The Hon. (Dr.) Nishantha Samaraweera

¶ 01 Hon. Speaker, I wish to add a few observations on the Regulations under the National Medicines Regulatory Authority Act presented by the Hon. Minister of Health.

¶ 02 The NMRA Act has governed the import of medicines, hospital-use drugs, and cosmetics since 2015. We know the people have faced serious issues in obtaining necessary medicines on time. The NMRA is the body regulating these supplies.

¶ 03 The NMRA handles registration and regulation of imported medicines, calling for applications, inspections, assessing quality, and considering international certifications before granting approval. This typically takes about 10 months (around 300 days).

¶ 04 Multiple products under the same generic are imported, and without a structured pricing mechanism, price control has been problematic. Although a Price Control Committee existed, it lacked a defined methodology, causing legal challenges.

¶ 05 These Regulations seek to provide the necessary legal and methodological strength for maximum retail price (MRP) determinations—both at the generic level and by brand where applicable—based on a structured formula. Previously, ad hoc determinations sometimes led to higher prices than necessary.

¶ 06 Under the new approach, prices will be derived from CIF value plus applicable duties (if any), logistics, and reasonable distribution costs. As most medicines are tax-exempt, this should enable lower consumer prices. We aim to ensure MRP and ceiling price frameworks across the public and private sectors, improving affordability.

¶ 07 Thank you, Hon. Speaker.