Allocation, Monitoring and Compliance

Last Updated on February 22, 2022

The Controlled Drugs Division, DRAP as a Secretariat of the Committee for Quota Allocation of Controlled Substances (CAQCS), has an oversighting regulatory role for the following aspects of Controlled Substances containing drug products:-

Quota Allocation

Allocation of Quota for narcotics, psychotropic substances and precursor chemicals used in manufacturing of registered drugs

Import Authorizations

Issuance of Import Authorizations / permits for import of APIs used in manufacturing of registered controlled medicines

Export Authorizations

Issuance of Export Authorizations / Permits for export of registered controlled medicines

In addition to above, Division is also performing detailed technical scrutiny of hundreds of applications for allocation of controlled substances, compilation of data relating to import, export and consumption of controlled drugs for submission to International Narcotics Board, issuance of permits for import, export and local procurement etc. The division also reports quarterly and annually various statistics related to controlled substances to International Narcotics Control Board as per requirements of UN conventions.    

Application for Allocation of Controlled Substance

Manufacturing companies have valid registered drug products containing controlled substances can apply for allocation of quota of controlled substances in the Division of Controlled Drugs, DRAP. Applications for quota allocation of controlled substance(s), shall be submitted by the firm(s)/applicants(s) latest by 7th January for each year, with consumption data (manufacturing & sale) till 31st December of previous year (this condition shall be applicable on the first meeting of the Committee for Allocation of Quota of Controlled Substances i.e. CAQCS, of that year only).

Applications forms templates and checklists for submitting an application for allocation of quota of controlled substance for manufacturing of controlled medicines provides guidance to the applicants. The standard operating procedure for applications submission and processing for import and export of controlled medicines are as:

  1. Import of Controlled Substances for local manufacturing of Controlled Medicines (View)
  2. Export of Controlled Medicines (view)