Pakistan’s drug regulator has decided to shift the quota allocation of controlled drug raw materials to a fully online system, aiming to improve transparency, accountability, and ease for pharmaceutical companies, official sources said.
Under the new system, the Drug Regulatory Authority of Pakistan (DRAP) will issue quotas for the raw materials used in sedatives, painkillers, anesthetics, cough syrups, and medicines for neurological and psychological disorders through an online platform. From January 1, no hard copy applications for controlled drug quotas will be accepted.
Sources said the online Controlled Drugs Quota Allocation System has already been developed by DRAP after detailed consultations with key stakeholders, including the Pakistan Pharmaceutical Manufacturers Association (PPMA) and the Pharma Bureau. The decision was taken with mutual agreement to address long-standing concerns over delays and lack of transparency in the manual process.
According to officials, pharmaceutical companies will submit electronic applications through the E-App system, and quota allocation certificates will also be issued online. The quota for controlled drug raw materials for the year 2026 will be released digitally, making the process faster and more traceable.
The move is expected to strengthen regulatory oversight, especially as controlled drug raw materials are used to manufacture medicines that require strict monitoring due to their potential for misuse. In Pakistan, the sale of such medicines without a doctor’s prescription is strictly prohibited.
Sources added that more than 60 pharmaceutical companies in the country manufacture controlled medicines. Each company will now be required to submit a three year record of how previously allocated quotas were used before applying for new allocations.
The quota for controlled drug raw materials is jointly issued by the Ministry of National Health Services and the Ministry of Interior. DRAP staff have completed training on the E-App system to ensure smooth implementation of the new digital process.
Officials believe the shift to an online system will not only reduce paperwork and human intervention but also help build public trust by ensuring fair distribution of sensitive pharmaceutical raw materials.
