23 Could SAHPRA and the SAPC Crack Down on Illegal Manufacturing of Unregistered GLP-1/ GIP Medicines
Pretoria, 23 Could 2026 – The South African Well being Merchandise Regulatory Authority (SAHPRA), in collaboration with the South African Pharmacy Council (SAPC), has intensified enforcement motion in opposition to the illegal manufacturing and distribution of unregistered GLP-1 and GIP medicines containing both Semaglutide, Tirzepatide, or a mix product containing each Semaglutide and Tirzepatide promoted for weight reduction. SAHPRA and SAPC performed a joint investigation inspection at iDexis (Pty) Ltd buying and selling as Sentra Pharmacy in Silverton, Pretoria, on 11 Could 2026. The inspection targeted on Semaglutide, Tirzepatide, and mixture formulations and found important regulatory non-compliance, all GIP/GLP-1 injectable merchandise discovered onsite had been seized.
The investigation revealed that the corporate was producing and supplying medicines beneath the pretext of “compounding”, however exterior the authorized framework permitted beneath South African regulation. Whereas compounding is strictly restricted to the preparation of medicines for particular person sufferers primarily based on a legitimate prescription, the power was discovered to be manufacturing and advertising and marketing GIP/GLP-1-based merchandise, together with semaglutide, tirzepatide, and mixture formulations, for broader business distribution, significantly for weight administration functions.
Additional inspection findings revealed severe deficiencies in high quality, security, and regulatory compliance. These included the unlawful importation of semaglutide and tirzepatide lively pharmaceutical components (APIs), the absence of analytical testing to verify id, efficiency and purity, insufficient sterile manufacturing situations, excessive threat of contamination, insufficient gear for aseptic medical preparations and the dearth of HVAC system, amongst others. The room allotted for producing GLP-1/GIP merchandise didn’t meet the necessities of aseptically ready merchandise. As well as, no pharmacovigilance system was in place to watch or reply to opposed drug reactions. SAHPRA has additionally famous stories of opposed occasions, together with hospitalisations, linked to the usage of these merchandise, in addition to considerations concerning attainable unlawful importation of APIs and promotional actions concentrating on healthcare suppliers and customers.
As a part of its enforcement motion, SAHPRA has seized all completed merchandise containing semaglutide, tirzepatide, and associated combos discovered on website. The corporate has been instructed to provoke a full Recall of affected merchandise distributed by way of healthcare suppliers, pharmacies, and different channels.
Based on the Medicines and Associated Substances Act, 101 of 1965, as amended, compounding should stay strictly inside the relevant parameters of the regulation and can’t be used as a mechanism for large-scale manufacture, promoting, or distribution of unregistered medicines.
“SAHPRA will proceed to take decisive regulatory and enforcement motion in opposition to any entity that contravenes the Medicines and Associated Substances Act. The illegal manufacture, importation, promoting, and distribution of unregistered medicines pose a severe threat to public well being. We won’t hesitate to behave to guard sufferers and safeguard the integrity of South Africa’s regulatory system,” mentioned SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
The South African Pharmacy Council can be taking additional motion in opposition to pharmacy skilled concerned in unlawful manufacturing practices. “Illegal manufacturing, promotion and distribution of unregistered GLP-1 medicines for weight reduction is a severe violation of the regulation and a direct menace to public security. Following the inspection performed at Sentra Pharmacy, the SAPC will pursue decisive regulatory motion in opposition to these concerned. Pharmacists and pharmacy help personnel discovered promoting, compounding or distributing these unregistered medicines threat extreme disciplinary motion. Together with attainable removing from the register. Council won’t tolerate any conduct that compromises affected person security or the integrity of the pharmacy occupation,” mentioned Vincent Tlala, CEO of South African Pharmacy Council.
Members of the general public are inspired to seek the advice of healthcare professionals for steering referring to weight administration or diabetes remedy choices, and to report any suspected opposed reactions or suspicious merchandise to SAHPRA.
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