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19 Aug 2015

India: EU bans 700 generic drugs alleging manipulation of trials by GVK Biosciences, company denies claim

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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. The commission's decision taken last week is in response to a recommendation by the EU drug regulator European Medicines Agency (EMA) in January, that marketing authorisation of these drugs should be suspended as they were based on clinical trial data allegedly manipulated by the company. 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.