India may drag EU to WTO if drugs ban is not lifted

India is considering the option of dragging the European Union (EU) to the World Trade Organisation for “unjustly’’ banning 700 Indian drugs that were clinically tested at the Hyderabad-based GVK Biosciences.

The Commerce Ministry is examining at least two technical grounds to see if a case can be made against the 28-member bloc at the multilateral forum, an official told BusinessLine .

The core allegation of data manipulation of electrocardiograms (ECGs) of volunteers levelled by the French drug regulatory authority, ANSM, against contract research lab GVK can be challenged as the lab has denied it and also produced evidence to support its position, the official said.

Moreover, the ministry is also examining the scientific validity of the requirement for ECGs for testing the efficacy of the banned drugs, he added.

Most of the banned generic drugs — copies of once patented medicines that are now off patent — were being sold in the European markets for several years without any adverse reports about their quality or effectiveness.

New Delhi is apprehensive that the EU’s decision could have been guided more by commercial concerns rather than on health grounds as the Indian generics are available at a fraction of the price of the patented versions sold by pharmaceutical majors, many of them based in Europe. “The bigger idea behind the move could be to discourage generic drug production,” the official said. India exports drugs approximately worth $15 billion annually.

India has already deferred its talks on the proposed Free Trade Agreement (FTA) to protest against the ban.

ANSM had complained to the European Medicines Agency (EMA) last year that clinical trials for bio-equivalence testing (tests 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 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,” the official said.

Apart from proving that the ECGs were of different persons, if India can establish that the ECGs are not necessary to prove that the tested drugs were effective, then it will have a “water-tight’’ case.

“We will take a decision … soon. Much also depends on whether the EU is prepared to sort out the issue bilaterally,” the official said.

The Commerce Ministry has been trying to convince the EU about the authenticity of the GVK clinical trials for the past eight months. Commerce Minister Nirmala Sitharaman had raised the issue with the EU Trade Commissioner in May this year.

COMMENT NOW