Drug Laws · Short notes

DRAP Act 2012: Short Notes & Cheat Sheet

Why DRAP was created after the 18th Amendment, what it regulates, its structure and its main functions.

Short notes

Read these before you attempt the topic's MCQs.

DRAP brings registration, licensing, pricing, quality and safety monitoring under one federal authority.

The 18th Constitutional Amendment (2010) devolved health to the provinces, leaving a gap in national drug regulation.
The DRAP Act 2012 created the Drug Regulatory Authority of Pakistan to regulate therapeutic goods nationally and coordinate inter-provincial trade.
DRAP is an autonomous federal body, working under the Ministry of National Health Services, Regulations and Coordination, with headquarters in Islamabad.
The Policy Board is its main governing organ. A full-time Chief Executive Officer heads the Authority and also serves as secretary of the Policy Board.
The Authority has thirteen divisions, each headed by a Director.

'Therapeutic goods' include drugs (human and veterinary), biologicals, medical devices, medicated cosmetics, and health and OTC products (alternative medicines such as Unani, Ayurvedic, homeopathic and nutritional products).
Its 13 divisions: Pharmaceutical Evaluation & Registration; Biological Evaluation & Research; Medical Devices & Medicated Cosmetics; Drug Licensing; Health & OTC; Quality Assurance & Laboratory Testing; Pharmacy Services; Costing & Pricing; Controlled Drugs; Admin, HR & Logistics; Budget & Accounts; Legal Affairs; Management Information Services.
Statutory bodies within DRAP include the Policy Board, Registration Board, Central Licensing Board and Appellate Board, with provincial representation.

Registering drugs and licensing manufacturers, and inspecting for GMP.
Recommending prices of controlled-price medicines.
Monitoring quality through testing laboratories, and managing recalls and alerts.
Pharmacovigilance: collecting and assessing adverse drug reaction reports.
Approving clinical trials and bioequivalence studies, and controlling imports and exports.
Coordinating with the provinces and international bodies such as WHO.

High-yield facts in one place. Cover the right-hand column and test yourself.

Item	Detail
Created by	DRAP Act 2012
Trigger	18th Amendment (2010) devolved health
Status	Autonomous federal authority
Headquarters	Islamabad
Head	Chief Executive Officer (also Policy Board secretary)
Governing body	Policy Board
Divisions	13, each under a Director
Statutory boards	Registration, Central Licensing, Appellate

Type	Examples
Drugs	Human and veterinary medicines, APIs
Biologicals	Vaccines, insulin, blood products
Medical devices	Syringes, stents, diagnostics
Alternative medicines	Herbal, homeopathic, Unani
Health and OTC products	Nutraceuticals, supplements
Medicated cosmetics	Products with therapeutic claims

2010 devolved, 2012 DRAP: The 18th Amendment (2010) devolved health; the DRAP Act followed in 2012.

DRAP is federal; provincial health departments still handle sale licences and local enforcement.
DRAP regulates more than drugs: devices, biologicals and alternative medicines too.
The Drugs Act 1976 was not repealed; DRAP administers it.
The 18th Amendment was passed in 2010, not 2012.

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