May 22, 2015 / 12:20 PM / 4 years ago

EU regulator confirms recommendation to suspend drugs over flawed studies

(Reuters) - The European Medicines Agency confirmed on Friday its recommendation to suspend a number of medicines that were granted EU approval based on clinical studies conducted at Indian firm GVK Biosciences’ facility in Hyderabad, India.

The Committee for Medicinal Products for Human Use (CHMP) said a re-examination of the medicines, prompted by a request from marketing authorization holders for seven of the drugs, revealed that concerns about the reliability of the clinical studies remained. (

About 700 pharmaceutical forms and strengths of medicines studied at the Hyderabad site remain recommended for suspension, the agency said.

One medicine included in the re-examination is no longer recommended for suspension as concerns about studies had been addressed, the agency said.

Europe’s drug regulator recommended suspension of the medicines in January, a month after France, Germany, Belgium and Luxembourg suspended the sale of 25 generic drugs that were approved based on trials conducted by GVK Biosciences.

These included drugs made by Mylan NV and Abbott Laboratories, as well as large Indian companies such as Lupin Ltd and Dr Reddy’s Laboratories.

GVK Biosciences said last month that India may approach the World Trade Organisation (WTO) if the EU did not reconsider its suspension.

Reporting by Roshni Menon in Bengaluru; Editing by Simon Jennings

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