South Africa is facing a critical juncture with the influx of illicit, compounded, substandard or falsified medicines, particularly in relation to GLP-1s, the medicines invented to combat the dual epidemic of obesity and type 2 diabetes.
This urgent situation prompted the South African Health Products Regulatory Authority (Sahpra) to launch a national action plan (NAP), backed by the World Health Organisation (WHO), last month.
It will be implemented between 2026 and 2030. It directly responds to the escalating threat of substandard and falsified medical products. These products not only jeopardise the progress made through scientific breakthroughs but also compromise the fundamental principles of health care: patient safety and wellbeing.
The pillars of the NAP stretch from surveillance and border control to supply-chain oversight, drawing in customs, law enforcement, the judiciary, importers, distributors, health providers, patients and procurement agencies to shut down unsafe channels before products reach the public.
These dangerous medicines fall into three categories. First, there are illicitly compounded versions: treatments mixed in unregulated spaces, bypassing the rigorous standards that regulators demand to ensure sterility, consistency and safety. Second, there are counterfeits: lookalikes that claim to be legitimate but contain the wrong ingredient, no active ingredient at all, or substances that may be toxic. Finally, there are mislabelled or adulterated products, which carry misleading information or conceal harmful additives.
Illicitly compounded medicines differ from counterfeits. While counterfeits mimic branding with the wrong or no active ingredient, compounded versions are unapproved mixes that bypass approval, manufacturing and quality controls.
Regulatory authorities have confirmed that adverse side-effects, including hospitalisation and deaths, have already been linked to these unapproved products. In one jurisdiction where we operate, the US, an FDA article this year reports 857 adverse side-effects associated with compounded semaglutide, many requiring hospital treatment, and 15 deaths, referenced in a local media report. Moreover, a 2024 WHO article states that at least one in 10 medicines in low- and middle-income countries are substandard or falsified.
The illicit trade in compounded medicines, as well as the substandard or falsified trade in South Africa, has grown into a crisis. Regulatory and media investigations have revealed that illegal medicine operators are supplying more than 5,000 patients every month in a single province, openly packaging products with labels that they admit are "not approved by Sahpra".
One legal case centres on a compounding outfit accused of distributing these unregistered treatments to thousands of people despite repeated regulatory warnings that their safety, efficacy and quality have never been assessed.
In 2021, according to Medicalbrief, Sahpra received roughly 130 reports of substandard and falsified medical products. By 2022, the number had more than doubled to 297. In 2023, it rose again to around 430. As of August 2025, the regulator had already received 507 reports: a sharp and worrying climb. According to Sahpra’s hotline data, much of this surge can be traced to dodgy e-commerce platforms and spaza shops. While these numbers by themselves are concerning, the cases that are never reported or captured are equally worrying.
These illicit products are not subject to the same post-marketing surveillance criteria as regulated products, known as pharmacovigilance. Therefore, one can expect that the underlying shadow numbers are, in fact, much higher. The sad truth is that it is only a matter of time before someone suffers the ultimate consequences of these illicit products if urgent action is not taken to remove them.
Recent laboratory analyses have exposed worrying gaps between approved medicines and their illicitly compounded copies. Scientists found that some of these products contained hidden impurities such as metals and chemical residues that were absent in the originals. Others had far less of the active ingredient than the label claimed, meaning they would not work as intended. In some instances, the medicines even clumped together, raising the risk of serious side effects, including hospitalisation or death.
These findings highlight the gamble patients take when using illicitly compounded treatments instead of properly tested, Sahpra-approved medicines. A gamble not only about safety, but also about the lack of efficacy and the failed hopes of a healthier life. In short, compounded copies may be weak, contaminated and/or dangerously unstable.
Spotting illicit, compounded, substandard or falsified medicines is not always straightforward. Still, there are clear warning signs, which can be put into two categories.
Packaging is often the first clue. Legitimate products carry Sahpra-approval details. The source of purchase is just as important. Licensed pharmacies must dispense prescription medications only upon a valid prescription, with no exceptions. Adverts promising "instant" or "guaranteed" weight loss are equally troubling, since no responsible health-care professional would make such claims.
The product’s appearance can also betray its origins: poor-quality labelling, spelling mistakes, missing safety seals, absent leaflets or lot numbers, and broken cold-chain packaging are all clear warning signs. Finally, it is only the approved and original GLP-1s that contain the active ingredients — semaglutide and tirzepatide — that are scientifically proven and approved by regulatory authorities for treatment.
We stand firmly behind the regulators because patient safety is our top priority. Only science-based medicines, tested in rigorous trials and approved by regulators, can be trusted.
GLP-1s require a prescription from a doctor and can be collected at or delivered by a pharmacy. This is not a consumer good product that can be purchased online or via social media. However, online doctors do exist and may prescribe medications based on a comprehensive online consultation. The "health-care professional locator" has been created to assist patients to find a doctor — whether physically or online — who is certified and committed to weight management treatment.
Illicit medicines are not a harmless grey area but an aberration to ethical medical practice. When criminal networks circumvent the rules of safe practice, they not only put lives at risk but erode the moral foundations of medicine. We urge the public to be vigilant, to honour their bodies, resist these dangerous shortcuts and recognise the warning signs. While product regulators and law enforcement go toe-to-toe with drug lords who trade in human suffering, every individual choice to report becomes part of the fight to protect lives. Your role in this fight is vital.
If you want more information about weight management, based on science and with tools to assess your health and access help from a doctor today, visit Novo Nordisk www.TruthAboutWeight.co.za.
• Lind-Hansen is the director of legal, ethics, compliance and quality, Novo Nordisk South Africa
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