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Government defers proposed talks of EU-BTIA

06 Aug 2015 Evaluate

Government of India, expressing its disappointment and concern over EU banning sale of around 700 pharma products clinically tested by GVK Biosciences, has decided to defer the proposed talks between the Chief negotiators on India-EU Broadbased Investment and Trade Agreement (EU-BTIA) for the present. Chief negotiators of India and the EU were scheduled to resume the negotiations on the BTIA this month.

The government has stated that the action of EU in imposing legally binding ban on the sale of around 700 pharma products clinically tested by GVK Biosciences, Hyderabad’ was a matter of concern. Most of these drugs are already in EU market for many years without any adverse pharmaco-vigilance report from any member state.

The Commerce and Industry Ministry in its statement said that pharmaceutical industry is one of the flagship sectors of India which has developed its reputation through strong research and safety protocols over the years and therefore, Government of India will examine all options in this regard. The Government has engaged on the issue with various EU regulators over past 8 months. After a gap of about two years, India and the European Union were expected to resume negotiations on 28 August on the proposed free trade agreement to boost two-way commerce and investment.

In a largest EU-wide suspension of sales and distribution of generic drugs, European Union has banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by India's pharmaceutical research company GVK Biosciences. The order by the European Commission will come into effect on August 21 and it will be applicable to all 28 member nations.