South Africa’s medicines watchdog is warning that Substandard And Falsified Medicines are becoming a bigger public health risk. The South African Health Products Regulatory Authority (SAHPRA) says products bought outside formal channels can lead to treatment failure, serious harm, and even death.
Weight-loss medicines have drawn attention in recent months. But SAHPRA stresses they are only one part of a wider problem. Other commonly affected products include painkillers, antibiotics, sexual enhancement products, skin-lightening products, and some chronic medicines. Many are sold through informal markets, unregulated outlets, online platforms, and cross-border smuggling routes.
Substandard And Falsified Medicines: Why The Risk Is Rising
The true scale is hard to measure because illegal trade is hidden. Still, SAHPRA’s own reporting suggests an upward trend. The regulator recorded 101 health product quality complaint reports in 2021/2022. That number rose to 297 in 2022/2023. SAHPRA’s Mokgadi Fafudi says the authority received 588 reports of possible non-compliance in 2024/2025. The 2025/2026 figure has already exceeded 570, although it is not yet officially published.
Globally, the World Health Organisation (WHO) estimates one in 10 medicines in low- and middle-income countries are substandard or falsified. That provides worrying context for South Africa’s rising reports.
How To Tell The Difference From Generics
WHO defines substandard medicines as products that fail to meet quality standards. This can happen through poor manufacturing or weak quality control. Falsified medical products deliberately misrepresent their identity, ingredients, or source.
Experts warn patients not to confuse these with generic medicines. Generics are assessed and approved by SAHPRA and must meet safety and effectiveness requirements. Compounded medicines are also different. They are custom-made for individual patients. They are usually not registered by SAHPRA, but they are not automatically illegal or falsified.
Substandard And Falsified Medicines: What Patients Should Do
Health experts say the risks can be severe. A product may contain the wrong ingredients. It may include too little active ingredient, harmful substances, or none at all. The result can be worsening illness, adverse reactions, and death.
Substandard antibiotics carry an added danger. They can fuel antimicrobial resistance, making infections harder and more expensive to treat. The health system also comes under strain when patients need second- or third-line treatments after ineffective first-line treatments.
SAHPRA urges the public to buy medicines only from licensed pharmacies and authorised healthcare providers. Red flags include very low prices, “miracle cure” claims, suspicious packaging, and unclear expiry dates. Industry leaders also encourage reporting. Jas Bhana, Chief Executive Officer of the Innovative Pharmaceutical Association of South Africa, says suspicious products can be reported to the National Department of Health or a nearby pharmacy.
Enforcement And The Case For Track And Trace
SAHPRA says it uses post-market surveillance, inspections, product recalls, whistleblower investigations, and monitoring of illegal advertising and online sales. It also works with police and customs on enforcement operations. Penalties under the Medicines and Related Substances Act can include fines and prison sentences of up to 10 years.
But pharmacy leaders argue enforcement remains under pressure. They cite gaps in regulatory capacity, border control, and the sheer scale of the illicit market. Experts are calling for routine sampling across the supply chain, tighter controls on online sales, and a national track-and-trace system. SAHPRA says its plans include stronger supply chain traceability, better detection, and expanded public awareness campaigns.