Large Molecule / Contract Manufacturing / Generic

Regulators Suspend Drug Approvals for 25 Generics Tied to Faulty Bio-equivalence Studies

Source: Economic Times

Dec 09, 2014

Economic Times

Regulators in France, Germany, Belgium and Luxembourg are suspending the marketing approval of 25 generic drugs due to concerns over data quality from clinical trials conducted by India's GVK Biosciences.

French watchdog ANSM and Germany's BfArM said they were investigating the drug approvals based on the bio-equivalence studies conducted by Hyderabad-based contract research organisation GVK Bio between 2008 and 2014. ANSM inspected GVK Bio's site in Hyderabad and found "anomalies" in the way electrocardiograms were monitored during the bioequivalence studies.

The specific drugs were not named, but include generics sold by a variety of drugmakers, including U.S.-based Mylan and Abbott Labs.

GVK Biosciences later announced that the company was ready to re-do all the clinical studies of drugs over which the European Medicines Agency raised alarm.

Read the Economic Times article