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Aug
21
ragupathyrenganathan
As GVK drugs go off EU shelves, India sees no scope now for FTA talks
Pharma News
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India has said there is no scope at the moment to mend bilateral economic relations with the European Union as the latter has refused to withdraw the ban on the sale of over 700 generics drugs tested by GVK Biosciences.

The ban will come into effect on Friday.

“From tomorrow, good quality generics, most of them manufactured by Indian companies, are going to be pulled off the shelves in 28 European countries. There is no way we can discuss free trade in this back-drop,” a government official told BusinessLine.

India was hopeful that Brussels would revoke the marketing ban, following the loud protests by New Delhi.

‘Ban unjust’

Labelling the ban unjust, India had called off talks on the proposed FTA scheduled later this month that was to have brought back to life negotiations stalled for over two years due to differences on key issues.

“Since the EU has not paid any heed to India’s repeated requests for a re-think on the ban despite proof supplied by GVK on the authenticity of its tests, we do not want to engage with the bloc in other areas till we are clear about what to do next,” the official said.

New Delhi is weighing the option of dragging the EU to the World Trade Organisation, but is yet to firmly build up its case against the ban. A team in the Commerce Ministry is examining the case.

The marketing ban on 700 generics placed by the EU is based on a complaint made by French regulator ANSM to the European Medicines Agency (EMA) last year alleging that clinical trials for bio-equivalence testing (test to prove that generic drugs are as effective as the ones whose patents have expired) of certain drugs conducted by GVK between 2008 and 2014 were unreliable.

It claimed that one person’s ECG data was used for different volunteers who underwent the tests.

GVK has already submitted to the EU the results of independent cardiologists who have gone through the ECGs and have stated that in most cases it was evident that the ECGs were of different individuals.

There have also been no complaints about drugs tested by GVK that are already being sold in Europe, the official added. New Delhi is apprehensive that the EU’s decision could have been guided more by commercial concerns as Indian generics are available at a fraction of the price of the patented versions sold by pharmaceutical majors, many of them based in Europe.



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