Disciplinary action looming for healthcare professionals over recalled iDEXIS weight-loss drugs
South Africa’s three health regulators have warned that pharmacists and medical practitioners who continue to prescribe, dispense or stock recalled iDEXIS weight-loss injections could face disciplinary action, saying the products pose a serious risk to patient safety.
In a joint statement, the South African Health Products Regulatory Authority (SAHPRA), the South African Pharmacy Council (SAPC) and the Health Professions Council of South Africa (HPCSA) warned the public, pharmacies and dispensing medical practitioners against the continued use of iDEXIS Semaglutide, iDEXIS Tirzepatide and iDEXIS Semaglutide/Tirzepatide, all of which were recalled by SAHPRA in June.
The regulators said any continued prescribing, dispensing or use of the products “poses a severe risk to patients’ safety and/or users.”
They warned that healthcare professionals who fail to comply with the recall could face formal disciplinary proceedings.
“Any healthcare professional found to have dispensed, prescribed or kept stock of the recalled products will face disciplinary action in accordance with applicable legislation, including the Medicines and Related Substances Act, 101 of 1965,” the statement said.
The products were recalled under a Class I, Type A Recall, the most serious category of medicine recall issued by SAHPRA.
The regulators said they had determined that the products pose a significant safety risk, adding that any practitioner who continues prescribing or dispensing them would be knowingly placing patients at risk.
“Any professional found to be prescribing or dispensing them to patients or users will knowingly be endangering the health of the public,” the statement said.
The joint statement was signed by SAPC Registrar and CEO Vincent Tlala, SAHPRA Chief Executive Officer Dr Boitumelo Semete-Makokotlela and HPCSA Interim Registrar Dr Karmani S. Chetty. Healthcare professionals and members of the public were directed to SAHPRA’s recall notice, which contains the full list of affected batches.
The latest warning follows a regulatory investigation that began in May, when SAHPRA and the SAPC conducted a joint inspection of iDEXIS (Pty) Ltd, trading as Sentra Pharmacy in Silverton, Pretoria.
Inspectors identified what regulators described as critical regulatory breaches, including the illegal importation of active pharmaceutical ingredients, the absence of testing to verify the identity, potency and purity of the products, inadequate sterile manufacturing conditions and an elevated risk of contamination.
Regulators also said the company had no pharmacovigilance system in place to monitor adverse drug reactions, despite reports of hospitalisations after use of the products.
At the time, SAHPRA CEO Dr Boitumelo Semete-Makokotlela said the authority would continue taking firm enforcement action against entities that contravene the Medicines and Related Substances Act.
“SAHPRA will continue to take decisive regulatory and enforcement action against any entity that contravenes the Medicines and Related Substances Act,” she said, warning that the unlawful manufacture, importation, advertising and distribution of unregistered medicines “pose a serious risk to public health.”
SAPC Registrar and CEO Vincent Tlala similarly described the unlawful manufacture, promotion and distribution of unregistered GLP-1 weight-loss medicines as “a serious violation of the law and a direct threat to public safety.”
He warned that pharmacists and pharmacy support personnel found selling, compounding or distributing the recalled products could face severe disciplinary sanctions, including removal from the professional register.
iDEXIS has rejected the regulators’ findings, maintaining that its compounding processes comply with the Medicines and Related Substances Act, SAHPRA’s Good Compounding Practice Guidelines and the Good Pharmacy Practice Guidelines.
The company has said its active pharmaceutical ingredients are sourced from internationally approved manufacturers, independently tested and that more than 200,000 patients have received its compounded medicines without reported adverse reactions.
The dispute ultimately reached the Gauteng High Court in Pretoria, which ruled in June that iDEXIS had been manufacturing large quantities of weight-loss injections containing an unregistered form of semaglutide.
The court found that only registered active pharmaceutical ingredients may be used when compounding medicines for individual patients on prescription.
Semaglutide and tirzepatide, marketed internationally under brands including Ozempic, Wegovy and Mounjaro, are approved for treating type 2 diabetes, obesity and weight management. Surging global demand has outstripped supply in recent years, creating a growing market for compounded alternatives produced outside the regulatory framework governing the registered products.
The regulators said Wednesday’s warning makes clear that, irrespective of the ongoing legal dispute, they regard the continued prescribing, dispensing or stocking of the recalled iDEXIS products as a serious threat to public health and will pursue disciplinary action against healthcare professionals who fail to comply with the recall.
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