The South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council (SAPC) have intensified a nationwide crackdown targeting the illegal manufacturing and supply of unregistered weight-loss medicines. On Tuesday, May 26, 2026, the two regulatory bodies conducted a joint inspection at iDexis (Pty) Ltd, trading as Sentra Pharmacy, located in Silverton, Pretoria. The focus of this investigation was on products containing Semaglutide, Tirzepatide, and various combination formulations that are being illegally distributed. The operation represents a significant effort by SAHPRA and SAPC to address the illicit market for these pharmaceutical products, which pose substantial risks to public health.
Regulatory Non-Compliance Uncovered
The investigation found that iDexis (Pty) Ltd, operating as Sentra Pharmacy, produced and supplied medicines under the pretext of ‘compounding’ but outside the legal framework permitted under South African law. The facility was manufacturing and marketing GIP/GLP-1-based products, including Semaglutide, Tirzepatide, and various combination formulations, for broader commercial distribution. These products were specifically aimed at weight management purposes, often advertised and distributed through channels typically reserved for registered and approved pharmaceuticals.
Further findings indicated the illegal importation of Semaglutide and Tirzepatide active pharmaceutical ingredients (APIs). This unauthorized sourcing bypasses critical quality control measures and regulatory oversight designed to ensure the safety and efficacy of pharmaceutical components. The inspection also revealed that the premises had inadequate equipment for aseptic medical preparations, a critical requirement for pharmaceutical manufacturing where sterile conditions are critical to prevent contamination. Additionally, the facility lacked proper heating, ventilation, and air conditioning systems, which are essential for maintaining controlled environments in pharmaceutical production, particularly for sensitive sterile products. The room designated for producing GLP-1/GIP products did not meet the necessary requirements for aseptically prepared products, compromising product sterility and safety and thereby exposing consumers to potential health hazards.
The investigation revealed a complete absence of analytical testing to confirm the identity, potency, and purity of the manufactured substances. This fundamental lapse meant there was no assurance that the products contained the stated active ingredients in the correct concentrations, or that they were free from harmful impurities. The inquiry uncovered inadequate sterile manufacturing conditions, which posed a high risk of microbial contamination for the products. Officials also noted that no pharmacovigilance system was in place at the facility to monitor or respond to potential adverse drug reactions, further compromising patient safety by failing to track and address any negative health outcomes experienced by users.
Public Health Risks and Actions Taken
SAHPRA has noted reports of adverse events, including hospitalisations, linked to the use of these illegally manufactured products. These incidents show the serious public health risks associated with unregistered and improperly compounded medicines. Following the inspection, all finished products containing Semaglutide, Tirzepatide, and related combinations found at iDexis (Pty) Ltd were seized. This immediate action was taken to prevent further distribution of potentially harmful products into the market. The company has also been instructed to initiate a full recall of affected products. This recall applies to all items distributed through healthcare providers, pharmacies, and other channels, ensuring a full removal of the non-compliant medicines from circulation.
Legal Framework and Enforcement
The unregistered medicines identified in the operation contain Semaglutide, Tirzepatide, or a combination product including both Semaglutide and Tirzepatide. These substances fall under the regulatory purview of the South African Health Products Regulatory Authority (SAHPRA). The Medicines and Related Substances Act, 101 of 1965, as amended, stipulates that compounding cannot be utilized as a mechanism for the large-scale manufacture, advertising, or widespread distribution of unregistered medicines. This legal framework defines the boundaries within which pharmaceutical preparations can be made and supplied, prohibiting practices that bypass formal registration and oversight processes. Compliance with this Act is central to ensuring the safety, quality, and efficacy of medical products available to the public. The actions taken against iDexis (Pty) Ltd serve as a clear reminder that regulatory bodies will enforce these provisions rigorously to protect consumers.
Officials Vow Continued Action
Critical regulatory non-compliance was discovered during the inspection, leading to the seizure of all GIP/GLP-1 injectable products found onsite. The investigation revealed a complete absence of analytical testing to confirm the identity, potency, and purity of the manufactured substances. The inquiry uncovered inadequate sterile manufacturing conditions, which posed a high risk of contamination for the products. Officials also noted that no pharmacovigilance system was in place at the facility to monitor or respond to potential adverse drug reactions, further compromising patient safety. SAHPRA and SAPC officials have affirmed their commitment to continuing these enforcement efforts across the country, sending a strong message to other entities engaged in similar illicit activities. The joint operation notes the collaborative approach of regulatory bodies in safeguarding public health against the dangers of unregulated pharmaceutical practices.
