Three South African regulatory bodies issued a joint warning, stating that pharmacists and healthcare professionals who continue to prescribe, dispense, or store the withdrawn iDEXIS weight-loss injections may face disciplinary action, as these products pose a serious threat to patient safety.
Withdrawn Drugs and Health Risks
The joint statement was made by the South African Health Products Regulatory Authority (SAHPRA), the South African Pharmacy Council (SAPC), and the Health Professions Council of South Africa (HPCSA). They warned the public, pharmacies, and practicing doctors about the inadmissibility of further use of iDEXIS Semaglutide, iDEXIS Tirzepatide, and iDEXIS Semaglutide/Tirzepatide, which were recalled by SAHPRA in June.
Regulators emphasized that any continuation of prescribing, dispensing, or using these products 'creates a serious risk to patient and/or user safety.' It was announced that specialists who do not comply with the recall may face formal disciplinary proceedings.
Consequences of Non-Compliance
The statement indicated that any professional who dispensed, prescribed, or stored stocks of the withdrawn products will face disciplinary measures in accordance with applicable legislation, including the Medicines and Related Substances Act, No. 101 of 1965. These products were recalled under Class I, Type A, which is the most severe category of drug recall issued by SAHPRA.
The regulators established that the products carry a significant safety risk and added that any practitioner continuing to prescribe or dispense them knowingly endangers patients. They noted that any professional prescribing or dispensing them to patients or users knowingly jeopardizes public health.
Investigation into iDEXIS Activities
The joint statement was signed by SAPC Registrar and CEO Vincent Tlala, SAHPRA CEO Dr. Boitumelo Semete-Makokotlela, and interim HPCSA Registrar Dr. Karmani S. Chatti. Healthcare workers and the public were advised to review the SAHPRA recall notice, which contains a full list of affected batches.
This warning followed a regulatory investigation initiated in May, when SAHPRA and SAPC conducted a joint inspection of iDEXIS (Pty) Ltd, operating as Sentra Pharmacy in Silverton, Pretoria. Inspectors found critical regulatory violations, including illegal importation of active pharmaceutical ingredients, lack of testing to verify identity, potency, and purity of products, as well as inadequate sterile manufacturing conditions and increased contamination risk.
Furthermore, regulators reported that the company lacked a pharmacovigilance system to monitor adverse drug reactions, despite reports of hospitalizations after product use.
Positions of Regulators and Company
At the time, SAHPRA CEO Dr. Boitumelo Semete-Makokotlela stated that the authority would continue to take decisive enforcement action against organizations violating the Medicines and Related Substances Act. She stressed that the illegal manufacture, importation, advertising, and distribution of unregistered medicines 'pose a serious risk to public health.'
Similarly, SAPC Registrar and CEO Vincent Tlala characterized the illegal manufacture, promotion, and distribution of GLP-1 weight-loss drugs as a 'serious breach of the law and a direct threat to public safety.' He warned that pharmacists and pharmacy support staff caught selling, mixing, or distributing withdrawn products could face severe disciplinary sanctions, including removal from the professional register.
iDEXIS rejected the regulators' findings, asserting that its mixing processes comply with the Medicines and Related Substances Act, SAHPRA Good Compounding Guidelines, and Good Pharmacy Practice Guidelines. The company stated that its active pharmaceutical ingredients come from internationally approved manufacturers, undergo independent testing, and that over 200,000 patients have received its compounded medications without reports of adverse reactions.
Legal Ruling and Market Context
The dispute ultimately reached the Gauteng High Court in Pretoria, which ruled in June that iDEXIS manufactured large volumes of weight-loss injections containing an unregistered form of semaglutide. The court determined that only registered active pharmaceutical ingredients can be used when compounding medications for individual patients by prescription.
Semaglutide and tirzepatide, sold internationally under brands such as Ozempic, Wegovy, and Mounjaro, are approved for the treatment of type 2 diabetes, obesity, and weight management. The rise in global demand has exceeded supply in recent years, creating a growing market for alternatives manufactured outside the regulatory framework governing registered products.
Regulators concluded that this warning clearly demonstrates that regardless of ongoing legal disputes, they view the continued prescribing, dispensing, or storing of iDEXIS withdrawn products as a serious threat to public health and will pursue disciplinary action against healthcare workers who fail to comply with the recall.