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The South African Health Products Regulatory Authority (SAHPRA) and V-Tech, a South African veterinary compounding company, has reached an agreement over the import of trilostane, an active ingredient used in the manufacturing of Cushing’s Disease medication. According to V-Tech, around 6 000 South African dogs suffer from Cushing’s Disease.
Earlier this month AgriOrbit reported on V-Tech’s struggle to import a consignment of trilostane that was stuck at OR Tambo International Airport since June this year. At the time, SAHPRA refused to release the shipment to V-Tech because this active pharmaceutical ingredient (API) was not present in any another registered medicine in South Africa. V-Tech, which has been importing the substance for a decade, maintained that trilostane was never called up for registration and therefore certain provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) did not apply.
The matter ended up in court during the first week of November and the parties were able to find common ground.
Read more about the court case.
Co-operation to find workable solutions
“The outcome of our negotiations has been productive and positive, with the CEO of SAHPRA, Dr Boitumelo Semete-Makokotlela, playing an instrumental role in reaching an agreement to have the shipment released immediately, subject to conditions. This is good news for both veterinarians and pet owners, as the medication we compound using trilostane will now be available again,” said Dr Johan Oosthuyse, a veterinarian and CEO of V-Tech.
He added that both parties have agreed to work together to find long-term solutions to the unique challenges faced by the South African veterinarian pharmaceutical industry, particularly in respect of certain medications.
“Both parties recognise that we have a national asset in terms of the diverse animal species we have in South Africa, and that we need to ‘think out of the box’ to find workable solutions to finding effective and safe medicines to treat them in a responsible and safe way within the regulatory framework.”
Dr Oosthuyse thanked Dr Gert Steyn, the managing director of the South African Veterinary Association (SAVA), for his instrumental role in resolving the matter. – Susan Marais, Plaas Media
