Drug Regulatory Authority of Pakistan

Formation

The Authority was formed by the passage of the Drug Regulatory Authority of Pakistan Act, 2012 by the Parliament of Pakistan.

Aims and objectives

According to the Authority, it has mainly two aims and purposes:

Divisions

The Authority has the following Divisions:

Pharmaceutical Evaluations and Registration Division

Pharmaceutical Evaluations and Registration Division shall be responsible for the evaluation, assessment and registration of pharmaceuticals drugs for human beings, animals and to perform other functions connected therewith and assigned by the Board.

Drug Licensing Division

Drug Licensing Division shall be responsible for the licensing of drug manufacturing facilities and to perform other functions connected therewith.

Quality Assurance and Laboratory Testing Division

Quality Assurance and Laboratory Testing Division shall be responsible for enforcement of current Good Manufacturing Practices under the Act, and for testing or research of drugs and to perform other functions connected therewith. The Division will also perform the functions related to post marketing surveillance and shall be responsible for the evaluation, coordination and monitoring of safety, efficacy and quality of registered drugs and inactive materials including clinical and toxicological study, drug recalls and withdrawls, and to perform other functions connected therewith.

Medical Devices and Medicated Cosmetics Division

Medical Devices and Medicated Cosmetics Division shall be responsible for the assessment, enlistment and registration of medical devices and medicated cosmetics, medicated shampoos and medicated soaps for human beings, animals and to perform other functions connected therewith.

Biological Drugs Division

Biological Drugs Division shall be responsible for the evaluation, assessment, registration and licensing of Biologicals for human beings, animals and to perform other functions connected therewith including all the functions of national control authority for biologicals as required for the pre-qualification by the World Health Organization of locally manufactured human biological drugs.

Controlled Drugs Division

Controlled Drugs Division shall in consultation with the Federal Government be responsible for regulation and allocation of quota of narcotic drugs, psychotropic substances and precursor chemicals and to perform other functions connected therewith.

Pharmacy Services Division

Pharmacy Services Division shall be responsible for the development and promotion of pharmacy services and to perform other functions connected therewith.

Health and OTC Products (Non-Drugs) Division

Health and OTC Products (Non-Drugs) Division shall be responsible for the assessment, licensing and registration of Alternative Medicines such as Ayurvedic, Chinese, Unani and Homeopathy, enlistment or registration of nutritional products and food supplements for human beings, animals and to perform other functions connected therewith.

Costing and Pricing Division

Costing and Pricing Division shall be responsible for the costing and pricing of therapeutic goods and to perform other functions connected therewith.

Budget and Accounts Division

Budget and Accounts Division shall be responsible for budgetary and financial aspects of the Authority and other daily accounting matters connected therewith or ancillary thereto.

Administration, Human Resources and Logistics Division

Administration, Human Resources and Logistics Division shall be responsible for administration, recruitment, appointment, capacity building and development for the Authority and other matters connected therewith and ancillary thereto.

Legal Affairs Division

Legal Affairs Division shall be responsible for legal aspects of the Authority and other matters connected with Drug Court and other court cases therewith or ancillary thereto.

Management Information Services Division

Management Information Services Division shall be responsible for development of automation of functions using information technology for the Authority and other matters connected therewith and ancillary thereto.

Committees

The Authority has the following Committees:

1. Drug Pricing Committee (DPC) that woks out prices to be granted, reduced or enhanced. It makes recommendations to the Federal Government which may approve, amend or refer back its recommendations for further evaluation.

2. Expert Committee on Veterinary Drugs (ECVD) that woks out registrations of generic veterinary drugs to be granted, deferred or rejected after evaluation of applications for registrations. It makes recommendations to the Drugs Registration Board which may approve, amend or refer back its recommendations for further evaluation.

3. Expert Committee on Biological Drugs (ECBD) that woks out registrations of biological drugs to be granted, deferred or rejected after evaluation of applications for registrations. It makes recommendations to the Drugs Registration Board which may approve, amend or refer back its recommendations for further evaluation.

4. Expert Committee on Medical Devices (ECMD) that woks out registrations of Medical Devices to be granted, deferred or rejected after evaluation of applications for registrations. It makes recommendations to the Drugs Registration Board which may approve, amend or refer back its recommendations for further evaluation.

Services

The Authority provides the following services:

Regulatory Services

1. Drug Registration

2. Biological Registration

3. Medical Devices Registration

4. Health Products Registration

5. Alternative Medicine Registration

6. Licensing of Drug Manufacturing units

7. Licensing of Biological Manufacturing sections and units

8. Licensing of Alternative Medicine manufacturing units

Guidelines

cGMP Guidelines

Guidelines for Enlistment and Registration of Alternative Medicines

Guidelines for Licensing of Pharmaceutical Units

Check Lists

Check Lists for Inspections of Drugs Manufacturing Premises

Check Lists for Inspections of Drugs storage for imported drugs

Check Lists for Inspections of Biologicals Manufacturing

Laboratories

The following laboratories function under the Authority:

1. Central Drugs Laboratory, Karachi

2. National Control Laboratory for Biologicals, Islamabad

3. Federal Drug Surveillance Laboratory, Islamabad