EU Generic Drugs Ban Sends Desi Pharma Cos Shivering

Published: 28th July 2015 06:39 AM  |   Last Updated: 28th July 2015 06:39 AM   |  A+A-

HYDERABAD: The recent European Union (EU) ban on 700 generic drugs may result in a business loss of $1-1.2 billion worth pharma exports, said Pharmexcil.

“We estimate that exports worth $1-1.2 billion are likely to be affected if the cancellation of 700 generic drugs by the EU stands,” P V Appaji, Director General, Pharmexcil, said adding the EU action was unjustified and unfair and that it will not only adversely affect GVK Bio but also the sector.

It may be noted that last week, the EU had banned 700 medicines alleging manipulation of data in trials conducted by GVK Biosciences.

Drugs.jpgAccording to the German drug regulator BfArM, the largest EU-wide suspension of sales and distribution of generic drugs ordered by the EU will come into effect from August 21 on all 28-member nations. Medicines affected by the sales ban will lose their validity for use in the EU and they should no longer be distributed or sold by pharma companies, wholesale dealers, drugs stores and other outlets, the EU had said last Thursday.

Though the affected pharma companies can appeal the suspension of marketing approvals, it will have no immediate effect as the ban will remain in force, it added.

Speaking to media on the sidelines of an event organised by the Department of Pharmaceuticals, Pharmexil and others, Appaji said, “For the first time there is a negative growth in pharma exports to the EU, which is affecting us. The Commerce Ministry is in discussion with all the stakeholders, including the Pharmexcil on the issue,” he added.

Meanwhile, according to Pharmexil, the country exports Rs 20,000 crore worth of pharma products, including APIs and formulations to the EU.

Overall, Appaji said, growth of API exports has been most disappointing in the last few years. Reeling out statistics, he said, “India’s APIs are worth $10 billion and we export about $3.5 billion. However, bulk drug exports have been falling from 31 per cent three years ago to 23 per cent in FY14,” he said.

Of the two types of APIs -- synthetic and biological molecules — our strength remains in synthetic NCEs, while the world is moving to biologicals, he said adding that global API industry is wroth $163 billion and has been growing at 6.5 per cent.

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