South African health regulators have intensified a crackdown on the unlawful manufacture and distribution of unregistered weight-loss medicines containing semaglutide and tirzepatide, following a joint inspection that uncovered major regulatory breaches at a Pretoria pharmacy.
The operation, conducted on 11 May by the South African Health Products Regulatory Authority and the South African Pharmacy Council, targeted iDexis (Pty) Ltd, trading as Sentra Pharmacy in Silverton, Pretoria. Authorities seized all injectable GLP-1 and GIP products found at the premises after investigators uncovered what they described as unlawful manufacturing activities involving semaglutide, tirzepatide, and combination formulations marketed for weight loss.
Regulators said the company had been producing and supplying medicines under the guise of “compounding,” a practice legally permitted only when medicines are prepared for individual patients based on valid prescriptions. According to SAHPRA, the facility instead engaged in broader commercial manufacturing and distribution of the products.
Inspectors also uncovered what they described as serious deficiencies in quality control and safety standards. Among the concerns raised were the alleged illegal importation of active pharmaceutical ingredients, the absence of analytical testing to verify purity and potency, inadequate sterile production conditions, and a high risk of contamination.
Authorities further found that the facility lacked appropriate aseptic manufacturing equipment and did not have a proper heating, ventilation and air-conditioning system required for sterile pharmaceutical preparation.
SAHPRA also said no pharmacovigilance system was in place to monitor adverse drug reactions linked to the products. The regulator noted reports of hospitalisations and other adverse events associated with the medicines.
As part of the enforcement action, the company has been ordered to initiate a full recall of all affected products distributed through pharmacies, healthcare providers and other channels.
Under South Africa’s Medicines and Related Substances Act of 1965, compounding may not be used as a mechanism for large-scale manufacturing, advertising or distribution of unregistered medicines.
“SAHPRA will continue to take decisive regulatory and enforcement action against any entity that contravenes the Medicines and Related Substances Act,” said Boitumelo Semete-Makokotlela, chief executive officer of SAHPRA.
“The unlawful manufacture, importation, advertising, and distribution of unregistered medicines pose a serious risk to public health. We will not hesitate to act to protect patients and safeguard the integrity of South Africa’s regulatory system,” she added.
The investigation forms part of growing regulatory scrutiny over the booming demand for GLP-1 medicines, which are increasingly being promoted globally for weight management and diabetes treatment.
Authorities urged members of the public to consult qualified healthcare professionals regarding weight-loss and diabetes treatments and to report suspicious medicines or adverse reactions to SAHPRA.