Last Updated on February 17, 2022
Drug Regulatory Authority of Pakistan has been established under the Drug Regulatory Authority of Pakistan Act, 2012. with a a mandate to provide effective coordination and enforcement of The Drugs Act, 1976 (XXXI of 1976) and to bring harmony in inter-provincial trade and commerce of therapeutic goods.
Drug Regulatory Authority of Pakistan (DRAP) is the main constitutional body to regulate therapeutic goods. DRAP has thirteen Divisions, these Division performs the functions as mandated to them under the DRAP Act, 2012.
The composition of Drug Regulatory Authority of Pakistan is as under:-
| Chief Executive Officer, DRAP | Chair |
| Director, Pharmaceutical Evaluation & Registration | Member |
| Director, Drug Licensing | Member |
| Director, Quality Assurance & Lab Testing | Member |
| Director, Medical Devices & Medical Cosmetics | Member |
| Director, Biological Drugs | Member |
| Director, Controlled Drugs | Member |
| Director, Pharmacy Services | Member |
| Director, Health & OTC Products (Non-Drugs) | Member |
| Director, Costing and Pricing | Member |
| Director, Budget & Accounts | Member |
| Director, Administration, Human Resource & Logistics | Member |
| Director, Legal Affair | Member |
| Director, Management Information Services | Member |
Followings are the main functions of Authority: –
- Administer the DRAP Act 2012 and the Drugs Act 1976 and advise the Provincial Governments for the laws that are applicable to the Provinces;
- Monitor the enforcement of drugs laws and collect relevant data and information;
- Issue guidelines and monitor the enforcement of:-
- Licensing of the manufacture of therapeutic goods;
- Registration of therapeutic goods;
- Regulation for the advertisement;
- Drug specifications and laboratory practices
- Regulation and allocation of quota of narcotic drugs, psychotropic substances and precursor substances (chemicals) in consultation with Federal Government
- Regulation for pricing and mechanism for fixation of prices of various therapeutic goods under its ambit
- Determining standards for biological manufacturing and testing
- Implementation of internationally recognized standards and guidelines
- Regulation, enforcement and monitoring of advertisement rule and ban on false advertisement
- Manufacturing of active pharmaceutical ingredients
- Coordinate, monitor or engage, in conjunction with other organizations, Provincial Governments and international agencies, in training, study or project related to therapeutic goods;
- Facilitate advancement and up gradation of the sector to meet international standards and also to promote manufacture and export of active pharmaceutical ingredients and therapeutic goods
- Coordinate at policy level and provide policy guidance to the Provincial Government in the performance of their functions with a purpose to bring uniformity;
- Facilitate the procurement and implementation of foreign aided technical assistance on therapeutic goods
- Take steps for development and promotion of pharmacy services;