Tuesday, July 28, 2015

IT IS OFFICIAL: MORE THAN 700 GENERICS LINKED TO INDIAN DRUGMAKER "GVK Biosciences" SUSPENDED IN EU.

IT IS OFFICIAL: MORE THAN 700 GENERICS LINKED TO INDIAN DRUGMAKER SUSPENDED IN EU: 

The Commission formally adopted the EMA panel recommendation to suspend use of about 700 generic drugs tested by the suspect Indian clinical trial company GVK Biosciences, Le Monde reports. http://bit.ly/1LMAYyc

Recall that the EMA in January had opened an investigation into GVK and concluded that data on electrocardiograms had been manipulated during some studies over five years, working off a tip from the French drug safety agency.

A Le Monde editorial calls the ban a “wake-up call” (more literally, “a call to order”) and highlights just how dangerously opaque clinical trialing for Indian and Chinese generic medicines can be — and just how vulnerable Europe is as a result. http://bit.ly/1D1HZrT

Find the EMA notice from May here: http://bit.ly/1KtvGXS

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