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India Takes Legal Advice on European Unionís 700 Generic Drugs Ban

by Shirley Johanna on  August 24, 2015 at 11:56 AM Drug News   - G J E 4
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.
India Takes Legal Advice on European Unionís 700 Generic Drugs Ban
India Takes Legal Advice on European Unionís 700 Generic Drugs Ban
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"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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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.

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.

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

Source: PTI
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Its a wonder how Drug regulatory agencies of the West act in such an abstract manner! The approved 700 Generic formulations of various Indian pharma companies over a periood of 10 years [ 2004 to 2014 ] and with a single decision ban these all together in one day! Does this mean that over the past 10 long years, millions of patients in the European countries received these formulations which according to the regulators were not tested in an appropriate manner. The regulators must now let people know what harm could have been done to those unsuspecting patients who took these medicines, over ten long years, with the confidence that these were approved by the regulators concerned, so that these patients can claim compensation from the regulatory agencies involved.The Drugs Controller General of India should grant a blanket approval to all these 700 "GENERIC" formulations for sale at reduced prices in India. This will help Indian patients immensely as they will get the cheaper "GENERIC" drugs rather than spending a fortune on the costly "BRANDED"versions of the same drugs. It will also help the Indian Pharma companies involved to prevent their monetary losses suffered due to this ban. It is the Indian patients who need cheaper "GENERIC" drugs and not the patients fro Europe or USA. The DCGI can take this opportunity to weed out "BRANDED GENERICS" proliferated by the Indian Pharma companies and offer only cheaper "GENERIC" formulations of drugs to the teeming poor population in India.
drmahajani Monday, August 24, 2015

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