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EU to suspend hundreds of drug authorisations after doubts over clinical studies in Hyderabad

BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.h574 (Published 02 February 2015) Cite this as: BMJ 2015;350:h574
  1. Rory Watson
  1. 1Brussels

The European Commission is preparing to suspend the marketing authorisations for more than 700 generic drugs after serious doubts emerged over the validity of the clinical studies conducted by GVK Biosciences in Hyderabad, India. The decision, which is expected within the next three to four weeks, will be legally binding throughout the 28 member European Union.

The unexpectedly tough action was based on a recommendation from the London based European Medicines Agency. At the commission’s request the …

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