Sri Lanka is taking important steps to strengthen the safety and quality of medical products through the development of a National Action Plan (NAP) on substandard and falsified medical products, supported by the World Health Organization (WHO). A week-long in-country mission from 25 – 29 May 2026, by an international consultant with expertise in the area, brought together key stakeholders across the health sector and beyond, marking a critical milestone in the country’s efforts to safeguard public health.
/countries/sri-lanka/int-consultant-with-nmra-chairman.jpg?sfvrsn=f6691866_3 "The international consultant and WHO team in discussion with representatives of the National Medicines Regulatory Authority (NMRA), including the Chairman and the Chief Executive Officer.")
In Sri Lanka, the National Medicines Regulatory Authority (NMRA) is responsible for the regulation and control of registration, licensing, manufacture, importation and all other aspects pertaining to medicines, medical devices, borderline products and for the conducting of clinical trials in a manner compatible with the national medicines policy. One of its main objectives is to ensure availability of efficacious, safe and good quality medicines, medical devices and borderline products to the general public at affordable prices. However, challenges exist which are shaped by complex supply chains, reliance on imported medicines, and evolving market dynamics. The development of a comprehensive National Action Plan aims to provide a structured and coordinated national response aligned with WHO guidance and global best practices.
The mission was conducted at the request of the Government of Sri Lanka and commenced with a high-level meeting with the senior management of the NMRA. Discussions focused on strengthening regulatory and market control mechanisms and identifying priority actions to prevent, detect and respond to unsafe medical products.
A key feature of the mission was its strong emphasis on inclusive, multi-sectoral consultation. Over the course of the week, discussions brought together stakeholders from across the public sector, private sector, and professional communities.
Engagements with the Medical Supplies Division (MSD) and the State Pharmaceuticals Corporation (SPC) explored procurement processes and supply chain integrity which are critical components in preventing the entry of poor-quality products into the system.
/countries/sri-lanka/nmra---msd-discussion-with-int-consultant.jpg?sfvrsn=656995a0_3 "Discussions with the National Medicines Regulatory Authority (NMRA), Medical Supplies Division (MSD) and the State Pharmaceuticals Corporation (SPC).")
Consultations with professional bodies, including the Sri Lanka Medical Association and specialist colleges, highlighted challenges at the institutional and clinical levels. Frontline enforcement perspectives were also captured through discussions with Food and Drug Inspectors and law enforcement agencies such as Sri Lanka Customs who play a central role in surveillance and enforcement.
/countries/sri-lanka/meeting-with-sl-customs-representatives.jpg?sfvrsn=3e2543f6_3 "Representatives of Sri Lanka Customs providing insights on the need for heightened surveillance and coordinated action with the NMRA and other partners.")
Further engagements extended to the private sector including pharmaceutical importers, manufacturers, and pharmacy owners. These discussions provided valuable insights into magnitude of the problem and the importance of engaging with all relevant stakeholders in addressing the issue.
/countries/sri-lanka/meeting-with-private-sector.jpg?sfvrsn=79c38853_3 "Private sector representatives from the pharmaceutical industry providing perspectives about Sri Lanka’s current challenges in the space.")
Image 4 – Private sector representatives from the pharmaceutical industry providing perspectives about Sri Lanka’s current challenges in the space.
The draft National Action Plan (NAP) being developed adopts WHO’s Prevention, Detection and Response (PDR) framework, which provides a comprehensive approach to tackling substandard and falsified medical products.
• Prevention focuses on strengthening regulatory systems, securing supply chains, and promoting access to quality-assured products.
• Detection emphasizes risk-based surveillance, laboratory testing, and reporting systems to identify suspect products early.
• Response ensures rapid investigation, recall, enforcement, and risk communication to protect the public.
Based on document reviews and stakeholder feedback, the National Action Plan outlines strategic priorities such as strengthening post-marketing surveillance, enhancing laboratory capacity, improving border controls, and increasing public awareness. It promotes a multi-sectoral approach involving health authorities, regulatory bodies, law enforcement, industry, and communities.
The mission concluded with a final debriefing with the Chairman, Chief Executive Officer, and senior officials of the NMRA. This meeting helped consolidate key findings from the consultations and identify next steps towards finalizing the National Action Plan and its implementation roadmap.
/countries/sri-lanka/group-photo-with-nmra-senior-reps-and-team.jpeg?sfvrsn=481accba_3 "A group photo with the international consultant, NMRA team, and WHO team after the final debriefing on the National Action Plan (NAP).")
The outcomes of the mission underscore the importance of sustained collaboration across sectors and all levels of the health system. By bringing together diverse stakeholders, the process has helped ensure that the Action Plan is grounded in national realities, responsive to existing challenges, and aligned with global standards. Once finalized and implemented, it will provide a robust framework for coordinated national action to ensure that all people have access to safe, effective, and quality medical products.
WHO remains committed to support the efforts of the Government to strengthen regulatory systems, improve access to quality-assured medicines, and protect populations from substandard and falsified medical products.