South African Court Blocks Sale of Unapproved Weight-Loss Drugs in Novo Nordisk Case.

South African Court Blocks Sale of Unapproved Weight-Loss Drugs in Novo Nordisk Case.

A South African High Court has temporarily stopped a local pharmacy group from producing and selling weight-loss medicines containing semaglutide, handing a significant legal win to Danish pharmaceutical giant Novo Nordisk.

The ruling, delivered by the Gauteng Division of the High Court in Pretoria, followed a legal challenge by Novo Nordisk, the maker of the widely used diabetes and weight-management drugs Ozempic and Wegovy.

The court ordered pharmacy group iDexis and its director to immediately cease the manufacture, distribution and promotion of their semaglutide-based products while regulatory investigations continue.

Novo Nordisk argued that the company was operating outside South Africa’s medicines regulations by supplying unregistered products to the public.

According to court documents, iDexis had been producing tens of thousands of units every month, making it a major player in the country’s growing weight-loss market.

In its defence, iDexis maintained that it was legally allowed to compound semaglutide medicines because the ingredient it used closely resembled the substance found in registered products such as Ozempic and Wegovy.

However, the court rejected this argument, ruling that South African law permits compounding only when the exact active ingredient is already contained in an approved medicine. The judge found that similarity alone was not sufficient.

The court also noted that iDexis used a synthetic version of semaglutide, while Novo Nordisk’s products are biologically derived.

Concerns were raised that the compounded products had not been assessed or approved by the South African Health Products Regulatory Authority (SAHPRA).

Judge Petrus van Niekerk said regulatory inspections revealed serious concerns around quality, safety, and compliance.

He ruled that the interim order was necessary to prevent ongoing unlawful activity and to protect public health.

The ban will remain in place until regulators and the South African Pharmacy Council complete their investigations, or until the courts make a final ruling on the matter.

The case highlights growing legal and regulatory pressure surrounding unapproved weight-loss treatments amid surging global demand for semaglutide-based drugs.