Last Updated on January 4, 2023
Drug Regulatory Authority of Pakistan is an autonomous body of Federal Government working under the administrative control of Ministry of National Health Services, Regulations & Coordination. General direction, administration and monitoring of the Authority vests with Policy Board of DRAP. The Authority has thirteen Divisions performing the functions as mandated under the Section 4 of the DRAP Act, 2012. In these Division mandated functions are performed through Boards and Committee, while officers in each Division also has decision making powers for functions assigned or entrusted or delegated to them.
For more information about decision making bodies for regulation of therapeutic goods, please click on Overview of decision making bodies and their communication channels for regulation of therapeutic goods in Pakistan.
The DRAP has following Divisions:-
1. Pharmaceutical Evaluation & Registration
Pharmaceutical Evaluations and Registration Division is responsible for the evaluation, assessment and registration of pharmaceuticals drugs for human beings and animals. The Division is also responsible for assessment and approval of post registration variation of pharmaceutical drugs.
2. Biological Evaluation & Research
Biological Drugs Division is 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 prequalification by World Health Organizations of locally manufactured human biological drugs.
3. Medical Devices & Medicated Cosmetics
Medical Devices and Medicated Cosmetics Division is responsible for the assessment, enlistment or registration of medical devices and medicated cosmetics, medicated shampoos and medicated soaps for human beings, animals and to perform other functions connected therewith.
4. Drug Licensing
Drug Licensing Division is responsible for the licensing of the drugs manufacturing facilities and to perform other functions connected therewith.
5. Health & OTC
Health and OTC Products (non-drugs) Division is 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.
6. Quality Assurance & Laboratory Testing
Quality Assurance and Laboratory Testing Division is 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 also performs the functions related to post marketing surveillance and is responsible for the evaluation, coordination and monitoring of safety, efficacy and quality of registered drugs and inactive materials including the clinical and toxicological study, drug recalls and with drawls, and to perform other functions connected therewith.
7. Pharmacy Services
Pharmacy Services Division is responsible for the development and promotion of pharmacy services and to perform other functions connected therewith.
8. Costing & Pricing
Costing and Pricing Division is responsible for the costing and pricing of therapeutic goods and to perform other functions connected therewith.
9. Controlled Drugs
Controlled Drugs Division in consultation with the Federal Government is responsible for regulation and allocation of quota of narcotic drugs, psychotropic substances and precursor chemicals and to perform other functions connected therewith.
10. Admin. HR & Logistics
Administration, Human Resource and Logistics Division is responsible for administration, recruitment, appointment, capacity building and development for the Authority and other matters connected therewith and ancillary there to.
11. Budget & Accounts
Budget and Accounts Division is responsible for budgetary and financial aspects of the Authority and other daily accounting matters connected therewith or ancillary thereto.
12. Legal Affairs
Legal Affairs is responsible for legal aspects of the Authority and other matters connected with Drug Court and other court cases therewith or ancillary thereto.
13. Management Information Services
Management Information Services Division is responsible for development of automation of functions using information technology for the Authority and other matters connected therewith and ancillary thereto.