South African pharmacy group iDexis has appealed a High Court ruling that barred it from manufacturing and selling compounded weight loss medicines containing semaglutide, escalating a legal dispute with Danish pharmaceutical company Novo Nordisk over the regulation of obesity and diabetes treatments.
The appeal follows a June ruling by the Gauteng Division of the High Court in Pretoria, which granted Novo Nordisk an interim interdict preventing iDexis and its director from compounding, supplying and marketing semaglutide based medicines pending the outcome of regulatory investigations and any subsequent legal proceedings.
Novo Nordisk, the manufacturer of the blockbuster drugs Ozempic and Wegovy, argued that iDexis had been producing and selling unregistered semaglutide medicines on a commercial scale in violation of South Africa’s Medicines and Related Substances Act. The company said the products had not received approval from the South African Health Products Regulatory Authority (SAHPRA) and raised concerns about patient safety and regulatory compliance.
During the court proceedings, Novo Nordisk alleged that iDexis was producing approximately 84,500 units of compounded semaglutide each month, exceeding the combined local sales of Ozempic and Wegovy. The company argued that South African law permits compounding only in limited circumstances for individual patients and does not allow large scale commercial production of unregistered medicines.
Judge Petrus van Niekerk rejected iDexis’ argument that it was using a chemically similar form of semaglutide rather than the exact active ingredient contained in Novo Nordisk’s registered medicines. The court ruled that the Medicines Act allows compounding only where the same active ingredient appears in a registered medicine, not one that is merely similar.
In its appeal, iDexis maintains that the High Court’s interpretation of the law is overly restrictive and argues that the ruling limits patient access to more affordable treatment options. The company has also insisted that its compounding practices comply with applicable pharmaceutical standards and that its products have been supplied safely to patients under medical supervision.
The legal dispute has intensified after South African health regulators ordered a nationwide recall of iDexis’ compounded weight loss medicines. The South African Pharmacy Council, the Health Professions Council of South Africa and SAHPRA warned healthcare professionals that prescribing, dispensing or retaining stock of the recalled products could result in disciplinary action, including possible suspension or removal from professional registers.
Regulators said inspections identified significant concerns relating to product quality, manufacturing practices and regulatory compliance. Authorities have also begun proceedings that could result in the withdrawal of iDexis’ pharmacy licence. The company has disputed those findings and said it intends to continue challenging the regulatory actions through legal channels.
The case is being closely watched by the pharmaceutical industry because it could shape how South Africa regulates compounded versions of high demand GLP 1 medicines at a time when global demand for obesity and diabetes treatments continues to surge.
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