January 23, 2015 / 12:40 PM / 5 years ago

EU regulator recommends suspension of drugs over Indian data

LONDON (Reuters) - Europe’s drug regulator said on Friday it had recommended the suspension of a number of drugs which were approved on the basis of clinical studies conducted at GVK Biosciences in Hyderabad, India.

The European Medicines Agency said the recommendation was based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of the pharmaceutical companies.

The move follows a similar decision from state regulators in France, Germany, Belgium and Luxembourg in December to suspend the marketing approval of 25 generic drugs due to concerns over the quality of data from clinical trials conducted by the Indian firm.

Reporting by Kate Holton; editing by Paul Sandle

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