by Shirley Johanna on  August 6, 2015 at 7:28 PM Drug News
India Backs Off Trade Agreement Talks With European Union Over Ban Of 700 Pharma Products
India has deferred the talks with the European Union on the proposed free trade agreement, following a ban imposed by the EU on 700 pharma products clinically tested by GVK Biosciences.

Chief negotiators of India and the EU were scheduled to resume the negotiations on the Broadbased Investment and Trade Agreement (BTIA) this month.

Government of India has taken a decision to defer the proposed talks between the Chief negotiators on BTIA for the present.

"This decision has been taken as the Government of India is disappointed and concerned by the action of EU in imposing legally binding ban on the sale of around 700 pharma products clinically tested by GVK Biosciences, Hyderabad," the Commerce and Industry Ministry said in a statement.

The government has engaged on the issue with various EU regulators over past eight months, it said.

Pharmaceutical industry is one of the flagship sectors which has developed its reputation through strong research and safety protocols over the years and therefore, the government will examine all options in this regard, it added.

"It is pertinent to mention that most of these drugs are already in EU market for many years without any adverse pharmaco-vigilance report from any member state," it said.

After a gap of about two years, India and the European Union were expected to resume negotiations on August 28 on the proposed free trade agreement to boost two-way commerce and investment.

The India-EU trade talks, formally known as the Broad- based Trade and Investment Agreement (BTIA), remain stuck as both sides are not satisfied with each other's offers.

The talks were launched in June 2007 and have missed several deadlines.

The two-way commerce between the two sides stood at about USD 99 billion in 2014-15.

The 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 largest EU-wide suspension of sales and distribution of generic drugs ordered by the European Commission will come into effect on August 21 and it will be applicable to all 28 member nations, according to Germany's drug regulator, the Federal Institute for Medicines and Medical Products (BfArM).

Industry body Pharmexcil has said that India's business loss arising from the European Union's ban on 700 generic drugs is likely to be around USD 1.2 billion.

Source: PTI

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