India's GVK Biosciences gets harsh accusations from EMA on fake generic trials

SINGAPORE--In a no-holds-barred action, the European Medicines Agency has accused India-based CRO GVK Biosciences of systematically faking clinical trials for about 700 generic drugs marketed throughout the world. The products of dozens of generic makers are among the drugs involved, including popular antidepressants.

The agency recommendation to the European Parliament came a month after four EU member countries took their own actions to suspend many of the drugs. The EMA said it examined about 1,000 drugs and formulae the Hyderabad-based CRO tested. It said 300 of those drugs were supported by trials and information from other sources and should remain on the market.

Among the generics makers whose products were among the 700 are Abbott Laboratories ($ABT), Actavis ($ACT), Dr. Reddy's Laboratories, Mylan Pharmaceuticals ($MYL), Sandoz and Takeda Pharmaceuticals.

GVK CEO Manni Kantipudi

GVK Biosciences did not respond immediately to the EMA action but said in December when the EMA expressed its doubts about the studies that it had suspended studies in progress at Hyderabad and would redo all of the studies in question at another facility in Ahmedabad. CEO Manni Kantipudi also denied at the time that the company had manipulated trial data.

The drugs involved passed through GVK clinical trials between 2008 and last year. The number in the EMA recommendation was far higher than the figures used in December. The highest number mentioned then was the 176 suspended by German regulators. Regulators in Belgium, Denmark, France and Luxembourg also suspended 25 of the drugs.

The U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) suggested it would wait for the EU recommendation, saying only that "This is a precautionary measure. There is no evidence to suggest that these medicines are not safe and effective." The U.S. FDA said it would take "swift and appropriate action" if it found similar issues with the drugs on the EMA list that it approved, according to Medscape.

The language of the EMA recommendation was unusually harsh. It said its action was based on "findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorization holders." It said French inspectors had discovered that electrocardiograms were falsified during clinical trials and that "these manipulations appeared to have taken place over a period of at least five years."

The EMA added, "Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the way trials were performed at the site generally and on the reliability of data generated at that site."

- here's the EMA release
- and more from Mad In America
- and the response from GVK

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