Drug Regulatory Authority of Pakistan — registration, licensing, and compliance framework for pharmaceutical manufacturers.
All drugs must be registered with DRAP before manufacture or import
Drug Manufacturing License (DML) required for all production facilities
DRAP conducts routine and complaint-based GMP inspections
DRAP has a national pharmacovigilance program — ADR reporting mandatory
The Drug Regulatory Authority of Pakistan (DRAP) regulates pharmaceutical products under the Drug Act 1976 and the DRAP Act 2012. All drugs intended for manufacture, sale, or export must be registered with DRAP. DRAP's Drug Registration wing evaluates pharmaceutical product dossiers according to DRAP's own guidelines, which are largely harmonized with WHO and ICH standards.
Every facility manufacturing drugs in Pakistan must hold a valid Drug Manufacturing License (DML) issued by DRAP. DML issuance is contingent upon satisfactory GMP inspection and compliance with DRAP's manufacturing standards. Licenses are product-category specific (e.g., oral solid dosage forms, injectable formulations, biologics) and are renewable periodically. Non-compliance can result in suspension or cancellation.
For export purposes, DRAP issues Certificates of Pharmaceutical Product (CoPP) in the WHO format, as well as WHO GMP certificates and Free Sale Certificates (FSC). These documents are required by regulatory authorities in importing countries to verify that the product is legally authorized for manufacture and sale in Pakistan. Applications can be submitted through DRAP's online portal (online.dra.gov.pk).