Johannesburg – The South African Health Products Regulatory Authority (SAHPRA), in collaboration with the South African Pharmacy Council (SAPC), has moved to stop the unlawful production of weight-loss medicines.
SAHPRA has revealed that, together with SAPC, it conducted a joint investigation inspection at iDexis (Pty) Ltd trading as Sentra Pharmacy in Silverton, Pretoria, on 11 May 2026.
The investigation revealed that the company was producing and supplying medicines under the pretext of “compounding”, but outside the legal framework permitted under South African law.
The inspection focused on Semaglutide, Tirzepatide, and combination formulations and discovered critical regulatory non-compliance; all GIP/GLP-1 injectable products found onsite were seized.
It was found that compounding was strictly limited to the preparation of medicines for individual patients based on a valid prescription.
According to the Medicines and Related Substances Act, 101 of 1965, as amended, compounding must remain strictly within the applicable parameters of the law and cannot be used as a mechanism for large-scale manufacture, advertising, or distribution of unregistered medicines.
However, SAHPRA said 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 inspection findings revealed serious deficiencies in quality, safety, and regulatory compliance,” SAHPRA said in a statement on Saturday, 23 May 2026.
These included:
- the illegal importation of semaglutide and tirzepatide active pharmaceutical ingredients (APIs),
- the absence of analytical testing to confirm identity,
- potency and purity, inadequate sterile manufacturing conditions,
- high risk of contamination,
- inadequate equipment for aseptic medical preparations and
- the lack of HVAC system, among others.
Of further concern to SAHPRA was that 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 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.
As part of its enforcement action, SAHPRA said it 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,” said SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
“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.”
The SAPC 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,” said Vincent Tlala, CEO of SAPC.
“Following the inspection conducted at Sentra Pharmacy, the SAPC will pursue decisive regulatory action against those involved.
“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.”
Members of the public are encouraged to consult healthcare professionals for guidance relating to weight management or diabetes treatment options, and to report any suspected adverse reactions or suspicious products to SAHPRA.
