South African pharmaceutical company declares war over weight-loss drugs

South African pharmacy group iDexis said on Tuesday it had applied to appeal a court judgment that curbed its production of compounded weight-loss medicines, disputing allegations about product safety and regulatory compliance.

The dispute follows a High Court interim order granted last month barring iDexis from manufacturing and selling GLP-1 medicines containing semaglutide.

A case brought by Novo Nordisk, this dispute comes amid heightened scrutiny of compounded versions of popular weight-loss and diabetes treatments.

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 representatives of iDexis have lodged an application for leave to appeal the interim interdict, iDexis Managing Director Ruaan Louw said in a statement.

As per the order, the pharmacy stopped compounding GLP-1 and GIP products after the judgment was handed down and remains committed to complying with the law and protecting public health, Louw said.  

He further expressed concern that iDexis had been singled out while other compounding pharmacies were allegedly producing similar products.

Louw said iDexis has also lodged separate appeals against findings and decisions by the South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council (SAPC).

This follows SAHPRA and SAPC’s inspections of the pharmacy group’s facility in May. These two groups are South Africa’s primary health and pharmaceutical regulatory bodies.

If internal remedies are exhausted, iDexis intends to pursue appropriate relief in court against the regulators, he added.    

The joint inspection by the regulators found that iDexis was producing GLP-1 medicines for broader commercial distribution – beyond that allowed by regulations.

They also cited serious deficiencies in quality, safety and compliance. Authorities seized products and ordered a recall of the medicines.

Louw said iDexis has no knowledge of any testing results disclosed by the regulators on those products. Instead, independent testing was commissioned.

An independent expert report, also shared with the regulators, found no evidence of sterility breaches and maintained that the products were safe for use and were compounded according to appropriate procedures. 

“The company will… take all necessary steps to vindicate its position and restore its reputation within the South African compounding pharmacy sector,” Louw said.