Pretoria: The South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council (SAPC) have ramped up a nationwide crackdown on the illegal manufacturing and supply of unregistered weight-loss medicines.
According to South African Government News Agency, the crackdown specifically targets products containing Semaglutide, Tirzepatide, or a combination of both. SAHPRA and SAPC conducted a joint investigation at iDexis (Pty) Ltd, trading as Sentra Pharmacy in Silverton, Pretoria. The inspection revealed significant regulatory non-compliance, resulting in the seizure of all GIP/GLP-1 injectable products found onsite.
The investigation determined that the company was producing and supplying medicines under the guise of 'compounding' but was operating outside the legal framework established by South African law. Compounding is strictly limited to preparing medicines for individual patients based on a valid prescription, but the facility was manufacturing and marketing GIP/GLP-1-based products, including Semaglutide and Tirzepatide, for commercial distribution, especially for weight management.
Further investigation found significant deficiencies in quality, safety, and regulatory compliance. These included the illegal importation of Semaglutide and Tirzepatide active pharmaceutical ingredients (APIs), the absence of analytical testing for identity, potency, and purity, inadequate sterile manufacturing conditions with a high risk of contamination, insufficient equipment for aseptic medical preparations, and a lack of proper heating, ventilation, and air conditioning systems.
Additionally, the room for producing GLP-1/GIP products did not meet the requirements for aseptically prepared products, and no pharmacovigilance system was in place to monitor or respond to adverse drug reactions. SAHPRA has reported adverse events, including hospitalizations, linked to these products and concerns about the illegal importation of APIs and promotional activities targeting healthcare providers and consumers.
All finished products containing Semaglutide, Tirzepatide, and related combinations have been seized. The company has been instructed to initiate a full recall of affected products distributed through healthcare providers, pharmacies, and other channels.
According to the Medicines and Related Substances Act, 101 of 1965, as amended, compounding must adhere strictly to legal parameters and cannot be used for large-scale manufacture, advertising, or distribution of unregistered medicines.
SAHPRA CEO, Dr. Boitumelo Semete-Makokotlela, emphasized that SAHPRA will continue to enforce regulatory and enforcement actions against entities contravening the Medicines and Related Substances Act. She stated that the unlawful manufacture, importation, advertising, and distribution of unregistered medicines pose a significant risk to public health.
SAPC CEO Vincent Tlala added that the council would take further action against pharmacy professionals involved in illegal manufacturing. He warned that pharmacists and pharmacy support personnel involved in selling, compounding, or distributing these unregistered medicines risk severe disciplinary action, including possible removal from the register. Tlala stressed that the council will not tolerate any conduct compromising patient safety or the integrity of the pharmacy profession.