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India maintains GVK Bio’s drug ban issue must be resolved for trade talks with EU

Amiti Sen New Delhi | Updated on January 23, 2018

In July this year, the EU had announced a ban on marketing of 700 generics (copied versions of off-patent drugs) tested at GVK Biosciences.

Bloc not responding to India’s willingness for re-testing banned drugs

India is not ready to play ball yet as Brussels has not made any attempt to sort out the issue of the ban placed on generic drugs tested by Hyderabad-based GVK Biosciences. This is despite leaders such as German Chancellor Angela Merkel pushing for resumption of the proposed India-EU free trade agreement (FTA) talks.

“We have been asking the EU to resolve the matter. We have said that we are even ready for re-testing of the banned medicines. But there is no official response from the bloc on the matter. We will not re-start FTA negotiations till there is some concrete movement on resolution of our problem,” a Commerce Ministry official told BusinessLine.

EU ban on 700 generics

In July this year, the EU had announced a ban on marketing of 700 generics (copied versions of off-patent drugs) tested at GVK Biosciences. Charges of manipulation of clinical trials for bio-equivalence testing (test to prove that generic or copied drugs are as effective as the ones whose patents have expired) of these drugs were made against the lab by a French standards agency ANSM. The ban was implemented on August 21.

In protest against the ban, India had called off the talks scheduled in July-end with EU to re-start the FTA negotiations that had not seen movement for more than two years.

Merkel, during her recent visit to India, raised the issue of resumption of FTA talks in her meeting with Prime Minister Narendra Modi, but it failed to make an impression on New Delhi.

“The ban on the 700 drugs was implemented despite all our efforts to convince the European Medicines Agency (EMA) that there was nothing wrong with the data. Now that we are prepared for re-tests to be run, the EU is not showing any interest. If the EU can be so stubborn, why should we relent?” the official asked.

With slowdown gripping the EU, the 27-member bloc is keen to have better access to the Indian markets for its goods, which an FTA can provide. “If the EU is interested enough in the FTA, we believe it will be more sensitive towards our concerns,” the official said.

Six-member panel

Last month, the Commerce Ministry set up a six-member panel consisting of experts from various departments, including drug regulators and cardiologists, to look into allegations made by ANSM against GVK for manipulation of data related to electrocardiograms (ECGs). The panel confirmed GVK’s assertion that there were no irregularities in the data.

“We feel that the EU may be slow in reacting because of pressure from big pharma companies who benefit if generics are out of the market. Since generics are several times cheaper than the patented variants, the profits of MNCs get dented,” the official said.

Published on October 18, 2015

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