The European Union (EU) has banned the marketing of around 700 generic medicines because of alleged manipulation of clinical trials conducted by Hyderabad-based GVK Biosciences. The EU-wide suspension of sales and distribution is due to come into effect on 21st August and will apply to all 28 member nations.
EMA's Committee for Medicinal Products for Human Use (CHMP) examined marketing authorisations for generic drugs that had been awarded on the basis of bio-equivalence studies conducted by GVK Bio between 2004 and 2014. This followed last year’s inspection of the company’s Hyderabad plant, which revealed "systematic manipulation of clinical trial data."
In an alleged breach of Good Clinical Practice, the inspection discovered "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.”
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