Last Updated on June 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:-
Allocation of Quota for narcotics, psychotropic substances and precursor chemicals used in manufacturing of registered drugs
Issuance of Import Authorizations / permits for import of APIs used in manufacturing of registered controlled medicines
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:
- Import of Controlled Substances for local manufacturing of Controlled Medicines (View)
- Export of Controlled Medicines (view)
How CAQCS allocate Quota of Controlled Substances
Process for Marketing Authorization Holders:-
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).
The first four meetings of the Committee are convened on monthly basis and then after every 45 days. Excluding any exigency, last date for submission of application of imported controlled substances shall be 15th September of each year except those locally produced/purchased controlled substance(s) for which applications can be submitted before 15th November of each year. The applications received till 7th date of each month for first four monthly meetings of the year shall be considered in the respective forthcoming monthly meeting of the Committee.
Application forms, checklists of required documentations, and templates for submissions of manufacturing and sales data are available on the website under Application Forms. The submitted data is carefully evaluated and presented before the Committee for Allocation of Quota of Controlled Substances and accordingly allocations and import permissions are granted to the applicants.
|Detail Procedure for Quota Allocation to Drug Registration Holders for local manufacturing along with documentation and data requirement||View|
Process for Basic / Semi Basic Manufacturing and Precursors:-
The licensed firm(s) shall submit an application along with required documents as per Checklist and the applicable fee to the DRAP. The firm can apply after consumption of previous allocation i.e. 75% in manufacturing and 65% in sales for locally purchased controlled substances and/or 65% in manufacturing and 55% in sales for imported controlled substances.
In case of complete application, DRAP causes an inspection through a panel for verification of previous consumption / recommendation of new quantity for import/local purchase. These recommendations / inspection report are forwarded to the Ministry of Narcotics Control, Islamabad. The Ministry of Narcotics Control issues the No Objection certificate (NOC) to the applicants.
|Detail Procedure for Quota Allocation for Basic / Semi Basic manufacturing and Precursors||View|
Process for Institutional supply (Govt tenders) of Controlled Substances:-
The marketing authorization holders / applicant firm will submit a separate application stating the details of the tenders along with quantity of controlled substance (s) to supply the required quantity of drug(s) along with applicable fee. Division of Controlled Drugs, DRAP shall verify the details from the concerned Hospital/Institution(s) and will evaluate the consumption of previously allocated quantity for the tender purpose, (if any)
The applicant will pledge on legal paper that quantity of controlled substances allocated shall only be used for supply of the drug containing the said controlled substance against the said tender and not for any other purpose. Applicant will also submit a certificate of receipt of stock from the concerned Hospital/Institution issued by MS/CEO/MD/ED of the concerned Hospital/Institutions(s) along with attested delivery challan within 15 days of the supply. Physical verification/Audit may be done, if deemed appropriate by the Division of Controlled Drugs/CAQCS.
The allocated quantity for the said purpose will not merge in the routine quota of the firm and quota allocated shall only be used against the applied tender and not for any other purpose, violation of any condition will result in blacklisting of the firm.
|Detail Procedure for Quota Allocation to Drug Registration for Government Hospital and Institutional Supply||View|
Process for Quota Allocation of Narcotic Drugs to the Hospitals Situated in Islamabad Capital Territory:-
Hospitals/institution will submit an application indicating the quantity of registered pharmaceutical products containing Narcotic substances to be purchased/ procured along with requisite documentations and checklist duly signed by the Head of the hospital/institution and Head of Pharmacy Department, to the Division of Controlled Drugs, DRAP.
All Hospitals shall implement their internal controls and Standard Operating Procedures as per Control of Narcotics Substances Rules, 2001 and relevant Drugs Sale Rules for storage, distribution/dispensing and prescription of drug products containing controlled substances, and maintain records accordingly.
The application will be evaluated and in case of any shortcoming(s) in application, the same will be communicated to applicant. The Controlled Drugs Division, DRAP shall cause an inspection of the Hospital by its Officer and forwards recommendations to the Ministry of Narcotics Control for issuance of No Objection Certificate (NOC) to the concerned hospital of the ICT, Islamabad for procurement of the narcotic drugs.
Hospitals applying for the first time for permission for purchase/procurement of Narcotic medicine or enhancement in the previous allocated quota shall provide justification of demanded quantity duly recommended by the Head of specialty to the panel of inspectors. This may include specialty details in which narcotic medicine are to be used, Number of beds with patient influx, estimated consumptions specialty wise details.
Application for subsequent allocation of quota of Narcotic medicine shall be made after documented evidence of consumption of 50% of quota of previous allocation. Hospitals shall furnish consumption details of previous allocation.
|Detail Procedure for Quota Allocation of Narcotics Drugs to Hospitals situated in Islamabad Capital Territory||View|
- All the hospitals located in Provinces and states shall apply to the Ministry of Narcotics Control, Islamabad for issuance of NOC for procurement of drugs containing controlled substances through the Director General Health Service of the respective provincial / state health department with their recommendations.
Process for Quota Allocation for Manufacturing of Controlled Drugs for Export Purpose:-
Application(s) for allocation of controlled substance for export purpose shall be submitted by the Drug Registration Holders along with requisite documentation to the Division of Controlled Drugs, DRAP. Applications are evaluated by desk officers followed by the Scrutiny Committee constituted jointly by the Ministry of Narcotics Control, Anti Narcotics Force (ANF) and DRAP. The complete applications along with the recommendation of Scrutiny Committee are considered by the Committee for Allocation of Quota of Controlled Substances (CAQCS) and accordingly allocation letter and Import Authorization (if applicable) are issued to the applicant firm.
At the time of Export, Applicant will provide information for export of finished products to the Division of Controlled Drugs, which will forward its recommendation to the Ministry of Narcotics Control, Islamabad for further processing and issuance of Pre Export Notification (PEN) and No Objection Certificate (NOC). Accordingly, Division of Controlled Drugs, DRAP issues the Export Permit / Authorization to the applicant in the light of NOC from Ministry of Narcotics Control, Islamabad.
The Applicant firms shall also submit following documents/information duly verified/attested by the Embassy/High Commission of Pakistan in Country of Import and Ministry of Foreign Affairs, Pakistan within 90 days of receipt of the shipment in the Country of Import:-
- Customs Clearance Documents (Importing Country)
- Goods Declaration Form (Importing Country),
- Packing List of exported shipment,
- Invoices of the shipment Exported,
- Notarized copies of clearance documents issued by Pakistan Customs
|Detail Procedure for Quota Allocation of Controlled Substances for Export Purpose||View|
Destruction of Controlled Substances:-
Applicant firms are required to seek permission from DRAP prior to destruction / safe disposal of controlled Substances in any form. Application explaining the reasons(s)/justification for destruction of controlled drugs (API & finished products) with the notarized copies of following documented evidence shall be submitted.
- Allocation and Import Authorization letter of respective controlled substance (s)/drug(s).
- Purchase invoice of respective controlled substance (s) cleared from the area Assistant Director, DRAP.
- Details of controlled drugs (API/ Finished Products) to be destroyed on prescribed format
Division of Controlled Drugs, DRAP evaluate the application for destruction of controlled substances and process it for approval the Secretary, Ministry of Narcotics Control, Islamabad to constitute a panel comprising representatives from DRAP, ANF and M/o Narcotics Control, to supervise the destruction process.
The panel will visit the site for verification of the quantity to be destroyed/disposed of, and take Samples of material/product as per prescribed procedure as per provision of DRAP Act 2012/Drugs Act 1976. The report of Quality Control laboratory may also be Verified particularly in case of spurious, substandard, recalled or rejected batches of the controlled substances to be destroyed. The panel will also evaluate the reasons for destruction as stated by the firm in their request and may take decision for safe disposal/destruction of the material and furnish a detailed report, otherwise may refer back the matter to Division of Controlled Drugs for further course of action. The panel also issues a certificate of destruction after completing the destruction / disposal activity, and submit its report of panel proceedings to the Division of Controlled Drugs, DRAP along with supporting documents.
|Detail Procedure for destruction / Safe Disposal of Controlled Substances||View|