Sahpra cracks down on illegal weight-loss drugs as GLP-1 demand booms

This article was first published on Business Day and is republished with permission.By Noxolo Majavu.South Africa's medicines regulator and pharmacy watchdog have intensified a crackdown on the unlawful manufacture and distributionof unregistered GLP-1 medicines as concerns mount over the rapid growth of the country's largely unregulated weight loss drug market.The South African Health Products Regulatory Authority (Sahpra), working alongside the South African Pharmacy Council (SAPC), confirmed it has seized multiple injectable products after an inspection at iDexis Compounding, trading as Sentra Pharmacy, in Silverton, Pretoria.The crackdown comes amid booming global demand for GLP-1 therapies — a class of drugs that mimic a natural hormone in the body that regulates blood sugar levels and reduces appetite - which have become one of the pharmaceutical industry's fastest-growing segments as obesity treatments reshape the healthcare market.The regulators allege the pharmacy was manufacturing and distributing unregistered GLP-1 medicines - including semaglutide, tirzepatide and combination formulations - under the guise of pharmaceutical compounding, in contravention of the Medicines & Related Substances Act."Sahpra will continue to take decisive regulatory and enforcement action against any entity that contravenes the Medicines & Related Substances Act. The unlawful manufacture, importation, advertising and distribution of unregistered medicines pose a serious risk to public health," Sahpra CEO Boitumelo Semete-Makokotlela said..According to Sahpra, inspectors uncovered extensive regulatory failures during the raid, including what it described as the illegal importation of active pharmaceutical ingredients (APIs), inadequate sterile manufacturing conditions and the absence of proper analytical testing to confirm product quality, potency and purity."We will not hesitate to act to protect patients and safeguard the integrity of South Africa's regulatory system," Semete-Makokotlela said.Inspectors allegedly found dust contamination, unsuitable equipment and no validated heating, ventilation and air-conditioning system required for sterile pharmaceutical production.Sahpra also raised the alarm over the absence of a pharmacovigilance system to monitor adverse drug reactions linked to the products, adding that it has already received reports of adverse events, including hospitalisations associated with some of the medicines under investigation.Compounding this is the practice of preparing customised medicines for individual patients, which is permitted under South African law only when done on the basis of a valid prescription and within tightly controlled parameters..Sahpra said the operation has moved beyond patient-specific compounding into the broader commercial manufacturing and marketing of GLP-1 medicines, particularly for weight management.As part of the enforcement action the regulator seized all finished products containing semaglutide, tirzepatide and related combinations found on site. The company has also been instructed to initiate a full recall of affected products distributed through healthcare providers, pharmacies and other channels.The SAPC said disciplinary action against pharmacy professionals implicated in the matter will follow."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," SAPC CEO Vincent Tlala said."Pharmacists and pharmacy support personnel found selling, compounding or distributing these unregistered medicines risk severe disciplinary action, including possible removal from the register. The council will not tolerate any conduct that compromises patient safety or the integrity of the pharmacy profession.".This article was first published on Business Day and is republished with permission.Sign up for your early morning brew of the BizNews Insider to keep you up to speed with the content that matters. The newsletter will land in your inbox every morning on weekdays. Register here.Support South Africa's bastion of independent journalism, offering balanced insights on investments, business, and the political economy, by joining BizNews Premium. Register here.If you prefer WhatsApp for updates, sign up to the BizNews channel here.

Sahpra cracks down on illegal weight-loss drugs as GLP-1 demand booms

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