By Elna Schütz
From unregulated weight loss injections to unsafe pain tablets, substandard and falsified medical products pose a threat to the health of people.
“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.”
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, manager of regulatory compliance, says.
“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 Organisation (WHO) Country Office in SA.
“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 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.
SA also appears to have rising rates.
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 there is no 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
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 health-care system and individuals are multi-faceted.
“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 health-care 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
Fafudi from Sahpra 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 police 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, 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 health-care providers.
“Be cautious of unusually low prices, miracle cure claims, and poor packaging,” Fafudi warns. “Always check packaging, expiry dates, and consult health-care professionals before use.”
Suspicious products or sellers can be reported on the SAHPRA website.
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.
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.
- Not her real name