From unregulated weight loss injections to unsafe pain tablets, substandard and falsified medical products pose a threat to the health of people. Spotlight reports on how regulators are fighting the problem in South Africa.
"I know that there is a risk, but at this point I feel that the benefits outweigh everything else," says Anna*, who buys unregulated medicine on the black market.
She was prescribed GLP-1 RA medicines by a doctor after being tested for insulin resistance. She has lost around 30kg and says the positive impact on her body, life, and self-esteem has been massive. GLP1 RAs (Glucagon-Like Peptide-1 Receptor Agonists) medicines, sold under brand names like Ozempic and Mounjaro, are increasingly used for weight loss and to prevent and/or treat diabetes.
When global shortages affected GLP-1 RA stocks in local pharmacies, Anna started buying similar drugs directly from unregistered sellers. For around R1 650, a fancy-looking box with a three-month supply of injections is delivered to her in a small cooler box. "I knew then already that what I was buying was unregulated and potentially inferior or even dangerous," she says, adding, "but I was finally starting to feel good about myself."
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Apart from being aware that the unregulated drugs could potentially harm her, Anna says she found that the regulated products were often out of stock, expensive, and came with stigma from pharmacists who quizzed her on whether she deserved the products. "If I could have kept doing it the proper way, I would have, but there were just too many obstacles," she says.
Defining the problem
Weight-loss medicines are only one of several types of health products that are frequently purchased outside of formal channels, according to the South African Health Products Regulatory Authority (SAHPRA).
"Commonly affected products include painkillers, antibiotics, weight-loss and sexual enhancement products, skin-lightening products, and some chronic medicines," Mokgadi Fafudi, SAHPRA's manager of regulatory compliance, tells Spotlight.
"Combating the threat of substandard and falsified medical products is one of the urgent global challenges of this decade," says Faridun Nazriev, the external relations and communications officer at the World Health Organization (WHO) Country Office in South Africa.
"Substandard products are those that do not meet quality standards and specifications, often due to poor manufacturing practices or inadequate quality control. Falsified medical products deliberately misrepresent their identity, composition or source", according to the WHO. These products, it adds, are often created and distributed with the intent to deceive consumers for financial gain.
Two other definitions should not be confused with these, cautions Dr Andy Gray, a senior lecturer in Pharmacology at UKZN and co-director of the WHO Collaborating Centre for Pharmaceutical Policy and Evidence-Based Practice.
Compounded medicines are custom formulations that may be specific to a patient, but are generally not registered by SAHPRA.
Generic medicines are those that have been tested and found to be as safe and effective as originator medicines, but are generally cheaper. Generic medicines on the market have been approved by SAHPRA and are not in any way substandard.
Gray says the term counterfeit is no longer used by the WHO, because it refers specifically to breaches of intellectual property, like trademarks.
Lack of data
While the WHO estimates that 1 in 10 medicines in low-and middle-income countries are substandard or falsified, all regions are affected and have been seeing an increase, according to a 2024 report from the WHO's Global Surveillance and Monitoring System.
South Africa also appears to have rising rates. SAHPRA's 2021/2022 annual report notes that 101 health product quality complaint reports were filed. In 2022/23, that figure nearly tripled to 297.
Fafudi says that the organisation received 588 reports of possible non-compliance in the 2024/2025 year. She says that for the 2025/26 year, this number exceeds 570 cases, though this has not yet been published by SAHPRA.
But such reports are likely only the tip of the iceberg. Gray laments that we don't have the full picture of how big the problem of substandard and falsified medical products really is.
This is partly because, by its very nature, the sale of substandard and falsified medicines is usually hidden. Fafudi says that these medicines are often sold through informal markets, unregulated outlets, online platforms, and cross-border smuggling networks.
Gray adds that these medications aren't necessarily always sold through informal means. "They may be infiltrated into wholesalers or state medicine depots, and then distributed," he says, "Or they may be sold directly to pharmacies or prescribers and then sold to patients."
A threat to patients
As in Anna's experience with GLP-1 RAs, there is often a demand for unregulated products because the properly regulated products can't meet the public demand.
Fentse Maseko, who works in the Department of Pharmacology and Pharmacy at Wits University, researched this issue in her Master's thesis and advocates in the space. She notes that in many low- and middle-income countries, particularly in remote and underserved areas, limited access to medicines may force patients to seek treatment from informal markets. She adds that in South Africa, porous borders and rising costs also play a role.
Whatever the reasons behind their proliferation, the risks to the healthcare system and individuals are multi-faceted.
#InsideTheBox | The sale of illegal medicines is a significant threat to public safety. Does the South African Health Products Regulatory Authority have the necessary tools to provide protection in this area, asks Dr Andy Gray in his latest column.
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"Substandard and falsified medicines are a serious threat to patient safety and public trust," says Refiloe Mogale, the executive director for the Pharmaceutical Society of South Africa (PSSA). "These products can lead to treatment failure, harm, or even death."
Maseko warns that it can also add to the growing problem of antibiotic resistance if antibiotics are substandard. It can also strain the healthcare system when second or third-line treatments are needed for issues initially addressed with unregulated products, or caused by them.
The role of the regulator
The main body in South Africa responsible for regulating substandard and falsified medicines is SAHPRA. Fafudi explains that they conduct post-market surveillance and inspections, run a whistleblower reporting system, manage product recalls, and monitor illegal advertising and online sales.
SAHPRA also works with specialised units in the South African Police Service as well as other stakeholders such as customs to enforce joint operations. Fafudi says such joint operations have been conducted on at least a monthly basis.
There are also legal actions, including issuing warnings, seizing or destroying products and criminal prosecution. According to the Medicines and Related Substances Act 101 of 1965, fines or prison sentences not exceeding 10 years may be prescribed.
The PSSA however charges that not enough is being done. "Key gaps are visible in insufficient regulatory capacity, weak border control, limited enforcement scale and the under-resourced National Action Plan," Mogale says. "The system is overwhelmed by the speed and sophistication of the problem."
Reporting unregulated products
The public can help address the problem of substandard and falsified medicines. SAHPRA advises buying only from licensed and authorised pharmacies and healthcare providers.
"Be cautious of unusually low prices, miracle cure claims, and poor packaging," Fafudi warns. "Always check packaging, expiry dates, and consult healthcare professionals before use."
Suspicious products or sellers can be reported on the SAHPRA website.
Jas Bhana, Chief Executive Officer of the Innovative Pharmaceutical Association of South Africa, adds that the public can also report suspicious products to the National Department of Health or their nearest pharmacy. "Combating this threat requires collective vigilance to safeguard every patient's right to safe, quality, and effective medicines," she says.
This goes hand-in-hand with the need for consumers to know the dangers, Maseko explains. "While public education plays an important role in mitigating this risk, effective risk communication remains a challenge, particularly in communities with limited health literacy," says Maseko.
BEHIND THE PRICE TAG | Unregulated launch prices. Hidden fees. Stark differences between public and private sector costs. Our medicine pricing framework may look robust, but there are gaps and grey areas. Find out more: tinyurl.com/2s3ftnbe
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On a bigger scale, Nazriev explains that the WHO prioritises prevention, detection, and response as the main pillars of action. This includes local regulation as well as collaboration between countries.
"Given the transnational nature of globalised medical product supply chains as well as criminal networks, collaborating across borders and sectors is essential to national, regional and global responses," he says.
Better regulation
Gray acknowledges that there is a challenge in budgets and laboratory capacity, but even so he calls for more to be done. "SAHPRA needs to move from a largely reactive stance to a more proactive one, sampling medicines from the distribution chain and submitting them for checking, and then report to the public on their findings," he suggests.
The PSSA recommends implementing a national medicine registry with a track-and-trace system and stricter control of online medicine sales, including mandatory certification and monitoring.
SAHPRA is already planning along some of these lines. "Future plans include strengthening supply chain traceability, enhancing detection systems, regulating online medicine sales, and increasing public awareness campaigns," says Fafudi.
Part of this direction comes from a National Action Plan (NAP), launched late last year by SAHPRA, with support from the National Department of Health and the WHO.
"All actors within the supply chain, particularly at key pinch points in both the public and private sectors, must be equipped with the knowledge, skills, and equipment to identify and report suspicious products to SAHPRA," Health Minister Dr Aaron Motsoaledi is reported to have said at the launch of the NAP. "All activities should mitigate the risk of substandard and falsified medical products. This includes increased vigilance at ports of entry, through to post-market surveillance of high-risk products, inspection of manufacturers, distributors and wholesalers."
Whether all this will be done, and what it will mean for people like Anna who knowingly choose to use unregulated medicines, remains to be seen.
*Not her real name
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