Doctors, pharmacists and other healthcare professionals who continue prescribing or dispensing recalled iDexis semaglutide and tirzepatide products face disciplinary action, South Africa's health regulators have warned.
In a statement on Wednesday, the South African Health Products Regulatory Authority (Sahpra), the Health Professions Council of South Africa (HPCSA) and the South African Pharmacy Council (SAPC) said healthcare professionals who prescribed, dispensed or retained stock of the recalled products would face disciplinary action under the Medicines and Related Substances Act.
"Any professional found to be prescribing or dispensing them to patients or users will knowingly be endangering the health of the public," the regulators said.
The warning follows Sahpra's June Class I, Type A recall of iDexis semaglutide, tirzepatide and combination semaglutide/tirzepatide products. A Class I, Type A recall is reserved for medicines that pose a serious risk to public health.
The recall stemmed from a joint inspection by Sahpra and the South African Pharmacy Council at iDexis's Pretoria facility, where inspectors alleged the company was manufacturing and supplying unregistered GLP-1 medicines beyond the scope permitted under South Africa's compounding framework. Sahpra subsequently ordered the products off the market and seized the stock.
The recall has since become the subject of legal proceedings.
iDexis has rejected Sahpra's findings, maintaining that it legally compounded the medicines using quality-tested active pharmaceutical ingredients and denying that its products posed a risk to patients. The company is challenging aspects of the regulator's decision.
Separately, pharmaceutical company Novo Nordisk approached the high court to stop iDexis from manufacturing and supplying compounded semaglutide products. The court granted an interim order preventing the company from producing and marketing the medicines pending the outcome of the dispute.
Against that backdrop, Wednesday's statement widens the regulatory response beyond the manufacturer. For the first time, the country's medicines regulator, doctors' regulator and pharmacy regulator have jointly warned healthcare professionals that continuing to prescribe or dispense the recalled products could expose them to disciplinary proceedings.
The regulators urged healthcare professionals to stop prescribing or dispensing the recalled medicines immediately and advised members of the public not to use them. They referred consumers and healthcare professionals to Sahpra's recall notice for the full list of affected iDexis products.
Last week, the Mail & Guardian reported on a growing underground market for illegal and unregistered weight-loss medicines sold through social media, gyms, wellness businesses and informal networks.
After publication, healthcare professionals contacted the newspaper warning that the illegal market extended far beyond one manufacturer and that unregistered weight-loss medicines remained available despite regulatory action.