The European Medicines Agency is standing by its original recommendation made earlier this year to suspend a number of medicines that received European Union clearance based on clinical studies conducted by GVK Biosciences in India.
Following a re-examination of the GVK Bio studies, the agency's Committee for Medicinal Products for Human Use said about 700 pharmaceutical forms and strengths of medicines studied by the company at its Hyderabad, India, site remain recommended for suspension. There was "sufficient supporting data from other sources" to allow about 300 other medicines to remain on the EU market, the group said in a press release.
The proposed suspensions were triggered after questions arose following an inspection by French authorities last year of the GVK site that handled the clinical trials for the medications. Those inspectors found that a number of electrocardiograms were falsified by GVK Bio employees as part of 9 approval studies between 2008 and 2014. GVK Bio has disputed the claims but also said it has set aside up to $6.5 million for new studies.
The agency's recommendation will be sent to the European Commission for a legally binding decision.
According to the Federal Institute for Drugs and Medical Devices, the German regulatory agency, no adverse effects have been reported from any of the suspect products.
- see the release