Content area
Full text
Here's another black mark against the pharma industry in India . European regulators are barring a slate of generic drugs whose approvals relied on data generated by India's GVK Biosciences. The treatments weren't named, but they include products sold by a variety of drugmakers, including U.S.-based Mylan and Abbott Laboratories ($ABT).
Drug watchdogs in France , Germany , Belgium and Luxembourg have suspended marketing on the drugs, citing "anomalies" in electrocardiograms handled by GVK employees, Reuters notes. According to a document from the European Medicines Agency , inspectors found that a number of electrocardiograms were falsified as part of 9 different approval studies.
"These falsifications cast doubts on the authenticity of all other clinical records of these 9 trials," the EMA document states, going on to say, "The systematic nature of the falsifications of electrocardiograms, the extended period of time during which...




