Hon. (Dr.) S. Sri Bavanandarajah

¶ 01 Hon. Presiding Member, thank you very much for granting me this opportunity to speak on matters related to the Regulations under the National Medicines Regulatory Authority Act.

¶ 02 Sir, I rise today to speak on a matter of great national concern: the rising cost of medicines and the urgent need to strengthen the role of the National Medicines Regulatory Authority (NMRA) in ensuring fair, affordable and accessible healthcare for all citizens. Access to essential medicines is a fundamental right. Yet many families struggle to buy life-saving drugs. Sharp price increases have placed an unbearable burden on ordinary citizens—especially the poor, the elderly and those with non-communicable diseases or chronic illnesses.

¶ 03 While global market fluctuations, import costs and currency depreciation have contributed, we must also recognize the critical role of domestic regulation. The NMRA was established to ensure medicines are safe, effective and reasonably priced. However, due to institutional weaknesses, insufficient oversight and limited enforcement capacity, it has not always fulfilled its mandate effectively. We must take decisive action to strengthen the NMRA so it can play a central role in reducing medicine prices through transparent, efficient and evidence-based regulation.

¶ 04 It is time to introduce an MRP and an MCP. Firstly, the NMRA should develop and implement a scientific, transparent pricing formula for essential medicines, considering international reference prices, local production costs and reasonable profit margins for importers and pharmacies—ensuring fairness to both consumers and suppliers.

¶ 05 Secondly, the Authority must expand and modernize monitoring. A digital system for price surveillance, registration and market review should be established to identify unjustified price hikes in real time and prevent artificial shortages and speculative pricing.

¶ 06 Thirdly, we must encourage local pharmaceutical manufacturing. The NMRA, together with the Ministry of Health and Mass Media and the Ministry of Industry and Entrepreneurship Development, should prioritize and fast-track registration of high-quality locally produced medicines, reducing import dependency and shielding our economy from global price rises.

¶ 07 Fourthly, greater transparency and accountability within the NMRA are essential. The processes of registration, approvals and pricing should be fully public, decisions based on scientific evaluation and subject to independent audits. Public confidence in the NMRA must be restored through openness and integrity.

¶ 08 The quality of drugs is also crucial. To evaluate quality, a quality control laboratory of international standard should be established. From my experience as a hospital administrator, we often received drugs from the MSD and days later were notified that certain batches were substandard and had to be withdrawn—causing financial loss and burdening patients.