Also included are industry partners and pharmaceutical companies, academic institutions offering research and training support, civil society and patient advocacy groups and the South African National Aids Council
Health
South Africa’s collaborative answer to fighting substandard and falsified medical products
The launch of the National Action Plan serves as a reminder of what is possible when institutions, partners, and communities collaborate, writes Dr Boitumelo Semete-Makokotlela
On 30 September 2025, South Africa took a decisive step in defending the health of its people. The country launched our National Action Plan (NAP) to combat substandard and falsified (SF) medical products which is a plan that has been almost a year in the making, built on consultation, collaboration, and a simple yet urgent truth which is that fake medicines are not just a nuisance, they are a deadly threat to public health, the economy, and our collective trust in healthcare systems.
The milestone reached, therefore, should not be treated as another bureaucratic achievement. It must be understood for what it is, a necessary shield in the face of a global epidemic of unsafe medicines that has already claimed the lives of children, shattered families, and put entire communities at risk across the continent and the world.
The World Health Organization’s (WHO) Global Surveillance Monitoring System has reported a steady rise in incidents of falsified medicines across Africa. In the Gambia, dozens of children died after consuming contaminated cough syrups. Those deaths were not accidents, and they could have been prevented as they were the direct result of unscrupulous actors exploiting weak regulatory systems and vulnerable populations. South Africa is unfortunately not immune to these occurrences.
SAHPRA’s data paints an equally disturbing picture. During the 2021/2022 reporting period, the organisation received 130 product quality complaints that required investigation. The following year, the number more than doubled to 297. By 2023/2024, it had escalated to 430. For the most recent year, 2024/2025, the figure has already risen to a staggering 507. Each of these cases represents a potential patient who might have consumed a dangerous product. Each investigation represents time, resources, and risk. Most importantly, each one represents an erosion of trust.
And let us be clear about what we are dealing with. Raids conducted with law enforcement have uncovered falsified products ranging from so-called weight-loss injections containing Glucagon-Like Peptide-1 (GLP-1) components, to sexual enhancers, to skin bleaching creams laced with corticosteroids, and anabolic steroids disguised as supplements. These are products regulated under the Medicines Act and require market authorisation, safety checks, and medical supervision. Yet they are being smuggled into our communities, sold online, and pushed on desperate people searching for quick fixes.
The economic cost of this trade is estimated at $30.5 billion by the WHO. Illicit markets undercut legitimate businesses, exploit patients, and place a financial burden on our healthcare system when people fall ill from consuming unsafe products. However, even more significant is the invisible cost of the slow erosion of trust. When communities lose faith in medicines, in regulators, and in the health system itself, the entire social contract begins to unravel.
This is why the launch of South Africa’s National Action Plan is so significant. Our country was selected by the World Health Organization to pilot its Draft Handbook for National Action Planning for Prevention, Detection and Response Strategies on SF medical products. This was not by accident. It was an acknowledgement of South Africa’s role as a regulatory leader on the continent, and of our commitment to finding solutions that other nations can adopt.
The handbook clearly states that combating falsified medical products requires political will, resources, and sustained, coordinated action. It cannot be left to regulators alone and requires law enforcement to be vigilant, healthcare professionals to educate patients, industry to maintain high standards and transparent supply chains, civil society and the media to shine a light on risks. Most importantly, it requires ordinary citizens to resist the temptation of unverified products and to demand accountability.
Through the NAP process, we have built a structure to deliver precisely this kind of coordinated action. A steering committee was established, supported by four sub-committees focused on education and awareness, enforcement, infrastructure, and supply chain integrity. Over the past year, these teams have worked tirelessly, engaging with stakeholders and presenting their progress at global forums in Geneva, Vienna, Nairobi, and Addis Ababa, gathering lessons that strengthen our collective response.
South Africa is stepping into this role with seriousness. The launch of the NAP marks the culmination of this work, but it is also only the beginning. Implementation is what matters. Our country currently chairs the WHO Member State Mechanism on SFs, as well as the SADC SF Focal Points committee. Later this year, we will present our NAP to the 14th meeting of the Member State Mechanism in Geneva. This will be presented as a result of a collaborative effort that is vital to our success, as emphasised by the Minister of Health, Dr Aaron Motsoaledi, at the launch.
But we must also be honest about the environment we are confronting. The demand for falsified medicines is increasing rather than decreasing and rising societal pressures around body image fuel the demand for unsafe weight-loss products. Economic hardship drives people toward cheaper, unregulated alternatives. The internet provides fertile ground for counterfeiters who exploit anonymity and weak enforcement. In this environment, fighting falsified medicines is not just about seizing boxes of illegal pills. It is about shifting behaviour, changing incentives, and closing the gaps that criminals exploit.
We must recognise, too, that this is ultimately about power and justice. Fake medicines disproportionately harm the poor, the desperate, and the marginalised. They prey on people with the least access to quality healthcare, the least ability to question what they are given, and the least recourse when things go wrong. To fight falsified medicines, therefore, is to fight inequality. It is to insist that safe, effective healthcare should not be a privilege but a right.
For SAHPRA, every counterfeit medicine removed from circulation is a victory; however, every new case reported reminds us how much more must be done. That is why we cannot afford to be complacent. Our vigilance must be relentless, our enforcement uncompromising, and our commitment to protecting the public unshakable.
The launch of the National Action Plan serves as a reminder of what is possible when institutions, partners, and communities collaborate. It is a call to every South African to be part of the solution by questioning suspicious products, by reporting concerns, and by trusting the system designed to protect them. Fake medicines are more than a health issue. They are a test of whether we can build a society where trust in our institutions is restored, where the vulnerable are protected, and where every life is valued. SAHPRA’s key mandate is the safety of all those who live in South Africa. This NAP is a step in the right direction.
Dr Boitumelo Semete-Makokotlela is the CEO of SAHPRA.