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‘Generics trials by GVK Bio under German regulatory scanner’

Firm says it had already submitted independent assessments

Hyderabad | Updated: December 6, 2014 2:07:53 pm

By: BV Mahalakshmi
GVK Biosciences allegedly manipulated the results of clinical trials of generic drugs it carried out on behalf of several European manufacturers, some German media reports said.

Germany’s drug regulators are currently examining whether to suspend the use of more than 100 medicines on the suspicion that they were given marketing licences for forged medical reports of human trials, said TV channels NDR and WDR and the Munich daily Sueddeutsche Zeitung.

A report in The Financial Express had stated on September 26 that GVK Bio received a letter from the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh), a European drug agency, along with French drug regulator Agency for Medicines and Health Products Safety (ANSM), following a ‘good clinical practice’ (GCP) inspection citing deficiencies that stretch back to 2008.

ANSM found out, during a routine control of medical reports earlier this year that GVK Bio had allegedly forged the outcome of a study of a heart drug. In nine studies, the French authorities found partial manipulation. The EMA had in July written to all manufacturers of generic drugs in the EU, seeking details of their cooperation with GVK Bio.

The Federal Institute for Medicines and Medical Products, which issues licences in Germany, confirmed that it had been investigating the allegations against the company. The agency said it was too early to determine the exact number of medicines involved, but they may be more than 100, according to the reports.

When contacted, GVK Bio said in an email response that it had already submitted independent cardiology assessments of the ECGs indicating that they belonged to multiple volunteers and it was difficult to conclude that they belonged to the same volunteer. The company said an inspection team of the German drug regulator inspected its facility in October.

“We also provided evidence that all key activities such as dosing, blood sampling and processing were adequately controlled, supervised and the staff were qualified to do the work. We also strengthened the operating procedures around taking the ECGs and these were accepted by the authorities,’’ the company said.

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