Last updateWed, 15 Apr 2015 11pm

#Generics: India may take action against EU over drug clinical trials

India may consider going to the World Trade Organization (WTO) if the European Union does not reconsider its decision to suspend the sale of about 700 generic drugs that were approved based on clinical trials by GVK Biosciences, the company’s CEO said.

The European Medicines Agency (EMA) suspension became effective in January, a month after France, Germany, Belgium and Luxembourg suspended the sale of 25 generic drugs that were approved based on trials conducted by GVK Biosciences.

The privately-held company, part of India's infrastructure builder GVK Group, conducts clinical research for domestic and foreign drug-makers.

The regulatory actions were taken after the French watchdog inspected a GVK Biosciences manufacturing plant in southern India last year and found manipulation of data from electrocardiograms (ECG) for at least five years.

The French regulator said at the time that suspensions were taken out of precaution and there was no reason to suggest the drugs were ineffective or harmful.

The drugs suspended by the EMA include those made by U.S. firms Mylan Inc and Abbott Laboratories, as well as large Indian companies such as Lupin Ltd and Dr Reddy's Laboratories.

After an appeal by the company, the Indian government set up a panel of experts last year to investigate the matter and found no manipulation, GVK Biosciences CEO Manni Kantipudi told Reuters.

An Indian government delegation visited the European authorities between February and March to ask for the suspension be reconsidered, Kantipudi said.

If that does not happen, New Delhi is ready to take commercial and legal action, which could include action at the WTO, India's Commerce Secretary Rajeev Kher told local daily Hindu BusinessLine last week.

The commerce department is yet to respond.

"There are some legal options, but we will see what comes out of these diplomatic talks and then we and the commerce ministry will decide on what to do," Katipudi said. He added that European authorities will get back to the company, but haven't said by when.

GVK Biosciences is the latest Indian firm to come under international scrutiny over quality issues. Several large Indian drugmakers have over the past two years faced U.S. and UK sanctions over issues ranging from data fabrication and manipulation, to sanitation.



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