Hyderabad-based contract research organisation GVK Biosciences on Monday said the company was ready to re-do all the clinical studies of drugs over which the European Medicines Agency (EMA) raised an alarm, citing the findings of the French drug regulatory agency, ANSM (Agence Française de Sécurité Sanitaire des Produits de Santé).
It may be recalled that four European countries, including France, had suspended the marketing authorisation of about 25 generic drugs which were approved based on the bio-equivalence studies conducted at GVK Bio’s facility here.
Though the findings of the ANSM inspectors were related to the alleged manipulation of certain portion of ECG reports of the volunteers at the check-out stage and it had got nothing to do with the core clinical research process, GVK Bio is willing to take the entire burden of re-doing the tests for the sake of the clients.
The company had taken a Rs 60-crore hit as new orders from the clients were stopped from August when the ANSM reported its findings on the company's Hyderabad site and on an average each clinical study of the 100-odd drugs handled by them would cost around Rs 30 lakh each, according to Manni Kantipudi.
He said they would re-do the studies in their Ahmedabad facility depending on the willingness of the clients and also planning to engage other agencies owing to the large amount of work. The clinical research contributes just about 10-12 per cent of their total revenues, according to him.
"However, it is a body blow we have taken. It's difficult get back into normal position," Manni Kantipudi said while assuring the full cooperation with European regulatory agencies in clearing the apprehensions over the clinical research of various undertaken by GVK Bio.
He asserted that the company had not resorted any kind of manipulation with the data or the reports.