India may go to WTO against EU over drug clinical trials

Written By Unknown on Rabu, 15 April 2015 | 15.45

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.

India may go to the World Trade Organisation (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 Pvt Ltd, the firm'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 drugmakers.

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 US 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 that 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 one of the Newspaper last week.

The commerce department did not respond to a request for comment by Agency.

"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.

EMA's press office did not immediately respond to a request for comment on Wednesday.

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 US and UK sanctions over issues ranging from data fabrication and manipulation, to sanitation.

Lupin stock price

On April 15, 2015, at 14:13 hrs Lupin was quoting at Rs 1969.00, down Rs 11.8, or 0.6 percent. The 52-week high of the share was Rs 2112.00 and the 52-week low was Rs 928.80.


The company's trailing 12-month (TTM) EPS was at Rs 56.97 per share as per the quarter ended December 2014. The stock's price-to-earnings (P/E) ratio was 34.56. The latest book value of the company is Rs 155.27 per share. At current value, the price-to-book value of the company is 12.68.


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