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Article

24 Jul 2015

Author:
Press Trust of India

India: GVK Bio slapped with largest EU-wide suspension of generic drug sales

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The European Union has banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by India's pharmaceutical research company GVK Biosciences. The largest EU-wide suspension of sales and distribution of generic drugs ordered by the European Commission will come into effect on August 21, and will be applicable to all 28 member nations, according to Germany's drug regulator, the Federal Institute for Medicines and Medical Products (BfArM)...The commission's decision taken last week is in response to a recommendation by the EU drug regulator European Medicines Agency (EMA)...The inspection revealed "data manipulation of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years...GVK Bio had vehemently denied the allegations made by the European drug regulators and offered to conduct fresh studies of the medicines involved at its own cost.