The High Court has temporarily stopped pharmacy group iDexis from manufacturing, supplying and marketing weight-loss medicines containing semaglutide.
The iDexis semaglutide ban follows an application by Danish pharmaceutical company Novo Nordisk. The company manufactures Ozempic and Wegovy.
Semaglutide is the active ingredient in both medicines. Ozempic is registered as a treatment for diabetes. Wegovy is approved for weight management.
The Gauteng Division of the High Court in Pretoria ordered iDexis and its director to immediately cease producing and selling the products.
The interim order will remain in place while the South African Health Products Regulatory Authority and the South African Pharmacy Council complete their investigations. The regulators are commonly known as SAHPRA and the SAPC.
The restriction could also continue during any internal appeals. Further court proceedings may ultimately determine the legal rights of the companies involved.
iDexis Semaglutide Ban Follows Novo Nordisk Claim
Novo Nordisk accused iDexis of competing unlawfully by selling unregistered semaglutide medicines.
Evidence submitted to the court alleged that iDexis was producing compounded semaglutide products on a large scale. The pharmacy group was reportedly supplying about 84,500 units each month.
Novo Nordisk claimed this figure exceeded the combined South African sales of Ozempic and Wegovy.
The company also alleged that iDexis was marketing weight-loss medicines without regulatory approval.
Medicine compounding usually involves preparing a product for the specific needs of an individual patient. Pharmacies may combine or alter ingredients when a suitable registered product is not available.
However, this practice is subject to strict legal and professional controls.
iDexis Semaglutide Ban Rejects Compounding Defence
iDexis argued that it was legally permitted to compound semaglutide. It said the ingredient it used was similar to those in Ozempic and Wegovy.
Judge Petrus van Niekerk rejected this interpretation of the Medicines Act.
He ruled that the law’s compounding exemption applies only if an existing registered medicine already contains that same active ingredient.
The exemption does not apply when the substance is only similar to an approved ingredient.
The court heard that iDexis used a chemically synthesised form of semaglutide. Novo Nordisk’s registered medicines contain a biological form of the ingredient.
This distinction was central to the court’s decision.
SAHPRA Inspection Identifies Regulatory Failures
Court evidence showed that SAHPRA never tested or approved the iDexis product. Furthermore, the makers reportedly sourced the active pharmaceutical ingredient from suppliers who did not disclose their identities.
A SAHPRA inspection identified serious deficiencies relating to product quality, safety and regulatory compliance.
Van Niekerk said the court could not ignore the regulator’s findings. He found that the inspection supported Novo Nordisk’s allegations that the manufacturers were unlawfully producing and supplying the products.
The judge concluded that the court needed an interim interdict to stop the alleged conduct. He also found that the order was necessary to protect public health.
The ruling highlights the regulatory risks surrounding compounded weight-loss medicines. It also reinforces the need for pharmacies to demonstrate product quality, traceable ingredients and compliance with medicine registration requirements.