South Africa has launched its National Action Plan (NAP) to tackle the ongoing threat of substandard and falsified medical products, a major step toward strengthening public health and regulatory collaboration. Introduced by the South African Health Products Regulatory Authority (SAHPRA) in partnership with the National Department of Health and the World Health Organization (WHO), the initiative seeks to address the growing crisis of fake and poor-quality medicines that endanger lives across the country and other low- and middle-income nations. WHO estimates that one in ten medical products in such regions is substandard or falsified, resulting in preventable deaths, treatment failures, and global health system losses amounting to over US$ 30 billion annually.
The NAP is built around three key pillars—prevention, detection, and response—designed to stop falsified medicines from entering the market, identify them quickly, and take decisive enforcement actions. These measures focus on protecting vulnerable populations and strengthening health security. Drawing from WHO’s Handbook on the Prevention, Detection and Response to substandard and falsified medical products, the plan also promotes regional cooperation, information sharing, and harmonized regulatory frameworks across Africa. SAHPRA’s CEO, Dr Boitumelo Semete-Makokotlela, emphasized that the initiative turns a fragmented challenge into a unified national effort, ensuring reliable access to safe medicines and empowering communities to report suspicious products.
The Johannesburg launch brought together government leaders, regulators, law enforcement, health experts, and civil society organizations, reflecting a strong national and international partnership. Health Minister Dr Aaron Motsoaledi underscored that fake medicines disproportionately affect the poor and that collective action is essential to protect lives and restore hope. The event showcased a united front against counterfeit medicines, reaffirming that safeguarding public health requires collaboration across sectors.
WHO praised South Africa’s leadership in addressing this health threat, highlighting that the NAP reinforces both national and global health security. Ms Shenaaz El-Halabi, WHO Country Representative, noted that the plan sets a regional precedent through its multi-sectoral approach, integrating government agencies, the private sector, academia, and civil society. WHO has played a vital role in shaping the NAP, ensuring alignment with global best practices and offering technical and operational support at all levels.
Mr Hiiti Sillo from WHO headquarters commended South Africa for demonstrating how strong national commitment and international cooperation can build safer healthcare systems. He emphasized that the NAP is not just a policy but a pledge to ensure only safe and effective medical products reach patients. The initiative will serve as a guiding model for other African countries, enhancing regulatory resilience across the continent and advancing WHO’s vision of universal access to quality-assured medicines.
