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GVK Bio manipulated clinical trials of generic drugs: Reports

Press Trust of India  |  Berlin 

India's leading pharmaceutical research company GVK Bio allegedly manipulated the of clinical trials of generic drugs it had carried out on behalf of several European manufacturers for many years, media reports have said.

Germany's drug regulators are currently examining whether to suspend the use of more than 100 medicines on suspicion that they were given marketing licences for forged medical reports of human trials supplied by the Hyderabad-based company, TV channels NDR and WDR and the Munich daily Sueddeutsche Zeitung reported yesterday.

Such studies are crucial for copy-cat drugs to gain marketing licences from the regulators. The manufacturers will have to prove that their generic copy is comparable to the original product.

GVK Bio has been conducting human trials of generic drugs on behalf of globally-operating companies. It also has been conducting tests of new medicines.

The Federal Institute for Medicines and Medical Products, which issues the licences in Germany, confirmed it has been investigating the allegations against the Indian company.

The agency said it is too early to determine the exact number of medicines involved, but they may be more than a hundred, according to the reports.

Two drugs manufactured by the German company Betapharm and anti-allergy medicine Fexofenadin by Hexal are among the medicines currently being investigated.

German authorities, so far, have no information that the drugs involved posed any health risk for the public, the reports said.

European Union's drug regulator, the European Medicines Agency (EMA), believes GVK Bio has been systematically manipulating its medical studies for a number of years, the reports said.

Documents of the EMA and the European Commission showed at least 10 GVK Bio staff members were involved in the forgery, which took place during the period between 2008 and 2013, according to the reports.

French drug regulator ANSM found out during a routine control of medical reports earlier this year that GVK Bio had forged the outcome of a study of a drug for heart patients.

In nine studies investigated by the French authorities, they found out that all of them were partly manipulated.

The EMA had in July written to all manufacturers of generic drugs in the EU, seeking details of their cooperation with GVK Bio.

The agency will decide shortly whether additional studies are needed for some medicines or they will be withdrawn completely from the market.

Germany's drug regulator too has been seeking similar clarifications from generic drug manufacturers in this country and it will decide shortly whether to suspend the use of the affected drugs.

First Published: Fri, December 05 2014. 16:55 IST