Healthcare professionals in South Africa are barred from prescribing, dispensing or holding stock of weight-loss medicines produced by pharmacy group iDexis.
This week, the South African Pharmacy Council (SAPC), the Health Professions Council of South Africa and the South African Health Products Regulatory Authority recalled the drugs and warned that disciplinary action would be taken against violators.
The warning follows a high court interim order granted last month barring iDexis from manufacturing and selling medicines containing semaglutide.
Novo Nordisk brought the case to court. The Danish drugmaker argued that iDexis was illegally manufacturing, selling unregistered semaglutide products and competing in South Africa’s fast-growing weight-loss market without complying with medicines regulations.
In a joint statement, the healthcare regulators said 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. 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.
Vincent Tlala, the SAPC CEO, said regulators had escalated the matter because, to their knowledge, iDexis had not carried out the recall as required.
He said pharmacists could face a fine ranging from R25 000 to R75 000. If an investigation found members of the public had suffered harm as a result of using the product, practitioners could be struck off the council’s register after a disciplinary hearing, he added.
Tlala said the SAPC was working with the health department’s director-general’s office to revoke iDexis’s licence and had 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. — Reuters
- South African healthcare regulators have banned professionals from prescribing, dispensing, or holding weight-loss drugs produced by iDexis due to regulatory violations.
- The South African Pharmacy Council, Health Professions Council, and Health Products Regulatory Authority recalled iDexis products containing semaglutide, tirzepatide, and their combinations.
- A high court interim order, following a legal case by Novo Nordisk, bars iDexis from manufacturing and selling semaglutide-containing medicines for breaching medicines regulations.
- Regulators warn that using iDexis products poses serious patient safety risks, with penalties for pharmacists ranging from fines of R25,000 to R75,000 or possible removal from professional registers.
- SAPC is working with health authorities to revoke iDexis’s license and has involved law enforcement to enforce compliance, while iDexis has not yet responded publicly.
