Berlin: India’s leading pharmaceutical research company GVK Bio allegedly manipulated the results 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 hu-man trials supplied by the Hyderabad-based co-mpany, TV channels NDR and WDR and the Munich daily Sueddeutsche Zeitung reported on Thursday.
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 co-mpanies. 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 German drug licence regulator said that 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 German firm Betapharm, which is owned by another Hyde-rabad-based drug maker Dr Reddy’s Laboratories, and anti-allergy medicine Fexofenadin by Hexal are among the medicines currently being investigated by the drug authorities.
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. It will decide whether additional studies are needed for some medicines or they will be withdrawn completely from the market.
Reacting to German media reports, GVK BIO said it had addressed the concerns and had submitted independent cardiology assessments of the ECGs indicating that the ECGs can belong to multiple volunteers. “We also provided evidence that all key activities were adequately controlled, supervised and staff were qualified to do the work,” the company said.
