South African health authorities have seized illegal weight loss medicines and ordered a nationwide recall after uncovering serious safety violations at a Pretoria pharmacy that was manufacturing unregistered products containing semaglutide and tirzepatide.
The South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council (SAPC) raided iDexis (Pty) Ltd, trading as Sentra Pharmacy in Silverton, on 11 May following reports of adverse events and possible illegal importation of raw materials.
Inspectors found the facility was mass-producing GLP-1 and GIP medicines for commercial distribution whilst disguising the operation as legitimate compounding for individual patients. All injectable products containing semaglutide, tirzepatide, and combination formulations found on site were immediately seized.
The crackdown comes as demand for weight loss medicines has surged in South Africa, with sales of tirzepatide-based products expected to exceed R1,3 billion this year. However, these medicines are only registered for treating type 2 diabetes in South Africa, not for weight management, leading some providers to seek alternative supply routes.
Critical safety failures put patients at risk
During the inspection, regulators discovered critical safety failures including illegally imported active pharmaceutical ingredients with no testing to confirm their identity, potency or purity. The manufacturing room failed to meet sterile preparation requirements, lacked proper air handling systems, and posed contamination risks to patients.
“The unlawful manufacture, importation, advertising and distribution of unregistered medicines pose a serious risk to public health,” said SAHPRA chief executive Dr Boitumelo Semete-Makokotlela. “We will not hesitate to act to protect patients and safeguard the integrity of South Africa’s regulatory system.”
SAHPRA has recorded hospitalisations linked to the use of these illegally manufactured products. The facility also had no system in place to monitor or respond to adverse drug reactions.
Under South African law, compounding is strictly limited to preparing medicines for individual patients based on valid prescriptions. It cannot be used for large-scale manufacturing, advertising or distributing unregistered products.
Pharmacists face disciplinary action and deregistration
The company has been ordered to recall all affected products distributed through healthcare providers, pharmacies and other channels.
Vincent Tlala, chief executive of the South African Pharmacy Council, warned that pharmacy professionals face severe consequences. “Pharmacists and pharmacy support personnel found selling, compounding or distributing these unregistered medicines risk severe disciplinary action, including possible removal from the register,” he said.
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Soaring demand drives illegal operations
The high cost of registered GLP-1 medicines in the private sector, combined with limited medical aid coverage and no availability in the public sector, has created conditions for illegal operations to flourish. Off-label prescribing of semaglutide for weight loss has increased sharply, despite the medicine being officially registered only for diabetes treatment.
SAHPRA has warned members of the public to consult healthcare professionals for guidance on weight management or diabetes treatment options, and to report any suspected adverse reactions or suspicious products to the authority.
The regulatory bodies confirmed that further enforcement action against entities contravening the Medicines and Related Substances Act will continue.
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