Veterinary pharmaceutical company, V-Tech is calling on the South African Health Products Regulatory Authority (Sahpra) to take action concerning the release of withheld medication, Trilostane – a drug used for treating adrenal disorders in dogs and cats.
According to the company, in October 2023, the dispute reached the courts, where a judge ruled that Sahpra and V-Tech should negotiate the release of an initial batch of Trilostane.
“Yet, despite this judicial intervention, Sahpra’s handling of the situation has been mired in delays, misinformation, and bureaucratic chaos,” V-Tech said.
V-Tech CEO, Dr Johan Oosthuyse said: “We are witnessing an unprecedented disregard for animal welfare.
Every day of delay costs lives. Pets who depend on Trilostane are being left to die because of a tangled web of misinformation and bureaucratic red tape.”
V-Tech lamented that without an immediate resolution, “the fallout will be catastrophic for countless pet owners and veterinarians who are left helpless to manage treatable conditions”.
Sahpra, however, said it has advised V-tech to apply for the relevant license needed while it was awaiting the outcome of an appeal process.
Sahpra spokesperson, Madimetja Mashishi said: “V-Tech has submitted an appeal in terms of Section 24A of the Medicines Act to the Minister of Health in respect of Sahpra’s decision not to allow it to import active pharmaceutical ingredients, including Trilostane, and Sahpra’s decision and insistence that V-Tech is required to have the relevant licence in terms of the Medicines Act. Such appeal is still pending before an Appeal Committee appointed by the Minister.
“While V-Tech operates a licensed/registered community pharmacy, community pharmacies lack the scope to engage in the trade of importing active pharmaceutical ingredients unless such pharmacies also hold the relevant licence in terms of the Medicines and Related Substances Act. Such scope of services for a community pharmacy is provided for in terms of the Pharmacy Act.”
According to the regulator, it was yet to receive applications to register a medicine or for the relevant license.
“Since June 2023, Sahpra has been advising V-Tech to either apply for the relevant licence required in terms of the Medicines and Related Substances Act or to procure its active ingredients through licensed establishments. V-Tech has in the past procured its active pharmaceutical ingredients using Multichem, an entity with a correct licence to import active pharmaceutical ingredients, such as Trilostane. These have been recorded in two court proceedings instituted against Sahpra by V-Tech. V-Tech has not submitted an application for a licence to Sahpra. Furthermore, the company in question has not submitted an application to register a medicine. It is a legal requirement to obtain a licence from SAHPRA in order for a company to trade as an importer of Active Pharmaceutical Ingredients,” Mashishi added.
Cape Times
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