EU banned marketing of around 700 generic medicines of GVK Biosciences

Jul 27, 2015 11:14 IST

The European Union (EU) on 25 July 2015 banned the marketing of around 700 generic medicines manufactured by India's pharmaceutical research company GVK Biosciences. These medicines will be banned in 28 member countries of European Union.

This is the largest suspension imposed on the sales and distribution of generic drugs and it will come into effect from 21 August 2015.

With this ban, 700 generic medicines will lose their validity for use in the EU and now they will not be distributed or sold by pharmaceutical companies, drugs stores, wholesale dealers and other outlets.

Reason of banning these generic medicines

The European commission took decision to ban around 700 generic medicines in response to a recommendation given by the EU’s nodal drug regulator European Medicines Agency (EMA) in January 2015.

In its recommendations, EMA had mentioned that the marketing authorisations of these drugs were based on clinical trial data which was allegedly manipulated by the Hyderabad -based pharmaceutical research company GVK Biosciences.

EMA's Committee for Medicinal Products for Human Use examined the marketing authorisation given to over 1000 generic drugs on the basis of bio-equivalence studies conducted by GVK Bio during the period between 2004 and 2014. The inspections showed systematic manipulation of clinical trial data.

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