Ozempic’s shadow market: Inside SA’s compounded weight-loss drug crisis

DAYS after IOL's investigation into South Africa’s unregulated aesthetics industry laid bare the dangers lurking beneath the country’s booming beauty economy, a fresh regulatory storm is gathering, this time targeting the exploding market for compounded versions of blockbuster weight-loss drugs like Ozempic and Mounjaro.

- KARABO NGOEPE

The South African Health Products Regulatory Authority (SAHPRA), working alongside the South African Pharmacy Council (SAPC), has executed its most significant enforcement action yet in the GLP-1 space, raiding a Pretoria-based compounding pharmacy and seizing an entire stockpile of unregistered injectable products.

The raid has ignited a fiery legal dispute, and experts warn the crackdown signals the beginning of the end for South Africa’s largely unregulated compounded weight-loss drug market.

On May 11, SAHPRA and SAPC conducted a joint inspection at iDexis (Pty) Ltd, trading as Sentra Pharmacy in Silverton, Pretoria. What inspectors found, according to SAHPRA’s official media release, was deeply troubling.

The regulator says it found that the company was not merely compounding medicines for individual patients, the legally permissible activity, but was manufacturing and marketing GIP/GLP-1-based products, including semaglutide, tirzepatide, and combination formulations, for broader commercial distribution, particularly for weight management purposes.

SAHPRA’s inspection uncovered what it described as “critical regulatory non-compliance,” including the illegal importation of active pharmaceutical ingredients (APIs), the absence of analytical testing to confirm identity, potency, and purity, inadequate sterile manufacturing conditions, and a high risk of contamination.

The room used for producing GLP-1/GIP products did not meet the requirements for aseptically prepared products. Crucially, there was no pharmacovigilance system in place to monitor or respond to adverse drug reactions, despite SAHPRA noting “reports of adverse events, including hospitalisations, linked to the use of these products.”

All GIP/GLP-1 injectable products found on the site were seized, and iDexis was instructed to initiate a full recall of affected products distributed through healthcare providers, pharmacies, and other channels.