NMRA introduces new drug pricing mechanism

The National Medicines Regulatory Authority (NMRA) has introduced a new pricing mechanism aimed at determining the maximum retail price (MRP) for specific dosages and strengths of medicines.  This regulatory initiative, outlined in a Gazette under the National Medicines Regulatory Authority Act, No. 5 of 2015, reflects extensive consultation with the Pricing Committee, Consumer Affairs Authority, and various stakeholders. The formulation of these regulations meticulously considered factors crucial to consumer protection laws.  

The primary objective of these regulations is to establish a structured pricing mechanism for determining the MRP of medicines, ensuring affordability and accessibility for consumers across the island.  

Further, retail prices from pharmacies nationwide and data from the State Pharmaceutical Corporation (SPC) will be scrutinized to ascertain accurate pricing benchmarks.  

According to the newly enacted regulations, the MRP for a specific dosage form and strength of a medicine will be calculated based on the median retail price of all available brands and generic versions that collectively hold 80% or more of the market share by value.   The methodology involves arranging these prices in ascending order and determining the median, ensuring a fair representation of market realities.   

Once calculated, the determined MRP will be published in the Gazette, making it legally binding for all stakeholders in the pharmaceutical supply chain, from manufacturers to retailers. Any violation of these regulations will constitute an offence punishable under Section 131 of the NMRA Act, ensuring compliance and accountability within the industry.