The Gauteng Division of the High Court in Pretoria has granted Danish drugmaker Novo Nordisk an interim interdict against South African pharmacy group iDexis, barring it from manufacturing and marketing compounded weight-loss medicines containing semaglutide.
The court ruled on Monday that iDexis and its director must immediately halt the compounding, supply, and distribution of the products pending the outcome of regulatory processes and potential review proceedings.
Novo Nordisk, the pharmaceutical manufacturer behind the global diabetes and weight-loss brands Ozempic and Wegovy, filed the application on the grounds that iDexis was unlawfully marketing and distributing unregistered versions of the molecule.
The Danish firm argued that the local group was competing in the high-demand weight-loss sector without complying with the statutory provisions of South Africa’s Medicines Act.
The High Court ruling marks a significant escalation in regulatory and legal scrutiny surrounding copycat glucagon-like peptide-1 (GLP-1) drugs.
Novo Nordisk has previously stated that its legal challenges against alternative compounders are driven by concerns regarding product quality, patient safety, and official regulatory oversight.
The court’s decision follows a separate joint enforcement action executed last month by the South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council (SAPC).
Following an inspection of iDexis’s Pretoria facility, regulators alleged that the group was manufacturing GLP-1 and GIP-based treatments, including semaglutide and tirzepatide, for broad commercial distribution beyond the narrow legal limits permitted for bespoke patient compounding.
During that multi-agency raid, authorities cited deficiencies in compliance and safety protocols, subsequently seizing stock and ordering a recall of the distributed products.
Prior to Monday’s ruling, iDexis and its managing director, Ruaan Louw, robustly defended their operations. The firm maintained that its active pharmaceutical ingredients were legally imported from internationally approved manufacturers and independently verified for quality and sterility.
In its filings, iDexis stated that it had successfully dispensed the compounded formulations to more than 214,000 patients under clinician prescriptions without any recorded material adverse reactions.
The legal friction underscores the intense market pressures within South Africa’s healthcare sector.
While Novo Nordisk recently reduced the domestic price of Wegovy injections to improve affordability, the high cost of original GLP-1 therapies has driven a substantial parallel market for compounded alternatives across regional pharmacies.
(The Whistler)