THE South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council (SAPC) have launched a crackdown on the illegal manufacturing and distribution of unregistered weight-loss medicines containing semaglutide and tirzepatide, following a significant raid at a pharmacy that revealed serious regulatory violations.
A joint investigation conducted at iDexis (Pty) Ltd, trading as Sentra Pharmacy in Silverton, Pretoria, on May 11, resulted in the seizure of all injectable GLP-1 and GIP products found on site after authorities uncovered what they described as critical non-compliance with South African medicines laws, IOL reported.
The inspection focused on medicines containing semaglutide, tirzepatide, and combination formulations marketed for weight loss.
“The investigation revealed that the company was producing and supplying medicines under the pretext of ‘compounding’, but outside the legal framework permitted under South African law,” said SAHPRA.
According to organisation, compounding is strictly limited to preparing medicines for individual patients based on valid prescriptions and cannot be used for large-scale commercial manufacturing or distribution.
The regulator said the investigation uncovered serious deficiencies related to product safety, quality assurance, and compliance, including the illegal importation of active pharmaceutical ingredients, a lack of analytical testing to verify potency and purity, inadequate sterile manufacturing conditions, and a high risk of contamination.
Authorities also found that the facility lacked appropriate equipment for aseptic preparation and did not have a heating, ventilation, and air conditioning (HVAC) system required for sterile pharmaceutical production.
No pharmacovigilance system was in place to monitor or respond to adverse drug reactions. SAHPRA said it had also received reports of adverse events, including hospitalisations, linked to the use of the products.
“SAHPRA will continue to take decisive regulatory and enforcement action against any entity that contravenes the Medicines and Related Substances Act,” said SAHPRA chief executive Dr Boitumelo Semete-Makokotlela.
“The unlawful manufacture, importation, advertising, and distribution of unregistered medicines pose a serious risk to public health.”
She added: “We will not hesitate to act to protect patients and safeguard the integrity of South Africa’s regulatory system.”
As part of its enforcement action, SAHPRA has ordered the company to initiate a full recall of all affected products distributed through healthcare providers, pharmacies and other channels.
The SAPC said it would also pursue disciplinary action against pharmacy professionals implicated in the illegal manufacturing practices.
“Unlawful manufacturing, promotion and distribution of unregistered GLP-1 medicines for weight loss is a serious violation of the law and a direct threat to public safety,” said SAPC chief executive Vincent Tlala.
Tlala warned that pharmacists and pharmacy support personnel found selling, compounding or distributing unregistered medicines could face severe sanctions, including possible removal from the professional register.
Authorities have urged members of the public to consult qualified healthcare professionals for advice on weight management and diabetes treatment, and to report suspected adverse reactions or suspicious products to SAHPRA.