EU sticks to ban on generics tested by GVK Bio, ends talks

06 Feb 2016


India's six-month-long negotiations with the European Union for revoking a ban on drugs whose trials were conducted by Indian biopharmaceutical company GVK Bio ended in failure as the EU closed negotiations without acceding to any of India's demands.

The European Union has imposed an EU-wide ban on 700 generic drugs that have been developed on the basis of clinical trials conducted by GVK Bio as the EU holds that GVK had manipulated these drug trials to get desired results.

The EU is reported to have told visiting commerce ministry officials that it was in no mood to reconsider the issue and would rather consider it as a closed chapter.

''Despite the best efforts of the government, they remain unconvinced and also are reluctant to pursue the matter further,'' the Hindu BusinessLine quoted a senior Indian official as saying.

The real issue at stake for the EU is the release of generic versions of 700 off-patent drugs, which would hit margins of European and other Western drug companies.

The EU in July last year imposed a ban on 700 generics versions of off-patent drugs tested by Hyderabad-based GVK Biosciences, after the French standards agency ANSM alleged that GVK had manipulated clinical trials for bio-equivalence testing.

According to ANSM, the electrocardiogram (ECG) data of volunteers examined by GVK between 2008 and 2014 had been doctored. But the agency had no proof of the manipulation.

There weren't any complaints regarding quality or efficacy of the medicines either.

However, drugs tested by GVK during the period were withdrawn from all EU markets in August 2015, following ANSM findings.

Bio-equivalence tests are conducted to prove generic drugs are as effective as the originals and such tests are vital for drug approvals. The issue will now have to be put on the backburner, say officials.

One positive development is that India will not have to bend backwards in its trade talks with the EU. The government had earlier softened its stance in trade talks with the EU since the drugs ban would bring severe loss to India's pharmaceuticals exports.

Yet, officials say, the process of finalising the Broad Based Trade and Investment Agreement (BTIA), to draw up a free trade pact, has begun.

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