The Hon. Ruwan Wijeweera

¶ 01 Hon. Presiding Member, I am pleased to contribute to today’s debate on regulations under the National Medicines Regulatory Authority Act, No. 5 of 2015.

¶ 02 Before my points, I must respond to Opposition remarks expressing “surprise” at the situation in the health sector: long waiting lists, overcrowding, in-patients on floors, and scarcity. This is not new to us. We have long known the hardships—patients lacking space, accommodation issues, long queues; a cardiac patient sometimes waiting until the next year for surgery. As policymakers, we all bear responsibility to alleviate these burdens on innocent people, including those without money to buy medicines, without shelter, and without basic sanitary facilities.

¶ 03 Our Government, led by the Hon. President and the Hon. Health Minister, is working to uplift the health sector: establishing primary care units, improving estate health services, and enhancing quality in indigenous and Ayurvedic services, along with broader improvements to hospital facilities. Today’s regulations under the NMRA Act are one such step. Beyond import, procurement, distribution and dispensing, the NMRA is also responsible for post-dispensing pharmacovigilance. It must keep prices fair and ensure quality—vital when people’s lives depend on medicines. Accordingly, matters relating to the Maximum Retail Price (MRP) and Maximum Ceiling Price (MCP) are included in these regulations.

¶ 04 The COPE report revealed serious issues with past NMRA practices, including use of Waiver of Registration (WOR) through special procedures without formal committee approval, forged documents, and even seeking approval for bulk purchases of human immunoglobulin at a dinner in a Colombo hotel—one of the most corrupt health procurements. Such conduct had negative, even critical, effects on people’s lives. Strengthening the NMRA as an independent authority with adequate powers across the procurement chain is essential.

¶ 05 A WHO report (April 2025) commended current Government measures to strengthen the NMRA: “Landmark initiative to strengthen integrity in medicine regulation: Sri Lanka takes the lead with support from WHO and UNODC,” noting steps toward transparency, accountability and integrity. WHO Regional Director for South-East Asia Ms. Saima Wazed observed Sri Lanka’s excellent progress, including the NMRA’s first assisted self-assessment of corruption risk. We are committed to implementing these processes to ensure affordable access to quality care, not just a Panadol strip, for our people.

¶ 06 Thank you.