The legal battle between Novo Nordisk and Pretoria-based pharmacy group iDexis could reshape South Africa’s compounding medicine landscape.
The Gauteng High Court ruled in favour of Novo Nordisk, issuing an interim order to prevent the local pharmacy group from manufacturing and selling weight-loss medicines containing semaglutide, the key ingredient in Novo Nordisk’s Ozempic and Wegovy.
In response, iDexis applied to appeal the judgment, disputing allegations about product safety and regulatory compliance.
Compounding involves pharmacies mixing or altering the active ingredients of a medicine to address specific patient needs.
In South Africa, it is restricted to a small number of patients and not allowed at a commercial scale.
Legal implications
While the case centres on Ozempic, it raises broader legal questions around pharmaceutical regulation, patient safety, intellectual property and the role of compounding pharmacies in South Africa.
Charles Green, a healthcare and pharmaceutical expert at leading law firm Cliffe Dekker Hofmeyr (CDH), says the ruling could have far-reaching implications for the healthcare sector.
“The court’s decision provides important clarity on the legal boundaries governing compounded medicines in South Africa.
“While compounding remains an essential part of healthcare, it cannot replace the commercial manufacture or distribution of medicines outside the country’s regulatory framework.
“As demand for GLP-1 medicines continues to grow, the decision also highlights the need to balance patient access, innovation and the integrity of South Africa’s medicines regulatory system,” adds Charles.
Nqobile Dludla 15 Jul 2026 Regulators’ recall
In the meantime, the South African Pharmacy Council (SAPC), the Health Professions Council of South Africa (HPCSA) and the South African Health Products Regulatory Authority (SAHPRA) are recalling iDexis’ compounded weight-loss medicines, and have warned healthcare professionals that prescribing, dispensing or holding stock of these drugs could lead to disciplinary action.
“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.
Tlala said SAPC was working with the Department of Health 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.
Although the matter is still before the courts, the ruling is expected to shape how pharmaceutical companies and regulators approach compounded medicines.
