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EMA suspends medicines over `flawed’ studies at GVK Biosciences

G Naga Sridhar Hyderabad | Updated on January 23, 2018 Published on May 22, 2015

700 pharmaceutical forms and strengths of medicines recommended for suspension

The European Medicines Agency (EMA) has confirmed its earlier recommendation to suspend a number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at Hyderabad-based GVK Biosciences.

This is the outcome of a re-examination requested by marketing authorisation holders for seven of the medicines concerned, according to a released issued by the agency on Friday.

As a result of this decision, around 700 pharmaceutical forms and strengths of medicines studied at the Hyderabad site remain recommended for suspension.

For around 300 other pharmaceutical forms and strengths, sufficient supporting data from other sources had been provided; these medicines will therefore remain on the market in the EU.

The recommendation to suspend these medicines was first given by EMA’s Committee for Medicinal Products for Human Use (CHMP) in January 2015 following an inspection of GVK Biosciences’ site at Hyderabad by the French medicines agency (ANSM).

It raised concerns about how GVK Biosciences conducted studies at the site on behalf of marketing authorisation holders.

The inspection revealed data `manipulations’ 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. 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 at the site generally and on the reliability of data generated.

During the re-examination, the CHMP concluded that concerns about reliability of the clinical studies remain and therefore maintained its recommendation of January 2015 to suspend medicines for which no supporting data from other studies were available.

However, exception was given to one medicine included in the re-examination for which concerns about studies were addressed. This medicine is now no longer recommended for suspension.

The 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.

Published on May 22, 2015
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