South African court bars iDexis from producing semaglutide drugs — Daily Maverick

The Gauteng High Court in South Africa in June ordered the iDexis pharmacy in Tshwane to stop producing drugs containing semaglutide, the active ingredient in Ozempic. The decision was made after large batches of compounded weight-loss injections were seized at the pharmacy’s premises, Daily Maverick reports.

The problem of illegal alternatives

Compounding prescription medicines in South Africa is permitted only under specific conditions, including when a patient needs a form of a drug that is not available among registered medicines. At the same time, according to Sahpra CEO Boitumelo Semete-Makokotlela, producing large volumes without confirmed patient demand effectively constitutes medicine manufacturing and requires a good manufacturing practice licence.

Pharmaceutical Task Group chair Stavros Nicolaou called the court ruling an important legal victory for regulators. However, he said its effect could be lost if Sahpra and the South African Pharmacy Council do not promptly establish clearer rules for pharmacies engaged in compounding medicines.

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Sahpra also points to the issue of the origin of active pharmaceutical ingredients. They must be registered in the country and imported by licensed entities, while a pharmacy’s operating licence does not grant the right to import unregistered ingredients.

Complaints and experimental drugs

Since the start of the current financial year, Sahpra has received about 600 complaints about illegitimate and counterfeit medicines sold through informal channels, online platforms, gyms and other outlets. Among the drugs openly sold in South Africa is retatrutide, an injectable weight-loss product that is still undergoing research and has not been approved for sale by any medicines regulator worldwide.

South African Pharmacy Council CEO Vincent Tlale said Sahpra, with the council’s involvement, is preparing updated guidelines for pharmacies. They are expected in February or March next year. Regulators advise buying medicines only through authorised channels and checking their registration. Signs of a questionable product may include unusual or empty packaging, the absence of an expiry date or instructions, as well as a damaged box.