Federal Minister for Economic Affairs and Establishment Division Senator Ahad Cheema on Tuesday called for comprehensive structural and policy reforms to transform the Drug Regulatory Authority of Pakistan (DRAP) into a stronger, more independent and empowered regulatory and pricing authority, alongside a review of the existing pricing formula for imported medicines.
Chairing a high-level meeting on drug pricing, the Minister emphasized the need to revisit DRAP's existing institutional and governance framework, including its relationship with the Ministry of National Health Services, its decision-making structure and the role and powers of its Policy Board.
Senator Ahad Cheema said the objective should be to establish a regulatory structure that provides DRAP with greater institutional and operational independence and reduces unnecessary ministerial involvement in regulatory and pricing decisions, while ensuring transparency, accountability and appropriate oversight.
Referring to the institutional models of NEPRA and OGRA, the Minister said relevant features of these independent regulatory frameworks should be examined while restructuring DRAP, keeping in view the specific requirements of pharmaceutical regulation and public health.
He stressed that reforms should not be limited to isolated procedural changes but should involve a comprehensive review of DRAP's overall institutional structure, mandate, governance arrangements and decision-making mechanisms.
The Minister particularly emphasized the need to strengthen and empower DRAP's Policy Board, enabling it to take timely, evidence-based regulatory and pricing decisions within a clearly defined policy framework. He said appropriate changes in the Policy Board, institutional structure and regulatory processes should be examined to enable DRAP to function as an effective and independent regulator.
Federal Minister for Climate Change Dr. Musadik Malik and Secretary Ministry of National Health Services Dr. Fakhr-e-Alam Irfan agreed on the need for a broader review of the existing policy and institutional framework and supported examining appropriate changes in DRAP's mandate, governance structure and decision-making arrangements.
The meeting also held detailed deliberations on the existing pricing formula for imported medicines. Senator Ahad Cheema said the pricing framework should be transparent, evidence-based and responsive to market realities, while ensuring the availability of essential medicines and protecting consumers from unjustified price increases.
The meeting noted that the existing pricing framework uses countries including India, Bangladesh and Sri Lanka as reference markets for benchmarking. The Minister observed that while this mechanism provides a workable basis where comparable medicines are available in Tier-I reference countries, difficulties arise when a medicine is not available in these markets and is primarily available in European or other Tier-II markets.
Senator Ahad Cheema said that in such cases, the existing methodology needs to be revisited, as meaningful price benchmarking becomes difficult in the absence of comparable medicines in Tier-I reference markets. He called for developing a more rational, transparent and workable comparative mechanism for imported medicines falling in this category.
"Where a medicine is not available in our primary reference markets, the pricing methodology should provide for a meaningful and realistic comparison while safeguarding consumer interests," the Minister said.
He said the overall objective of the proposed reforms should be to establish a transparent, predictable and efficient drug regulatory and pricing system that ensures the availability of essential medicines, protects consumers and facilitates timely and effective regulatory decision-making.
The meeting also reviewed pending drug pricing and hardship cases. The Minister called for their case-by-case review, taking into account the nature and classification of each medicine, its availability, market conditions and other relevant considerations.
He emphasized that pending cases should be considered on their individual merits, with particular focus on ensuring the availability of essential medicines while safeguarding consumers from unjustified price increases.
The meeting was attended by Federal Minister for Climate Change Dr. Musadik Malik, Secretary Ministry of National Health Services Dr. Fakhr-e-Alam Irfan, CEO DRAP, Director Pricing DRAP and other senior officials.