On 30 September 2025, South Africa took a major step to strengthen public health protection with the launch of its National Action Plan (NAP) to combat substandard and falsified medical products. The initiative aims to safeguard communities across the country and enhance regulatory cooperation across borders.
The plan was jointly introduced by the South African Health Products Regulatory Authority (SAHPRA), the National Department of Health, and the World Health Organization (WHO). It targets a global health crisis that continues to endanger lives — WHO estimates that at least one in ten medical products in low- and middle-income countries, including South Africa, are substandard or falsified. These unsafe products contribute to serious health complications, treatment failures, and thousands of avoidable deaths each year. Economically, they drain an estimated US$30.5 billion annually from global health systems and worsen financial strain on South African families already coping with high healthcare costs.
Built on three pillars — prevention, detection, and response — the NAP outlines a coordinated strategy to stop falsified and substandard medicines, particularly those posing as critical treatments for HIV, tuberculosis, and chronic diseases. The plan focuses on stronger border controls, rapid supply chain surveillance, and decisive enforcement action.
Guided by the WHO draft Handbook on Prevention, Detection and Response to Substandard and Falsified Medical Products, the NAP marks a milestone in South Africa’s health security agenda. It also serves as a blueprint for regional cooperation across Africa, promoting shared learning and harmonized regulatory standards to combat the growing threat of unsafe medicines.
“This launch is more than a milestone as it is a lifeline for our people and a blueprint for Africa,” said Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA. “Through unwavering collaboration, we’ve transformed a fragmented challenge into a unified front, ensuring that every family, from rural clinics to urban pharmacies, can access medicines they can trust. The NAP will not only detect and destroy fake products but empower communities to report threats, turning passive victims into active guardians of health.”
The Johannesburg launch brought together senior government officials, regulatory authorities, industry leaders, law enforcement agencies, civil society representatives, and global health partners — underscoring the collective commitment and cross-sector collaboration powering this national initiative.
“Fake medicines don’t discriminate! They strike the poorest the hardest, stealing futures from our children and hope from our elders,” said Minister of Health Dr Aaron Motsoaledi in his keynote address. “Today’s commitments from across government, industry, and civil society affirm that no single entity can win this war alone. South Africa stands ready to lead, but we triumph together, protecting every African life from this scourge.”
This collaboration embodies the shared responsibility of ensuring every patient, everywhere, can access safe, effective, and quality-assured medical products they can trust.
“The launch of South Africa’s National Action Plan (NAP) against substandard and falsified medical products marks a pivotal step in the country’s commitment to strengthening health systems and safeguarding public health. The implementation of the NAP is not only vital to ensuring the safety, quality, and efficacy of medical products but also to reinforcing public trust in health institutions and advancing national and global health security,” said Ms Shenaaz El-Halabi, Country Representative WHO South Africa. “South Africa’s NAP is a clear demonstration of the power of multi-sectoral collaboration bringing together government agencies, regulators, healthcare providers, law enforcement, the private sector, academia, and civil society. By addressing the issue through a structured, national framework, South Africa is setting a strong precedent in the region. WHO reaffirms its support for the successful implementation of this plan and stands ready to continue its collaboration with national stakeholders.”
WHO was instrumental in shaping and supporting South Africa’s NAP to address substandard and falsified medical products, ensuring alignment with global standards and best practices, and providing coordinated technical, strategic and operational support across its headquarters, regional, and country levels.
“WHO stands with South Africa and all its Member States in the fight against substandard and falsified medical products. These products steal trust, waste resources, and most tragically, cost lives. By investing in strong regulatory systems and coordinated national action plans, we are laying the foundation for safer health care and restoring confidence in the medicines people depend on every day,” said Mr Hiiti Sillo, Unit Head of Regulation and Safety, Regulation and Prequalification Department, in Health Systems, Access and Data Division at WHO headquarters. “South Africa’s leadership in piloting the WHO handbook shows what is possible when commitment meets collaboration. This national action plan is more than a document — it is a promise to patients that only safe, effective, and trusted medical products will reach them. Let this inspire other countries to act boldly and ensure that no life is lost to preventable failures.”
South Africa’s NAP will guide future national plans across Africa, reinforcing the continent’s regulatory resilience and advancing WHO’s goal of universal access to safe, effective, and quality-assured medical products.