A High Court application by compounding pharmacy iDexis for leave to appeal against an interim order prohibiting it from making medicines containing semaglutide has been dismissed, with the judge describing the application as “an abuse of process”, reports Business Day.
In June, the court upheld an application against iDexis by Novo Nordisk, handing down an interim ruling banning the company from selling compounded semaglutide products pending the outcome of investigations by regulatory authorities.
In dismissing iDexis’s application to appeal against the ruling, Judge Petrus van Niekerk criticised it for submitting to the court a “lengthy diatribe”, saying it failed to make a clear and succinct case as to why another court would find differently. Counsel for iDexis had simply rehashed arguments previously made in court, he said.
Van Niekerk also held that the June ruling was an interim order, being tied to the finalisation of investigations into iDexis by the South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council (SAPC).
The outcome of these investigations was likely to be taken on review and would ultimately be determined by the courts, he said.
The Pharmaceutical Task Group (PTG) welcomed the ruling, saying it underscored the critical role of South Africa’s regulatory authorities in safeguarding public health, and reinforced the importance of allowing regulatory authorities to carry out their statutory responsibilities and investigations.
“Healthcare professionals and patients must be able to trust that medicines are manufactured, supplied and distributed in accordance with the standards established to protect public health,” said PTG chair Stavros Nicolaou.
iDexis’ legal team said it would seek leave to appeal at the Supreme Court of Appeal.
iDexis was raided by SAHPRA and the SAPC in May and directed to recall its semaglutide and tirzepatide products over safety concerns.
SAPC registrar Vincent Tlala said iDexis’ registration status was under review by both the SAPC and the national Department of Health. Meanwhile, iDexis could operate only as a community pharmacy and not as a manufacturing pharmacy, he said.
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