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

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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 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.


It is devastating, that Indian corruption and moral values are destroying India, as a world leader in business.
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