In the name of Allah, indefinitely beneficent, boundlessly merciful

Noor Muhammad MaharB.Pharm, LLB, M.A (International Relations)

Media Secretary PPAConsultant – CEO NCI – NOOR CONSULTANT INT.Ex. Regulatory Affairs Manager – Export/Import/Local

(Ferozsons, BF Biosciences, Medipak, CCL)Ex. Medico legal Executive – FDA USA

DRAP ACT 2012 Issues and Future Health Challenges

D R A P

Drug Regulatory Authority Pakistan

12 November 2012 President signs Drug Regulatory Authority Bill

  DRAP Act. 2012

 DRAP Act. 2012

PRELIMINARY This Act may be called the Drug Regulatory Authority of

Pakistan Act, 2012. Definitions

“Act” means the Drugs Act, 1976 (XXXI of 1976).“Alternative Medicine” means a product used exclusively in

Homeopathic, Unani, Ayurvedic, Biochemic, Chinese or other traditional system of treatment.

DRUG REGULATORY AUTHORITY PAKISTAN

Composition of authority - 13 Directors

1. Director Pharmaceutical Evaluations & Registration.

2. Director Drug Licensing

3. Director Quality Assurance & Laboratory testing

4. Director medical devices and medical cosmetics

5. Director Biological Drugs

6. Director Controlled drugs

7. Director Pharmacy Services

8. Director Health & OTC Products

9. Director Costing & Pricing

10.Director Budget & Accounts

11.Director Administration, Human Resource & Logistics.

12.Director Legal Affairs

13.Director Management of Information Services

D R A PPOLICY BOARD

The General Director, Administration & Monitoring

(Members)

a. National Regulations And Services Division (NRSD) Chairperson

b. CEO Member

c. Representative of ministry of law & justice Member

d. Secretary of concerned Department Govt of Balochistan Member

e. Secretary of concerned Department Govt of Sindh Member

f. Secretary of concerned Department Govt of KPK Member

g. Secretary of concerned Department Govt of Punjab Member

h. Secretary of concerned Department Govt of Gilgit Baltistan Member

i. Representative of Federally Administered Tribal Area Member

j. Six experts from Public & Private Sector with equal representation from each province, these members from different specialties, Members

  DRAP Act. 2012

  Drug Regulatory Authority Pakistan

Aims & objectives

1. To prevent the sale of fake, substandard & non registered medicines/ Therapeutics 2. Stop hoarding,3. To provide a competitive a edge in advance manufacturing technologies like USA,

Canada4. To focus on ISO, cGMP, GLP, GSP etc.5. To improve the Export standards to create foreign exchange opportunities.6. To compete the Global market with the theme “ MADE IN PAKISTAN”.7. To bring harmony in manufacturing, storage, distribution, sales, exports, imports of

medicines/ Nutraceuticals/herbal remedies/Unani/Ayuvedic.8. Develop ethical criteria for drug promotion, marketing , advertising .9. Registration of herbal medicines to acknowledge, recognize & legalize the role of

alternative medicines in modern era.10. To improve manufacturing standards, scope, worth & Status of pharma related

industry11. To build the confidence of patients, Doctor, Hakeem and allied departments.12. To develop healthy competition on quality, efficacy & affordability.13. To build & establish the trust on alternative medicine through global standards.14. To provide customer friendly environment for all segments of Pharma manufacturing

industry.                                                                                    

DRAP, Nutraceuticals /Herbal SRO 412 & FUTURE OF DRAPPHARMACIST AS Technical/QUALIFIED PERSONINDUSTERIAL GROWTH & NEXT FEW YEARS …PHARMACIST ROLE IN NUTRACEUTICALS TESTING LABRole of Pharmacy Dept. & future Study planning

  DRAP Act. 2012 "Alternative Medicine"

"Alternative Medicine" means medicinal products which include, indigenous or

Unani medicine, imported medicinal product, Homeopathic medicines ,new medicines with“therapeutic

claim” herbal preparation, herbal substance ,proprietary medicines,

herbal medicinal product , Phytomedicines or any other product meant for therapeutic or preventive use which have been derived from plant, animal or mineral ingredients alone or their combinations but does not contain chemically defined synthetic ingredients; “therapeutic claim”

Nutraceuticals/Food Supplement, “pro-biotics”

Health and OTC Products. a. Food supplements (Neutraceuticals or dietary or health supplements). b.

Nutritional supplements, pro-biotics

c. Baby Milks and Foods (infant or baby formulae, follow up formulae, formulae for special medical purposes or complementary foods intended for infants and young children).

d. Disinfectants.

e. Medicated cosmetics, and shampoos containing natural ingredients.

f. Medicated Soaps containing natural ingredients

g. Tooth pastes/mouthwashes/throat lozenges/gargles containing natural ingredients.

h. Medicated cosmetics/Derma-care products/Balms/ patches/ medicated oils natural ingredients

i. Any other.

Enlistment of OTC & Health Products. Documents?1. Product Profile Master Formula. 3. Manufacturing process and in-process controls 3. Testing specifications for raw material and finished products. 4. Shelf life and storage.(shelf life shall base on stability data). 5. Recommended Conditions for use / disease reduction claims as

per standards of evidence. 6. Packaging and labeling information. 7. Maximum Retail price. 8. Fee deposit receipt. 9. undertaking

Challenges for Authorized Person “PHARMACIST”

a. Food supplements (Neutraceuticals or dietary or health supplements). b. Nutritional supplements, pro-biotics and pre-biotics

c. Baby Milks and Foods (infant or baby formulae, follow up formulae, formulae for special medical purposes or complementary foods intended for infants and young children).

d. Disinfectants.

e. Medicated cosmetics, and shampoos containing natural ingredients.

f. Medicated Soaps containing natural ingredients

g. Tooth pastes/mouthwashes/throat lozenges/gargles containing natural ingredients.

h. Medicated cosmetics/Derma-care products/Balms/ patches/ medicated oils natural ingredients

i. Any other.

SRO 412 “Top Challenges of alternative products business PHARMACIST”

Industrial management “Contract Acceptor” means a manufacturer who manufacturers the

finished product under the label and brand of contract giver.

“Contract Giver” means the person who awards the contract of particular products under his brand .

Business Scope & SRO 412Business competition Documentation – LAYOUT- Production FLOW & managmentExport & import – market & new challenges

S.R.O. 412 Pharmacist Future

DRAP & technical staff Name, along with appointment letter, address, qualification and

experience of the technical staff responsible for manufacturer and testing. The qualification and experience should be backed up with attested proof.

EMERGENCE OF NUTRACEUTICALS

Higher Confidence in Product Quality and Effectiveness

Improved Market for Nutraceutical ProductsIncreased Public AwarenessIncreased Healthcare Industry Awareness

Nutraceuticalsworld come back to nature………

Nutraceutical Int.

International status & scopeINDIAUSA & other country

Nutraceutical increase life exceptancy

Bourne Partners released an April 2013 Nutraceutical Sector Report that put the global nutraceutical market at $142 billion in 2011.

With an estimated growth rate of 6.4% (CAGR), the market is expected to reach $204.8 billion by 2017.

More than 60% of Americans use alternative medical therapies, nutraceuticals (herbals/botanicals) account for a significant proportion. 

REQUIREMENT OF REGULATION FOR NUTRACEUTICAL PRODUCTS

Confusion regarding the original use, potency and safety of the product.

Need for a uniform nomenclature for this booming Nutraceutical market across the globe.

Requirement of careful formulation in a hygienic environment.

A REVIEW OF RULE AND REGULATION IN MODERN WORLD

COUNTRY LEGAL BODY

United States Food and Drug Administration (FDA) according to the Dietary Supplement, Health and Education Act (DSHEA) of 1994

European Union European Food Safety Authority (EFSA)according to Directive 2002/46/EC of the European Parliament and Council of 2002

Canada Natural Health Products as per The Natural Health Product Regulations 2004

Japan Foods for Specified Health Use (FOSHU) established in 1991

Australia  Therapeutics Goods Act, 1989

Russia Concerning the Procedure for the Examination and Health Certification of Active Dietary Supplements 1997  Biologically Active Dietary Supplements (BADS)

Greek physician HIPPOCRATES (known as father of medicines) said:

“LET FOOD BE YOUR MEDICINE”