Europe's response "disproportionate" says GVK Biosciences
The Indian contract research organisation (CRO) has been under investigation since May when an inspector from France’s ANSM suggested data from a single electrocardiogram (ECG) had been used in nine studies conducted at its site in Hyderabad.
At the time, the French regulator also said because the employees suspected of reusing the “check-out” ECGs may have been involved other aspects of trials, data from all of the bioequivalence studies would need to be reviewed.
Earlier this month, German regulators pulled marketing authorization for several generic drugs whose approval depended on data from trials run by GVK. Since then drug watchdogs in Belgium, France and Luxembourg have followed suit.
The European Medicines Agency (EMA) told Outsourcing-pharma.com “We are in close contact with different EU Member States to identify the medicines that may be affected.
“The CHMP has issued a list of questions to be addressed by the marketing authorisation holders for medicines for which the clinical part of bioequivalence studies has been carried out by the GVK Bio-Hyderabad site since July 2004 and a recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected in January 2015.”
In a statement emailed to us over the weekend GVK said: “We believe that the conclusions of the ANSM and the subsequent actions by the EMA are highly disproportionate to the actual risk posed to human health.”
The Indian CRO rejected the suggestion that the ECGs had come from a single volunteer citing reports by four independent cardiologists and reiterated that such tests “have no direct relevance to the quality of the testing of drugs.”
The EMA told us it has no comment on this statement by GVK. The organisation did say that it is still reviewing that situation and stressed that: "EU legislation gives Member States the possibility to take precautionary or temporary measures while reviews are ongoing at the EU or national level."
No new contracts since August
GVK’s updated statement follows reports in the Indian media that the review has had a very negative impact on its operations.
CEO Manni Kantipudi told the Economic Times that since last summer the firm has not won a contract and INR500m ($7.9m) worth of orders have been cancelled adding that “the number of trials a month have more than halved at 6-7 now from 15-20 before August.”
He told the Hindu that GVK is ready for customer requests that work is redone or refunded but not for compensation claims.
