European Medicines Agency alleged that results of clinical trials conducted or tested by GVK Biosciences were manipulated.
The European Medicines Agency, the EU drug regulator had recommended that the marketing authorisation of these drugs should be suspended on the grounds that they were based on clinical trials allegedly manipulated by the Hyderabad-based company. There had been investigations into bio-equivalence studies conducted by GVK Bio during the period between 2004 and 2014.
There were revelations of "data manipulation of electrocardiograms during the conduct of studies of some generic medicines" over at least five years period.
However, the ban on certain medicines could be lifted.
... Pharmaceutical companies affected by the suspension of marketing authorisation have the possibility to challenge it only in a European court as the agency's decision is based on the European Commission's order, the spokesman said.
BfArM had offered them the possibility to reverse its decision if they provide new clinical trial data. Drugs manufacturers have one year to furnish the results of fresh bio-equivalence studies of their medicines, according to the spokesman.
Medicines affected by the commission's marketing ban have lost their validity for use in the EU . . . and they should no longer be sold or distributed by pharmaceutical companies, wholesale dealers, drugs stores or other outlets, the agency said in a press statement. ..."
"... London-based EMA's Committee for Medicinal Products for Human Use (CHMP) had examined the marketing authorisation given to over 1,000 generic medicines from EU member nations on the basis of clinical trials conducted by GVK Bio during the period between 2008 and 2014 after an inspection of the company's facility in Hyderabad by the French Medicines Agency (ANSM) in May, 2014 showed "systematic manipulation of clinical trial data," according to the agency.
EMA later extended its investigation to cover the clinical trials conducted by GVK Bio during 2004-2008. ..."
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