Hindu Business Line – Data manipulation: India contests EU charges against GVK Bio

April 5, 2015, Hindu Business Line

New Delhi | Amiti Sen

India has challenged the allegations of data manipulation levelled by European and French drug regulatory agencies against GVK Biosciences.

New Delhi is ready to take “commercial and legal action” against the European Union (EU) if it does not react positively to evidence, a senior official told BusinessLine. It has supplied evidence to establish that the clinical trials were authentic.

“We have met the European Medicines Agency (EMA) and the French agency and given them evidence to show the tests by GVK Biosciences were not manipulated,” Commerce Secretary Rajeev Kher said.

Moving WTO an option

If there is no response soon, India will be constrained to take commercial or legal action against the countries, Kher said. “Legal action could be in the form of action at the World Trade Organisation,” he said.

Late last year, French medicines agency (ANSM) alleged that its inspection of GVK Biosciences, Hyderabad, an Indian contract research organisation, revealed data manipulation of electrocardiograms (ECGs), over five years, during research on generic medicines.

In January, the EMA gave its harsh recommendation that a number of medicines for which authorisation in the European Union (EU) were primarily based on clinical studies conducted at GVK Biosciences in Hyderabad should be suspended.

“The European agencies have suspected the clinical trials on grounds that are absolutely flimsy. Not just GVK, but the companies for which the clinical trials were done, which include several multinationals, have given a plethora of evidence to show that there was no manipulation,” Kher said.

The government has even got independent cardiologists to examine the ECGs, and they have given GVK a clean chit. “We have asked EMA and some other European agencies to cross check the ECGs and get back to us,” Kher said.

The Secretary said that there were just a few big multinationals that were driving an agenda against the generic (off-patent drug) industry, affecting India’s annual drug exports of $15 billion. “It is important for us to take the matter to its logical conclusion,” Kher said.

India’s strong retaliation against the EU action comes at a time when both the US and EU are taking an unprecedented number of measures against Indian pharmaceutical companies over quality issues.

“The past few years have seen a lot of action where the fault was not seen in the substance of the medicines but in the processes. We feel that this approach needs to be tempered,” Kher said.

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