Last Updated on May 2, 2023
The Drug Regulatory Authority of Pakistan is the public institution of Government of Pakistan. The Authority is working as an autonomous body under the administrative control of Ministry of National Health Services, Regulation & Coordination. The legal basis of DRAP is the Drug Regulatory Authority of Pakistan Act, 2012. The general direction, administration and monitoring of the Authority is vested to the Policy Board constituted under Section 9 of the DRAP Act, 2012.
Drug Regulatory Authority of Pakistan started operation in November, 2012, when the DRAP Act, 2012 came in to force. The former Federal Drug Control Administration and its laboratories were merged in the formation of DRAP. The new area of responsibility takes into account the regulation and quality standards of Medical Devices, Alternative Medicines, Health & OTC products, in addition to the implementing international standardization and harmonization to assure the quality, safety and effectiveness drugs and biological products.
The functional chart of DRAP is as under:-
The organizational structure and positioning of DRAP in the national health regulation system of Pakistan is illustrated in the below flowcharts.