Last Updated on January 19, 2023
Established under DRAP Act 2012, Drug Regulatory Authority of Pakistan (DRAP) is responsible for providing 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. Therapeutic goods regulated by the DRAP include:
- Pharmaceutical and biological drugs for human or veterinary use,
- Medical Devices and Medical Cosmetics
- Health & OTC (non-drugs) also known as alternative medicines such as:
- Nutritional products
- Food supplements for human beings, animals
DRAP ensures that therapeutic goods, approved and available in market, meet prescribed standards of quality, safety and efficacy. The regulatory functions performed by DRAP include registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection, laboratory testing, clinical trials oversight, pharmacovigilance, and lot release of biologicals etc.
DRAP as an organization
Our Commitment to ensure access to safe, quality assured and efficacious therapeutic goods is in line with national laws and international best practices.
DRAP enforces DRAP Act 2012 and rules framed thereunder. Keeping in view of scientific and technological development, DRAP also recommends various laws to Government of Pakistan for regulation of therapeutic goods.
Regulatory responsibilities of DRAP include regulation of licensing and manufacturing of therapeutic goods. For this purpose, there are separate divisions within DRAP that deal with specific type of therapeutic goods.
DRAP provides regulatory guidelines which provide guidance to manufacturers / importers of therapeutic goods for ensuring quality assured, safe and therapeutic goods in the country.
DRAP issues nationwide recall, suspension or cancellation of licenses and registration of therapeutic goods, and safety alerts. It advises provincial governments on regulation related matters of therapeutic goods.
DRAP has established regulatory procedures for enforcement of applicable laws. Regulatory procedures and evaluation process flows for applications of therapeutic goods are available on DRAP website for information and understanding purpose for stakeholders.