Data Manipulations in India Cause EU Suspensions

Applied Clinical Trials

The manipulation of data from studies conducted in India have led the European Medicines Agency (EMA) to confirm suspensions of a number of medicines.

The manipulation of data from studies conducted in India have led the European Medicines Agency (EMA) to confirm suspensions of a number of medicines for which authorization in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad. This outcome came from a re-examination requested by marketing authorization holders for seven of the medicines concerned.

EMA’s Committee for Medicinal Products for Human Use (CHMP) had adopted its original recommendation in January 2015, following an inspection of GVK Biosciences’ site at Hyderabad by the French medicines agency (ANSM) that raised concerns about how the company conducted studies. The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines over at least five years. Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the conduct of trials and on the reliability of data.

The CHMP’s recommendation will now be sent to the European Commission for a legally binding decision. This decision will apply to all Member States irrespective of whether or not they have taken interim measures to suspend medicines.

The full list of medicines for which the CHMP recommends suspension is available on the EMA website.

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