The South African Health Products Regulatory Authority (SAHPRA), in collaboration with the South African Pharmacy Council (SAPC), has intensified its enforcement action against the unlawful manufacturing, promotion and distribution of unregistered GLP-1 and GIP medicines containing either semaglutide, tirzepatide, or a combination of both for weight loss. 

A joint inspection at iDexis (Pty) Ltd, trading as Sentra Pharmacy (Pretoria), found critical regulatory non-compliance, and all the GIP/GLP-1 injectable products found onsite were seized.

The investigation revealed that the company was producing and supplying medicines under the guise of “compounding”, but it was outside the legal framework. 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.

Further inspection unearthed serious deficiencies in quality, safety, and regulatory compliance. These included illegal import of semaglutide and tirzepatide active pharmaceutical ingredients (APIs); absence of analytical testing to confirm identity, potency and purity; inadequate sterile manufacturing conditions, high risk of contamination, and inadequate equipment for aseptic medical preparations, among others.

The room allocated for producing GLP-1/GIP products didn’t meet the requirements of aseptically prepared products. In addition, no pharmacovigilance system was in place to monitor or respond to adverse drug reactions. SAHPRA has also noted the reports of adverse events, including hospitalisations, linked to the use of these products, as well as concerns regarding possible illegal importation of APIs and promotional activities targeting healthcare providers and consumers.

SAHPRA has seized all the finished products containing semaglutide, tirzepatide, and related combinations found on site. The company has been instructed to initiate a full recall of the affected products distributed through healthcare providers, pharmacies, and other channels.

(Source: SAHPRA)

Published on June 1, 2026