PREQUALIFICATION DOCUMENTS - Punjabeproc.punjab.gov.pk/BiddingDocuments/55185_BIDDING... ·...

PREQUALIFICATION DOCUMENTS

(DRUG/ MEDICINE & NON DRUG)

(PHARMACEUTICAL MANUFACTURING UNITS AND SOLE AGENTS OF

FOREIGN PRINCIPALS)

(FINANCIAL YEAR 2016-17)

GOVERNMENT OF THE PUNJAB

PRIMARY & SECONDARY HEALTHCARE

DEPARTMENT

PUNJAB CIVIL SECRETARIAT, LAHORE

Pre-Qualification Documents –Drug/ Medicines & Non Drug items - Year 2016-17

Government of the Punjab, Primary & Secondary Healthcare Department of 36

GOVERNMENT OF THE PUNJAB PRIMARY & SECONDARY

HEALTHCARE DEPARTMENT

INVITATION FOR PREQUALIFICATION

(DRUG/ MEDICINE and NON DRUG ITEMS)

1. Government of the Punjab, Primary & Secondary Healthcare Department advertised for Prequalification of Pharmaceutical Manufacturing Units & Sole Agents of Foreign Principals earlier for two different lists of Drug items for Financial Year 2016-17.

2. Now, the applications for Prequalification of remaining Drug/ Medicines and Non Drug items are open to all Pharmaceutical Manufacturing Units & Sole Agents of Foreign Principals as per detail contained in the Prequalification Documents under Punjab Procurement Rules 2014.

3. A complete set of the Prequalification Documents can be downloaded from the websites [www.ppra.punjab.gov.pk] & [www.pshealth.punjab.gov.pk]. The interested applicants shall pay a non-refundable Prequalification Fee of Rs. 15,000/- (Rupees Fifteen Thousand only) in the Head of Account [C 02871- Health others] in any branch of National Bank of Pakistan and attach the original receipt along with application for prequalification.

4. Applications for prequalification in Tape Binding should be submitted in sealed envelope in the Procurement Cell of the Department on or before 28.07.2016 (Thursday) till 11:00 AM positively and be clearly marked “Prequalification of Drug/ Medicine & Non Drug Items.” The applications received till stipulated date & time shall be opened publically on the same day at 11:30 AM in the presence of the applicants or their authorized representatives who choose to attend.

5. Technical and Financial Proposals will be called from the Prequalified Firms later on by various Procuring Agencies working under the Primary & Secondary Healthcare Department, Government of the Punjab.

Additional Secretary (Admn) Primary & Secondary Healthcare Department, Government of the Punjab

1-Birdwood Road, off Jail Road, Lahore, Pakistan Phone: +92(42) 99205822



Contents Section I: Instructions to Applicants (ITA) ......................................................... 5

A. General ............................................................................................................................... .... 5

1. Scope of Application.................................................................................................... 5

2. Fraud and Corruption ................................................................................................ 5

3. Eligible Applicants........................................................................................................ 6

B. Contents of the Prequalification Document............................................................. 6

4. Sections of Prequalification Document ............................................................... 6

5. Clarification of Prequalification Document ....................................................... 6

6. Amendment of Prequalification Document ....................................................... 6

C. Preparation of Applications............................................................................................ 7

7. Cost of Applications...................................................................................................... 7

8. Language of Application ............................................................................................. 7

9. Documents Comprising the Application............................................................... 7

10. Application Submission Form................................................................................. 7

11. Documents Establishing the Eligibility of the Applicant............................. 7

12. Documents Establishing the Qualifications of the Applicant .................... 7

13. Signing of the Application and Number of Copies.......................................... 7

D. Submission of Applications .............................................................................................. 8

14. Sealing and Identification of Applications.......................................................... 8

15. Deadline for Submission of Applications............................................................ 8

16. Late Applications .......................................................................................................... 8

17. Opening of Applications ............................................................................................. 8

E. Procedures for Evaluation of Applications ................................................................ 8

18. Confidentiality ................................................................................................................ 8

19. Clarification of Applications ..................................................................................... 8

20. Responsiveness of Applications .............................................................................. 9

21. Domestic Bidder Price Preference.......................................................................... 9

F. Evaluation of Applications and Prequalification of Applicants.......................... 9

22. Evaluation of Applications.......................................................................................... 9



23. Right to Accept or Reject Applications .................................................................... 9

24. Prequalification of Applicants......................................................................................... 9

25. Notification of Prequalification .................................................................................. 9

26. Validity of Prequalification ………………………………………………………………… 9 Section II: Prequalification Criteria Drug and Non Drug …............................... 11-13

Section III: ............................................................................................................... ........................ 35-36

A: List of NON DRUG items …………………………………………………………. 26-27

B: Lit of DRUG Items ………………………………………………………………….. 28-33

C: Application Submission Form.................................................................. 34

D: Application Affidavit........................................................................................ 35

E: Bank Challan Form 32A …………………………………………………………… 36

****************************************



Section I: Instructions to Applicants (ITA)

A. General

1. Scope of

Application

1.1 In connection with the Invitation for Prequalification “as per PPR 2014” the Primary & Secondary Healthcare Department, Government of the Punjab issues this Prequalification Document (PQD) to applicants interested to prequalify Pharmaceutical Manufacturing Units & Sole Agents of Foreign Principals for Drugs/Medicines and Non Drug Items against the list of items contained in the Prequalification Documents. Prequalification will be carried only for the items which comes under the definition of drugs under Drugs Act 1976/DRAP Act 2012 for Drug items. Applications for non-drug items will also be filed for the items contained in this document.

2. Fraud and Corruption

2.1 Government of the Punjab Primary & Secondary Healthcare Department requires that applicant observe the highest standard of ethics during the submission of application for prequalification and further documents required for prequalification. (a) In pursuance to this, the following terms are defined:

(i) “corrupt practice” is the offering, giving, receiving or soliciting, directly or indirectly, of anything of value to influence improperly the actions of another party; (ii) “fraudulent practice” is any act or omission, including a misrepresentation, that knowingly or recklessly misleads, or attempts to mislead, a party to obtain a financial or other benefit or to avoid an obligation; (iii) “collusive practice” is an arrangement between two or more parties designed to achieve an improper purpose, including to influence improperly the actions of another party; (iv) “coercive practice” is impairing or harming, or threatening to impair or harm, directly or indirectly, any party or the property of the party to influence improperly the actions of a party; ( v ) “obstructive practice” is deliberately destroying, falsifying, altering or concealing of evidence material to the investigation or making false statements to investigators in order to materially impede a Bank investigation into allegations of a corrupt, fraudulent, coercive or collusive practice; and/or threatening, harassing or intimidating any party to prevent it from disclosing its knowledge of matters relevant to the investigation or from pursuing the investigation; or



(b) Government of the Punjab, Primary & Secondary Healthcare Department will reject a proposal for prequalification if it determines that the applicant has directly or through an agent, engaged in corrupt, fraudulent, collusive, coercive or obstructive practices in competing for the contract in question;

(c) Government of the Punjab, Primary & Secondary Healthcare Department will declare ineligible, either indefinitely or for a stated period of time, if it, at any time, determines that the firm has, directly or through an agent, engaged in corrupt, fraudulent, collusive, coercive or obstructive practices in competing for prequalification.

3. Eligible Applicants

3.1 An Applicant can be a private or public entity.

3.2 If Government of Pakistan prohibits commercial relations with any Country, the firms dealing with such countries are ineligible to apply.

3.3 A firm declared disqualified / blacklisted / debarred by any of the public sector organization in Pakistan shall be ineligible for prequalification

B. Contents of the Prequalification Documents

4. Sections of Prequalification Documents

4.1 The documents for the prequalification of Applicants (hereinafter -“prequalification documents”) consists of all the sections indicated below, and should be read in conjunction with any Addendum if issued. Section I. Instructions to Applicants (ITA)

Section II. Prequalification criteria Section III. A: Application Form B: Application affidavit

4.2 The “Invitation for Prequalification Applications” (IPA) issued by the Procuring Agency is not part of the prequalification documents.

4.3 The Primary & Secondary Healthcare Department accepts no responsibility for the completeness of the prequalification documents and its addenda unless the original receipt of the bank deposit slip is attached with the documents

4.4 The Applicant is expected to examine all instructions, forms, and terms in the Prequalification Documents and to furnish all information or documentation required by the Prequalification Documents.

5. Clarification of Prequalification Document

5.1 A prospective Applicant requiring any clarification of the Prequalification Documents shall contact the Primary & Secondary Healthcare Department in writing at the address indicated in the Invitation for Pre-Qualification Drug/ Non Drug items. The Primary & Secondary Healthcare Department will respond in writing to any request for clarification provided that such request is received no later than ten (10) days prior to the deadline for submission of applications. The Primary & Secondary Healthcare Department shall forward copies of its response to all applicants who have acquired



the prequalification documents through its official website including a description of the inquiry but without identifying its source. If the Primary & Secondary Healthcare Department deemed it necessary to amend the prequalification documents as a result of a clarification it shall do under intimation to all the applicants who have obtained the prequalification documents through its official website.

6. Amendment of Prequalification Document

6.1 At any time prior to the deadline for submission of applications, the Primary & Secondary Healthcare Department may amend the Prequalification Documents by issuing addenda.

6.2 Any addendum issued shall be part of the Prequalification Documents and shall be communicated in writing to all who have obtained the prequalification documents from the Primary & Secondary Healthcare Department.

6.3 To give prospective Applicants reasonable time to take an addendum into account in preparing their applications, the Primary & Secondary Healthcare Department may, at its discretion, extend the deadline for the submission of applications.

C. Preparation of Applications

7. Cost of Applications

7.1 The Applicant shall bear all costs associated with the preparation and submission of its application. Primary & Secondary Healthcare Department will in no case be responsible or liable for those costs, regardless of the conduct or outcome of the prequalification process.

8. Language of Application

8.1 The application as well as all correspondence and documents relating to the prequalification exchanged by the Applicant and Primary & Secondary Healthcare Department, shall be written in the language specified in the Prequalification Documents. Supporting documents and printed literature that are part of the application may be in another language, provided they are accompanied by an accurate translation of the relevant passages in the language specified in the Prequalification Documents, in which case, for purposes of interpretation of the application, the translation shall govern.

9. Documents Comprising the Application

9.1 The application shall comprise the following: a. Application Submission Form, in accordance with ITA; b. Documentary evidence establishing the Applicant’s

eligibility to prequalify, in accordance with ITA & Prequalification Criteria;

c. Documentary evidence establishing the Applicant’s qualifications, in accordance with ITA and & Prequalification Criteria

d. Any other document required as specified in the Prequalification Documents.

10.Application

Submission Form

10.1 The Applicant shall prepare an Application Submission Sheet using the form provided in Section III, Application Forms. This Form must be completed without any alteration to its format.



11. Documents Establishing the Eligibility of the Applicant

11.1 To establish its eligibility in accordance with ITA, the Applicant shall complete the eligibility declarations in the Application.

12. Documents

Establishing the Qualifications of the Applicant

12.1 To establish its qualifications the Applicant shall provide the information requested in the corresponding Information Sheets included in Section III, Prequalification Criteria

13. Signing of the Application

13.1 The Applicant shall prepare and submit the application for prequalification as described in ITA & Prequalification Documents. The application shall be typed or written in indelible ink and shall be signed by a person duly authorized to sign on behalf of the Applicant.

D. Submission of Applications

14. Sealing and Identification of Applications

14.1 The Applicant shall enclose the application in a sealed envelope that shall:

a. bear the name and address of the Applicant; b. be addressed to the Secretary, Primary & Secondary

Healthcare Department in accordance with ITA; and c. bear the specific identification of this prequalification

process indicated in the Prequalification Documents

14.2 The Procuring Agency will accept no responsibility for not processing any envelope that was not identified as required.

15.Deadline for Submission of Applications

15.1 Applicants will submit their applications by hand. Applications shall be received by the Primary & Secondary Healthcare Department at the address and no later than the deadline indicated in the Invitation for Prequalification.

15.2 The Primary & Secondary Healthcare Department may, at its discretion, extend the deadline for the submission of applications by amending the Prequalification Documents in which case all rights and obligations of the Primary & Secondary Healthcare Department and the Applicants subject to the previous deadline shall thereafter be subject to the deadline as extended.

16. Late Applications

16.1 Any application received by the Primary & Secondary Healthcare Department after the deadline for submission of applications will not be entertained as indicated in the Invitation for Prequalification.

17. Opening of Applications

17.1 The Primary & Secondary Healthcare Department shall open all Applications at the date, time and place specified in the Invitation for Prequalification. Late Applications shall be treated in accordance with ITA.

17.2 Primary & Secondary Healthcare Department shall prepare a record of the opening of applications that shall include the name and other details of the Applicant. A copy of the record shall be distributed to all Applicants.



E. Procedures for Evaluation of Applications

18. Confidentiality 18.1 Information relating to the evaluation of applications, and recommendation for prequalification, shall not be disclosed to Applicants or any other persons not officially concerned with such process until the notification of prequalification is made to all Applicants.

18.2 From the deadline for submission of applications to the time of notification of the results of the prequalification, any Applicant that wishes to contact the Primary & Secondary Healthcare Department on any matter related to the prequalification process, may do so but only in writing.

19. Clarification of

Applications

19.1 To assist in the evaluation of applications, the Primary & Secondary Healthcare Department may, at its discretion, ask any Applicant for a clarification of its application which shall be submitted within a stated reasonable period of time. Any request for clarification and all clarifications shall be in writing.

19.2 If an Applicant does not provide clarifications of the information requested by the deadline, the application shall be evaluated based on the information and documents available at the time of evaluation of the application.

20. Responsiveness of

Applications

20.1 All applications not responsive to the requirements of the prequalification document shall be rejected.

21. Domestic Bidder Preference

21.1 A margin of preference for domestic bidders shall not apply in the bidding process resulting from this prequalification.

F. Evaluation of Applications and Prequalification of Applicants

22. Evaluation of application

22.1 Prequalification shall be done Section/Item wise for drug items and item wise for Non Drug items which the Applicant meets the appropriate requirements of this prequalification document. The information provided in response to the invitation for prequalification will be evaluated as per Prequalification Documents and will also be physically verified by the department through inspection teams to inspect the premises of the firm for verification of requirements.

23. Right to accept or reject the applications

23.1 The Primary & Secondary Healthcare Department reserves the right to accept or reject all the applications, and to annul the prequalification process, without thereby incurring any liability to Applicants.

24. prequalification of applicants

24.1 All Applicants whose applications have met the specified requirements will, to the exclusion of all others, be prequalified by the Primary & Secondary Healthcare Department.

25. Notification of prequalification

25.1 Once the Primary & Secondary Healthcare Department has completed the evaluation of the applications it shall notify all Applicants in writing indicating their Section/Item wise status as to



prequalified or disqualified or ineligible.

26. Validity of Pre-Qualification

26.1 The Pre-Qualification shall be valid for TWO YEARS.



Section II: PREQUALIFICATION CRITERIA (Drug Items) (Knock Down type)

To establish its qualification, the firm shall provide the information requested in the respective

annexures and requirements:

I. The manufacturer shall provide Annexure-A & Annexure “B”.

II. Authorized Sole Agents of Foreign Principal shall provide information in Annexure “B”

as well as information of their Foreign Principals in Annexure “C”.

III. The firm shall indicate the Section (s), Pharmaceutical Category & Items intended to be

prequalified.

KNOCK DOWN CRITERIA (Section Wise)

a) The firm shall provide valid Drugs Manufacturing License issued by DRAP/Valid

Drugs Sale License issued by Competent Authority for Sole Agents of Foreign

Principal (The Applicant should have manufactured/imported and marketed the

Goods for at least one year i.e., from 01-07-2015).

b) The firm shall provide valid Drugs Registration Certificates, issued by DRAP, of the

Items/Products quoted for prequalification out of the list of the essential

drugs/medicines etc. contained in the prequalification documents at Annexure-D.

c) The firm blacklisted/debarred by any procuring agency is ineligible. The firm will

submit an affidavit on stamp paper in this regard.

d) The firm shall provide valid GMP Certificate issued by DRAP/Drug Regulatory

Authority of Country of Manufacturer. Only those Sections & Pharmaceutical

Category will be considered for prequalification whose GMP Inspection Report

declared satisfactory and/or which are mentioned in the GMP Certificate.

e) The firm shall provide valid ISO/Internal Quality Management System/other

International Certificate of the manufacturer.

f) The firm shall provide annual sales value section(s) wise separately for private and

public sector for last one year. The firm shall also provide Income tax return for last

three years.

g) The firm whose any product declared spurious by any Govt. Labs will not be

prequalified. The firm shall provide an undertaking in this regard.

h) Any Product of the firm whose samples from the tested/analyzed batches declared

sub-standard (on the basis of Active Pharmaceutical Ingredients) by Drugs Testing



Laboratories Punjab w.e.f 01.01.2015, will be ineligible for prequalification for that

particular product.

i) The section (s) whose equipment was not found calibrated & validated will not be

considered for prequalification. In case the equipment installed in quality control,

quality assurance & microbiological laboratories were not found calibrated &

validated, none of the section (s) of the firm will be prequalified.

j) In case the equipment installed in quality control, quality assurance &

microbiological laboratories were found deficient to perform official tests of the

product (quoted for), none of specific section of the firm will be prequalified.

k) The department will evaluate production capacity of the manufacturing unit

according to the requirement as per GMP.

l) The firm not having batch recall history of the substandard/adulterated samples

since 01-01-2015 as per cGMP shall not be prequalified for that particular drug.

m) Any punitive action taken by DRAP as described in Annex-C, the specific

product/section of the firm will not be prequalified.

n) The product/section of the firm due to which firm convicted by Drugs Court w.e.f

01.01.2015 will not be prequalified.

o) Certification from Environmental Protection Department/NOC etc; if it is mandatory

for particular manufacturing unit.

p) The production unit must have central Heating, Ventilation & Air Conditioning

System (HVAC).

q) In case of Medical Devices, the product must bear CE/JMHLW/FDA or approved by

WHO. A valid Certificate in this regard will be attached.

r) Comments of Inspection Team with respect to proper implementation of cGMP

Protocols including quality and production of water, Quality Control/ Test Analysis

equipment and its functionality, Stability Studies, API Protocols.



Section II-a: PREQUALIFICATION CRITERIA (Non Drug Items) (Knock Down type)

To establish its qualification, the firm shall provide the information requested in the respective

annexures and requirements with documentary proof:

I. The bidder should be an Authorized Sole Agent of Foreign Manufacturer for at least one

year.

II. The firm shall indicate the item, name of the manufacturer, country of origin and quality

standards that it conforms to.

III. The manufacturing unit should have ISO 9000; ISO13485, ISO 14000 certification.

IV. The firm should have its own quality testing lab.

V. The product should be certified by any international quality certification body, like US

FDA / WHO.

VI. Proper ware house/ storage facility as per recommendations of the manufacturer.

VII. The product must be tried and tested successfully in local environment for at least three

years.

Note: The firm will be prequalified for the particular item/ brand.

For evidence, the firm has to attach the relevant documents/ certificates.



“Annex-A”

GENERAL FIRM’S INFORMATION (Drugs/ Medicines)

I. Company Profile.

1. Name of company : ______________________________________________________

Year established : _____________________________________

Form of company : [ ] Individual

[ ] Partnership

[ ] Corporation

[ ] Other (specify)

Legal status : _______________________________________________________

Trade registers number : _______________________________________________________

NTN & Sales Tax number (If applicable): :______________________________________________________

Mfg. License Number : ______________________________________________________

(attach valid copy)

2. Address : ______________________________________________________

Telephone : _________________________________ Telefax:______ _____________________

E-mail: : ________________________________________________________________________

3. Employees:

S.No. Category Quantity

1 Management

2 R &D

3 Sales

4 Administrative

5 Production and quality control

6 Others (specify)

Total

Please attach the company organizational chart II. Product Information Please provide the information as per Annexure-C



1. Are all manufacturing operations (processing, packaging, labeling) carried out internally? [ ] YES [ ] NO

If “No,” attach a list of pharmaceuticals and/or raw materials manufactured by other companies and marketed by you. Please give the names of the companies, for each item.

S.No. Product Name Manufacturer Address

1.

2.

3.

If any products are repackaged, attach a list of such products with the name and address of the manufacturer for each product:

S.No. Product Name Manufacturer Address

1.

2.

3.

III. QUALITY DEPARTMENT 1. Do you maintain your own quality control laboratory?

[ ] YES [ ] NO (if NO please provide details of alternate arrangements) 2. Number of specialized personnel working in your quality control, quality assurance and

microbiological laboratory/ies (excluding administrative personnel). Provide their academic and

professional details on a separate sheet.

Pharmacists : _______________________________________________

Chemists : _______________________________________________

Others : _______________________________________________ 3. List of Equipment installed in quality control, quality assurance and microbiological laboratory/ies

for quality assurance as per BP/USP.

________________________________________________________________________________________

________________________________________________________________________________________ 4. Are these equipment calibrated & validated.

[ ] YES [ ] NO

If yes, then provide record.

5. Are all raw materials completely tested prior to use or is a Certificate of Analysis accepted?



[ ] YES [ ] NO [ ] Certificate of Analysis

6. Are control samples of each batch retained?

[ ] YES [ ] NO 7. Name and title of the authorized person (s) responsible for batch release:

Name:________________________________________________________

Title: _________________________________________________________

Experience in pharmaceuticals: _______________________________ years 8. Name and qualification of the head of the Quality Control department:

Name: ________________________________________________________

Qualification: ___________________________________________________

Experience in pharmaceuticals:________________________________ years

9. Indicate if you perform quality tests conducted routinely:

[ ] active starting materials

[ ] non-active starting materials

[ ] packaging materials

[ ] intermediate products

[ ] bulk products

[ ] finished products 10. Explain process of approving sources for starting materials and describe basis for approving

specifications of starting materials. __________________________________________________________

__________________________________________________________

11. Do you conduct tests on each container of the active starting material?

[ ] YES [ ] NO If not, explain your way of sampling: _________________________________________________________________________________________

_______________________________________________________________________________________

12. Do you test each container of non-active starting materials?

[ ] YES [ ] NO If “No,” describe method of sampling:

_______________________________________________________________________________________ _______________________________________________________________________________________



13. Are stability tests routinely conducted for every product?

[ ] YES [ ] NO If not, state reason why not: _______________________________________________________________________________________ _______________________________________________________________________________________

14. Do you keep samples of each batch?

[ ] YES [ ] NO

Indicate how long do you keep the samples:_______________ years 15. Describe your storage facilities:

_______________________________________________________________________________________

_______________________________________________________________________________________ _______________________________________________________________________________________



Annexure “B”

Authorized Sole agent for Foreign Principal’s Qualification (Drug/ Medicines Items)

I. Company Profile.

1. Name of company : ______________________________________________________________________

Year established : __________________________________________________

Form of company : [ ] Individual

[ ] Partnership

[ ] Corporation

[ ] Other (specify)

Legal status : ____________________________________________________

Trade registers number : ____________________________________________________

NTN & Sales Tax number (If applicable): Valid sole agency agreement (attach valid copy)

2. Address : ___________________________________________________________________ Telephone : _______________________________ Telefax: __________________________

E-mail & Web : ___________________________________________________________________

Please attach the company organizational chart Please attach the company organizational chart

3. Type of activity carried out by the company (tick the appropriate category/ies)

[ ] Manufacturer

[ ] Branded products

[ ] Generic products

[ ] Medical supplies

[ ] Laboratory reagents

[ ] Other products (specify below) *Indicate % of annual turnover:

1 Pharmaceutical formulations : ____________%



2 Bulk drugs : ____________%

3 Medical Supplies : ____________%

[ ] Products sold to Public Sector

[ ] Market Sale

[ ] Both

4. Names and addresses of international pharmaceutical companies, parent companies and/or subsidiaries and associated companies with whom there is collaboration or joint venture, if any:

S.No. Product Name Company Address

1.

2.

3.

5. Employees:

S.No. Category Quantity

1 Management

2 R &D

3 Sales

4 Administrative

5 Production and quality control

6 Others (specify)

Total

6. Capital value of the company (specify currency)

(a) Authorized capital: ________________________

(b) Paid up capital: ___________________________

(c) Administration: ___________________________

7. Annual sales turnover in the previous one year. Mention Private Sector and Public Sector sales



separately (in Pak Rupees) (In Million)

Annual turnover Open market sales Public Sector Sale Year

Arbitration History (if any):________________________________________________________



Authorized Sole agent for Foreign Manufacturer (Non Drug items)

Product applied for:

S.No. of the item

Name of Item Name of

Manufacturer Country of

Origin Quality Compliance

standards

Name of firm ___________________________________________________________________________________________________

Address ________________________________________________________________________________________________________

Phone ___________________________________________________ Fax __________________________________________________

E-mail __________________________________________________ URL http://www.___________________________________

Type of firm: Sole Proprietor Partner Ship Limited

Other__________Date of establishment _____________________________

List of Board of Directors, Partners, Key Management Personnel (both Technical, Sales &Management - include position, professional qualification, experience).

______________________________________________________________________

Total area of the firm premises _________________ Owned Rented

Total Area of ware house ____________________________________________________________________________________

Facilities in ware house ______________________________________________________________________________________

__________________________________________________________________________________________________________________

Total no. of Employees: Technical____________________________ Non – Technical ___________________________

National Tax Number ____________________________________________ Date______________________________________

General Tax Number _____________________________________________ Date _____________________________________

Registrations / Prequalification with other departments:________________________________________________

_________________________________________________________________________________________________________________



Detail of Head / Branch Office / Workshop (s):

Address: ______________________________________________________________

Phone __________________________________ Fax __________________________

Address ______________________________________________________________

Phone __________________________________ Fax __________________________

Annual business turnover, last 3 years (Rs.)______________________________________

Annual Income tax paid, last 3 years (Rs.) _______________________________________

Main Contracts during last three years:

S.No. Name of Item Name of

Manufacturer Quantity Year Institution

Sales / Marketing Staff:

Name Designation / Responsibility

Qualification Total

Experience

Experience with Current

Firm

Training Detail (Local &abroad)

Technical Staff:

Name Designation / Responsibility

Qualification Total Experience Experience with

Current Firm

Name & Capacity of the Authorized Contact Person:________________________________________________________

Signature of the Authorized Contact Person: _______________________________________________________________

Date:____________________________________ Stamp of the Firm: ________________________________________________



DOCUMENTS TO BE ATTACHED (COPIES):

a) Organizational Chart showing chain of command.

b) Valid Sole agency agreement (s)

c) NTN Certificate and GST Certificate

d) Registration / Pre-qualification with other departments.

e) Manufacturer’s certification of ISO 9001, ISO 14385, ISO 14000.

f) References from existing Customers.

g) Quality certificates of the product like FDA.



“Annex-C”

NAME OF THE APPLICANT __________________________________________________________

SECTION & PHARMACUTICAL

CATEGORY

ITEM NO. MENTIONED IN

THE LIST AT ANNEXURE-D

INTENDED TO BE QUOTED FOR

BRAND NAME OF THE QOUTED

PRODUCT

DRUG REGISTRATION NO. ISSUED BY

DRAP

Manufactured by

Maximum Retail Price

fixed by DRAP

EQUIPMENT CAPABILITY PERSONELL (Technical Only i.e.,

Pharmacist, Chemist,

Other)

TECHNICAL & MANAGERIAL CAPABILITY Any Punitive action Imposed by DRAP

during last 1year like Stop Production of any section, Cancellation/ Suspension of Drugs

Manufacturing License/Drugs

Registration Certificate of any Product etc.

Convicted by Drugs Court Since 01-01-

2015.

Batch Capacity of the Quoted

Product

Installed Annual

Production Capacity of

finished pharmaceut

icals products

Products & their batches whose

sample declared sub-standard/

adulterated by any Govt. Lab during last one year i.e.

01-01-2015

Batch recall record/fate of the batch i.e. from 01-

01-2015

Major equipment Installed &

Capacity

Validated Or Not (Attach

Validation Record)

Tablet Sections



SECTION & PHARMACUTICAL

CATEGORY

ITEM NO. MENTIONED IN

THE LIST AT ANNEXURE-D

INTENDED TO BE QUOTED FOR

BRAND NAME OF THE QOUTED

PRODUCT

DRUG REGISTRATION NO. ISSUED BY

DRAP

Manufactured by

Maximum Retail Price

fixed by DRAP

EQUIPMENT CAPABILITY PERSONELL (Technical Only i.e.,

Pharmacist, Chemist,

Other)

TECHNICAL & MANAGERIAL CAPABILITY Any Punitive action Imposed by DRAP

during last 1year like Stop Production of any section, Cancellation/ Suspension of Drugs

Manufacturing License/Drugs

Registration Certificate of any Product etc.

Convicted by Drugs Court Since 01-01-

2015.

Batch Capacity of the Quoted

Product

Installed Annual

Production Capacity of

finished pharmaceut

icals products

Products & their batches whose

sample declared sub-standard/

adulterated by any Govt. Lab during last one year i.e.

01-01-2015

Batch recall record/fate of the batch i.e. from 01-

01-2015

Major equipment Installed &

Capacity

Validated Or Not (Attach

Validation Record)

*(Authorized Agents/Importers will fill proforma separately for their each manufacturer for the section (s) intended to be prequalified and whose products imported in Pakistan).



Annexure-D

NON-DRUG ITEMS

SR. NO. NON-DRUG NAME FORM STRENGTH

1. Nitrous Oxide Inhalation

2. Oxygen (medicinal gas) cylinder 9 hydrochloride) Inhalation Different Sizes

3. Charcoal Activated Powder

4. Rigid Intraocular Lens Intraocular Lens All sizes

5. Condoms

6. Copper T / Multi-load IUCD

7. Instrumental Disinfectant Solution Of appropriate composition

8. Hollow Fiber Dialyzer All sizes

9. AVF Needle All sizes

10. Blood Tubing Line

11. Adhesive Tape (Hypoallergenic) Roll 1inch, 2 inch

12. Examination Gloves Pairs Box of 100

13. Sterile Surgical Gloves Pairs 6 ½, 7, 7 ½, 8

14. Face Masks Disposable

15. Blood Lancets Sterile Pack

16. Endo-Tracheal Tube Sterile Pack all sizes

17. Naso-Gastric Tube Sterile Pack Adult / Paeds All Sizes

18. Foley’s Catheter Sterile Pack All sizes

19. Nelton Catheter Sterile Pack All sizes

20. Urine Bags Sterile Pack Adult / Paeds

21. Disposable Airways Sterile Pack Adult / Paeds All sizes

22. Suction Catheter Sterile Pack All sizes

23. Sterilized Cord Clamps Sterile Pack

24. Spinal Needle Sterile Pack All Sizes

25. Sterilized Surgical Blades Sterile Pack All Sizes



SR. NO. NON-DRUG NAME FORM STRENGTH

26. Resuscitator Bag with Mask

27. Ambo-bag Paediatric Size with two sizes Infant / Paeds / Child

28. Barium Sulfate Powder

29. HCV PCR

30. Elisa C

31. Elisa B

32. Rapid C

33. Rapid B

34. Paper Tape

35. Paper Tape

36. Three way Stopper

37. CVP Line (Single Lumen)

38. CVP Line (Double Lumen)

39. CVP Line (Triple Lumen)

40. Autoclave Validation Kits

41. Steam Indicator/ Autoclave Tape

42. Steam Indicator Tape for Disposable Wraps



45. Ethylenediaminetetraacetic acid (EDTA)/Edetate Disodium



Annexure-E DRUG ITEMS

SR. NO. GENERIC DRUG NAME FORM STRENGTH

1 Thiopental (Sodium)Z Injection 10mg/ml; 20 mg/ml

2 Neostigmine (methyl sulfate) Injection 0.5 mg/ml (Amp of 1, 5ml)

3 Lignocaine + Epinephrine (adrenaline) Injection 2% + 1:200 000

4 Ephedrine (hydrochloride) Ampoule 50mg in 1-ml

5 Morphine (Sulphate or Hydrochloride) Ampule 10 mg in 1ml (SOP)

6 Pethidine (Hydrochloride) Ampule 50 mg/ml in 2ml (SOP)

7 Midazolam Tablets 7.5mg

8 Paracetamol Suppository 100mg

9 Promethazine (HCL) Tablets 25mg

10 Promethazine (HCL) Injection 25 mg/ml in 2 ml

11 Dexamethasone (disodium phosphate) Tablets 0.5mg

12 Pheniramine (maleate) Injection 22.7mg/2ml

13 Atropine (Sulfate) Ampule 1 mg in 1 ml

14 Flumazenil Ampule 0.1mg/ml-10ml

15 Protamine Sulphate Injection Amp of 5ml

16 Naloxone (gydrochloride) Ampule 400mg in 1 ml

17 Valproic (as sodium) Injection 500 mg (amp of 5 ml)

18 Magnesium Sulphate Injection 500mg/ml

19 Phenobarbital (sodium) Tablets 30mg

20 Phenobarbital (sodium) Injection 200mg / 2ml

21 Phenytoin (sodium) Tablets 100 mg

22 Benzylpenicillin (potassium) Injection 1 ml IU

23 Moxifloxacin Syrup 100mg/5ml

24 Clarithromycin Injection 500 mg

25 Procaine benzylpenicillin Injection 1, 3 m IU

26 Albendazole Syrup 250mg/5ml



27 Fluconazole Syrup 50mg/ml

28 Nystatin Tablets 500, 000 IU

29 Nystatin Pessary

30 Ethambutol Tablets 400mg

31 Ethambutol Oral Liquid 25mg/ml

32 Isoniazid Tablets/Syp 50mg, 100mg, 300mg

33 Pyrazinamide Tablets 500mg

34 Rifampicin Caps/Syp(100 mg. 5ml

150mg, 300mg, 450mg, 600mg

35 Rifampicin Syp/Sacchet 100mg/5ml

36 Streptomycin Injection 1 gm

37 Isoniazid + Pyrazinamide + Rifampicin Tablets 75mg + 400mg + 150mg

38 Sodium stibogluconate Injection 100mg/ml in 30ml vial

39 Chloroquine (phosphate or sulfate) Tablets 150mg

40 Primaquine (diphosphate) Tablets 15mg

41 Sulphadoxine + Pyrimethamine Tablets 500 + 25mgmg

42 Hyoscine (Butylbromide) Injection 4mg/ml

43 Hyoscine (Butylbromide) Tablets 10mg

44 Glycerin Suppository

45 Magnesium Oxides and Hydroxides Suspension 7.9% w/v

46 Lamivudine Tablets 150mg

47 AmiodaroneHcl Injection 150 mg

48 Isosorbidedinitrate Sublingual 5mg

49 Methyldopa Tablets 250mg, 500mg

50 Methyldopa Injection 250mg

51 Propranolol Tablets 10mg, 40 mg, 80 mg

52 Verapamil (hydrochloride) Injection

53 Adenosine Inj (3mg/1ml)

54 Dexamethosone Eye Drops 0.1% w/v

55 Gentamicin (Sulfate) Eye Drops 0.30%



56 Propracaine Ear Drops 0.50%

57 Miconazole (Nitrate) Eye Ointment 2%

58 Prostaglandins Analogues Eye drops

59 Tetracycline Eye ointment

60 Soda Glycerine Ear Drops 10ml

61 Chloramphenicol Ear Drops

62 Ephedrine Nasal Drops 0.50%

63 Dextran 40/Plasma Substitutes Infusion Dextran 6% w/v, Glucose 5 % w/v

64 Modified Fluid Gelatin 4% Infusion 500ml

65 Sodium Bicarbonate (50ml) Injection 1.4% isotonic

66 Calcium Gluconate Injection 100 mg/ml in 10 ml

67 Ferrous salt Tablets Equ 60mg

68 Ferrous salt Syrup Equ 25 mg/ml

69 Folic Acid Tablets 1mg & 5mg

70 Vitamin K Injection 10mg

71 Vitamin D3 Tab 10000 iu/ml

72 Hydroxocobalamin Ampule 1mg in 1ml

73 Salicylic Acid Solution 5%

74 Miconazole (Nitrate) Cream / Ointment 2%

75 Amitriptyline (hydrochloride) Tablets 25mg

76 Carbamazepine Tablets 100mg; 200mg

77 Chlorpromazine (hydrochloride) Injection 25mg in 2ml

78 Chlorpromazine (hydrochloride) Tablets 100mg

79 Clomipramine (hydrochloride) Tablets 10mg; 25mg

80 Heloperidol Injection 5mg/ml

81 Diazepam Tablets 2, 5mg

82 Diazepam Injection 10mg

83 Levonorgestrel PO pills 30 mcg

84 Norethisteroneenantate Injection 200mg/ml in 1ml

85 Estradiol cypionate + medroxyprogesterone acetate Injection 5mg + 25mg



86 Levonorgestrel – releasing implant Subdermal Implant 2 rod 75mg each

87 DPT Vaccine

88 Measles Vaccine

89 Diphtheria Antitoxin Vial 10 000 IU; 20 000 IU

90 Intraperitoneal dialysis solution Parenteral solution Of appropriate composition

91 Bicarbonate Solution Solution Of appropriate composition

92 Azathioprine (as sodium salt) Tablets 50mg

93 Azathioprine (as sodium salt) Injection 100mg in vial

94 Methotraxate Tab

95 10/0 Nylon Stitches

96 Amidotrizoate Injection 140 to 420 mg iodine / ml in 20ml

97 Dextran 40 in Saline Infusion

98 Lignocaline + Epinephrine Dental Cartridge

99 Epinephrine (adrenaline) Ampoule

100 Cefixime Injection

101 Suspension Semethicon Suspension

102 Inj. Hydrated Phloroglucinol 40mg, trimethylPhloroglucinol

Injection 40mg

103 Infusion 1/2 Normal Saline Injection

104 Infusion 0.18% Sodium Chloride In 3.4% Dextrose Injection

105 Isoniazid Tablet 100 - 300 mg

106 Isoniazid Tablet (scored) Tablet 50mg

107 Pyrazinamide Tab. (Dispersible) Tablet 150mg

108 Pyrazinamide Tablet (scored) Tablet 150mg

109 Rifampicin+Isoniazid Tablet(Dispersible)60mg+30mg Tablet

110 Rifampicin+Isoniazid Tablet (Dispersible): 60mg+60mg Tablet

111 Rifampicin+Isoniazid 150mg+150mg

112 RIFAMPICIN+ ISONIAZID+ PYRAZINAMIDE 60MG+30MG+150MG(DISPERSIBLE)

113 RIFAMPICIN+ ISONIAZID+ PYRAZINAMIDE 150MG+75MG+400MG

114 RIFAMPICIN+ ISONIAZID+ PYRAZINAMIDE 150MG+150MG+500MG (FOR INTERMITTENT USE



115 P-AMINO SALICYLIC ACID (PAS) GRANULES: SACHET / JARS 100 G TABLET: 500MG

Tablet

116 CAPREOMYCIN POWDER FOR INJECTION :1GM/ VIAL Vial 1G

117 CLOFAZAMINE CAPSULE: CAP: 50 MG , 100 MG Capsule 50mg, 100mg

118 Ethambutol Oral Liquid Oral Liquid

119 Rifampicin Caps/Syp(100 mg. 5ml

120 Sodium stibogluconate Injection Injection

121 Primaquine (diphosphate) Tablets Tablet

122 Digoxin Tablets Tablet

123 Methyldopa Tablets Tablet

124 Dextran 40/Plasma Substitutes Infusion Injection

125 Calcium Gluconate Injection Injection

126 Measles Vaccine WHO approved

127 Nevirapine/Lamivudin/Zidovudine 200/150/300 mg

128 Zidovudine Tablet Tablet

129 Zidovudine/Lamivudine]+ Efavirenz Tablet [300/300]mg+600mg

130 Lamivudine/Tenofovir]+Nevirapine [300+300]+

131 Abacavir/Lamivudine 600/300

132 Zidovudine Tab 300mg Tablet

133 Nevirapine Tab 200mg Tablet

134 Efavirenz Tab 600mg Tablet

135 Keletra Tab 200mg/50mg Tablet

136 Didanosine Caps 250 mg Capsule

137 Nevirapine oral solution 10mg/ml Oral Solution

138 Zidovudine oral solution 10mg/ml Oral Solution

139 Efavirenz oral solution 30mg/ml Oral Solution

140 Abacavir oral solution 20mg/ml Oral Solution

141 Lopinavir/Ritonavir (Kaletra) oral solution 80/20mg/ml Oral Solution

142 Lopinavir/Ritonavir 100/25mg

143 (Kaletra) Tablet Tablet

144 Black Silk Size 3/0, 1/2Circle 30mm Needle. Box of 12



foils.

145 Black Silk Braided size 6/0 with 10mm reverse cutting microprint needle. Box of 12 foils.

146 Virgin Silk Size 8/0 with 6 mm micropoint, reverse cutting double needle Box of 12 foils.

147 Poly Propylene on Needle 10/0 Box of 12 Foils

148 Polyglactin, Antibactarial, 1/2 Circle Round Body needle 2/0, Box of 36 Foils or less.

149 Polyglactin, Antibactarial on Needle 3/0, Box of 36 Foils or less.

150 Polyglactin/ Polyglycolic acid Size 4/0, 1/2 Circle RB 20mm / 31mm

151 Polyglactin/ Polyglycolicacid Size 6/0 (Opthalmology), Box of 36 Foils or less.

152 Catgut Chromic Size 3/0 with 30mm, R.B. Needle, Box of 12 Foils.

153 Catgut Chromic Size 4/0 with 30mm, R.B. Needle, Box of 12 Foils.

154 Infusion Dextrose in Water 5%, Bottle of 1000 ml with IV set

155 Syp Pheniramine Maleate 5 ml Syrup

156 Antiseptic Lotion 4% Lotion

157 Dimercaprol

158 Colchicine Tablet, 500mcg (0.5mg) Tablet

159 Amphotericine B (Liposomal) Injection, 50mg/100mg Injection

160 Cephradine 500mg Capsule

161 Methyleted Spirit Bottle 450 ml Tropical Solution



Section III: Application Forms

Application Submission Form

Date: _ __ /_ __/2016

To The Secretary Government of Punjab Primary & Secondary Healthcare Department.

I/we, the undersigned, apply to be prequalified for the referenced Pre-qualification and declare that:

(a) I/we have examined and have no reservations to the Prequalification Documents, including Addendum(s). (if any) issued in accordance with Instructions to Applicants (ITA) [insert the number and issuing date of each addendum].

(b) I/we, have nationalities from eligible countries, in accordance with ITA [insert the nationality of the Applicant, including that of all partners in case of a Joint Venture /Consortium if applicable];

(c) I/we, for any part of the application resulting from this prequalification, do not have any conflict of interest;

(d) I/we for any part of the contract resulting from this prequalification, have not been declared disqualified / blacklisted by any of the public organization of the Procuring Agency’s country

(e) I/we understand that you may cancel the prequalification process at any time, the prequalification does not bound the procuring agency to call for the bids from the prequalified firms.

(f) All information, statements and description contained in the Application are in all respect true, correct and complete to the best of our knowledge and belief.

Signed [insert signature(s) of an authorized representative(s) of the

Applicant] Name [insert full name of person signing the application]

In the Capacity of [insert capacity of person signing the application]

Duly authorized to sign the application for and on behalf of: Applicant’s Name [insert full name of Applicant]

Address [insert street number/town or city/country/ address]

Dated on _ -_/_ -_/2016



Affidavit (Pak Rs.100/-)

a) Applicants signed affidavit on PKR 100.00 judicial paper confirming not having been declared ineligible by any of the public sector organization in Pakistan, as described in the documents.

b) Applicants confirming not having been involved in any litigation during last three years.

Signed [insert signature(s) of an authorized representative(s) of the Applicant] Name [insert full

name of person signing the application]

In the Capacity of [insert capacity of person signing the application]

Duly authorized to sign the application for and on behalf of: Applicant’s Name [insert full name of Applicant]

Address [insert street number/town or city/country/ address]

Dated on _ -_/_ -_/2016



FORM NO.32-A

CHALLAN NO. Treasury/Sub-Treasury/

National Bank of Pakistan/

State Bank of Pakistan

Provincial

TO BE FILLED IN BY THE REMITTER

TO BE FILLED IN BY THE

DEPARTMENT OFFICER OR THE

TREASURY

By whom

Tendered

Name (or designation) and address of the person on whom behalf money is paid

Full particulars

of the remittances and

the authority (if any)

Amount Head of Account Order to

the Bank

{ N

am

e o

f th

e firm

}

Secre

tary

Govern

men

t of

the P

unja

b

Prim

ary

& S

econ

dary

Hea

lthcare

De

part

ment

Lahore

.

Fee for

Pre

qualif

ication a

s for

the

supply

of dru

gs/m

ed

icin

es/N

on

Dru

gs

Fin

ancia

l year

2016

-17

Rs.15,000.00

C0

28

71

- H

EA

LT

H &

OT

HE

RS

Date

Correct

Receive and

grant Receipt

Signature and

full

designation of

the officer

ordering the

money to be

paid in

Total Amount: Rs.15,000.00

Signature

To be used only in the case of

(In words) Fifteen thousand only. remittances to Bank through

an officer of the Government

Received payment

Treasurer Accountant

Treasury Officer

PREQUALIFICATION DOCUMENTS - Punjabeproc.punjab.gov.pk/BiddingDocuments/55185_BIDDING... ·...

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Transcript of PREQUALIFICATION DOCUMENTS - Punjabeproc.punjab.gov.pk/BiddingDocuments/55185_BIDDING... ·...