demanded Shelf Life

1. Poliomyelitis Vaccines Inactivated, Suspension for Injection 0.5ml vial/dose (IM/SC)

24 months (02 years) 36 months (03 years)

The firm has submitted for following documents: -

a. Application on Form 5A with required fee as per relevant SRO (Rs. 5000/-). b. Copy of registration letter and last renewal status. c. NOC for CRF clearance (not required in case of importer). d. Justification for proposed change. e. Approval of regulatory body of country of origin / Original and legalized

Certificate of Pharmaceutical Product as per WHO format indicating shelf life 36 months.

f. Free sale certificate and GMP certificate g. Stability studies for product 2-80C. h. The firm has also provided WHO prequalification evidence indicating the shelf

life from 24month to 36 month at 2-80C.

Usually extension of shelf life case is placed before the Drug Registration Board after

getting the experts opinion from different experts. However considering the polio emergency in

the country and WHO prequalified data of the said drug, the case is placed before the board for a

decision.

Decision: The request of the firm was approved. WHO status shall be checked from

WHO website before issuance of letter to the company. It shall also be mentioned in the

registration letter that incase of any change in WHO status, the company shall immediately

report to the Board and decision of the Board shall stand cancelled.


Case No. 21. Local manufacturing of Allergen vaccines by M/s. Pakcure Pharma, Rawat.

The case of manufacturing of Allergen vaccines by M/s. Pakcure Pharma, Rawat was

under consideration of Board. The following products were discussed in different meetings of the

Board.

Applicant Product specifications Registration No. of similar product already in the market as manufactured by NIH, Islamabad

Decision

M/s Pakcure Pharma, Rawat, Islamabad.

Allergex-MP Each ml contains: Beef protein extract…….10mcgChicken protein extract. 10mcgEgg protein extract……...10mcg Fish protein extract……..10mcg Mutton protein extract..10mcg Shelf Life: 6 months when stored at +2 to +8˚C Allergy vaccine, immunostimulant

016742 Deferred for Product specific inspection by the panel.


Allergex-Px1 Each ml contains: Cannabis sativa protein extract 10mcg Acacia niloticaa protein extract 10mcg Eucalyptus globulus protein extract 10mcg Pininus longfolia protein extract 10mcg House dust extract 10mcg Shelf Life: 6 months when stored at +2 to +8˚C Allergy vaccine, immunostimulant

-do- Deferred for Product specific inspection by the panel.



Allergex-Px2 Each ml contains: Cannabis sativa protein extract 10mcg Acacia niloticaa protein extract 10mcg Eucalyptus globulus protein extract 10mcg Pininus longfolia protein extract 10mcg Mixed grass extract of Lolim temulentum + Cynodon dactylon …10mcg House dust extract ..10mcg Shelf Life: 6 months when stored at +2 to +8˚C Allergy vaccine, immunostimulant

-do- Deferred Product specific inspection by the panel.


Allergex-Px3 Each ml contains: Cannabis sativa protein extract 10mcg Acacia niloticaa protein extract 10mcg Eucalyptus globulus protein extract 10mcg Pininus longfolia protein extract 10mcg House dust extract ..10mcg Paper mulberry extract…10mcgThrasher extract…10mcg Raw cotton extract…10mcg Shelf Life: 6 months when stored at +2 to +8˚C Allergy vaccine, immunostimulant




Allergex-Px4 Each ml contains: Cannabis sativa protein extract 10mcg Acacia niloticaa protein extract 10mcg Eucalyptus globulus protein extract 10mcg Pininus longfolia protein extract 10mcg House dust extract ..10mcg Paper mulberry extract…10mcgThrasher extract…10mcg Shelf Life: 6 months when stored at +2 to +8˚C Allergy vaccine, immunostimulant


The product specific inspection of the company was conducted and presented before the board in its 243rd Meeting wherein the deficiencies of the facility were discussed and the board decided as under;

Past Decision: - The Board decided to defer the case till removal of deficiencies. Reference may also be sent to the Licensing Board to ensure compliance as per requirement of Biological Drugs. The firm after making improvements, approached again for the inspection. The inspection of the company was again carried out by the panel. The panel observed that the firm has not made substantial improvements. However, the panel was also of the opinion that the company may be allowed trial manufacturing to ensure that all necessary requirements are met by the company. The trial manufacturing is not for utilization of allergy vaccines for human use.

In the light of inspection report and recommendations of the panel, the case is placed before the Board for a decision.

Decision: The Board offered personal hearing to Mr. Agha Sadrad ud Din, CEO of the company. The applicant explained his status of improvements and assured the Board for its compliance. The Board decided to conduct the inspection of the company by already approved panel as and when the firm informs for compliance and will be ready for inspection. The report of panel shall be considered in the next meeting of Board.


Case No. 22. Court case of M/s Forward Solution V/S DRAP.

The case of M/s Forward Solution was discussed in 243rd Meeting of the Drug Registration

Board. The board decided that since the case is sub judice and under the consideration of the

Honorable Court. The firm M/s. Well Pharma, Lahore will be asked to substantiate their claim of

sole agent of the manufacturer in order to satisfy the legal procedure.

The decision of the board was communicated both the companies. M//s Well Pharma, Lahore has

not provided any sole agent agreement.

The firm M/s Forwarded Solution filed a writ petition in the Honourable Islamabad High

Court, Islamabad on 13.09.2014 on the grounds that the Drug Regulatory Authority of Pakistan

is not granting the Registration due to inaction of the functionary of the Drug Regulatory

Authority of Pakistan (CEO, DRAP, Director, Registration and Director Biological Products).

Parawise comments have been prepared and submitted to the Lawyer of DRAP for finalization

and submission to Honourable Court. Meanwhile, Federal Investigation Agency (FIA) has also

directed to appear before them to provide the details of the case, probably on the complain of

aggrieved company for non grant of registrations. The matter is submitted for information of the

Honorable Drug Registration Board and necessary instruction/orders if any.

Decision: The information was noted by the Board.


Item No: VIII Quality Control Cases – Quality Assurance & Lab Testing Division

Case No. 01: Deferred Cases

Sr. No

Name of Drugs

Firm CDL Report Appellate Testing Detail / Decision

1 Kohsar DS Tablets

(Artimether & Lumifantrin) Tablets

Batch No.001

Mfg. Sep-13

Exp. Aug-15

(F. No. 03-63/2013)

M/s Kohs Pharmaceuticals (Pvt) Ltd

Hyderabad.

Substandard with regard to :-

Assay for Artemether:

Found:- 80.256%

Limit: 90% to 110%

Does not comply

Remarks:- The sample is of substandard quality under the Drugs Act 1976.

Test report No. 852/2013

Firm challenged the report after 30 days as per record provided by FID so the request was not valid for re testing by the Appellate Lab NIH Islamabad under Section 22(5) of Drugs Act 1976

The Board was apprised about the background of the case as under:-

The Sample of Kohsar DS Tablets Batch No. 001 manufacture by M/s Kohs Pharmaceuticals (Pvt) Ltd Hyderabad, drawn on 10-10-2013 from manufacturer’s premises by FID Hyderabad, was declared substandard by Federal Government Analyst CDL, Karachi vide Test report No. 852/2013 dated 10-12-2013. The firm did not respond FID’s explanation letter dated 17-12-2013 so reminder letters dated 06-01-2014 and 30-01-2014 were issued by the FID. The firm vide its response dated 11-02-2014 disagreed and challenged the CDL report. As per record provided by the FID


the report was conveyed to the firm by the FID vide letter dated 17th December 2013, while the firm challenged the report vide its letter dated 11th February 2014. The FID nominated following as responsible persons.

i. Owner of the firm, M/s Kohs Pharmaceuticals (Pvt) Ltd.,

ii. Quality Control Incharge of M/s Kohs Pharmaceuticals (Pvt) Ltd

iii. Mirza Saleemullah, Production Manager, M/s Kohs Pharmaceuticals (Pvt) Ltd

The FID has not given any recommendations nor made any comments regarding validity of the act of challenging the CDL report by the firm. However, as


per record provided by the FID, it appears that firm has challenged the report after the 30 days period prescribed under Section 22(4) of Drugs Act 1976, therefore, the request was not valid for retesting by Appellate Lab.

As per responsibility fixed by the FID, show cause notices dated 05-05-2014 were issued to the firm and the accused persons of the firm.

The case was placed before Drug Registration Board in its 244th meeting held on 23-24th July 2014. The accused of the firm were also called for personal hearing in the said meeting of the Board but they could not appear before the Board. The Board decided to defer the case and provide a final opportunity of personal hearing to the accused.

The case was again placed before Drug Registration Board in its 245th meeting


held on 29-30th September 2014. The accused of the firm were also called for personal hearing in the said meeting of the Board but they could not appear before the Board. The Board decided to defer the case and provide a final opportunity of personal hearing to the accused.

The case was presented before the registration board in its 246th meeting on 11-12-2014. The Board decided the case as under in the light of personal hearing of Mr. Pardeep Kumar Director of the firm:-

Decision:-

The Board took the following decision

i. Cancellation of Kohsar DS Tablets Registration No 070898.

ii. Panel Inspection for PSI.

iii. The panel will be constituted by Director


QA&LT.

2. Dozabitol

(Paracetamol Syrup.

Batch No. DB 110

Mfg-Jul -13

Exp. Jun-15

(F.No. 03-12/2014)-QC


Hyderabad

Sub-Standard:-

With regard to assay for Paracetamol

Found :-82.2984%

Limit:- 90% to 110%

Does not comply



Firm challenged the report after 30 days as per record provided by FID so the request was not valid for re testing by the Appellate Lab, NIH Islamabad under section 22(5) of Drugs Act 1976


The Samples of Dozabitol Syrup, Batch No. DB110 manufacture by M/s Kohs Pharmaceuticals (Pvt) Ltd Hyderabad, drawn on 10-10-2013 from manufacturer’s premises by FID Hyderabad, were declared substandard by Federal Government Analyst CDL Karachi vide Test report No. 848/2013 dated 27-11-2013. . In response to FID’s explanation letter, the firm disagreed and challenged the CDL report. As per record provided by the FID the report was conveyed to the firm by the FID vide letter dated 03rd December 2013 and reminder was issued vide letter dated 30-


01-2014 for firm’s response in the matter. The firm challenged the report vide its letter received in DRAP Karachi office on 13-02-2014. so the request for retesting was not valid as the same was received by FID office after 30 days The FID has nominated following as responsible persons.

i. Owner of the firm, M/s Kohs Pharmaceuticals (Pvt) Ltd.,

ii. Quality Control Incharge, M/s Kohs Pharmaceuticals (Pvt) Ltd

iii. Mirza Saleemullah, Production Manager, M/s Kohs Pharmaceuticals (Pvt) Ltd

The FID has not given any recommendations nor made any comments regarding validity of the act of challenging the


CDL report by the firm. However, as per record provided by the FID, it appears that firm has challenged the report after the 30 days period prescribed under Section 22(4) of Drugs Act 1976, therefore, the request was not valid for retesting by Appellate Lab.

As per responsibility fixed by the FID, show case notices dated 05-05-2014 were issued to the firm and the accused persons of the firm.

The case was placed before Drug Registration Board in its 244th meeting held on 23-24th July 2014. The accused of the firm were also called for personal hearing in the said meeting of the Board but they could not appear before the Board. The Board decided to defer the case and provide a final opportunity of personal hearing to the accused.

The case was again placed


before Drug Registration Board in its 245th meeting held on 29-30th September 2014. The accused of the firm were also called for personal hearing in the said meeting of the Board but they could not appear before the Board. The Board decided to defer the case and provide a final opportunity of personal hearing to the accused.

The case was presented before the registration board in its 246th meeting on 11-12-2014. The Board decided the case as under in the light of personal hearing of Mr. Pardeep Kumar Director of the firm:-

Decision:-


i.. Cancellation of Registration of Dozabitol (Paracetamol Syrup


Registration No.006201.


iii. The panel will be constituted by Director QA&LT

3. Dozabitol (Paracetamol Syrup.

Batch No. DB 089

Mfg- Jan-13

Exp- Dec-14

(F.No. 03-31/2013)-QC


Hyderabad

Sub-Standard with regard to:-

Assay for Paracetamol:- Found:- 88.62%

Limit:- 95.0% to 105%

Does not comply with BP 2011



Sub-Standard

With regard to:- i. Assay for

paracetamol:-

85.52%

Does not comply with BP 2011.

ii. Description pink colored syrup having un dissolved masses which do not disperse even on shaking

Does not comply with BP 2011, which states that suspension may show a sedimentation which is readily dispersed on


The Sample of Dozabitol Syrup Batch No. DB089 manufacture by M/s Kohs Pharmaceuticals (Pvt) Ltd Hyderabad, drawn on 21-03-2013 from manufacturer premises by FID Hyderabad, was declared substandard by Federal Government Analyst, CDL Karachi vide Test report No. 535/2013 dated 06-05-2013. On explanation letter issued by the FID, the firm requested Appellate testing under section 22(5) of Drugs Act 1976. The Appellate Laboratories also


shaking.

Test report No.08-MNHRS/2013

declared the sample sub-standard vide test report No.08-MNHRS/2013 dated 06th August 2013. The repot of Appellate Laboratories was forwarded to the FID for sending complete case along with recommendation and name of the responsible persons. The FID in response has nominated following as responsible person with request for permission for prosecution and cancellation of registration.

i. Owner of the firm, M/s Kohs Pharmaceuticals (Pvt) Ltd., Hyderabad.

ii. Miss Rakhshanda Perveen (Quality Control Manger).

iii. Production Manager of the firm

As per responsibility fixed by the FID, show cause notices dated 07-05-2014 were issued to the firm and the accused persons of the firm..

The case was


placed before Drug Registration Board in its 244th meeting held on 23-24th July 2014. The accused of the firm were also called for personal hearing in the said meeting of the Board but they could not appear before the Board. The Board decided to defer the case and provide a final opportunity of personal hearing to the accused. They have been called for personal hearing again accordingly.

The case was again placed before Drug Registration Board in its 245th meeting held on 29-30th September 2014. The accused of the firm were also called for personal hearing in the said meeting of the Board but they could not appear before the Board. The Board decided to defer the case and provide a final opportunity of personal hearing to the accused.

The case was


presented before the registration board in its 246th meeting on 11-12-2014. The Board decided the case as under in the light of personal hearing of Mr. Pardeep Kumar Director of the firm:-

Decision:-


i.. Cancellation of Registration of Dozabitol (Paracetamol Syrup Registration No.006201.


iii. The panel will be constituted by Director QA&LT.

4. Stearox 1ml

Injection Batch No. H110112

Mfg:-01-12

Exp:-01-14

M/s Gyton Pharmaceutical Lahore

Sub-Standard

With regards to:-

i. pH

Determined 5.94

Limit 7.0 to 8.5

Does not comply with USP 34

Not Challenged

Batch No. H110112,

The Brief about the background of the case is as under:-

The samples of Stearox Injection Batch No. H110112, Manufactured by M/s Guyton Pharmaceutical Lahore drawn by FID


(F.No.03-25/2013 QC)

ii. Assay for Dexamethasone

Phosphate 14.59%

Limit 90% to 115%


Karachi from Central Pharmacy of JPMC, Karachi on 26-02-2013, was declared Substandard vide test report No.261/2013 dated 03-04-2013 by Federal Government Analyst. The FID has identified following persons responsible in the case.

. Mr. Talat Ahmad Anjum (Q.C In-charge)

.Muhammad Imran Khalil

(Production In-charge)

As per procedure show cause notices was issued to the firm 20th February 2014 and above accused, offering opportunity of personal hearing before the Drug Registration Board. They have also been called for personal hearing accordingly.

The case was placed before 244th meeting of Registration Board which decided the case


as under:- “The accused of the firm were called for personal hearing, but they could not appear before the Board. The Board decided to defer the case and a final opportunity of personal hearing shall be given in next meeting of the Board”

Accused as identified by FID Lahore has also been called for personal hearing accordingly. The case was again placed before 245th meeting of Refistration Board which decided the case as under:-

Decision:- Mr. Muhammad Salman Ali, Advocate High Court appeared on behalf of M/s Guyton Pharmaceutical Lahore. The Board did not accept power of Attorney on behalf of the firm. The Board decided the case as under:-

i. The production of the injection Stearox 1ml Registration No.


040336 shall be stopped. One more opportunity of personal hearing is granted with the direction that the Management and Technical Personnel shall appear before the Board failing which the ex-parte decision shall be taken.

ii. The Board further decided that the firm will recall all the marketed batches of sub-standard drugs from distribution / sale outlets / institutional supplies if any and area FID shall take report from the firm and submit a compliance report to Chairman Registration Board.

In the light of decision taken in 245th meeting of Registration Board The One more opportunity of personal hearing is granted with the direction that the Management and Technical Personnel shall appear before the Board failing which


the ex-parte decision shall be taken.

The case was presented before the registration board in its 246th meeting on 11-12-2014. The Board decided the case as under in the light of personal hearing of Mr. Bilal Khurshid Chief Executive of the firm:-

Decision:-

The Board took the following decision:-

i. Area FID Mr. Abdul Rasool Shiekh to take the samples of the batch and submit the investigation report of the case again as the firm has disowned the supply of specific Batch.

ii. The production of the firm in the steroidal Injectable section shall be stopped along with suspension of registration of


Stearox 1ml Registration No. 040336 which had already been suspended in 245th meeting till investigation of the case is finalized.

iii. The firm will be asked to provide on stamp paper regarding their statement of disownership of supply of this batch.

iv. The case will be submitted before the Registration Board after the completing the investigation.

Case No. 02 New Cases.


Sr. No

Name of Drugs Firm CDL Report Appellate Testing Detail / Decision

1. Rehumetic 50 Tablets (Diclofenac Potassium)

Batch No. RT012

Mfg Date:-03-14

Exp Date:- 03-16

(F.No.03-42/2014-QC)

M/s Rehmat Pharma Lahore.

Sub-Standard with regard to:-

i. Assay for diclofenac Potassium:-

Determined amount/tablet:- 48.44mg

Stated amount/tablet:-50mg

Percentage:- 96.88%

Fail on Dissolution test as under:-

ii. Dissolution test:-

Tablet No:- (%)age

1. 17.25

2. 14.37

3. 17.82

4. 13.5

5. 12.94

6. 16.10

No Challenged The background of the case is as under:-

The FID has submitted the investigation report. The FID has fixed the responsibility and submitted the name of Directors, Production Incharge, Quality Control Incharge as under:-

i. Mr. Bashir Ahmed, Chief Executive,

M/s Rehmat Pharma, Sheikhupura Road,

Lahore.

ii. Mr. Muzaffar Bashir

Production Incharge

M/sp Rehmat Pharma, Sheikhupura Road


Limits: Not less than 75.0%



Test Report No. LHR.136/2014

Lahore.

iii. Mr. Muhammad Sarwar, Quality Control Incharge, M/s Rehmat Pharma, Sheikhupura Road,

Lahore.

The FID has concluded that the firm has violated Section 23(1)(a)(v) of the Drug Act, 1976 and rules framed there under.

The tablet Rehumetic 50 was declared substandard by CDL on the basis of dissolution test. The firm vide its reply dated 18-08-2014 to FID did not challenge the report and requested to drop the proceeding against them in the interest of justice. The FID has submitted the copies of recall of the product from market by M/s Rehmat pharma, Lahore.

Keeping in view above since the firm has not challenged


the report of CDL therefore the report dated 21st July, 2014 is the adducing evidence under the law.

As per procedure a show cause notice was issued to the firm and other accused, offering opportunity of personal hearing before the Drug Registration Board.

The case was presented before the registration board in its 246th meeting on 11-12-2014. The Board decided the case as under in the light of personal hearing of Mr. Abid Hussain Awan Technical Advisor and Mr. Muhammad Sarwar QC Incharge of the firm:-

Decision:-


i. Warning to the firm.

ii. Destroy the


recalled quantity (1,34000) of Rehumetic 50mg tablets in presence of area FID Lahore. The area FID will submit the report of destruction to the Directorate of QA/LT.

iii. The firm will submit the measures taken to overcome such incidence in future.

3. D. Dron (Dexamethason) Injection (IM/IV)

Batch No. DF.137

Mfg:- 06-13

EXP:- 06-15

&

M/s Epharm Laboratories, Karachi.

Adulterated & Substandard with regards to Description:-

Finding of Lab:-

Colorless solution in clear glass ampoule. Out of 25 ampoules (referred portion of sample) one ampoule contain black particles and another ampoule contains white fibers.

Not challenged The Board was apprised about the background of the case as under:-

The samples of D-Dron Injection Batch No DF.137 & DF-138 manufactured by M/S Epharm Laboratories, Karachi were taken by FID Hyderabad at Karachi on 29-01-2014 from manufacturer’s premises. The samples were


Batch No. DF.138

Mfg:- 07-13

EXP:- 07-15

Does not comply with Description

Remarks:-

The sample is of “Adulterated & Substandard” under the Drugs Act 1976.

Adulterated & Substandard with regards to Description:-

Finding of Lab:-

Clourless solution in clear glass ampoule. Out of 15 ampoules (referred portion of sample) two ampoules contain black particles.

Does not comply with Description

declared Adulterated & Substandard by Federal Government Analyst vide test reports No.KQ.60/2014 & KQ.61/2014 dated 18th February 2014 respectively.

The FID communicated the test reports to the firm vide his letter No.05-10/2014-FID-H (K) 255-257 dated 19-02-2014. The firm in their reply mentioned about their right of exercise the power under subsection (4) of Section 22 of Drugs Act 1976 for retesting of their samples from appellate lab Islamabad. As per submission of complete case by the FID, the firm’s reply was received in the office of DRAP Karachi on 08-04-2014 which was well after the expiry of time allowed under section 22(4) of the Drugs Act 1976 and hence not valid as per FID’s remarks.


(F.No.03-10/2014-QC)

Remarks:-

The sample is of “Adulterated & Substandard” under the Drugs Act 1976.

The FID has furnished the names of the following persons of the firm responsible for committing the offence under the law.

i. M/S Epharm Laboratories Karachi.

ii. Mr. Asad Ilyas Nainitalwala, Director,

iii. Mr. Ahmed Nadeem Qasmi, QC Manager,

iv Dr. Mohammad Khokhar Production Manager,

Show cause notices were issued to the firm and other accused, offering opportunity of personal hearing before the Drug Registration Board after the approval of the competent authority. They have been also


called for personal hearing accordingly.

The case was presented before the registration board in its 246th meeting on 11-12-2014. The Board decided the case as under in the light of personal hearing of Mr. Asad Ilyas Director of the firm and Mr. Ahmed Nadeem Qasmi QC Manager of the firm.

Decision:-


i. The Board decided to suspended the registration of D-Dron Injection Registration No.058424 (IM/IV) for a period of three months.

ii. PSI Inspection by a panel comprising of Director DTL Quetta and area FID will be conducted and


they will submit the report to the Registration Board

3. i. Loose pink cloured tablets- Rumin (Ibuprofen) 400mg Tablets

Batch No. Nil

Mfg Date:- Nil

Exp Date:- Nil

M/s Ankaz Pharmex (Pvt) Ltd Karachi

Substandard with regard to “Assay”

for Ibuprofen:

Determined amount/Tab =49.512mg

Stated amount/tab =400mg

Percentage:- 12.378%

Limit: 95% to 105%

Does not comply


Test Report No. RKQ.212/2014.

Substandard with regard to “Assay” for Ibuprofen (BP)

Stated:- 400mg/Tab

Found:- 313mg/tab.

Percentage:- 78.29%

Limit: 95% to 105%


Conclusion:-

The sample is of substandard quality on the basis


The Federal Inspector of Drug, Karachi-III vide his letter dated 21-04-2014 informed that he alongwith Dr. Shahid Hussain, FID Karachi and others raided the premises of M/s Ankaz Pharmax (Pvt) Ltd., Karachi on 19-04-2014 at 07.45 AM. The raid was conducted on the source information of FIA Crime Circle Karachi. Deputy Director FIA Mr. Fakeer Muhammad headed the raid alongwith his team. Ten samples of different products were taken from the manufacturers premises for


of tests performed.

test/analysis on the prescribed Form-3.

The FID vide his investigation report of the case intimated that eight samples of the drugs taken have been declared to be substandard by the Federal Government Analyst, CDL Karachi. In the light of the same, the FID issued explanation letter regarding the matter of manufacture and sale of substandard drugs to the firm. As per documents provided by the FID, the firm challenged the test reports and requested to get the samples retested from the Appellate Laboratory, NIH Islamabad. The Appellate Laboratory also declared the drug sample under reference as Substandard.

The FID concluded that the manufacturer is


guilty of manufacturing substandard drugs and de-registered drug in violation to the provisions of Drugs Act 1976 and rules framed there under. He has requested for cancellation DML of the firm or permission to lodge the prosecution against the firm.

Following persons of the firm have been held responsible for committing the offence by the FID.

i. Ali Abbass, Managing Director of the firm.

ii. Akbar Ali Production Incharge.

iii. Safdar Alam,

Quality Control Incharge.

As per procedure Show cause notices were issued to the firm and other accused, in the light of the test reports of the


Appellate Lab and report of the FID, offering them opportunity of personal hearing before the Drug Registration Board.

They have also been called for personal hearing accordingly.

The Federal Inspector of Drugs, Karachi-III vide his letter dated 21-04-2014 informed that he alongwith Dr. Shahid Hussain, FID Karachi and others raided the premises of M/s Ankaz Pharmax (Pvt) Ltd., Karachi on 19-04-2014 at 07.45 AM. The raid was conducted on the source information of FIA Crime Circle Karachi. Deputy Director FIA Mr. Fakeer Muhammad headed the raid alongwith his team.


The FID vide his investigation report of the case intimated that eight samples of the drugs taken have been declared to be substandard by the Federal Government Analyst, CDL Karachi. In the light of the same, the FID issued explanation letter regarding the matter of manufacture and sale of substandard drugs to the firm. As per documents provided by the FID, the firm challenged the test reports and requested to get the samples retested from the Appellate Laboratory, NIH Islamabad. The Appellate Laboratory declared the drug sample under reference as Misbranded.

The FID concluded that the manufacturer is guilty of


ii. Loose pink cloured tablets- Rumin (Ibuprofen) 200mg Tablets

Batch No. Nil

Mfg Date:- Nil

-do.


Assay for Ibuprofen:

Determined amount/Tablet =24.756mg

Stated amount/tablet =200mg


Limit: 95% to 105%

Does not comply


Test Report No.


Stated:- 200mg/tab

Found:- 153.38mg/tab.

manufacturing substandard drugs and de-registered drug in violation to the provisions of Drugs Act 1976 and rules framed there under. He has requested for cancellation DML of the firm or permission to lodge the prosecution against the firm.




iii. Safdar Alam,

Quality Control Incharge.

As per procedure Show cause notices were issued to the firm and other accused, in the light of the test reports of the Appellate Lab and


Exp Date:- Nil

-do-

RKQ.213/2014





Percentage:- 76.69%

Limit: 90% to 105%


Conclusion:-

The sample is of substandard quality on the basis of tests performed.

Test Report No.09-MNHSR/2014


report of the FID, offering them opportunity of personal hearing before the Drug Registration Board.

They have also been called for personal hearing accordingly.

The FID vide his investigation report of the above case also reported that the firm was found manufacturing its one of de-registered product namely syrup Rumin mentioning the old manufacturing date on the label. It has been intimated that Syrup Rumin was found stored in bulk in big vessel placed in liquid manufacturing areas of the firm. A huge quantity of finished goods of same de-registered syrup was also seen placed in finished good wear house


iii. Tablet Rumin (Ibuprofen) 400mg

(Blister packing)

Batch No. 1105

Mfg Date:- 1-12

Exp Date:- 12-14


Limit: 95% to 105%

Does not comply


Test Report No. RKQ.215/2014




Stated amount/tablet

Stated:- 400mg/tab


Percentage:- 79.81%

Limit: 95% to 105%


Conclusion:-



The FID concluded that the manufacturer is guilty of manufacturing substandard drugs and de-registered drug in violation to the provisions of Drugs Act 1976 and rules framed there under. He has requested for cancellation DML of the firm or permission to lodge the prosecution against the firm.




iii. Safdar Alam,

Quality Control


iv. Tablet Rumin (Ibuprofen) 200mg

Batch No. 640

(Jar Packing)

Mfg Date:- 2-13

Exp Date:- 01-16

-do-

=200mg


Limit: 95% to 105%

Does not comply



Substandard with regard


Stated:- 200mg/tab


Percentage:- 72.80%

Limit: 95% to 105%


Conclusion:-


Test Report

Incharge.

As per record of Quality Control Section, registration of this product was cancelled by DRB in its 237th meeting held on 26-02-2013, which was communicated of the firm vide their officer letter bearing No.03-16/2012-QC, dated 22-03-2013.

As per procedure Show cause notices were issued to the firm and other accused, in the light of report of the FID, and record of QC Section regarding the de-registration of the product offering them opportunity of personal hearing before the Drug Registration Board.

They have also been called for personal hearing accordingly


-do-

to :-

Assay for Sulphamethoxazole:

Determined amount/Tablet =101.328 mg



Does not comply



No.012-NHSR/2014

Misbranded with the following remarks:-

“Labeling on the immediate pack is not legible. More over batch number and expiry date is printed with removable ink and some strips found without batch numbers and expiry date which is violation of the labeling and packing rules of Drugs Act 1976.

Conclusion:- The sample is misbranded.

Test Report No.06-


The Federal Inspector of Drug, Karachi-III vide his letter dated 21-04-2014 informed that he alongwith Dr. Shahid Hussain, FID Karachi and others raided the premises of M/s Ankaz Pharmax (Pvt) Ltd., Karachi on 19-04-2014 at 07.45 AM. The raid was conducted on the source information of FIA Crime Circle Karachi. Deputy Director FIA Mr. Fakeer Muhammad headed the raid alongwith his team. Ten samples of different products were taken from the manufacturers premises for test/analysis on the prescribed


v.. Biprim (Co-Trimoxazole) DS Tablets

Batch No. 305

(Blister packing)

Mfg Date:- 11-13

Exp Date:- 10-16

MNHSR/2014

Form-3.

The FID vide his investigation report of the case intimated that eight samples of the drugs taken have been declared to be substandard by the Federal Government Analyst, CDL Karachi. In the light of the same, the FID issued explanation letter regarding the matter of manufacture and sale of substandard drugs to the firm. As per documents provided by the FID, the firm challenged the test reports and requested to get the samples retested from the Appellate Laboratory, NIH Islamabad. The Appellate Laboratory declared the drug sample under reference as of standard quality.

As per Section 22


vi. Rumin (Iburofen) Suspension

Batch No.408

Mfg Date:-03-13

Exp Date:-02-16

vii. Biprim DS (Co-Trimoxazole) Tablets

Batch No. 305

(Jar packing)

Mfg Date:- 11-13

Exp Date:- 10-16

The sample is of standard quality with regard to tests performed.

Test report No. RKQ.210/2014.






Does not comply

(5) of the Drugs Act 1976 and the report of conclusive evidence so in the light of the same the present case with regard to drug under reference may be filed.

.

Submitted for Information of the Board please.

-Do-

-Do-

The case was presented before the registration board in its 246th meeting on 11-12-2014. The Board decided the case as under in the light of personal hearing of Mr. Salim Isharat Husain,


viii. Biprim

(Co-Trimoxazole) Tablets

Batch No. 524

(Blister packing)

Mfg Date:- 01-13

Exp Date:- 12-15

ix. Loose white cores claimed/suspected of Tablets- Rumin (Ibuprofen) 200mg

Batch No. Nil

Mfg Date:- Nil

Exp Date:- Nil

(F.No.03-17/2014-QC)








Does not comply





Determined amount/Tablet

Technical Consultant on behalf of M.D of the firm.

Decision:-

The Board in view of personal hearing of Mr Saleem Isharat Hussain on behalf of Managing Director Ankaz Pharmex and available record/facts of the case decided as under:-

1. The Board decided to cancel the registration of the following products as per its consideration:-

i. Loose Pink Colored Tablets- Rumin (Ibuprofen) 400mg Tablets. Registration No. 007545

ii. Loose Pink colored Tablets- Rumin (Ibuprofen) 200mg Tablets, Reg. No. 007543.

iii. Tab. Rumin 400mg. (Blister Packing) Reg.


-Do-

=30.945mg



Limit: 95% to 105%

Does not comply



N.A

The Sample has been declared of Standard Quality on the basis of tests performed.


The Sample has been declared of Standard Quality of the basis of tests performed

No. 007545

iv. Tab. Rumin 200mg (Jar Packing) Reg. No. 007543.

v. Tab. Biprim (Co-Trimoxazole) DS (Blister Packing) Reg. No. 008409

vi. Rumin (Ibuprofen) Suspension, Reg. No. 008526

2. The Board further decided to recommend to the Central Licensing Board for cancellation of the Drug Manufacturing License of the firm on the violation of manufacturing of already De-registered product i.e. Rumin Suspension Reg. No. 008526.



The Sample has been declared of Standard Quality on the basis of tests performed by the Appellate Lab, NIH, Islamabad.

(Test Report No.010-MNHSR/2014)

4. Kemycillin (Ampicillin) Syrup

Batch No. A-1028

Mfg. Oct-13

Exp. Use with in three years

(F. No. 03-34/2014)

M/s Alkemy Pharmaceutical Laboratories

Hyderabad.


Assay for Ampicillin

Determined amount/5ml:- =103.32mg

Stated amount /5ml

=125mg

Percentage:- 82.66%

Limit: 90% to 120%

Does not comply

Remarks:- The sample is of substandard quality under the Drugs

Sub-Standard

With regard to:- Assay for

Ampicillin:-

Stated 125mg/5ml

i. First day Found

=101.14mg/5ml

Percentage:- 80.91%

i. On 07th Day Found = 78.53mg/5ml

Percentage:-


The Sample of Kemycillin Syrup Batch No A-1028, manufactured by M/s Alkemy Pharmaceutical Laboratories P/9, SITE Hyderabad Sindh was taken by FID Hyderabad at Karachi on 24-04-2014 from manufacturer’s premises. It was declared substandard by Federal Government Analyst vide Test report No. KQ.230/2014 dated 27th May 2014. In


Act 1976.

Test report No. KQ.230/2014

62.82%

Limit:- 80-120%

Does not comply with BP 2011.

Conclusion:-


Test report No. 015-MNHSR/2014

response to the explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory also declared the sample as Substandard vide test report No. 015-MNHSR/2014 dated 08th August 2014. The FID in response to this office letter dated 29th August 2014 concluded that the firm has violated Section 23(1)(a)(v) of Drugs Act 1976. FID has recommended immediate action under Section 7(11) of the Drugs Act 1976 and has furnished the names of the following persons of the firm responsible for the offence.

i. M/s Alkemy Pharmaceutical Laboratories


(Pvt.) Ltd Hyderabad,

ii. Mr.Fraz Ahmed Sheikh, Managing Director,

iii. Mr. Asif Najeeb Laghari, QC Manager,

iv. Mr.Abid Ali Khoso Production Incharge,

As per responsibility fixed by the FID, show case notices dated 05-05-2014 were issued to the firm and the accused persons of the firm.

The case was presented before the registration board in its 246th meeting on 11-12-2014. The Board decided the case as under in the light of personal hearing of Mr. Asif Najeeb Laghari QC Manager of the firm.

Decision:-

The Board took the following decision:


i. Suspended the registration of Kemycillin (Ampicillin) Syrup, Reg. No. 022520 for a period of six (06) months.



5. Empoir 500mg (Ciprofloxacin) Tablets.

Batch No. 283

Mfg Date- 03-14

Exp Date. 02-17

(F.No. 03-33/2014)-QC

M/s Alkemy Pharmaceutical Laboratories

Hyderabad.

Sub-Standard:-

With regard to Dissolution test

Tablet 01= 38.23%

Tablet 02= 48.94%

Tablet 03= 39.30%

Tablet 04= 32.26%

Tablet 05= 39.15%

Tablet 06= 39.15%

Limit:- Not less than 80%

Does not comply with

Substandard with regard to Dissolution test

Determined:- 59.9%

57.71% (repeated)

Limit:- Not less than 80% of the stated amount

Does not Complies with USP 32

Conclusion:-


The Sample of Empoir 500mg Tablets Batch 283 manufactured by M/s Alkemy Pharmaceutical Laboratories (Pvt.) Ltd, P/9, SITE Hyderabad was taken by FID Hyderabad at Karachi on 24-04-2014 from manufacturer’s premises. The Sample was declared substandard by


USP 35.


Test report No. KQ.228/2014


Test report No. 014-MNHSR/2014

Federal Government Analyst CDL Karachi vide Test report No. KQ.228/2014 dated 15th May 2014. In response to the explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory also declared the sample as Substandard vide test report No. 014-MNHSR/2014 dated 12th August 2014. The FID in response to this office letter dated 18th September 2014 has concluded that the firm has violated Section 23(1)(a)(v) of Drugs Act 1976. FID has furnished the names of the following persons of the firm responsible for the offence.

i. M/s Alkemy Pharmaceutical


Laboratories (Pvt.) Ltd Hyderabad,

ii. Mr.Fraz Ahmed Sheikh, Managing Director,

iii. Mr. Asif Najeeb Laghari, QC Manager,

iv. Mr.Abid Ali Khoso Production Incharge,

.As per responsibility fixed by the FID, show case notices have been issued to the firm and other accused persons of the firm.

The case was presented before the registration board in its 246th meeting on 11-12-2014. The Board decided the case as under in the light of personal hearing of Mr. Asif Najeeb Laghari QC Manager of the firm.

The case was presented before the registration board in its 246th meeting on


11-12-2014. The Board decided the case as under in the light of personal hearing of Mr. Asif Najeeb Laghari QC Manager of the firm.

Decision:-


i. Suspended the registration of Empoir 500mg (Ciprofloxacin) Tablets Reg. No. 039367 for a period of six (06) months.



Case No. 03 Substandard Rifacin (Rifampicin Suspension BP 60ml) manufactured by M/s Pharmawise Labs Pvt Ltd Lahore

Brief Background

The FID Islamabad-II on 03-04-2012 drew samples of Rifacin Suspension Batch No.152

of M/s Pharmawise Labs (Pvt) Lahore, from T.B Center, Asghar Mall Road Rawalpindi for


test/analysis. The samples were declared substandard by the F.G Analyst vide test report

No.T.B.64/2012 dated 01-08-2012. The firm did not challenge the report and case was

accordingly processed and decided by the Registration Board in its 237th meeting, held on 26-02-

2013 and cancelled the registration of the product under reference. The firm filed an appeal

before Appellate Board against the decision of DRB vide appeal No.04/2013, dated 06-09-2013,

which was dismissed by the Appellate Board in its 140th sitting.

. .The firm filed a writ petition No.4442-2013, before Honorable Islamabad High Court,

Islamabad against the decision of Appellate Board but the Court upheld the decision of Appellate

Board. The firm filed a C.P.L.A No. 2/2014 before the Honorable Supreme Court of Pakistan

which in its order dated 22-08-2014 the directed to retest the sample in accordance with law.

Accordingly the sample was sent to Appellate Lab (NIH) for retesting which also declared the

sample is of Sub-standard quality.

S.No. CDL Test Report No. TB.64/2012 & Findings

Appellate Test Report No.016-MNHSR/2014 & Findings

Remarks

1. i. pH Determined 5.18 ii. Limits:- 4.2 to 4.8 Does not comply with BP 2011 Assay for Rifampicin i. Determined amount per ml =15.514mg/ml ii. Stated amount / ml= 20mg/ml iii. Percentage:- 77.57% iv. Limits:- 90% to 110% Does not comply with BP 2011

i. pH Determined 4.75 ii. Limits:- 4.2 to 4.8 Comply with BP 2011 . iii. Volume Determined 60ml Complies with volume stated on the label Assay for Rifampicin i. Determined amount per ml =17.31mg/ml ii. Stated amount / ml= 20mg/ml iii. Percentage:- 86.63% iv. Limits:- 90% to 110% Does not comply with BP 2011

The sample is of Substandard quality on the basis of test performed by FGA CDL Karachi and Appellate Testing Lab Islamabad.

The case is submitted of the consideration / decision of Registration Board under

intimation to Assistant Registrar motion for Deputy Registrar Judicial in the light of brief

background please.

Decision:-


The Board after through celebration decided as under:-

1. Up held the decision of cancellation of registration of substandard Rifacin (Rifampicin Suspension BP60ml), Regn. No. 037528 manufactured by M/s Pharmawise Labs (Pvt) Ltd., Lahore taken in 237th meeting, Registration Board.

2. The Board further decided that the case with brief background shall be intimated to Assistant Registrar motion for Deputy Registrar Judicial in the light of decision of the Board and substandard test report by the Appellate Lab NIH Islamabad and Medical Superintended T.B Hospital Asghar Mall Road Rawalpindi for their further necessary action if any.

3. The firm will recall all its supplied batches to T.B Hospital Asghar Mall Road Rawalpindi under intimation to area FID-II Islamabad.

Case No. 04 Deaths of persons allegedly due to consumption of cough syrup manufactured by M/S Ethical Laboratories (Pvt) Ltd and M/S Reko Pharmecal Laboratories Lahore

The Registration Board in its 245th meeting decided the case as under:-

Decision:- Registration Board decided that Mr. Jamil Anwar Member of the Registration Board, Deputy Director General (E&M) Lahore & Islamabad will furnish the pending status of these petitions filed by M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore for consideration of the Board in its up-coming meeting

The pending status of the petitions filed by M/s Reko and Ethical Laboratories pvt Ltd Lahore

have not yet been received from the Honorable member Mr. Jamil Anwar, and DDG (E&M) Lahore and

Islamabad as communicated to them.

Decision: Registration Board again decided that that Mr. Jamil Anwar Member, Registration Board, Deputy Director General (E&M) Lahore & Islamabad will furnish the pending status of these petitions filed by M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore for consideration of the Board in its up-coming meeting


Case No. 05 Damage Samples for Board Portion

Board portion of sealed samples from ADC Quetta and FID Peshawar were received in damage

conditions (File No.13-09/2013-QC)

S. No.

Product & Batch No. Manufacturer Condition

1. Canrce Tablets Q18

M/s Merck (Pvt) Ltd Quetta

Badly damaged, broken carton and seal.

2. Optifam Tablets 38



3. Naproxen Imported Raw Material


Badly damaged, glass broken bottle and seal.

4. Metformin-Hcl Imported Raw Material


Badly damaged, glass broken bottle and seal.

5. Tablet Klaribact 250mg Q64



6. Liquid Glucose 014270-Bulk

Rafhan Maiz Pakistan Badly damaged, leaked bottles and torn memorandum.

7. Liquid Serbetol 00470114

Made in China Badly damaged, leaked bottles and torn memorandum

. The Board portions of the samples at serial No. 1-5 have been sent by ADC Quetta

whereas the samples at serial No.6-7 have been sent by FID Peshawar. Both officers had been

informed telephonically about the status of these samples.

. The Registration Board in its 238th meeting allowed the QC Section to get fresh samples

from the inspectors if they are received in damage conditions. In view of above following

proposal is submitted.

i. The FID Peshawar and ADC Quetta may be advised to take special care for packing and transportation of the Boards portion of samples in future all the DDGs in the field offices may also be advised to instruct FIDs/ADCs to ensure appropriate packing and sealing of such samples.

ii. FID Peshawar and ADC Quetta may be advised to draw fresh samples, of the same batches/raw materials, of damaged drugs for test analysis.

Decision:- The Board approved the proposals of QC Section and Directed that all DDGs, FIDs and ADCs be asked to send the Board Portion intact form and ensure appropriate packing and sealing of such samples before sending. In future such approvals will be taken from Director QA/LT on file.


Case No. 06 Manufacture and supply of sub-standard Hepaferon Injection by M/s Pharmedic, Lahore to Govt of Khyber Pakhtoonkhawa

BRIEF BACK GROUND: The case of M/s Pharmedic Laboratories (Pvt) Ltd was discussed with reference to the decision taken in also 243rd & 244th meeting of Registration Board which is reproduced as under.

Decision taken in 243rd Meeting of Registration Board

i The Federal Inspector of Drugs Peshawar is advised to get the case completed covering details of findings, conclusion fixation of responsibilities with his recommendations.

ii. The Board further decided to get update regarding Suo Moto notice taken by Hounrable Peshawar High Court Peshawar and fate of case referred to NAB Khyber Pakhtoon Khawa.

The FID Peshawar has submitted the investigation of the case fixing the responsibility of name of

persons accused & co accused in manufacture and sale of substandard Hepaferon Injection Batch No 80-

87 which are involved directly or indirectly. The FID has also submitted the suo moto judgment a copy of

Honorable High Court Peshawar but did not submitted the report regarding investigation by NAB.

Name of accused persons.

i. Mr. Iftikhar Ahmed Shiekh Director/C.E.O ii. Mr. Mazhar Hussain Production Incharge. iii. Mr. Asim Mehmood Quality Control Inchage

Name of Co-accused persons.

Dr. Chuhan Director Dr. Sharif, Director Dr. Ghulam Subhani Director Hapatitis Program Mubarik Shah, Store Keeper LRH Hapatitis Program Dr. Nigar Ahmed, Ms DHQ Mardan. Mr. Aurengzaib, Store Incharge, DHQ Mardan.

The case was again presented before 244th meeting of the Board in the light of recommendations of

the FID Peshawer as above which decided the instant case as under:-

Decision:- The Board decided to issue show cause notices to accused of M/s Pharmadic Laboratories (Pvt) Ltd Lahore regarding manufacture and supply of substandard Injection Hepaferon (3MIU) Interferon Alpha 2a to government of KhyberPakhtoonKhawa.


The The FID Peshawar has submitted the complete investigation of the case fixing the

responsibility of name of persons accused / co-accused in manufacture and sale of substandard Hepaferon

Injection Batch No 80-87and proposed their names for prosecution under Section 23(1)(a)(v)(vii) and 23

(1)(a)(vii), 23(1)(b)(f) which are involved directly or Indirectly in this case some of the co-accused are

employees of Government of Khyber Pakhtoon Khawa.

As directed by Chairman Registration Board the case is again submitted for consideration of the

Registration Board keeping in view of the Public health at large, Suo Moto Notice by Peshawar High

Court, & NAB investigation in instant case please.

Decision:- The Board decided that Federal Inspector of Drugs Peshawar will be asked to submit the certified copies of decisions of Drug Court Peshawar and Peshawar High Court, Peshawar in the instant case with in 07 days. Reference will be sent to Law division to ascertain whether government officials under provincial governments can be issued show cause notice for violations any provision of Drug Act, 1976 or otherwise.

The Show Cause Notice to the accused of firms will be issued after the receipt of the letter from the FID and approval from Chairman, Registration Board. However, show cause to government officials will be served after clarification from Law Division.

Case No.07 Supply of substandard /adulterated injection of cil 100ml to DHQ hospital Hafizabad (25000 vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-km, Raiwind Manga Road, Lahore which supplied Almajax 250ml Suspension to DHQ Hospital Hafizabad (35600 bottles).

The Secretary Provincial Quality Control Board (PQCB) Punjab Mr. Tallat Farooq Ahmad has forwarded two recommendations to DRAP as under:-

i. The Federal Government Cancel the Drug Manufacturing License of M/s Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore on supply of Sub-standard / Adulterated injection Ofcil 100ml to DHQ Hospital Hafizabad (25000 vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore which supplied substandard Almajax 120ml Suspension to DHQ Hospital Hafizabad (35600 bottles).

ii. The Federal Government Cancel the Registrations of the said drugs of M/s Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore and M/s Medisearch Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore.


Brief Background

The Provincial Quality Control Board (PQCB) after scrutiny of the report of Government

analyst i.e report Nos. TRA. 22863 & 22864 dated 21-11-2014 Batch No. JX168 of Almajax

suspension, and statement of the Drug Inspector observed that this is a criminal negligence on

the part of manufacturers and gross loose in GMP compliance. The Punjab Government (PQCB)

observed that there is a dire need to take quick action against the said firms to safeguard the

public health at large and submitted the above mentioned recommendations.

The case is placed before Registration Board for decision on the recommendations of

(PQCB) Punjab by Registration Board regarding cancellation of Registrations of Drugs of these

firms as per law with the proposal that recommendations may also be send to Division of

Licensing for further necessary action at their end so that public health may be saved from risk.

Decision:- The Board decided as under:-

a. To get the complete investigation along with all the reports and case background from the Secretary Provincial Quality Control Board Health Department Government of Punjab Lahore through the DDG (E&M) Lahore.

b. The area FID Lahore will be asked to submit the case background in writing along with all relevant reports for perusal of the Registration Board for decision.

The Board further decided the case shall be forwarded to Directorate of Licensing for further necessary action in the light of recommendation of the Provincial Quality Control Board (PQCB) Punjab.


Item No.IX Registration of Medical Devices – Medical Devices Division

Case No.01. Applications for registration of medical devices for import.

Registration Board considered the following applications of medical

devices for import and decided as mentioned against each. Approved applications have already

been recommended by Expert Committee on Medical Devices and are subject to inspection of

manufacturer abroad, verification of storage facilities etc as per policy:-

A) Cannulas:

S.No.

Name of Importer and Manufacturer/Exporter.

Name of Medical Device

Price Pack size Shelf life

Decision

1. M/s Kaf Surgical & Disposable Equipments, GF-116, Panorama Centre, Plot No.248, Staff Lines, Fatima Jinnah Road, Karachi/

Manufactured by

M/s Plasti Lab S.A.R.L,

Roumieh El Metn, Industrial Area, Main Road, Khoury Bldg, P.O.Box 70407, Beruit, Lebanon.

JRZ Intravenous Canula without Wings without Injection Port (Pencil Type).

Decontrolled till policy decision by the Policy

Board/ Federal Government.

(14G, 16G, 18G, 20G, 22G, 24G, 26)

50 per box

5 years

Approved.

2. M/s Kaf Surgical & Disposable Equipments, GF-116, Panorama Centre, Plot No.248, Staff Lines, Fatima Jinnah Road, Karachi/

Manufactured by

JRZ Intravenous Canula without Wings without Injection Port (Pen Type)

-do-

(14G, 16G, 18G, 20G, 22G, 24G, 26)

5 years

Approved.


M/s Plasti Lab S.A.R.L,

Roumieh El Metn, Industrial Area, Main Road, Khoury Bldg, P.O.Box 70407, Beruit, Lebanon.

50 per box

3. M/s Lab Link Enterprises, 192-N, Block-II, PECHS,

Karachi.

Manufactured by:

M/s PT Nipro Indonesia Jaya, Kawaran Industri Suryacipta, JI Surya Utama Kav, 122B, 23 & 24, Desa Kutamekar, Kec, Ciampel, Karawang, Jawa Barat, Indonesia.

Nipro Safelet Cath (I.V Cannula Pen Type)


Board/ Federal Government

(16G,18G, 20G,

22G, 24G)

50 per box

5 years

Approved.


Karachi.

Manufactured by:


Nipro Wing Cath (I.V Cannula with Injection Port & Wing)

-do-

(16G, 18G, 20G, 22G, 24G)

50 per box

5 years

Approved.

5. M/s. A. Feroz & Co., Medicine Street No.1, Marriot Road, Karachi

Star IV. Catheter with Injection Port.

-do- (14G, 16G, 18G, 20G, 22G,

24G)

5 years

Approved.


Manufactured by

M/s. Engineering Technical Plastic Industries (Enteplin-Egypt) 10th of Ramadan City, Industrial Zone, A-1 Part 41/3. Sharqia, Egypt.

100 per box

B: Infusion Set:

S.No.



Price Pack size

Shelf life

Decision


Karachi.

Manufactured by:


Nipro Infusion Set

(with needle)


Board/ Federal Government

1’s 5 years

Approved.

C: Syringes:

S.No.



Price Pack size

Shelf life

Decision


Karachi.

Nipro Disposable Syringe (with needle)

Decontrolled till policy decision by the Policy Board/Federal

1ml

3ml

5 years

Deferred for clarification from the


Manufactured by:


Government

5ml

10ml

20ml

applicant regarding non-permanent marking of 10ml & 20ml syringes with delible ink.


Karachi.

Manufactured by:


Nipro Disposable Syringe (without needle)

-do- 30ml

50ml

5 years

Deferred for clarification from the applicant regarding non-permanent marking of 30ml & 50ml syringe with delible ink.


Karachi.

Manufactured by:


Nipro Disposable Syringe U-100 Insulin with needle

-do- 1 ml

5 years

Approved.


Case No.02. Withdrawal of registration applications of medical devices.

The following importing firms are withdrawing their registration applications of

medical devices as mentioned against each. The firms have also not deposited differential fee as

per revised fee schedule for their products:-

S.No Name of Importer and Manufacture/Exporter.

Name of Medical Device (s)

Demanded price & Pack size

Shelf life

Remarks

1. M/s Otsuka Pakistan Ltd. 30-B Sindhi Muslim Cooperative Housing Society, Karachi. Manufactured by M/s Micro Port Medical (Shanghai) Co. Ltd., China.

Jive Stent (PTCA Balloon Catheter)



2 years

Reference No.27/12/ Stent-Reg. Dated: 26-12-2011.


Firebird (Rapamycin Eluting Stainless Steel Coronary Stent System)



12 month

s



Firebird-2 (Rapamycin Cobalt Chromium Coronary Stent System)



09 months


4. M/s Otsuka Pakistan Ltd. 30-B Sindhi Muslim Cooperative Housing Society, Karachi. Manufactured by M/s Micro Port Medical

Mustang Stent (Stainless Steel Coronary Stent System)



2 years

Reference No.28/12/ Stent-Reg. Dated : 26-12-2011.


(Shanghai) Co. Ltd., China.

5. M/s. Intek Corporation, Rawalpindi. / Manufacturer: M/s. OrbusNeich Medical B.V. Drs, W. Van Royenstraat, AN Hoevelaken, The Netherlands. Shipped From:- M/s. Asia Cardiovascular Products Ltd., Kwai Chung, N.T. Hong Kong.

Blazer CoCr Alloy Coronary Stent Delivery System (Cobalt Chromium Stent). (Medical Device).



24 months

The firm has informed that further action on this product is no more required.

Decision: Registration Board considered the request of the firms for withdrawal of their applications for registration of above mentioned medical devices and approved the request.

Case No.03. Cancellatiuon of sole agency agreement.

M/s. A.H Distributors, Kh-1183, Lane No.5, Peshawar Road, Rawalpindi had

applied for registration of Primum Guiding Catheter and Pointer Angiographic Catheter for

import from foreign manufacturer i.e. Pendra Care International B.V Van der Waalspark 22 9351

VC leek the Netherlands. The importing firm was advised to complete the

documents/information including fresh authorization letter and differential fee as per revised fee

schedule but the importing firm has not responded till now. The authorization letter of principal

manufacturer in respect of importer M/s A.H Distributors, Rawalpindi was expired on 31-12-

2011. The manufacturer M/s Pendra Care International B.V Netherlands, has sent a termination

letter in respect of M/s A.H Distributors for the above mentioned products directly to Drug

Regulatory Authority of Pakistan. In the aforementioned letter the manufacturer has confirmed

that they terminated the business relationship with A.H Distributors, Rawalpindi.

Decision: The Board after thorough discussion decided that final reminder should be issued to the firm for submission of all deficient documents including fresh


authorization letter from the principal manufacturer, attested by the Embassy of Pakistan in the country of origin and the prescribed differential fee. If the applicant fails to provide the aforesaid documents and prescribed differential fee within 15 days, the above mentioned applications shall not be entertained for registration.

Case No.04. Case remanded back by the Appellate Board.

The Registration Board in its 240th meeting held on 7th November, 2013 considered and

rejected the following medical device of M/s Mana & Co, Karachi due to the reason mentioned

below against the product:-

S.No. Name of Importer and Manufacturer/Exporter.


Demanded price & Pack size

Shelf life

Decision

1. M/s Mana & Co, 204 New Medicine Market, Near Densohall, Karachi. Manufactured by M/s Jiangxi Huali Medical Instrument Co.Ltd. Yudu Industrial Zone,Ganzhou, Jiangxi, China.

Medicare IV Catheter with Injection Port.

Decontrolled (14G, 16G, 18G, 20G, 22G, 24G )

5 years

Rejected due to incomplete and unsatisfactory stability profile.

Rejection letter was issued to the importing firm. The said firm filed an appeal against the

decision of Registration Board before Appellate Board. The Appellate Board in its 142nd

meeting held on 24th June, 2014 decided as under:-

“The Board in light of the stability data submitted before it and taking a lenient view decided to remand the case to the Registration Board for decision under the rules.”

Decision: Registration Board decided to ask the importing firm to submit complete stability profile for the above mentioned device for review.


Case No.05 Miscellaneous Cases.

a. Relaxation in the condition of Drug (Labeling & Packaging) Rules, 1986. (Deferred in 245th meeting of Registration Board).

M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has requested for relaxation in

condition of Drug (Labeling & Packaging) Rules, 1986 i.e. Urdu version, Pak Registration

Number and MRP of their already registered imported Prowler Micro Catheters (Registration

No.074692).

The firm has submitted that Prowler family of Micro Catheters being labeled as

per the requirement of Medical Device directives 93/42, GHTF labeling recommendation. As

Prowler Micro Catheters belongs to sterile sensitive class of medical device and it is supplied in

sterile peel open packages after carrying out all recommended package integrity and sterility

validation tests. To ensure the sterility of product till it is received by key user, packaging

qualification testing is performed on all Prowler Micro Catheters which are packaged in a

preformed tray, sealed in packaging pouch and placed in a folding carton. The same sterilized

pack being supplied in all International countries. The firm has deposited the required fee for

above mentioned product.

The firm has further submitted that the demand forecast of Prowler Micro Catheters in

Pakistan is only 1% of the global supply, so it is not viable for their Principal manufacturer to

produce country specific packs for such a small volume. Therefore, the firm requested for the

following approval:-

“That they may be allowed to import Prowler Micro Catheters in international packs provided that company will perform ink jet printing of Urdu version, Pak Registration No. and maximum retail price at their locally licensed premises.”

The case was placed before Registration Board in its 245th meeting and the Board

deferred the case and decided to call the firm M/s Johnson and Johnson Pakistan (Pvt) Ltd,

Karachi for personal hearing alongwith samples of the product in the forthcoming meeting of the

Board. Accordingly letter was issued to the firm for personal hearing alongwith provision of

samples.


Decision: Registration Board deferred the case and decided to call the firm M/s Johnson and Johnson Pakistan (Pvt) Ltd, Karachi for personal hearing alongwith samples of the product in the next meeting of the Board.

b. Inspection of Manufacturer Abroad M/s Biosensors Interventional Technologies Pte Ltd., Kampong Ubi, Industrial Estate, Singapore.

The Registration Board in its 238th meeting held on 5TH & 6TH August, 2013

considered and approved the following medical devices of M/s Promed International, Islamabad

subject to inspection of manufacturer abroad, local storage facility etc:-

S. No

Name of Importer and Manufacturer/Exporter

Name of Medical Device (s)

Demanded Price & Pack Size

Shelf Life

1. M/s. Promed International, Ground Floor, Jamil Mohsin Mansion, G-6 Markaz, Islamabad. Manufacturer: Biosensors Interventional Technologies Pte Ltd., Kampong Ubi, Industrial Estate, Singapore.

Power Line TM PTCA Catheter Balloon Dia (mm): 1.5, 2.0, 2.5, 2.75, 3.0, 3.5, 4.0. Balloon Length (mm): 10,15, 20, 25, 30. (Many product codes)

Decontrolled

1’s

36 months

2. M/s. Promed International, Ground Floor, Jamil Mohsin Mansion, G-6 Markaz, Islamabad Legal Manufacturer: Biosensors Europe SA, Ch-1110 Morges, Switzerland. Manufacturing Site: Biosensors Interventional Technologies Pte Ltd., Kampong Ubi, Industrial Estate, Singapore.

Bio Matrix TM Drug Eluting Coronary Stent System. Stent Inner Dia (mm): 2.25, 2.5, 2.75, 3.0, 3.25, 3.50, 4.0. Stent Length (mm): 8, 11, 14, 18, 23, 24, 28. (Many product codes)

Decontrolled

1’s

19 months


3. M/s. Promed International, Ground Floor, Jamil Mohsin Mansion, G-6 Markaz, Islamabad Legal Manufacturer: Biosensors Europe SA, Ch-1110 Morges, Switzerland. Manufacturing Site: Biosensors Interventional Technologies Pte Ltd., Kampong Ubi, Industrial Estate, Singapore.

BioMetrix Flex TM Drug Eluting Coronary Stent System

Stent Inner Dia (mm): 2.25, 2.5, 2.75, 3.0, 3.50, 4.0.

Stent Length (mm): 8, 11, 14, 18, 24, 28, 33, 36. (Many product codes)

Decontrolled

1’s

24 months

4. M/s. Promed International, Ground Floor, Jamil Mohsin Mansion, G-6 Markaz, Islamabad Legal Manufacturer: Biosensors International Pte. Ltd, 21 Kallang Avenue, Singapore Manufacturing Site: Biosensors Interventional Technologies Pte Ltd., Kampong Ubi, Industrial Estate, Singapore.

Gazelle Coronary Stent System Stent Dia (mm): 2.25, 2.5, 2.75, 3.0, 3.25, 3.50, 4.0. Stent Length (mm): 8, 11, 14, 18, 23, 24, 28. (Many product codes)

Decontrolled

1’s

24 months

Accordingly the inspection of manufacturer abroad has been carried out by the panel

comprising Mr. Sayyad Hussain Khan, DDC (LA) and Ms. Sara Mehreen, ADC, DRAP,

Islamabad on 1st and 2nd September, 2014. The panel has not recommended the products for

registration on the basis of following major concerns:-

(i) Firm is importing stents in finish form either from Germany or from China. So there was no way to verify their manufacturing standard.

(ii) Sterility testing is outsourced and either performed in Malaysia or Germany. So the panel was not able to check the process of sterilization for the applied products. However, final release of the products is firm itself.

(iii) As the firm was shifting to their own constructed new premises and few operations including microbiological testing had already been shifted to the new premises. So the panel was not able to check their microbiological testing process as inspection of new premises was not the mandate of the panel.


(iv) One of the applied products namely BioMatrix Flex Drug Eluting Coronary Stent is not on free sale in the country of origin, which is one of the conditions for registration of imported drugs in Pakistan.

Decision: Regiastration Board discussed the inspection report in detail and keeping in

view nature of the observations being critical rejected the above applications of M/s.

Promed International, Iislamabad manufactured by M/s. Biosensors Interventional

Technologies Pte Ltd., Kampong Ubi, Industrial Estate, Singapore.


Item No.X: Local Manufacturing of Biological Drugs.

The following cases for the local manufacturing biological drugs were decided in the

244th Meeting of the Drug Registration Board. The details of the cases and decisions taken by the

Drug Registration Board in its 242nd, 243rd and 244th Meeting are as below: -

Sl.# Applicant Product Specifications 1. Getz Pharma, Karachi. Eptifib Solution for Infusion 75mg/100ml

2. Getz Pharma, Karachi Eptifib Solution for Injection 20mg/10ml

3. Getz Pharma, Karachi

Enoxa Injection 20mg/0.2ml Injection Each Pre-filled syringe


Enoxa 40mg/0.4ml Injection Each Pre-filled syringe






Gilia solution for injection Glatiramer acetate 20mg/ml


Lira Solution for injection 6mg/ml Solution for Injection in Cartridge

9. Getz Pharma, Karachi . Menocon Lyophilized Powders for Injection 1000 IU USP


Menocon Lyophilized Powders for Injection 5000 IU USP

11. Getz Pharma, Karachi Menoget Menotropins 75IU /2ml vial


Menoget Menotropins 150IU / 2ml vial

13. Getz Pharma, Karachi Neupeg injection


14. Getz Pharma, Karachi Getiferon Solution for Injection 3 MIU in Vials


Getiferon Solution for Injection 5MIU in Vials

16. Getz Pharma, Karachi Getiferon Solution for Injection 3 MIU in Pre-Filled Syringes Each Pre-Filled

17. Getz Pharma, Karachi Getiferon Solution for Injection 5 MIU in Pre-Filled Syringes


Uniferon Solution for Injection 3 MIU in Vials


Uniferon Solution for Injection 5 MIU in Vials


Uniferon Solution for Injection 3MIU in Pre-Filled Syringe


Uniferon Solution for Injection 5MIU in Pre-Filled Syringes

22. Getz Pharma Unipeg 80 Solution injection 180mcg/mL in vial

23. Getz Pharma Unipeg 40 Solution injection 180mcg/0.5 mL in Prefilled Syringe

24. Getz Pharma Unipeg Solution injection 180mcg/mL in vial

25. Getz Pharma Unipeg Solution injection 180mcg/0.5mL in Prefilled syringe

Applicant Product Specifications 26. Macter International

Limited, Karachi

Heberon 2a Injection 3MIU/0.3ml. (Liquid Solution)

27. Macter International Limited, Karachi

Heberon 2a Injection 5MIU/0.5ml. (Liquid Solution)


Heberon 2a Injection 3MIU/ml (Lyophilized Powder)


Heberon 2a Injection 5MIU/ml (Lyophilized Powder)



Peg-In Injection 50mcg /0.5ml (Lyophilized Powder)


Peg-In Injection 80mcg /0.5ml








Neupeg 6mg/ml Injection Each vial

36. Macter International, Karachi.

Prance Injection Recombinant Human Basic Fibroblast growth factor.

37. Macter International, Karachi.

Macgrastim Injection Pre-filled Syringe Granulocyte colony stimulating factor.

Applicant Product specifications 38. Hilton Pharma (Pvt)

Ltd., Karachi. Xiro Injection Filgrastim 300ug

39. Hilton Pharma (Pvt) Ltd., Karachi.

Lameo Injection 3MIU Interferon alfa 2a

40. Hilton Pharma (Pvt) Ltd., Karachi.

Lameo Injection 5MIU Interferon alfa 2a

Applicant Product specifications 41. M/s Nextar Pharma

(Pvt) Ltd., Karachi

Nexfil 150 Injection

42. M/s Nextar Pharma (Pvt) Ltd., Karachi

Nexfil 300 Injection Each Prefilled syringe


Pegaron Injection



NP-POETIN 2000 INJECTION


NP-POETIN 4000 INJECTION

Decision of 242nd Meeting of Drug Registration Board. Product Approved, however, cGMP / COPP is required of the finished Drug manufactured using this particular drug substance in the country of origin. Biosimilarity data of locally manufactured drug needs to be disclosed by the local manufacturer. However the minutes of the meeting were quarantine due to observation of members of Drug Registration Board. Decision of 243rd Meeting of Drug Registration Board: - Decision recorded in 242nd Meeting upheld. Further, all firms will submit Bio-comparability data followed by regular Pharmaco-vigilance report. Final Decision of the Drug Registration Board in its 244th Meeting: -

“ a) Biosimiliarity is the principal requirement for the registration of biological drugs, as it is part of requirements of DRAP Act, 2012 mainly focusing on patient safety and also to promote biological production and availability of biological products.

b) All those manufacturing units which have been approved by Central Licensing Board for manufacturing of biological drugs and also had qualified product specific inspection by panel of Registration Board, are allowed registrations of applied biological drugs for local manufacturing on case to case basis. Item for which product specific inspection is required, then it will be conducted by already constituted panel of Registration Board.

c) Local manufacturer will provide legalized documents from concerned regulatory body confirming the status of licensed manufacturer of concentrate/bulk source in its country of origin. Moreover manufacturer will provide legalized documents for confirmation that finished product is also available in market from the same biological material. Case will be processed for issuance of registration letter after fulfillment of above mentioned requirements, with following conditions:

i. Registration is exclusively for trial manufacturing of the drug and manufacturer shall not be allowed in any way to sale/utilize these trial manufactured drugs. Manufacturer will perform biosimilarity studies as per WHO guidelines confirming the biosimilarity of applied product to original innovator product.

ii) Manufacturer will submit actual result of conducted biosimilarity studies to the Biological Division for its scientific evaluation through Expert Committee on Biological Drugs (ECBD). Moreover manufacturer will also provide sufficient quantity of these trial manufactured drugs to Biological Division for testing by


National Control Laboratory for Biological (NCLLB) as per WHO guidelines.

iii) Recommendation of ECBD and report of NCLB will be submitted to Registration Board for permission of commercial manufacturing of the product or otherwise.

d) This decision supersedes all the already taken decisions so far in the earlier meetings of Registration Board on the subject cases”.

The decision of the Board was communicated to the concerned companies. In response to which the companies have submitted documents. The documents of M/s Nextar, Karachi were complete and inspections of the company already conducted supported the trial manufacturing of biological products. Accordingly trial production of 04 products out of 05 products (for one product COPP was missing) was allowed to the company. Product specific inspection of the company has not been conducted. The Board may decide the requirement of product specific inspection of the company. The documents of M/s Getz Pharma, Karachi required further support (COPP not provided) of their case and under process while M/s Hilton has not responded yet. Two products of M/s Macter Pharma, Karachi i.e., Prance and Macgrastim are to be imported in the form of labelled finished vial and repacked locally which may be dealt as per procedures of import policy for finished drugs. For rest of the products the documents submitted by the company are under review. The case of local manufacturing of biological drugs was also under examination of Honourable Ombudsman on the complaint of M/s Macter International, Karachi. The findings/recommendations of the Honourable Wafaqi Mohtasib are as below: -

The record of DRAP showed that more than 300 drugs of similar formulation were freely available in the market. Moreover, DRAP had already registered/approval more than 500 vaccines. The complainant’s case was approved in 243rd board meeting with certain conditions which the complainant’s fulfilled. He was never informed as to why without assigning any reason new conditions were imposed. It was surprising to note that although the decision of 243rd meeting had become final and the minutes were displayed on DRAP Website yet again the earlier decision was revised in 244th Board meeting and fresh stringent requirements were proposed. The record also indicates that the drugs registration board did not work in a systematic and organized manner. The complainant’s case was examined and scrutinized by an expert committee and cleared by the drug registration board which included technical experts and eminent health professionals. It was noteworthy that the conditions prevalent at the time of submission of application by the complainant were met and subsequently additional conditions were applied retrospectively which was an unfair practice. New conditions could only have been applied to fresh application. After finalization of the decision of the 243rd Drug Registration Board Meeting, imposition of a new condition by DRAP tantamount to mal-administration in


terms of Article 2(2) of the President’s Order No.1 of 1983. It is therefore, recommended that: -

1) The complainant’s product be registered in line with the decision of 243rd board meeting and already done in the case of more than 300 registered biological products which are already being manufactured in accordance with previous requirements.

2) There should be no discrimination and the complainant be allowed a time frame as had been granted to other manufacturers of registered biological products to bring their products in conformity with the new requirements.

Compliance should be reported within 30 days of the receipt of a copy of these findings or the reasons for not doing so be submitted in terms of Article 11(2) of the President’s Order No 1 of 1983. Under provision of Article 11(2A) of P.O. 1 of 1983 read with section 13 of Federal Ombudsmen Institutional Reforms Act, 2013 and Article 32 of P.O. 1 of 1983 under which any person, aggrieved by a decision or an order by the Wafaqi Mohtasib may also, within thirty days: -

(a) File a review petition before the Wafaqi Mohtasib; or (b) Make a representation to the President.

Discussion: On the direction of the Honorable Ombudsman, the case was taken up by the Drug

Registration Board on priority.

The matter related to local manufacturing of biological drugs was discussed on 10th

December, 2014 in the meeting. The Board discussed / examined in detail its earlier decisions

taken in 243rd and 244th Registration Board meeting regarding registration of biological drugs.

The Board observed that there is no difference in both decisions and in later meeting (244th), the

Board only devised implementation process for decision taken in 243rd meeting. The members of

the Board also examined the decision of Honorable Ombudsman and the whole matter of local

manufacturing of biological drugs was re-examined with holistic approach, keeping in view

ensuring the public health and safety, efficacy, quality of locally manufactured biological drugs.

It was also agreed by the Board that these local manufacturers (M/s. Macter International

Karachi, M/s. Getz Pharma Karachi, M/s. Nextar Pharma, Karachi and M/s. Hilton Pharma,

Karachi) will be provided an opportunity for appraising their views with the Registration Board

on next day.

Following representatives of four manufacturers attended the meeting for presentation of

their case.


i. Mr. Abdur Jabbar Saya (M/s. Nextar, Karachi) ii. Syed Asghar Abbass Alve (M/s. Nextar, Karachi)

iii. Mr. Saleem Riaz (M/s. Hilton Pharma, Lahore) iv. Dr. Salman Ahmad (M/s. Macter Pharma, Karachi) v. Mr. Farooq Mustafa (M/s. Macter Pharma, Karachi)

vi. Mr. Zeeshan Ahmad (M/s. Getz Pharma, Karachi) vii. Mr. Ayub Malik (M/s. Getz Pharma, Karachi)

viii. Mr.Shamim Ahmad, PPMA representative for the meeting

The firms unanimously presented / argued that Registration Board previously did not implement/

demand CoPP/ Free sale certificate from local manufacturer of biological drugs. But now only

GMP certificate of the foreign manufacturer can be provided which should be accepted by the

Drug Registration Board. Moreover, the condition of providing bio-similarity data should not be

imposed as per previous practice of the Registration Board for already registered locally

manufactured drugs as this condition will result in further delay which can be very damaging to

new biopharmaceutical units. Condition of clinical studies should not be imposed. The

manufacturer shall ensure the quality, safety and efficacy of locally manufactured biological

drugs by them.

Representatives of the firms, PPMA and Pharma Bureau re-iterated that already

registered biological drugs may be re-assessed in light of safety, efficacy and quality parameters.

Decision: After all detailed discussion and directions of the Ombudsman, Registration

Board decided as follows:

1. As the Registration Board in 244th meeting has already approved registration of

biological drugs for four manufacturers (M/s. Macter International Karachi, M/s.

Getz Pharma Karachi, M/s. Nextar Pharma, Karachi and M/s. Hilton Pharma,

Karachi) for local manufacturing. In order to issue registration letter, the Board

advised these manufacturers to provide following document as discussed and agreed

during the deliberations with manufacturers:

a. The firms shall provide legalized GMP certificate of biological drug

manufacturer abroad (who will provide concentrate / ready to fill bulk of

biological drug to Pakistani manufacturers for further processing) as an

evidence that the manufacturer is an authorized manufacturer of that

particular biological drug in its country of origin.


b. The firm shall provide studies conducted by manufacturer abroad (dully

verified with statement for correctness / genuineness of data) regarding

structural similarity of subject biological drug product (concentrate/ ready to

fill bulk for further processing) with reference biological product

(innovator).

c. The local manufacturer shall be authorized to manufacture the finished

biological product and then perform bio-comparability studies including

identity testing to parent molecule, purity testing, in vitro biological activity,

potency and toxicity with support of iso-electro focusing data, gel

electrophoresis, Western-Blot and other analytical techniques) and stability

studies of finished biological product. Data provided by the local

manufacturer shall be evaluated by the Expert Committee on Biological

Drugs. Recommendation of the committee shall be considered by the

Registration Board for issuance of registration letter.

d. The firms shall conduct parallel bio-similarity studies as per WHO

guidelines immediately after grant of registration and shall submit complete

studies with in two (2) years in any case. Manufacturer will provide progress

report to this effect to Directorate of Biological Drugs on quarterly basis.

e. Regular monitoring through pharmacovigilance reporting system shall be

observed through proper pharmacovigilance cell of the manufacturer and

report will be forwarded to the National Pharmacovigilance Centre, Division

of Pharmacy Services and Biological Division of DRAP. In case of any severe

adverse event, immediate mandatory reporting procedure shall be followed.

f. If any of the conditions is not fulfilled or public health risk reported at any

stage, the drug registration shall stand cancelled with immediate effect.

g. All the provisions as contained in the Drugs Act, 1976 and rules made there

under including provisions of Lot Release certification from National

Control Laboratory for Biologicals shall be strictly adhered to.

2. Already registered biological drugs shall be reviewed in the same manner.

3. New applications for registration of biological drugs shall be considered after compliance of above point.


Item No.XI: Applications for transfer of registrations

Various firms (column II) have applied for transfer of registrations. Registration Board

on 10.12.2014 advised P E & R Division to bring such applications for its consideration. Various

applications were considered as per following details:

S. No. Name of applicant(s)

Name of existing manufacturer

Date of application, Diary No . &

Form

Registration No.

Name of product with composition

I II III IV V VI 1. M/s

GlaxoSmithKline Pakistan Ltd, Kara

M/s Akhai Pharmaceuticals, Karachi

20-06-2014 Dy.No.594

Form-5 Rs.40000/-

017889 Traxon 1gm IM/IV Injection Each vial contains:- Ceftriaxone Sodium …………..1gm

2. -do- -do- 20-06-2014 Dy.No.595

Form-5 Rs.40000/-

017890 Traxon 500mg IM/IV Injection Each vial contains:- Ceftriaxone Sodium …………..500mg

3. -do- -do- 20-06-2014 Dy.No.596

Form-5 Rs.40000/-

017891 Traxon 250mg IM/IV Injection Each vial contains:- Ceftriaxone Sodium …………..250mg

4. M/s Martin Dow Ltd, Karachi

M/s Martin Dow Pharmaceuticals (Pakistan) Ltd, 45-KM, Multan Road, Lahore

10-02-2014 Dy.No.113

Form-5 Rs.20,000/-

027216 Biprofin Tablets Each tablet contains:- Flurbiprofen …………..50mg

5. -do- -do- 10-02-2014 Dy.No.112

Form-5 Rs.20,000/-

027216 Biprofin Tablets Each tablet contains:- Flurbiprofen …………..100mg

6. -do- -do- 10-02-2014 Dy.No.111

Form-5

049189 Fexinol-D Tablet Each tablet contains:- Pseudoephedrine HCl


Rs.20,000/- …….120mg Fexofenadine HCl ………. 60mg

7. -do- -do- 10-02-2014 Dy.No.110

Form-5 Rs.20,000/-

018485 Covatine Coated Tablet Each tablet contains:- Captodiamine HCl ……….50mg

8. -do- -do- 14-04-2014 Dy.No.341

Form-5 Rs.20000/-

042810 Fexinol Tablets 30mg Each tablet contains:- Fexofenadine HCl ……30mg

9. -do- -do- 14-04-2014 Dy.No.342

Form-5 Rs.20000/-

024311 Fexinol capsule Each capsule contains:- Fexofenadine HCl ……80mg

10. -do- -do- 14-04-2014 Dy.No.340

Form-5 Rs.20000/-


11. -do- -do- 14-04-2014 Dy.No.343

Form-5 Rs.20000/-


12. M/s Novartis Pharma

(Pakistan) Ltd, (DML

No.000193), West Wharf

Road, Karachi

M/s Novartis Pharma (Pakistan) Ltd, (DML No.000010), Jamshoro.

24-06-2014 Dy.No.636

Form-5 Rs.20,000/-

18-09-2014 Dy.No.800 Rs.80,000/-

022204 Lozal 20mg Capsule Each capsule contains:- Omeprazole …………..20mg

13. M/s Elko Organization

(Pvt.) Ltd, Karachi

M/s Macquin’s International, Karachi

12-11-2013 Dy.No.1003

Form-5 Rs.20,000/-

048507 Aqua Teas Eye Drops Each ml contains:- Dextran………1mg HPMC……….3mg


Glycerin……...2mg (Manufacturer’s Specification)

14. -do- -do- 12-11-2013 Dy.No.1003

Form-5 Rs.20,000/-

044457 MetaDex Eye / Ear Drop Each ml contains:- Ciprofloxacin…..3mg Dexamethasone..1mg (Manufacturer’s Specification)

15. -do- -do- 12-11-2013 Dy.No.1003

Form-5 Rs.20,000/-

044449 Blepharite Eye Drop Each ml contains:- Sulfacetamide…0.10g Prednisolone Acetate.…..2mg Phenyephrine HCl……..1.2mg (Manufacturer’s Specification)

16. M/s GlaxoSmithKline Pakistan Ltd, F-268, S.I.T.E,

(DML No.000233)

Karachi

M/s AGP (Pvt.) Ltd, Karachi

26-06-2013 Dy.No.1084

Form-5 Rs.20,000/-

015027 Atarax Syrup Each 5ml contains:- Hydroxyzine Dihydrochloride..10mg

17. -do- -do- 26-06-2013 Dy.No.1084

Form-5 Rs.20,000/-

007591 Atarax Tablet 10mg Each tablet contains:- Hydroxyzine Dihydrochloride..10mg

18. -do- -do- 26-06-2013 Dy.No.1084

Form-5 Rs.20,000/-

002287 Navidoxine Tablet Each tablet contains:- Meclozine Dihydrochloride..25mg Pyridoxine Hydrochloride..50mg

19. -do- -do- 26-06-2013 034675 Xyzal Tablet


Dy.No.1084 Form-5

Rs.20,000/-

Each film coated tablet contains:- Levocetirizine Dihydrochloride…………….5mg

20. -do- -do- 26-06-2013 Dy.No.1084

Form-5 Rs.20,000/-

016937 Zyrtec Syrup Each ml contains:- Cetirizine 2HCl ………….1mg

21. -do- -do- 26-06-2013 Dy.No.1084

Form-5 Rs.20,000/-

011020 Zyrtec Tablet 10mg Each tablet contains:- Cetirizine 2HCl ………….1mg

22. M/s Bosch Pharmaceuticals

(Pvt.) Ltd, (DML

No.000707), Karachi (Plant-

II)

M/s Bosch Pharmaceutical

s (Pvt.) Ltd, (DML

No.000350), Karachi (Plant-

I)

12-03-2014 Dy.No.190

Form-5 Rs.20,000/-

037306 Ambac Injection 0.75gm Each vial contains: Ampicillin sodium USP eq. to Ampicillin…….500 mg Sulbactam Sodium USP eq. to Sulbactam……250 mg

23. -do- -do- 12-03-2014 Dy.No.188

Form-5 Rs.20,000/-

037629 Ambac Injection 1.5gm Each vial contains: Ampicillin sodium USP 1.06gm eq. to Ampicillin………1gm Sulbactam Sodium USP 0.545gm eq. to Sulbactam……500 mg

24. -do- -do- 12-03-2014 Dy.No.189

Form-5 Rs.20,000/-

042424 Bactamox Plus 0.75gm Injection Each vial contains: Amoxicillin Sodium (as Amoxicillin Sodium Anhydrous)B.P …0.50 gm Sulbactam Sodium USP ….0.25gm


(USP Specification) 25. -do- -do- 12-03-2014

Dy.No.187 Form-5

Rs.20,000/-

042425 Bactamox Plus 1.5gm Injection Each vial contains: Amoxicillin Sodium (as Amoxicillin Sodium Anhydrous)B.P …1.0 gm Sulbactam Sodium USP ….0.5gm (USP Specification)

26. -do- -do- 12-03-2014 Dy.No.186

Form-5 Rs.20,000/-

042426 Bactamox Plus 3gm Injection Each vial contains: Amoxicillin Sodium (as Amoxicillin Sodium Anhydrous) B.P …2.0 gm Sulbactam Sodium USP ….1.0gm (USP Specification)

27. -do- -do- 12-03-2014 Dy.No.185

Form-5 Rs.20,000/-

015906 Boschoclox Injection 250mg Each vial contains: Cloxacillin Sodium USP eq. to 250mg Cloxacillin Base

28. M/s GlaxoSmithKline Pakistan Ltd, Korangi Plant Karachi

M/s GlaxoSmithKline Pakistan Ltd, West Wharf, Karachi

14-06-2012 Dy.No.315

Form-5 Rs.8,000/-

29-04-2013 Rs.12000/-

0001859 Kenacomb Cream Each gram contains:- Triamcinolone Acetonide USP …1mg Nystatin USP ………….100,000 units Gramidicin USP ………...0.25mg

29. -do- -do- 14-06-2012 Dy.No.314

Form-5

005026 Kenacomb Ointment Each gram contains:- Triamcinolone


Rs.8,000/- 29-04-2013 Rs.12000/-

Acetonide USP ….1mg Nystatin USP ………….100,000 units Gramidicin USP ……………...0.25mg Neomycin Sulphate eq. to 2.5mg base

30. -do- -do- 14-06-2012 Dy.No.316

Form-5 Rs.8,000/-

29-04-2013 Rs.12000/-

009452 Kenalog Orabase Ointment Each gram contains:- Triamcinolone Acetonide USP ….1mg

31. M/s Hilton Pharma, Karachi

M/s Brookes Pharma, Karachi

11-07-2013 Dy.No.692

Form-5 Rs.20,000/-

021661 Zinum 250mg Injection Each vial contains:- Ceftazidim Sodium ……….250mg

32. -do- -do- 11-07-2013 Dy.No.693

Form-5 Rs.20,000/-

021662 Zinum 500mg Injection Each vial contains:- Ceftazidim Sodium ……….500mg

33. -do- -do- 11-07-2013 Dy.No.697

Form-5 Rs.20,000/-

021663 Zinum 1gm Injection Each vial contains:- Ceftazidim Sodium ……….1gm

34. -do- -do- 11-07-2013 Dy.No.696

Form-5 Rs.20,000/-

021664 Axone 250mg Injection Each vial contains:- Ceftriaxone Sodium …….250mg

35. -do- -do- 11-07-2013 Dy.No.699

Form-5 Rs.20,000/-

021665 Axone 500mg Injection Each vial contains:- Ceftriaxone Sodium …….500mg

36. -do- -do- 11-07-2013 Dy.No.695

021666 Axone 1gm Injection Each vial contains:-


Form-5 Rs.20,000/-

Ceftriaxone Sodium …….1gm

37. M/s Indus Pharma, Karachi

M/s Nimrall Laboratories,

Islamabad

05.11.2014 Dy.No.394

Form-5 Rs.20,000/-

054553 Rudra 5mg Tablet Each tablet contains:- Rosuvastatin (as Calcium) …….5mg

38. -do- -do- 05.11.2014 Dy.No.395

Form-5 Rs.20,000/-

054554 Rudra 10mg Tablet Each tablet contains:- Rosuvastatin (as Calcium) …….10mg

39. M/s Sante (Pvt.) Ltd, Karachi

M/s Elko Organization (Pvt.) Ltd, Karachi

18-09-2014 Dy.No.657

Form-5 Rs.20,000/-

070516 Dequsan Throat / Mouth Spray Solution Each 100ml contains:- Dequalinium Chloride BP………15mg Benzalkonium Chloride BP………..35mg

40. M/s Pfizer Pakistan Ltd,

DML No.000025

(Formulation) at B-2, SITE,

Karachi

M/s wyeth Pakistan Ltd., Karachi contract manufactured by M/s Spencer & Co (Pakistan) Ltd, Karachi.

06-02-2014 Dy.No.68 Form-5

Rs.20,000/-

000083 Ativan 1mg Tablets (Lorazepam)

41. -do- -do- 06-02-2014 Dy.No.68 Form-5

Rs.20,000/-

000084 Ativan 2mg Tablets (Lorazepam)

42. M/s Ambrosia Pharmaceuticals, Rawat

M/s Spencer & Co, Karachi

29-10-2014 Dy.No.634

Form-5 Rs.20,000/-

006348 Calcipan-T 50 mg Tablet Each tablet contains:- Calcium Pantothenate……..50 mg

43. -do- -do- 29-10-2014 067454 Infacol 40 mg Drops

Each ml contains:-


Dy.No.635 Form-5

Rs.20,000/-

Simethicone …………40 mg

44. -do- -do- 29-10-2014 Dy.No.633

Form-5 Rs.20,000/-

008801 Infacol Suspension Each 5 ml contains:- Dicyclomine HCl ……….5 mg Simethicone ……… …50 mg

45. M/s Glitz Pharma,

Islamabad

M/s Caraway Pharmaceutical

, Rwat

784; 09.12.2014 Rs.50000/-

Form 5

066362 G-Cal 5 mg Injection Each ampoule contains:- Cholecalciferol eq. to Cholecalciferol ……………. 5 mg

46. M/s Focus & Rulz, Islamabad

M/s Highnoon Labs, Lahore

970; 10.12.2014 Rs.20000/-

Form 5

027104 Helezol 20 mg Capsule Each delayed-release capsule contains:- Omeprazole enteric coated pellets 8.5% ≡ Omeprazole……. 20 mg

47. -do- -do- 976; 10.12.2014 Rs.20000/-

Form 5

051054 Helezol 40 mg Capsule Each delayed-release capsule contains:- Omeprazole enteric coated pellets 8.5% ≡ Omeprazole……. 40 mg

48. -do- -do- 971; 10.12.2014 Rs.20000/-

Form 5

025098 Angiocard 2.5mg Capsule Each sustained-release capsule contains:- Nitroglycerin SR Pellets ≡ Nitorglycerin……..2.5 mg

49. -do- -do- 969; 10.12.2014 Rs.20000/-

Form 5

025099 Angiocard SR 6.5 mg Capsule Each sustained-release capsule contains:- Nitroglycerin SR Pellets ≡ Nitorglycerin……..6.5 mg


50. -do- -do- 974; 10.12.2014

Rs.20000/- Form 5

024929 Artonec 50 mg Capsule Each delayed-release capsule contains:- Diclofenac Sodium enteric coated pellets ≡ Diclofenac Sodium …... 50 mg

51. -do- -do- 972; 10.12.2014 Rs.20000/-

Form 5

024930 Artonec SR-100 Capsule Each sustained-release capsule contains:- Diclofenac Sodium sustained release coated pallets ≡ Diclofenac Sodium ….100 mg

52. -do- -do- 973; 10.12.2014 Rs.20000/-

Form 5

027105 Neopres 5 mg Tablet Each tablet contains:- Amlodipine Besylate eq. to Amlodipine……….5mg

53. -do- -do- 968; 10.12.2014 Rs.20000/-

Form 5

027106 Neopres 10 mg Tablet Each tablet contains:- Amlodipine Besylate eq. to Amlodipine…10 mg

54. -do- -do- 975; 10.12.2014 Rs.20000/-

Form 5

051057 Delergic 5 mg Tablet Each film coated tablet contains:- Desloratidine……..5 mg

55. M/s. Synchro Pharmaceuticals Lahore

M/s. Obsons Pharmaceuticals, Lahore

05-06-2013 926

Form-5

059991 Obdin Tablet 5mg Each tablet contains:- Desloratadine…. 5mg

56. -do- -do-

05-06-2013 5549

Form-5

025404 Azrocin Suspension Each 5ml contains:- Azithromycin dihydrate eq. to Azithromycin.. 200mg

57. -do- -do- 05-06-2013 5548

Form-5

054157 Obflox Tablet Each tablet contains:- Levofloxacin Hemihydrate equivalent to


Levoflocaxin …………. 500mg

58. -do- -do- 05-06-2013 5547

Form-5

030488 Obflox Tablet Each tablet contains:- Levofloxacin Hemihydrate equivalent to Levoflocaxin …………. 250mg

59. -do- -do- 05-06-2013 5554

Form-5

054166 Obpra Capsule 40mg Each capsule contains:- Enteric coated pellets of Esomeprazole magnesium trihydrate eq. to Esomeprazole …………… 40mg

60. -do- -do- 05-06-2013 5552

Form-5

029834 Vincam Capsule 20mg Each capsule contains:- Piroxicam…… 20mg

61. -do- -do- 05-06-2013 5551

Form-5

025406 Rubinol Tablet Each tablet contains:- Flurbiprofen.. 100mg

62. -do- -do- 05-06-2013 5553

Form-5

025403 Azrocin Capsule Each capsule contains:- Azithromycin dihydrate….. 250mg

63. -do- -do- 05-06-2013 5550

Form-5

054153 LevortizinTablet Each tablet contains:- Leocetirizine dihydrate 5mg

64. -do- -do- 05-06-2013 5555

Form-5

054165 Obpra Capsule Each capsule contains:- Esomeprazole magnesium trihydrate enteric coated pellets equivalent to Esomeprazole …………. 20mg

65. M/s. Searle IV Solutions (Pvt.) Ltd;

M/s. the Searle Company,

22-04-2014 780

Form-5

018632 Metronzine Injection Each 100 ml


Lahore Karachi contains:- Metronidazole ……….. 500 mg

66. -do- -do- 22-04-2014 783

Form-5

044077 Vaptor 20 mg Tablets Each tablet contains:- Rosuvastatin (as Calsium) 20 mg

67. -do- -do- 22-04-2014 790

Form-5

047384 Searl-α 0.5 mcg Tablets Each tablet contains:- Alfacalcidol ……………0.5 mcg

68. -do- -do- 22-04-2014 778

Form-5

047391 Rhulef 20 mg Tablets Each film coated tablet contains:- Leflunomide …………. 20 mg

69. -do- -do- 22-04-2014 782

Form-5

014408 Gravinate Injection Each ml contains:- Dimenhydrinate ………… 50 mg

70. -do- -do- 22-04-2014 779

Form-5

047383 Searl- α 1 mcg Tablet Each tablet contains:- Alfacalcidol ……………….. 1 mcg

71. -do- -do- 22-04-2014 797

Form-5

067114 Peditral Liquid Each 5 ml contains:- Sodium Chloride …...... 17.50 mg Potassium Chloride …… 7.50 mg Trisodium Citrate Dihydrate .. 14.5 mg Dextrose… 100.00 mg (Flavour: Orange)

72. -do- -do- 22-04-2014 781

Form-5

067113 Peditral Liquid Each 5 ml contains:- Sodium Chloride ...... 17.50 mg


Potassium Chloride …… 7.50 mg Trisodium Citrate Dihydrate .... 14.5 mg Dextrose… 100.00 mg (Flavour: Regular)

73. -do- -do- 22-04-2014 787

Form-5

047390 Rhulef 10 mg Tablets Each film tablet contains:- Leflunomide…. 10 mg

74. -do- -do- 22-04-2014 789

Form-5

047382 Searl- α 0.25 mcg Tablet Each tablet contains:- Alfacalcidol….0.25 mcg

75. -do- -do- 22-04-2014 791

Form-5

058022 Co-Olesta Tablet Each tablet contains:- Olmesartan…... 20 mg Hydrochlorothiazide ….. 12.5 mg

76. -do- -do- 22-04-2014 792

Form-5

044075 Vaptor Tablets Each tablet contains:- Rosuvastatine (as Calcium) 5 mg

77. -do- -do- 22-04-2014 793

Form-5

050736 Olesta 20 mg Tablet Each tablet contains:- Olmesartan Medoxomil … 20 mg

78. -do- -do- 22-04-2014 794

Form-5

050737 Olesta 40 mg Tablet Each tablet contains:- Olmesartan Medoxomil … 40 mg

79. -do- -do- 22-04-2014 795

Form-5

067116 Peditral Liquid Each 5 ml contains:- Sodium Chloride …… 17.50 mg Potassium Chloride ….. 7.50 mg


Trisodium Citrate Dihydrate .. 14.5 mg Dextrose… 100.00 mg (Flavour: Banana)

80. -do- -do- 22-04-2014 796

Form-5

067115 Peditral Liquid Each 5 ml contains:- Sodium Chloride …… 17.50 mg Potassium Chloride ….. 7.50 mg Trisodium Citrate Dihydrate….. 14.5 mg Dextrose...100.00 mg (Flavour: Bubble gum)

81. -do- -do- 22-04-2014 798

Form-5

058023 Co-Olesta Tablet Each tablet contains:- Olmesartan ... 40 mg Hydrochlorothiazide ….. 12.5 mg

82. -do- -do- 22-04-2014 783

Form-5

044048 Simbex Tablets Each tablet contains:- Simvastatin …. 10 mg Ezetimibe …… 10 mg

83. -do- -do- 22-04-2014 783

Form-5

044076 Vaptor Tablet Each tablet contains:- Rosuvastatin (as Calcium) 10 mg

84. -do- -do- 22-04-2014 786

Form-5

044049 Simbex Tablets Each tablet contains:- Simvastatin.. 20 mg Ezetimibe …… 10 mg

85. -do- -do- 22-04-2014 788

Form-5

047389 Rhulef 100 mg Tablets Each tablet contains:- Leflunomide …………… 100 mg

86. -do- -do- 22-04-2014 876

Form-5

060631 Requested for

change of name

Levomac Infusion Each 100 ml contains:- Levofloxacin.. 500 mg


87. -do- -do- 22-04-2014 781

Form-5

060632 Requested for

change of name

Moxirains Infusion Each 250 ml contains:- Moxifloxacin as HCl …… 400 mg (Mac & Rains Specs)

88. M/s. The Searle

Company Limited 32-Km Multan

Road, Lahore (DML # 000647)

M/s. The Searle

Company Limited F-

319, S.I.T.E, Karachi (DML # 000016)

23-10-2013 487

Form-5

018627 Sermol Suspension Each 5ml contains:- Paracetamol…..120mg

89. -do-

-do- 23-10-2013 486

Form-5

018628 Sermol Forte Suspension Each 5ml contains:- Paracetamol ………….. 250mg

90. -do- -do-

23-10-2013 488

Form-5

018629 Sermol Tablet Each tablet contains:- Paracetamol ……….. 500mg

91. M/s. Allmed (Pvt.) Ltd;

Lahore at same premises

M/s. Ever Green

Pharmaceuticals (Pvt.) Ltd; Plot No. 509

Sundar Industrial

Estate, Lahore

21-02-2013 469

Form-5

052455 Hemfil Syrup Each 5ml contains:- Iron Polymaltose complex eq. to Elemental Iron …………….. 50mg

92. -do- -do- -do- 052434 Hemifim-F Tablet Each tablet contains:- Iron hydroxide Polymaltose complex …. 100mg Folic Acid … 0.35mg

93. -do- -do- -do- 059964 Uriflow Capsule Each capsule contains:- Tamsulosin


Hydrochloride …………….. 0.4mg

94. -do- -do- -do- 052462 Protx 20mg Capsuel Each capsule contains:- Esomeprazole ……………… 20mg

95. -do- -do- -do- 052460 Protx 40mg Capsuel Each capsule contains:- Esomeprazole ……………… 40mg

96. -do- -do- -do- 052422 Everlom-400 Tablet Each tablet contains:- Lomefloxacin as HCl ….. 400mg

97. -do- -do- -do- 063136 Ichunil D Syrup Each 10ml contains:- Pseudeophedrine (HCl) . 13.3mg Phlocodine ... 3.33mg Paracetamol … 200mg

98. -do- -do- -do- 063135 Ichunil D Syrup Each 10ml contains:- Pseudeophedrine (HCl) . 13.3mg Phlocodine . 3.33mg Paracetamol… 200mg Diphenhydramine …….. 3.33mg

99. -do- -do- -do- 052424 Okcin-200 Tablet Each tablet contains:- Ofloxacin …. 200mg

100. -do- -do- -do- 052440 Meamin Capsule Each capsule contains:- Mecobalamin..500mcg

101. -do- -do- -do- 067918 Everlose Syrup


Each 5ml contains:- Lactulose …. 3.35mg

102. -do- -do- -do- 067898 Methemin Injection Each ml contains:- Mecobalamin.. 500mcg

103. -do- -do- -do- 052444 Itrdym Capsule Each capsule contains:- Itraconazole ... 100mg

104. -do- -do- -do- 052461 Sopra-Praz Capsule Each capsule contains:- Lansoprazole… 30mg


Cancellation of above registrations from name of manufacturer (column II) except item at S.No.45 as it is case for change of contract manufacturer, which is deferred for processing in light of contract manufacturing policy.

Grant of above registrations in name of manufactyrer (column III). Chairman, Registration Board will permit issuance of registration letter after evaluation / completion of Form 5A as per check list approved by Registration Board, renewal status and comments of Cost & Pricing Division about MRP of the drug.

Meeting ended with a vote of thanks to and from the chair.

______________________________________________________________________________

End of the Document

Minutes for 246th Meeting of Registration Board held on 10 …dra.gov.pk/userfiles1/file/Minutes...

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