A Gazette notification has been issued for the implementation of a maximum retail pricing mechanism for medicinal drugs.

The regulations, published in the gazette by the Minister of Health and Mass Media, Dr. Nalinda Jayatissa, are aimed at ensuring transparency, fairness, and affordability in the pricing of medicines.

The Medicines (Pricing Mechanism for Medicines) Regulations, No. 01 of 2025, published in the Gazette Extraordinary yesterday (25), introduce a structured system for determining the Maximum Retail Price (MRP) and Maximum Ceiling Price (MCP) for medicines sold in the country.

Key Highlights of the Regulations:

1. MRP Calculation: The Maximum Retail Price will be determined based on the Cost, Insurance, and Freight (CIF), Duties and Taxes (DT), and a Supply Chain Total Markup (SCTM). The exchange rate will be considered based on the average value of the past three months, as published by the Central Bank of Sri Lanka (CBSL).

2. MCP Calculation: The Maximum Ceiling Price for medicines will be determined by considering retail prices across different pharmacies and market shares of brands and generics. A statistical method involving the median retail price will be used.

3. Regulation Enforcement: Medicines cannot be sold above the MCP. If a product’s MRP is lower than the MCP, it cannot be increased. The authorities reserve the right to revise the MRP and MCP periodically based on market conditions and fluctuations in exchange rates.

4. New Registration: For newly registered medicines, if the calculated MRP exceeds the MCP, the MCP will be adopted as the price.

5. Penalties for Non-Compliance: Sellers who violate the pricing regulations will be subject to penalties under the National Medicines Regulatory Authority Act.

The Authority may review the MRP biannually. However, it may also revise the MRP if there is a fluctuation in the exchange rate beyond an accepted tolerance level, which the Authority will consider necessary in the public interest.

Additionally, the Authority has the legal right to recall MRPs issued based on market conditions and improve access to medicines by substituting them with a new MRP.

See the relevant Gazette below:

2429-12_E by Adaderana Online on Scribd