DRAP was established under the Drug Regulatory Authority of Pakistan Act, 2012, with a mandate to provide effective coordination and enforcement of The Drugs Act, 1976, and to bring harmony to inter-provincial trade and commerce of therapeutic goods. Therapeutic goods regulated by the DRAP include drugs, biological, medical devices, alternative medicines & health products. The regulatory structure of DRAP comprises 13 Divisions under Section 4 of the DRAP Act 2012, performing various regulatory functions as entrusted under Section 7 of DRAP Act 2012 across the country. DRAP has set up its headquarters in Islamabad along with provincial chapters as field offices in Lahore, Karachi, Peshawar, and Quetta. DRAP has also established two Quality Control Laboratories, namely Central Drug Testing Laboratory (CDL) at Karachi and National Control Laboratory for Biologicals (NCLB) at Islamabad. DRAP in collaboration with the drug regulatory structures of all federating units, is responsible for ensuring that therapeutic goods approved and available in the market meet prescribed standards of quality, safety, and efficacy. Its regulatory operations include Registration and Marketing Authorization, Market Surveillance and Control, Licensing Establishments, Regulatory Inspection, Laboratory Testing, Clinical Trials Oversight, Pharmacovigilance, and Lot Release of Biologicals.
