India Takes Legal Advice on European Union’s 700 Generic Drugs Ban

The largest suspension of sales and distribution of generic drugs ordered by EU, has already come into effect and will be applicable to all 28 member nations.

To deal with the ban imposed by the European Union (EU) on 700 generic drugs clinically tested by GVK Biosciences, India is seeking legal advice.

“We are certainly exploring what are the options for India. We are taking legal advice... We will take a call on this to move forward,” said Commerce Secretary, Rita Teaotia.

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There is no evidence of harm or lack of effectiveness in the medicines. They were taken off to ensure patient safety and to retain confidence in EU system.

The largest EU-wide suspension of sales and distribution of generic drugs ordered by the European Commission, has already come into effect and will be applicable to all 28 member nations, according to Germany’s drug regulator, the Federal Institute for Medicines and Medical Products.

Peeved at the move, India has already deferred talks with the EU on the proposed free trade agreement. India-EU trade talks, launched in June 2007, remain stuck as both sides are not satisfied with each other’s offers.

Teaotia added India also has the option to use a global framework to resolve the issue. The EU has banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by the Hyderabad-based GVK Biosciences.

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Industry body Pharmexcil pegs India’s business loss from the EU ban at around $1.2 billion.

The pharmaceutical sector, which contributes over $20 billion in India, is facing a lot of regulatory issues in several developed countries, including the US.

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India and the EU were scheduled to resume the negotiations on the Broadbased Investment and Trade Agreement on August 28 to boost two-way commerce and investment.

In 2014-15, India’s pharmaceuticals exports grew 2.63 percent to $15.34 billion.

Source-PTI

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