SAHPRA clamps down on unregistered weight-loss drugs
In a recent collaborative investigation and inspection, the South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council (SAPC) seized and ordered a recall of unregistered weight-loss drugs manufactured in Pretoria.
Image credit: SAHPRA
Both agencies are intensifying efforts to halt the production and distribution of unregistered GLP-1 and GIP medicines containing semaglutide, tirzepatide, or a combination thereof, marketed for weight loss.
Critical non-compliance found
The joint investigation and inspection at iDexis (Pty) Ltd, trading as Sentra Pharmacy, focused on semaglutide, tirzepatide, and combination formulations.
The agencies found critical regulatory non-compliance.
The investigation 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 for broader commercial distribution, particularly for weight management purposes.
Further inspection findings uncovered 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, inadequate sterile manufacturing conditions, high risk of contamination, inadequate equipment for aseptic medical preparations and the lack of an HVAC system, amongst 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 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.
Pharmaceuticals
Aspen Pharmacare to capitalise on GLP-1 demand in sub-Saharan Africa
Nqobile Dludla 4 Mar 2026
Seized and recalled
As part of its enforcement action, SAHPRA 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.
According to the Medicines and Related Substances Act, 101 of 1965, as amended, compounding must remain strictly within the applicable parameters of the law.
It cannot be used as a mechanism for large-scale manufacture, advertising, or distribution of unregistered medicines.
“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,” said SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
Pharmaceuticals
Price war in weight-loss drugs heats up as Novo Nordisk reduces Wegovy prices
Nqobile Dludla 26 Mar 2026
Further action
The South African Pharmacy Council indicated that it 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.
“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,” said Vincent Tlala, CEO of the SAPC.