India defers trade talks following EU suspension of GVK Biosciences-tested products

6 August 2015

India has deferred its trade talks with Europe following an European Union decision to ban the sale of around 700 pharmaceutical products that had been tested by GVK Biosciences, an Indian contract research organization.

The talks between India’s Commerce and Industry Ministry and the EU regarding the Broadbased Investment and Trade Agreement were scheduled to resume this month, but have now been deferred.

The European Medicines Agency confirmed its recommendation to suspend the drugs, which received their European approval based largely on studies by GVK Biosciences. The EMA said an inspection of the contract research firm’s Hyderabad site revealed “systematic” manipulation of data on electrocardiograms in some generics studies over the past five years or more. The largest suspension of sales and distribution of generic drugs ordered by the European Commission will come into effect on August 21. It will apply to all 28 member nations, according to Germany's drug regulator, the Federal Institute for Medicines and Medical Products (BfArM).

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