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 objective of these regulations is to establish a transparent and fair pricing structure for medicines across Sri Lanka. By leveraging insights from an internationally recognized information portal, alongside data from retail pharmacies nationwide and the State Pharmaceutical Corporation (SPC), the NMRA intends to calculate the MRP effectively. This approach ensures that pricing reflects market dynamics and promotes accessibility to essential medicines.
The newly introduced mechanism mandates the determination of MRP based on the median retail price of all available brands and generic versions that collectively dominate 80% or more of the market share by value. This methodical approach aims to strike a balance between affordability and maintaining quality standards in pharmaceuticals.
Moving forward, the NMRA emphasizes the publication of these MRPs in the Gazette, thereby legally binding all stakeholders involved in the pharmaceutical supply chain. Non-compliance with these regulations will be subject to legal repercussions under Section 131 of the NMRA Act, underscoring the authority's commitment to ensuring adherence and accountability within the industry.
These regulations define key terms such as 'brand' and 'generic version of a medicine,' emphasizing criteria for bioequivalence and efficacy. Furthermore, 'market share by value' is defined to encompass the ratio of domestic sales values in a calendar year, thereby enhancing the precision of price determinations.
For further information and updates, http://documents.gov.lk/files/egz/2024/6/2390-18_E.pdf
