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Regulatory Overhaul
The Pakistani government has decided in principle to limit the powers of the Drug Regulatory Authority of Pakistan (Drap) and establish a new, independent body specifically tasked with overseeing the pricing of life-saving drugs. This move aims to address ongoing issues with drug shortages and pricing efficiency.
Industry Reaction
The Pakistan Pharmaceutical Manufacturers’ Association (PPMA) has welcomed the decision, expressing optimism that the new regulatory body will expedite the resolution of pending drug pricing cases and prevent future shortages. PPMA members believe that separating drug pricing from registration functions will improve efficiency and effectiveness.
Government Rationale
A senior official from the health ministry noted that in many countries, drug pricing is managed separately from drug registration authorities. The proposed separation in Pakistan is intended to address recurring drug shortages and streamline the pricing process. Prime Minister Shehbaz Sharif has directed the separation of the pricing department from Drap, and a committee led by Law Minister Azam Nazeer Tarar is working on this change.
Committee’s Review
Law Minister Tarar emphasized the importance of distinguishing between regulation and pricing functions and suggested including provincial representation in the new pricing body. The committee is also reviewing global and regional practices to inform their decisions on drug pricing regulation.
Previous Actions and Industry Insights
In February, the caretaker federal cabinet approved the deregulation of prices for non-essential medicines, following recommendations from the Ministry of National Health Services. This move was aimed at alleviating concerns among manufacturers and importers, addressing rising input costs, and ensuring the availability of medicines.
Usman Shaukat, a PPMA member, highlighted that while deregulation was a positive step, essential medicines still required periodic price adjustments. He expressed hope that the new regulatory body would facilitate timely resolutions of pricing cases and encourage multinational companies to return to the Pakistani market.
Future Prospects
The formation of a new regulatory body is expected to address current pricing issues and improve market conditions for both local and international pharmaceutical companies. The new body will focus on ensuring that essential medicines remain available while managing the pricing of pharmaceuticals more effectively.
