Regulate Manufacturing of Controlled Medicines

Last Updated on February 22, 2022

Division of Controlled Drugs, DRAP in consultation with the Ministry of Narcotics Control is responsible for regulation and allocation of Quota of Narcotic Drugs, Psychotropic Substances and Precursor Chemicals. A number of psychoactive/chemical entities having important therapeutic uses are regulated internationally through UN Conventions. There are three categories of controlled substances, namely: –

  1. Narcotic Drugs
  2. Psychotropic Substances
  3. Precursor Chemicals

Laws: Controlled substances (used as medicines) are regulated under:-

  • DRAP Act, 2012.
  • Drugs Act, 1976.
  • Control of Narcotic Substances (CNS) Act, 1997 and rules framed thereunder

Substances in above categories which are registered as drugs are regulated under DRAP Act, 2012 and Control of Narcotic Substances (CNS) Act, 1997, which provides framework for the regulations of production, sales, storage, import and export of these substances in Pakistan. Ministry of Narcotics Control is the competent authority to enforce this Act in collaboration with DRAP and Anti-Narcotics Force (ANF).

Committee for Allocation of Quota of Controlled Substances (CAQCS)

Under the CNS Act 1997, a Committee i.e., Committee for Allocation of Quota of Controlled Substances was notified under the Chairmanship of Secretary, Ministry of Narcotics Control, (MNC), Director General, Anti-Narcotics Force (ANF) or his representative as member and Director Controlled Drugs, DRAP as member/Secretary of the Committee, responsible for quota allocation of controlled substances to various pharmaceutical firms as per prescribed.

Equitable Access to Controlled Medicines

The main objective of the Controlled Drugs Division, DRAP is to ensure smooth supply of medicines containing controlled substances to needy patients by timely allocation of quota of controlled substances to various applicant firms. The division also facilitates export of medicines containing controlled substances by processing the application received for quota allocation of controlled substances for export purpose.  Further division also ensures effective coordination with the other national and international agencies involved in regulation of controlled substances.