Doctors, pharmacists and others who are still prescribing or dispensing recalled iDexis semaglutide and tirzepatide products have been warned by regulators that they face disciplinary action, reports the Mail & Guardian.
In a statement last week, the South African Health Products Regulatory Authority (SAHPRA), the Health Professions Council of South Africa (HPCSA) and the South African Pharmacy Council (SAPC) said that under the Medicines and Related Substances Act, “any professional found to be prescribing or dispensing the products to patients or users will knowingly be endangering the health of the public”.
This comes after SAHPRA’s Class I, Type A recall of iDexis semaglutide, tirzepatide and combination semaglutide/tirzepatide products last month. This type of recall is reserved specifically for medicines posing a serious risk to public health.
It has since become the subject of legal proceedings, after a joint inspection by SAHPRA and the SAPC at iDexis’ Pretoria facility, where inspectors said the company was manufacturing and supplying unregistered GLP-1 medicines beyond the scope permitted under the country’s compounding framework.
SAPHRA subsequently ordered the products off the market and seized the stock.
iDexis rejected the findings, maintaining 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, after Novo Nordisk approached the High Court to stop iDexis from manufacturing and supplying compounded semaglutide products, an interim order was granted preventing it from producing and marketing the medicines pending the dispute’s outcome.
Last week’s statement signified the first time the regulator, doctors’ regulator and pharmacy regulator have jointly warned healthcare professionals that continuing to prescribe or dispense the recalled products could lead to disciplinary proceedings.
The Mail & Guardian recently 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 remain available despite regulatory action.
Mail & Guardian article – Regulators Tighten Noose On Recalled GLP-1 Medicines (Open access)
See more from MedicalBrief archives:
iDexis seeks legal advice after court halts compounding
Novo wins round one to block compounded Ozempic by local pharmacy
Pretoria pharmacy denies infringing Novo Nordisk patent rights