Sri Lanka’s Medicines (Pricing Mechanism for Medicines) Regulations, No. 01 of 2025
The National Medicines Regulatory Authority (NMRA) has published the Medicines (Pricing Mechanism for Medicines) Regulations, No. 01 of 2025, under Gazette No. 2429/12, dated March 25, 2025.
Copy attached for your reference.
A key concern is the lack of clarity regarding the Pricing Mechanism outlined in the regulation.
Example: Section 8
In simpler terms, this can be expressed as:
– Section 8: The Maximum Retail Price (MRP) shall be calculated according to the following formula:
– MRP = CIF + DT + SCTM
– Maximum Retail Price = Cost, Insurance, and Freight (CIF) + Duties and Taxes paid in local currency supply Chain Total Markup (SCTM) in local currency.
Providing such examples would help industry stakeholders better understand how to apply the rules in practice, reducing confusion and promoting compliance.
Country Example: India
India provides a good example of how pricing regulations for pharmaceuticals are often structured with clear guidelines and examples. The National Pharmaceutical Pricing Authority (NPPA) in India issues detailed pricing guidelines that include step-by-step methodologies for calculating the Maximum Retail Price (MRP) for medicines. These pricing formulas typically consider factors like:
• Cost of production,
• Import duties,
• Marketing costs,
• Profit margins, and
• Other relevant costs.
For instance, under India’s Drugs (Price Control) Order, 2013, the formula for calculating the MCP includes a breakdown of all these cost components, which is made transparent through regulations and publicly available documents.
