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Southern Africa’s largest veterinary compounding pharmacy, V-Tech, and the South African Health Products Regulatory Authority (SAHPRA) are gearing up to battle each other in court this week due to SAPHRA’s alleged refusal to release a vital consignment of trilostane, a key ingredient in V-Tech’s Cushing’s Disease medication.
According to V-Tech, it has been struggling to have its latest consignment imported since June 2023.
“The company is stunned by the authorities’ sudden decision that it can no longer be imported,” said Dr Johan Oosthuyse, CEO of V-Tech. He added that the company has been importing and using trilostane in the production of their Cushing’s disease medication for a decade. “It is a reasonable technical argument, but in essence, SAPHRA decided that trilostane should be classified as a medicine and therefore it is not welcome in the country.”
Cushing’s disease mostly affects dogs and to a lesser extent cats and horses, Oosthuyse said. “This happens when an animal’s adrenal gland becomes hyperactive and starts excreting excessive amounts of cortisol. The disease is becoming more prominent and small animal veterinarians report at least a case per week now.”
“Cushing’s disease leads to hair loss and weight gain. All the animal’s organs will be affected, especially the heart, and this will eventually lead to the premature death of the animal,” Oosthuyse explained.
Without trilostane, V-tech won’t be able to produce the necessary medication, and this would practically mean that veterinarians won’t be able to treat animals effectively.
“V-Tech is firmly of the view that trilostane belongs to a category of medicine that has never been called up for registration and our opinion is supported by the South African Veterinary Association (SAVA), which represents over 1 800 registered veterinarians in the country,” Oosthuyse added.
“We feel that this decision (by SAHPRA) will cause untold and unnecessary suffering for dogs suffering from the disease.”
SAHPRA did not want to comment on the matter at the time of publication as the issue is being addressed by its legal team. – Susan Marais, Plaas Media