Sri Lanka strengthens capacity to investigate substandard and falsified medical products

The National Medicines Regulatory Authority (NMRA), with support from the World Health Organization (WHO), conducted a workshop in Colombo in July 2026 to strengthen national capacity to investigate incidents involving substandard and falsified (SF) medical products. The workshop brought together regulators, technical experts and representatives of key institutions involved in preventing, detecting and responding to SF medical products, with the aim of enhancing investigation practices, improving inter-agency coordination and supporting evidence-informed regulatory action to protect patients and communities.

Prof. Ananda Wijewickrama, chairman of the National Medicines Regulatory Authority (NMRA) of Sri Lanka speaking at the workshop in July 2026.

Substandard and falsified medical products pose a significant threat to patient safety and public confidence in health systems. They can contribute to treatment failure, adverse events, antimicrobial resistance, economic losses and reduced trust in health services. Strong market surveillance and timely investigation of suspected incidents are therefore essential to an effective regulatory system.

The workshop reflects WHO’s continued technical support to strengthen Sri Lanka’s regulatory system. Since the WHO Global Benchmarking assessment in 2018, Sri Lanka has taken important steps to improve core regulatory functions. More recently, WHO supported NMRA in developing a draft National Action Plan and communication strategy to address the risks associated with SF medical products.

The workshop was facilitated by three experts from the WHO South-East Asia Regional Office (SEARO) and WHO headquarters, two of whom participated in person. They shared global and regional experience, technical guidance and practical approaches to strengthen the investigation of incidents involving SF medical products.

Adrien Inoubli, Unit Head - Medical Products Quality & Regulation, WHO SEARO speaking on complaint investigation & reporting during the workshop with NMRA in July 2026

A key focus of the workshop was Sri Lanka’s current system for investigating and reporting SF medical products, and opportunities to strengthen collaboration among agencies responsible for protecting the medical product supply chain. Discussions covered key areas such as risk-based surveillance, complaint investigation & reporting and product recall oversight. The roles of Sri Lanka Customs, law enforcement authorities, the Medical Supplies Division of the Ministry of Health and the State Pharmaceuticals Corporation were also discussed, highlighting the importance of coordinated action across regulatory and enforcement systems.

Participants of the substandard and falsified products investigations workshop in July 2026.

The workshop adopted a practical and interactive approach. Participants took part in simulation exercises and case studies based on recent incidents investigated by NMRA. Through these exercises, they applied investigation principles to realistic scenarios, assessed evidence, identified information gaps, conducted risk assessments and prepared investigation reports. WHO experts reviewed participants’ reports and provided technical inputs to strengthen investigation methods, improve documentation and enhance the quality of evidence used in regulatory decision-making.

Dr Anita Sands, Technical Officer, Market Surveillance and Control Team, WHO headquarters, conducting a technical session at the workshop in July 2026. 

The workshop also contributed to refining NMRA’s investigation report template and generated feedback to guide future capacity-building activities. Sessions also addressed market surveillance and investigation approaches for medical devices and in vitro diagnostics. Participants also examined how investigation findings can inform regulatory responses that protect patients and help prevent safety related incidents.

By the end of the workshop, participants had enhanced their skills in conducting investigations, analyzing evidence, assessing risks and preparing investigation reports. The training reinforced the importance of timely detection, inter-agency collaboration and evidence-informed regulatory action to prevent harm and maintain confidence in health systems.

WHO remains committed to supporting NMRA and national partners to strengthen regulatory systems and market surveillance functions. Through continued collaboration, Sri Lanka is advancing its capacity to prevent, detect and respond to substandard and falsified medical products, helping to ensure that people have access to safe, effective and quality-assured medical products.

With a closing message, WHO Representative to Sri Lanka, Dr Rajesh Sambhajirao Pandav reiterated:

“Access to safe, effective and quality-assured medical products is fundamental to universal health coverage and public trust in the health system. Strengthening the capacity to prevent, detect and respond to substandard and falsified medical products is therefore a critical public health priority. WHO remains committed to supporting Sri Lanka in building resilient regulatory systems that protect people’s health.”