Unregistered GLP‑1 weight‑loss drugs seized in Sahpra raid

The South African Health Products Regulatory Authority (SAHPRA), has launched a sweeping crackdown on illegal weight‑loss injections, seizing unregistered GLP‑1 products and vowing decisive action against rogue manufacturers.

South Africa’s medicines watchdog, in collaboration with the South African Pharmacy Council (SAPC), intensified enforcement action against the unlawful manufacturing and distribution of unregistered GLP-1 medicines.

Inspection

This follows an inspection conducted at iDexis Compounding (Pty) Ltd, trading as Sentra Pharmacy, in Silverton, Pretoria, during which significant regulatory non-compliance was identified, and multiple injectable products were seized.

The investigation revealed that the company was allegedly producing and supplying medicines under the pretext of “compounding”, but outside the legal framework permitted under South African law.

According to Sahpra, 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 GLP1-based products, including semaglutide, tirzepatide, and combination formulations, for broader commercial distribution, particularly for weight management purposes.

The Citizen has contacted iDexis for a response on the raid.

Serious deficiencies

Sahpra said the investigations revealed serious 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 to confirm identity, potency and purity, and inadequate sterile manufacturing conditions, including dust contamination, unsuitable equipment, and the lack of a validated HVAC system.

Authorities also found that no pharmacovigilance system was in place to monitor or respond to adverse drug reactions. Sahpra has also noted 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.

Product seizure

As part of its enforcement action, Sahpra has seized all finished products containing semaglutide, tirzepatide, and related combinations found on site.

The company has been instructed to initiate a full Recall of affected products distributed through healthcare providers, pharmacies, and other channels.

“SAHPRA will continue to take decisive regulatory and enforcement action against any entity that contravenes the Medicines and Related Substances Act,” Sahpra chief executive Dr Boitumelo Semete-Makokotlela said.

“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.

Action

SAPC chief executive Vincent Tlala said they will be taking further action against pharmacy professionals involved in illegal manufacturing practices.

“Unlawful manufacturing, promotion and distribution of unregistered GLP-1 medicines for weight loss is a serious violation of the law and a direct threat to public safety. Following the inspection conducted at Sentra Pharmacy, the SAPC will pursue decisive regulatory action against those involved.

Warning

Tlala warned that pharmacists and pharmacy support personnel found selling, compounding or distributing unregistered medicines could face severe sanctions, including possible removal from the professional register.

Authorities have urged members of the public to consult qualified healthcare professionals for advice on weight management and diabetes treatment, and to report suspected adverse reactions or suspicious products to Sahpra