On 30 September 2025, South Africa launched its National Action Plan (NAP) to address the persistent threat of substandard and falsified medical products, marking a significant step toward safeguarding public health, protecting people’s health across South Africa and beyond, and strengthening regulatory collaboration
Unveiled by the South African Health Products Regulatory Authority (SAHPRA) in partnership with the National Department of Health and the World Health Organization (WHO), the NAP addresses a crisis that continues to harm and claim countless lives. According to WHO data, at least one in ten medical products in low- and middle-income countries (LMICs), including South Africa, is substandard or falsified. This leads to severe health complications, treatment failures and thousands of preventable deaths annually. Economically, rogue products cost global health systems an estimated US$ 30.5 billion each year and further deepen the financial burdens on South African households, already strained by rising healthcare costs and limited access to quality care.
Three pillars: prevention, detection, and response
In South Africa, where falsified and substandard medicines often masquerade as essential treatments for HIV, tuberculosis and chronic conditions, the NAP’s three pillar strategy, grounded in prevention at borders, rapid detection in supply chains, and decisive response through enforcement, aims to protect vulnerable populations from this silent threat. Anchored in the WHO draft Handbook on Prevention, Detection and Response to substandard and falsified medical products, the NAP represents a key milestone in the country’s health security agenda and stands as a model for regional collaboration across Africa, fostering the exchange of best practices and the harmonization of regulatory frameworks.
“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.”
Strengthened collaboration and a shared commitment to health security
The launch event, held in Johannesburg, gathered senior officials, regulators, industry representatives, law enforcement, civil society, and global health partners, reflecting the broad collaboration driving this national effort
“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.
