Europe Seeks Drug Withdrawals

The European Medicines Agency (EMA) is recommending that member countries withdraw hundreds of generic pharmaceuticals that were tested by GVK Biosciences, an Indian contract research organization. Data generated by GVK formed the basis upon which the drugs were granted marketing approvals across Europe. An inspection of GVK’s site in Hyderabad, India, by the French medicines agency found manipulation of electrocardiogram data, EMA says. The manipulation was systematic, occurred over at least five years, and involved a number of GVK staff members. The findings are serious enough to cast doubts on the integrity and reliability of other data generated by GVK, EMA adds. The list of manufacturers affected includes industry leaders Sandoz, Teva Pharmaceutical Industries, and Mylan. Essential drugs that aren’t available from alternative suppliers will not be removed from the market. GVK calls the recommendation “unprecedented and highly disproportional.” The company points out that the French medicines agency stated that the faulty electrocardiograms were not essential in demonstrating bioequivalence with the original drugs.