DRAP shifts controlled drugs quota to online platform
The Drug Regulatory Authority of Pakistan (DRAP) has decided to move the quota allocation system for the raw material of controlled medicines to an online platform from next month. The change will initially cover quota allocations for 2026 and will apply to a wide range of sedatives, narcotic painkillers and other controlled therapies.
According to officials, DRAP has completed development of the new Controlled Drugs Quota Allocation System after consultations with major stakeholders, including the Pakistan Pharmaceutical Manufacturers Association, pharmaceutical companies, the Pakistan Bar and the Anti-Narcotics Force.
The move is aimed at modernising a sensitive regulatory process, improving traceability and reducing opportunities for misuse and diversion of high-risk medicines.
Online applications to replace paper-based process
Under the new system, pharmaceutical companies will receive their raw material quotas for controlled medicines through DRAP’s dedicated online portal. From 1 January onward, companies will be required to submit electronic applications for quota allocation; hard copy applications will no longer be accepted.
All requests for controlled drugs quotas will be routed through the e-application system, and quota allocation certificates will also be issued online. DRAP has already completed training its staff on the new platform so that applications can be processed smoothly once the system goes live.
Officials say the digital portal will provide a central, time-stamped record of every application and approval, making it easier to monitor volumes, detect irregularities and ensure that quotas are aligned with legitimate production needs.
What counts as controlled medicines in Pakistan
Controlled drugs raw material is used in the manufacturing of a wide range of medicines, including sedatives, narcotic painkillers, treatments for neurological and psychiatric disorders, anaesthesia drugs and certain cough syrups.
Because of the risk of dependence and abuse, the sale of such medicines without a doctor’s prescription is banned in Pakistan. Strict regulation of raw materials is therefore critical to prevent these products from being diverted into unregulated markets or misused for non-medical purposes.
More than 60 pharmaceutical companies in the country are currently involved in the manufacturing of controlled medicines. For these firms, timely and transparent access to raw materials is essential to maintain uninterrupted supply for patients while still respecting legal and safety requirements.
New documentation requirements for pharma companies
As part of the new online process, companies applying for controlled drugs quotas will be required to submit a three-year record of their raw material usage. This historical data will help regulators compare requested quotas with past consumption and production patterns.
The additional documentation is intended to discourage inflated or unjustified quota requests and to ensure that allocations reflect actual therapeutic demand. It will also make it easier to flag unusual spikes in raw material use that may warrant closer inspection.
Sources added that the quota for controlled drugs raw material is jointly issued by the Ministry of National Health Services and the Ministry of Interior. Moving the process online is expected to streamline coordination between the two ministries and provide a clearer audit trail for each decision.
Digital oversight to improve control and transparency
Regulators believe that the new online quota allocation system will significantly improve oversight of controlled medicines by providing real-time data on allocations, approvals and company-wise usage.
With a centralised digital record, authorities such as DRAP and the Anti-Narcotics Force will be better placed to track the flow of raw materials from import or local procurement through to finished product manufacturing.
Industry stakeholders expect that, if implemented properly, the system will both tighten control over potentially abused substances and reduce bureaucratic delays for compliant manufacturers. For patients, stronger regulation of controlled medicines is seen as a necessary step to balance access to essential treatments with protection from misuse and illegal trade.
