The Swiss surveillance authority for medicines today checked for any corresponding preparations of the 700 generic...
The Swiss surveillance authority for medicines today checked for any corresponding preparations of the 700 generic medicines subjected to clinical trials by India’s GVK Biosciences, whose marketing rights were suspended by the European Medicines Agency (EMA).
Although, it did not find any such production, it did “find three products that have been authorised for distribution abroad” but not available in the Swiss market yet and is initiating a review procedure for these authorisations.
The Swiss agency, Swissmedic, has asked GVK Biosciences to respond in 30 days. The EMA had claimed last year that the Hyderabad-based company manipulated the results of clinical trials, on the basis of which approvals for 700 medicines were revoked.
Also, 300 other medicines were found to qualify the clinical tests by GVK.
The EMA had said that the studies were flawed because they did not generate sufficient data.
“If the company provides additional studies to support the medicines then there is a chance that their market authorisation remains but if not, then we will suspend or withdraw the authorisations,” said Peter Balzli, spokesperson for Swissmedic.
“We would stress once again that there is no evidence of any threat to patient safety. The three medicines concerned contain the correct dosage of the correct active ingredient,” he added.
EMA’s recommendation has set the stage for a decision by the European Commission, whose decision will be binding on all member states.
The process was initiated when the French medicinal products agency Agence Nationale de SÃ©curitÃ© du MÃ©dicament et des Produits de SantÃ© (ANSM) sounded an alarm about bioequivalence studies conducted between 2008 and 2014.
The suspension recommendations came in January, four months after EMA launched a review of GVK.
A number of EU states had started suspending the GVK bio-tested medicines based on their own review.
Although, GVK had maintained during the review that,”all key activities such as dosing, blood sampling and processing were adequately controlled, supervised and staff were qualified to do the work.