Last Updated on October 11, 2022

The Drug Regulatory Authority of Pakistan Act, 2012 and the Drugs Act 1976 sets out legal requirements for the manufacture, import, export, storage, distribution and sale of therapeutic goods in the country. The DRAP Act 2012 is mandated to provide effective coordination and enforcement of The Drugs Act,
1976 and to bring harmony in inter-provincial trade and commerce of therapeutic goods.

The DRAP Act, 2012

  1. Drug Regulatory Authority of Pakistan Act, 2012  (as of November-2012)
  2. SRO 913 (I)/2017 (issued on 6th September-2017)
  3. SRO 824 (I)/2018 (issued on 26th June-2018)
  4. SRO 219 (I)/2022 (issued on 14th February-2022)

The Drugs Act 1976

The Drugs Act 1976 (as at February-2022)

These Acts are supported by various rules and regulations which provides further details on the regulatory aspects of therapeutic goods, including their licensing, registration, quality assurance and others matters which are covered in these Acts. Therapeutic goods regulated under the Acts include drugs, biological products, medical devices, medicated cosmetics, alternative medicines and Health & OTC products. The regulatory mechanisms established under the Acts comprehensively includes registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection, laboratory testing, clinical trials oversight, pharmacovigilance, and lot release of biologicals.