DRUG LAWS, REGULATIONS & RULES-

WHATS HAPPENING IN PAKISTAN?

LECTURE NO. 2
 OBJECTIVE OF THE SESSION

 Introduction to the Regulatory Affairs of pharmaceutical industry in Pakistan

 Basic concepts regarding laws and regulations operating in Pakistan
 Understanding how local laws governs pharmaceutical industry
 What are drugs, non-drugs, and alternative medicines?
 Is everything flawless? GAP ANALYSIS
 WHAT ARE LAWS, RULES AND REGULATIONS?

 The terms; “Act” and “Law” are often used interchangeably but may be distinguished as follows:

ACT LAW
Act is a subset of law Law is the set of rules &
passed by state legislature regulations enforce by state

Act is specific in its Law ensures that people

application, referring to a adhere to the established
particular field or body norms and regulations

Eg. Drugs Act 1976 passed Eg. Drugs Act 1976

by the Parliament of contains rules for of drug
Pakistan to regulate the compliances, & defines
drug products & penalties in case of
manufacturers violation
MINISTRY OF HEALTH & DRUGS ACT 1976

Drugs
Drugs (FID, DTL (Labeling & Prescribing information,
& Govt. Analyst) Packaging)
Rules 1976 Rules, 1986 Storage & Specifications

Passed on DRUGS Drugs

ACT 1976/ Specification
18th May 1976 Rules 1978
MoH

Drugs
(Licensing, Grant of Drug Licenses,
Provincial Drug Registering &
Rules Advertising) Registrations, Renewals
Rules, 1976
 SCHEDULES IN DRUGS ACT 1976

 Drugs (Lic, Reg & Adv) Rules 1976 regulates drugs via following schedules of rules:

SCHEDULE REGULATES PROVISIONS FOR

A Drug Mfg. & sale • Grant/ Renewal of License to Manufacture by Way of Basic Manufacture/ Semi-
Licenses Basic Manufacture/ Formulation/ Repacking
• Forms provided for applications & approvals for license, warranty for sale,
product registrations, renewals, etc.

B-I & B-II cGMP Compliance • Conditions of plant, equipment, personnel, location, premises, storage, etc.
• cGMP Guideline for grant of license to manufacture drugs

C Biologicals • List of Biological drugs requiring supervision of a qualified person (degree in

medicine or veterinary sciences, with at-least 3 years experience of manufacturing
Biologicals)
D Drugs for Repacking • List of Drugs for Repacking for which license for repacking is required
E Prohibited • List of diseases for which advertisement for treatment is prohibited (Venereal
Advertisement diseases, sexual diseases, amenorrhea, eye diseases etc.)
F Fee • Fee schedule for various approvals/ applications required from MoH
G Contract • Guideline for Contract Manufacturing of drugs
Manufacturing
DRUG REGULATORY AUTHORITY OF PAKISTAN &
DRAP ACT 2012

• Federal Agency with • Established under DRAP Act

Provincial Offices 2012, on 13th Nov 2012
• To bring harmony in inter-
provincial trade and commerce

18th Drug
Amendment in Regulatory
1973 Authority of
Constitution Pakistan

Regulation of
Enforcement of
Therapeutic
DRAP Act 1976
Goods
• In addition & not in derogation • Regulates import, export,
of Drugs Act 1976 manufacture & sale of
• Shall not override previous laws allopathic drugs, HOTC
• In case of inconsistency, DRAP products & Medical devices
Act shall prevail
 SCHEDULES IN DRAP ACT 2012

 DRAP Act 2012 comprises of following schedules for rules & regulations:

SCHEDULE REGULATES PROVISIONS FOR

I Definition of • Elaborated definition & categorization of Drugs, Biologicals, and Medical Devices &
Therapeutic Medicated Cosmetics as therapeutic drugs
Goods • Alternative medicines which were not classified as drug as per Drugs Act 1976

II Prohibitions • Prohibition on import, export, manufacture & sale of spurious, counterfeit, fake &
substandard therapeutic goods
• Control on advertisement, sampling and printing/ labeling of therapeutic goods
III Penalties for • Penalty of imprisonment ranging from 3 -10 years, and/or fine from 1-5 lacs, depending
Offences upon contravention of provisions
IV Cognizance of • Initiation of prosecution of the contravention by Federal or Provincial Inspector
Offences • Offences punishable shall be tried in the Drug Court established under the Drug Act.
V Powers & • Powers & procedures for drug sampling, testing & prosecution
Procedures • Role of Govt. Analysts, Provincial Quality Control Board & Registration/ Licensing
Boards
VI Drugs Act • Reference given to Drugs Act 1976
1976
 GENERAL STEPS OF DRAP APPROVAL

• Application prepared according to SOP with cover Letter & Fee Challan by the firm
1

• Submitted through the Liaison Manager in R&I section DRAP

2
• Registration Board for pharma
• Copy of cover letter is stamped and signed by R&I and returned to firm as receiving registration
3 • Pricing Committee for price
approval
• Case evaluated by the concerned officer of the department for complete and correct • Enlistment Evaluation Committee
4 documentation for HOTC enlistment
• Central Licensing Board for
Manufacturing License
• After evaluation, forwarded to relevant Board/ Committee for deliberation/ approval
5

• If approved by Board/ Committee, formal Approval Letter is issued to the firm

6
 TYPES OF LICENSES, CERTIFICATES & APPROVALS

S.NO. TYPE DESCRIPTION UNIQUE RENEWAL

FEATURES
1. Drug License to manufacture drugs issued to a manufacturer DML No. specific to Every 5
Manufacturing with the address of the premises where the manufacturing a Manufacturer years
License (DML) operations would be conducted. name & address

2. Registration Certificate for a particular formulation with a specified Reg. No. specific to Every 5
Certificate brand name, finish product specs, dosage form, pack size at a product years
a specified MRP and shelf life.

3. Post-Registration Approval Letter for change in brand name, pack size, shelf Changes are made to As per
Variation (PRV) life, packing material, color, shape, specifications, the original Reg original Reg
Approvals manufacturing site, manufacturer, etc. issued to the Certificate Certificate
applicant company.

4. Price Increase/ Approval Letter for increase/ revision in MRP of a product MRP for a particular NA
Revision issued to the applicant company in accordance with Drug product and pack
Pricing Policy 2018, for annual CPI inc., hardship cases, or size
as per any other SRO issued by DRAP.
 TYPES OF LICENSES, CERTIFICATES & APPROVALS

S.NO. TYPE DESCRIPTION UNIQUE RENEWAL

FEATURES
1. Routine GMP Report of Routine Inspection issued by Area Federal Shows current Inspection every 6
Inspection Inspector of Drugs (FID) of the mfg. facility to assess GMP GMP status of a months/ Certificate
compliance in day to day operations, GMP certificate issued mfg. facility every 2 years
2. Panel GMP Panel Inspection by FID + 2 DRAP nominated officers for GMP status of Depends upon the
Inspection DML renewal, product specific inspection for registration or firm specific to purpose of
reported quality issue, and/ or for regularization of new purpose of inspection
manufacturing sections, Report issued for relevant approval. inspection
3. Enlistment License to manufacture alternative / HOTC products issued E. No. specific to NA
License to a manufacturer with the address of the premises where a Manufacturer
the manufacturing operations would be conducted. name & address

4. Enlistment Certificate for a particular formulation with a specified Product E. No. NA

Certificate brand name, dosage form, pack size, indication, and defined specific to a
shelf life product
REFERE NCE/ STRINGENT REGULATORY
AUTHORITIES

Previously identified as 5 In Oct 2017, Registration Board

regulatory authorities; USFDA, approved a list of 21 SRAs as
Health Canada, TGA Australia, reference authorities for
UK MHRA, & PMDA Japan registration of pharma products

RRAs / SRAs

For vet drugs, SRA already Filtration of “bogus” formulations

registered formulations (SRA or that are unqualified for safety and
Non-SRA) are used as reference efficacy parameters
for registration

SRA ref.pdf
 DEFINITION OF “DRUG” AS PER 1976 ACT

• For internal or external use

• For treatment, mitigation,
prevention, diagnosis, abnormal
INCLUDES
physical state/ symptoms

EXCLUDES
• For restoration, correction, or
modification of organic functions
• Substance exclusively used or
• Contraceptive agents/ devices
prepared for use in accordance
• Bandages/ sutures
with the ayurvedic, unani,
• Disinfectants/ Antiseptic
homoeopathic or biochemic
• Destruction or repulsion of
system of treatment
vermin, insects, rodents and other
organisms as cause, carry or
transmit disease in human beings
or animals
• Pesticides as may cause health
hazards
 DEFINITION OF “DRUG” AS PER 2012 ACT

AMENDMENTS
INCLUDES

• The term “Therapeutic goods"

• All categories defined in the coined that included:
1976 Act  Drugs
• Biological drugs/ vaccines  Alternative Medicines
 Medical Devices,
 Medicated Cosmetics
 Biologicals
 ALTERNATIVE MEDICINES AND HEALTH PRODUCTS
(ENLISTMENT) RULES, 2014
 SRO 412 (1)/ 2014, under DRAP Act 2012, issued on 27th May 2014 regulates manufacturing, import,
sales & distribution of Alternative Medicines & HOTC Products

Health & OTC (Non-

Alternative Medicines
drug) Products

Unani, Ayurvedic, Pre-biotics,

Chinese, Probiotics, baby
Homeopathic milk/ food,
(pharmacopeial) nutritional products,
medicines multivitamins

Herbal preparations
Medicated cosmetic,
& Phytomedicines
soap, shampoo,
(derived from plants
patches, plasters, etc.
naturally) SRO 412.pdf
 OVER VIEW OF THE ENLISTMENT RULES 2014

 HOTC Manufacturers & Products (local & imported) need to be enlisted by HOTC Division
DRAP
 Dedicated Mfg areas required for Local Manufacturing of HOTC products

 Only Permitted Excipients (additives, preservatives, anti-oxidants, coloring agents, flavoring agents,
alternate sweeteners, etc.) as specified in SRO to be used
 Prices are de-regulated for HOTC products at present.

 Labelling Rules are drafted but not finalized yet.

 Advertisement need prior approval by Pharmacy Services (TVC/Radio/Print media etc.) but not
being practiced
Class Assignment: Review the Enlistment Rules 2014 and identify the list of permitted excipients.
 KINDS OF ALTERNATIVE MEDICINES

S.NO. TYPE DESCRIPTION

1. NUTRACEUTICAL Plant extracts (usually powdered plant ingredients) or derivatives

DRUG formulated in allopathic dosage forms indicated for some
therapeutic effect e.g. cranberry extract

2. HERBAL DRUG Parts of plants/ herbs formulated into decoctions or alcoholic

extracts indicated for some therapeutic effect e.g. unani or
homeopathic products
3. HEALTH & OTC Health supplements or food supplements e.g. multi-vitamins and
mineral supplements. May be nutraceutical or herbal in nature,
usually not for treatment of any disease.
 VITAMIN POLICY

Concluded after a decade of

deliberation by MoH/DRAP in Vitamin/ Mineral products are
September 2019, implemented “shared” entity between pharma
vide DRAP Circular dated & HOTC laws and regulations
14.01.2020

VITAMIN
POLICY

RDA/UT Limits used for Pharma to HOTC transfer not

categorization as pharma or allowed for sole benefit of de-
HOTC product in line with regulation, Same brand name not
Reference/ Stringent Regulatory allowed in case of transfer from
Authorities (RRA/ SRA) one class to another
DRAP circular 14.01.2020.pdf
 GREY AREA MOLECULES

Grey Area molecule/ formulations

already registered as “drugs” shall
The Authority in its 70th Meeting remain in pharma category regardless
identified list of Grey Area molecules / of their RRA status unless withdrawn
formulations overlapping in both due to safety/ efficacy issue, Such
Pharma & Alternative/HOTC molecules/ formulations if enlisted as
Alternative/ HOTC shall be un-enlisted

GREY AREA
MOLECULES

For registered molecules/ formulations

not available in RRAs, but already
This decision does not apply to Vitamin registered and have proof of
and mineral formulations covered by prescription and availability for past 10
Vitamin Policy years shall continue to register as drugs
unless withdrawn for safety/ efficacy
reason
list of grey area mol.pdf
 IS EVERYTHING FLAWLESS?

DRUG/ NON-DRUG GREY AREA

ISSUE MOLECULES

?
QUALITY COSMETICS & FOOD
PARAMETERS, SUPPLEMENTS
LABELING RULES

Class Assignment: Write down at least 3 points for gap analysis under the above 4 areas.

list of grey area mol.pdf

THANK YOU!