South Africa: When Medicines Are Made Outside the Factory - Why Pharmacovigilance Matters More Than Ever

What the report says

AllAfrica, carrying a Spotlight article from Cape Town dated 22 July 2026, reports that a court matter involving Pretoria-based compounding pharmacy iDexis has intensified debate in South Africa over medicines prepared outside conventional factory manufacturing. The article, by Professor Renier Coetzee and Lara van Niekerk, says public discussion has centred on access to medicines, intellectual property, regulatory authority and demand for semaglutide-containing products such as Ozempic.

The authors argue that the dispute also raises a broader public-health question: how South Africa tracks the safety of medicines once they are widely used. They point to pharmacovigilance — the ongoing detection, assessment and prevention of adverse effects or other medicine-related problems — as essential because clinical trials cannot reveal every risk, especially rare reactions or effects in groups underrepresented in trials, including older people, pregnant patients and those with multiple illnesses.

According to the article, South Africa’s regulator, the South African Health Products Regulatory Authority, expects manufacturers of registered medicines to maintain safety-monitoring systems, collect and investigate reports, and provide continuing safety data. Health workers and patients can also contribute reports that may lead regulators to update warnings, restrict use or, in rare cases, remove a product from the market.

The Spotlight authors distinguish traditional pharmacy compounding — preparing a medicine for a particular patient when no suitable registered option exists — from large-scale or routine supply that may resemble manufacturing. They note that South African law permits compounding within frameworks including the Medicines and Related Substances Act, the Pharmacy Act and South African Pharmacy Council rules, but say growing demand and shortages can blur regulatory boundaries. The importance of the issue, as presented, is whether safety oversight is strong enough when compounded products reach many patients.