Fake and substandard medicines, along with bogus healthcare practitioners, pose a growing threat to patient safety in South Africa.
The sale of fake and substandard medicines is a significant threat to patient safety around the world. In South Africa, the main affected products are painkillers, antibiotics, weight-loss and sexual enhancement products, skin-lightening products, and some chronic medicines.
In pealing back the different layers of this problem, it is essential to get the definitions right.
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Substandard products are those that do not meet quality standards and specifications.
Falsified products deliberately misrepresent their identity, composition or source.
Neither of these should be confused with generic medicines, which have the medicines regulator's green light for being safe, effective, and of good quality.
People are often duped into purchasing substandard and falsified products, especially when the real thing is not available or too expensive. But, as Elna Schütz this week reports for Spotlight, there are also people who buy these medicines fully aware of the risks.
FAKE MEDS | From unregulated weight loss injections to unsafe pain tablets, substandard and falsified medical products pose a threat to people's health. Spotlight reports on how regulators are fighting the problem in South Africa.
www.spotlightnsp.co.za/2026/05/20/f...
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These unregulated medicines are mostly distributed through informal channels, unregulated outlets, online platforms, and cross-border smuggling networks. It is also possible that some substandard and falsified medicines have been infiltrated into otherwise reputable medicines distribution channels.
Data on the scale of the problem is scant, but there is agreement that the problem is substantial. The WHO estimates that around 1 in 10 medicines in low- and middle-income countries are substandard or falsified.
The South African Health Products Regulatory Authority (SAHPRA) is the main body responsible for regulating substandard and falsified medicines. It does this through post-market surveillance and inspections, a whistleblower reporting system, product recalls, and monitoring illegal advertising and online sales. A new National Action Plan and comments from the Minister of Health suggests there is some intent to step up these efforts.
What of regulated medicines?
In two separate columns for Spotlight, Dr Andy Gray looked at the broader issues of the quality of medicines and sanctions for non-compliance with medicines legislation.
#InsideTheBox | In his regular Spotlight column, Dr Andy Gray explores key issues affecting South Africa's healthcare and pharmaceutical sectors. Take a look at some of his recent columns: www.spotlightnsp.co.za/special-inve...
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The good news is that we can generally trust that the medicines we buy at pharmacies contain what they are supposed to and that they were manufactured according to good quality standards. As regulatory entities go in South Africa, SAHPRA is generally one of the better-functioning ones.
But, outdated legislation means that SAHPRA doesn't have all the tools it needs to stamp out the sale of unauthorised medicines. For instance, it has limited powers in relation to advertising and marketing, cannot block a web site, and cannot issue infringement notices, or impose sanctions on entities or individuals whose actions potentially place the public at risk of harm.
Fake health professionals
Falsified medicines are not the only misrepresentations that should concern us in the health sector. Spotlight recently reported that South Africa is also battling the problem of bogus health practitioners. The issue goes beyond people pretending to be doctors and can include physiotherapists, interns, or anyone else treating patients without being properly qualified or registered.
The misrepresentation may include using fraudulent certificates, using another practitioner's registration, or still offering healthcare services while being suspended or erased from the register.
ICYMI | The controversy over bogus doctors gained widespread attention in late 2023 when it was discovered that 'TikTok doctor' Matthew Lani lied about being a medical doctor.
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From early 2024 through late 2025, 66 bogus practitioners were caught and arrested, with the majority operating in the economic hubs of the Western Cape, Gauteng, and KwaZulu-Natal.
You can help curb these problems. Suspicious practitioners can be reported to the HPCSA, and suspicious products or sellers can be reported to SAHPRA. People are also advised to buy only from licensed and authorised pharmacies and checking if healthcare providers are registered.
And then there is fake news
In some areas, as with bogus health professionals and falsified medicines, the solution to misrepresentation is clearly to have legally empowered regulators with enough muscle to consistently enforce the law.
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But when it comes to misinformation and disinformation - call it fake news if you will - the way forward is much less obvious. In recent years, we've seen a toxic mix of political polarisation, conspiracy theories, disinformation campaigns, and twisted social media algorithms - often fuelling a rejection of science and evidence-based policy-making. Beyond just our screens, these trends have unfortunately started to distort the real world, as we've seen at various critical health institutions in the United States.
In our view, regulators should have a role in preventing misinformation and disinformation about medicines. But how exactly to make such regulation work in an age of largely unaccountable social media networks is not at all clear.
What we think is clear, is that much of the solution to the problem of health misinformation and disinformation, is simply to keep creating its opposite, high-quality, rigorous, and evidence-based journalism.
This is the core of what we try to do at Spotlight. It is also why we have made our journalism subject to the South African Press Code, work hard to stick to our Editorial Policy and Style Guide, and why we urge you to hold us accountable when we get things wrong, as we will inevitably do from time to time.
Please always feel free to get in touch at Editors@SpotlightNSP.co.za.
