From unregulated weight loss injections to unsafe pain tablets, substandard and falsified medical products pose a massive health threat. For Spotlight, Elna Schütz reports on how regulators are taking on the problem in South Africa.
Weight-loss medicines are among several types of health products frequently purchased outside formal channels, according to the South African Health Products Regulatory Authority (SAHPRA), with Mokgadi Fafudi, manager of regulatory compliance, adding that others include painkillers, antibiotics, weight-loss and sexual enhancement products, skin-lightening products, and some chronic medicines.
“Combating the threat of substandard and falsified medical products is one of the urgent global challenges of this decade,” said Faridun Nazriev, the external relations and communications officer at the World Health Organisation (WHO) country office in South Africa.
The WHO defines substandard products as those that do not meet quality standards and specifications, often due to poor manufacturing practices or inadequate quality control, while falsified medical products deliberately misrepresent their identity, composition or source, and are often created and distributed with the intent to deceive consumers for financial gain.
Two other definitions should not be confused with these, cautioned 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 said 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 one 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 noted that 101 health product quality complaint reports were filed. In 2022/23, that figure nearly tripled to 297.
Fafudi said the organisation received 588 reports of possible non-compliance in the 2024/2025 year, and that for the 2025/26 year, the number exceeds 570 cases, though this has not yet been published by SAHPRA.
But such reports may be only the tip of the iceberg. Gray lamented 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 said these medicines are often sold through informal markets, unregulated outlets, online platforms, and cross-border smuggling networks.
Gray added that they aren’t necessarily always sold through informal means. “They may be infiltrated into wholesalers or state medicine depots, and then distributed, or sold directly to pharmacies or prescribers and then sold to patients.”
A threat to patients
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, noting 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. In South Africa, porous borders and rising costs also play a role, she said.
Whatever the reasons behind their proliferation, the risks to the healthcare system and individuals are multi-faceted.
“Substandard and falsified medicines are a serious threat to patient safety and public trust,” said Refiloe Mogale, executive director for the Pharmaceutical Society of South Africa (PSSA). “These products can lead to treatment failure, harm, or even death.”
It also adds to the growing problem of antibiotic resistance if antibiotics are substandard, Mogale added, and further strains 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
SAHPRA is responsible for regulating substandard and falsified medicines in this country, and Fafudi said it conducts post-market surveillance and inspections, runs a whistleblower reporting system, manages product recalls, and monitors illegal advertising and online sales.
SAHPRA also works with specialised units in the South African Police Service as well as other stakeholders like Customs to enforce joint operations. Fafudi said 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 said. “The system is overwhelmed by the speed and sophistication of the problem.”
Reporting unregulated products
SAHPRA and Fafudi say the public can help by buying only from licensed and authorised pharmacies and healthcare providers.
“Be cautious of unusually low prices, miracle cure claims, and poor packaging,” Fafudi warned. “Always check packaging, expiry dates, and consult professionals before use.”
Suspicious products or sellers can be reported on the SAHPRA website, but Jas Bhana, CEO of the Innovative Pharmaceutical Association of South Africa, added that suspicious products could also be reported to the National Department of Health or the nearest pharmacy.
“Combating this threat requires collective vigilance to safeguard every patient’s right to safe, quality, and effective medicines,” she said.
Nazriev said the WHO prioritises prevention, detection, and response as the main pillars of action, and 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.”
Better regulation
Gray acknowledged the challenge in budgets and laboratory capacity, but even so, called 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 reporting to the public on their findings," he suggested.
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,” Fafudi said.
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 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 remains to be seen.
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