EMA halts approval of generics tested at Indian CRO

The European Medicines Agency (EMA) said some member states are suspending approvals of generic drugs whose marketing authorizations were based on bioequivalence studies conducted at GVK Biosciences Pte. Ltd. (Hyderabad, India), a CRO.

The "precautionary" suspensions are subject to a final conclusion of an investigation by EMA's CHMP. In September, CHMP began a review of findings by inspectors from the French National Agency for Medicines and Health Products Safety (ANSM). The inspectors alleged that 10 GVK employees falsified electrocardiograms in 9 clinical trials from 2008 to 2013, raising concerns about all clinical bioequivalence trials performed at the site. ...