In the name of Allah, indefinitely beneficent,
boundlessly merciful
Noor Muhammad Mahar
B.Pharm, LLB, M.A (International Relations)
Media Secretary PPA
Consultant – 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 DRAP Act. 2012
Drug Regulatory Authority Pakistan
12 November 2012
President signs Drug Regulatory Authority Bill
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
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Composition of authority - 13 Directors
Director Pharmaceutical Evaluations & Registration.
Director Drug Licensing
Director Quality Assurance & Laboratory testing
Director medical devices and medical cosmetics
Director Biological Drugs
Director Controlled drugs
Director Pharmacy Services
Director Health & OTC Products
Director Costing & Pricing
Director Budget & Accounts
Director Administration, Human Resource & Logistics.
Director Legal Affairs
Director Management of Information Services
D R A DRAP
P Act. 2012
POLICY BOARD
The General Director, Administration & Monitoring
(Members)
a.
National Regulations And Services Division (NRSD)
Chairperson
b.
CEO
c.
Representative of ministry of law & justice
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
j.
Six experts from Public & Private Sector with equal representation from each
province, these members from different specialties, Members
Member
Member
Member
Drug Regulatory Authority Pakistan
Aims & objectives
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To prevent the sale of fake, substandard & non registered medicines/ Therapeutics
Stop hoarding,
To provide a competitive a edge in advance manufacturing technologies like USA,
Canada
To focus on ISO, cGMP, GLP, GSP etc.
To improve the Export standards to create foreign exchange opportunities.
To compete the Global market with the theme “ MADE IN PAKISTAN”.
To bring harmony in manufacturing, storage, distribution, sales, exports, imports of
medicines/ Nutraceuticals/herbal remedies/Unani/Ayuvedic.
Develop ethical criteria for drug promotion, marketing , advertising .
Registration of herbal medicines to acknowledge, recognize & legalize the role of
alternative medicines in modern era.
To improve manufacturing standards, scope, worth & Status of pharma related
industry
To build the confidence of patients, Doctor, Hakeem and allied departments.
To develop healthy competition on quality, efficacy & affordability.
To build & establish the trust on alternative medicine through global standards.
To provide customer friendly environment for all segments of Pharma manufacturing
industry.
DRAP, Nutraceuticals /Herbal
 SRO 412 & FUTURE OF DRAP
 PHARMACIST AS Technical/QUALIFIED PERSON
 INDUSTERIAL GROWTH & NEXT FEW YEARS …
 PHARMACIST ROLE IN NUTRACEUTICALS
 TESTING LAB
 Role of Pharmacy Dept. & future Study planning
DRAP Act. 2012 "Alternative Medicine"
 "Alternative Medicine" means medicinal products which include,
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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
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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
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particular products under his brand .
Business Scope & SRO 412
Business competition
Documentation –
LAYOUT- Production FLOW & managment
Export & 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 Products
 Increased Public Awareness
 Increased Healthcare Industry Awareness
Nutraceuticals
world come back to nature………
Nutraceutical Int.
 International status & scope
 INDIA
 USA
 & 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.
growth rate of 6.4%
(CAGR), the market is expected to reach $204.8
billion by 2017.
 With an estimated
 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”