EMA recommends suspending drugs tested by Indian CRO

EMA recommended that marketing authorizations be suspended for GVK Biosciences Pte. Ltd. (Hyderabad, India), a CRO. EMA sent its recommendation to the European Commission for review in advance of a legally binding decision.

EMA based its recommendation on CHMP's review of over 1,000 "pharmaceutical forms and strengths of medicines" studied at the Indian site. CHMP began the review last September after inspectors from the French National Agency for Medicines and Health Products Safety (ANSM) alleged that 10 GVK employees falsified electrocardiograms in nine clinical trials of generic drugs from 2008-13 (see BioCentury Extra, Dec. 5, 2014). ...