Beginning of end to Indian CROs?

India’s pharma sector yet again is squirming under the glaring heat of international regulatory bodies. As a year-end shocker, December 2014 was a trying time for Hyderabad-based contract research organization (CRO) GVK Biosciences


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Given the countries clinical trial woes already, the fresh new controversy seems to have given yet another major blow to India in the international clinical trials scene. The country is also tasting the bitter pill of witnessing the dwindling number of CROs.

Four European Union (EU) countries including Belgium, France, German, and Luxembourg banned marketing authorizations of 25 generic drugs whose clinical tests were conducted by GVK Bio at its Hyderabad site.

On December 5, 2014, the European Medicines Agency (EMA), the EU drug regulator, said on its website, "Some member states have decided to suspend the marketing authorizations of medicines that have been authorized on the basis of studies conducted at the GVK Biosciences site in Hyderabad. EMA is currently reviewing findings of non-compliance with good clinical practice at this site, and determining their impact on medicines authorized on the basis of studies performed."

The suspensions taken at national level are precautionary measures until the review is finalized, EMA said. The regulatory body now believes that GVK Bio has been ‘systematically manipulating' its clinical studies.

Data reliability

EMA pointed that it started the review back in September 2014 post the inspection carried out by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), the French medicines agency, at the GVK Biosciences site, raising issues related on the reliability of studies conducted between 2008 to 2014.


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