Pharmaceutical bodies are cracking the whip against illegal manufacturers and professionals involved in dangerous weight loss medicines.
The South African Health Products Regulatory Authority (SAHPRA), and the South African Pharmacy Council (SAPC), said the target is the unlawful manufacturing and distribution of unregistered GLP-1 and GIP medicines containing either Semaglutide, Tirzepatide, or a combination product containing both Semaglutide and Tirzepatide.
This follows a jointly held investigation by both bodies, which led to an inspection of the iDexis (Pty) Ltd trading, known as Sentra Pharmacy in Silverton, Pretoria, last week.
All GIP/GLP-1 injectable products found at the facility were seized.
Moreover, it was found that the company was producing and supplying medicines under the pretext of “compounding”, but outside the legal framework permitted under South African law.
While compounding is strictly limited to the preparation of medicines for individual patients based on a valid prescription, the facility was found to be manufacturing and marketing GIP/GLP-1-based products, including semaglutide, tirzepatide, and combination formulations, for broader commercial distribution, particularly for weight management purposes.
Further findings revealed serious deficiencies in quality, safety, and regulatory compliance.
The room allocated for producing GLP-1/GIP products also didn’t meet the requirements of aseptically prepared products.
Dr Boitumelo Semete-Makokotlela, SAHPRA CEO, said “SAHPRA will continue to take decisive regulatory and enforcement action against any entity that contravenes the Medicines and Related Substances Act. 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.”
Vincent Tlala, CEO of South African Pharmacy Council, agreed with Makokotlela, and added “pharmacists and pharmacy support personnel found selling, compounding or distributing these unregistered medicines risk severe disciplinary action, including possible removal from the register. Council will not tolerate any conduct that compromises patient safety or the integrity of the pharmacy profession.”