By Nqobile Dludla
JOHANNESBURG, July 9 (Reuters) – South African health regulators are recalling weight-loss medicines compounded by a local pharmacy group, iDexis, and have warned healthcare professionals that prescribing, dispensing or holding stock of these drugs could lead to disciplinary action, they said on Thursday.
The warning follows a High Court interim order granted last month barring iDexis from manufacturing and selling medicines containing semaglutide, in a case brought by Novo Nordisk.
The Danish drugmaker argued that iDexis was illegally manufacturing and selling unregistered semaglutide products and competing in South Africa’s fast-growing weight-loss market without complying with medicines regulations.
The South African Pharmacy Council (SAPC), the Health Professions Council of South Africa (HPCSA) and the South African Health Products Regulatory Authority (SAHPRA) said in a joint statement that the affected products in the recall include semaglutide, tirzepatide and semaglutide/tirzepatide combinations that are mixed together by iDexis.
Semaglutide is the key ingredient in Novo Nordisk’s Ozempic and Wegovy drugs, while tirzepatide is found in Eli Lilly’s blockbuster Mounjaro and Zepbound.
“The continued use, prescription and dispensing of these (iDexis) products pose a severe risk to patients’ safety and/or users,” the regulators said.
The agencies warned that any healthcare professional found to have dispensed, prescribed or retained stock of the recalled products could face disciplinary action.
Vincent Tlala, CEO of SAPC, told Reuters that regulators had escalated the matter because, to their knowledge, iDexis had not carried out the recall as required.
He said that pharmacists could face a fine ranging from 25,000 rand ($1,531.43) to 75,000 rand. If an investigation found members of the public had suffered harm as a result of using these, practitioners could be struck off the council’s register following a disciplinary hearing, he added.
Following last month’s ruling, Sara Norcross, general manager for Novo Nordisk South Africa, told Reuters that the judgment highlighted the risks posed by unregulated compounded versions of GLP-1 medicines.
Tlala said SAPC was working with the health department’s director-general’s office to revoke iDexis’s licence and had also engaged law enforcement authorities to take action against those found to be contravening medicines regulations.
IDexis did not immediately respond to a request for comment.
($1 = 16.3246 rand)
(Reporting by Nqobile Dludla; Editing by Susan Fenton)
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