EU refuses to budge on GVK Bio case, closes talks

G Naga Sridhar | | Updated on: Jan 19, 2018


India had protested the ban on 700 generics tested by the pharma firm

The Centre’s six-month-long negotiations with the European Union for revoking a ban on drugs based on clinical trials conducted by GVK Biosciences appears to have come to a nought.

At a recent meeting with a team from the Commerce Ministry, the EU conveyed its unwillingness to reconsider its decision, a senior Indian official said. “Despite the best efforts of the government, they (EU) remain unconvinced and also are reluctant to pursue the matter further,” he told BusinessLine.

In July 2015, the EU banned 700 generics (versions of off-patent drugs) tested by Hyderabad-based GVK Biosciences, following charges of manipulation of clinical trials for bio-equivalence testing by French standards agency ANSM.

The ban was based on the allegation that the electrocardiogram (ECG) data of volunteers examined by GVK between 2008 and 2014 had been doctored. The drugs tested by GVK during the period were withdrawn from all EU markets in August 2015 despite the lack of evidence against, or complaints regarding, the quality or efficacy of the medicines.

Bio-equivalence tests are vital for drug approvals as they are used to prove that the generic drugs are as effective as the originals. The Commerce Ministry official added that the issue might be put on the backburner for now.

Positive takeaway

Despite the lack of progress on this issue, the ministry takes heart from the positive takeaways from the meeting. “Many other approvals have been fast-tracked and there has been no loss to India’s brand image insofar as clinical trials are concerned,” the official said. The government too has softened its stance since July 2015, when it put off trade talks with the EU.

But now, the process of finalising the Broad Based Trade & Investment Agreement (BTIA), to draw up a free trade pact, has just begunand “things will move on”, he said.

GVK Biosciences declined to comment

Published on February 05, 2016
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