Sunday 20 April 2014

Us Regulator Stifles Indian Drug Exports

India's drug export growth in 2013-14 may have dipped sharply from the projected 16-17 per cent to six-seven per cent, officials said.


Pharmaceuticals - India's third fastest growing export industry - sold overseas grew 10.55 per cent to $14.65 billion (Rs 87,900 crore) during 2012-13. The country exported $12.4 billion of drugs during the first 10 months of 2013-14, according to the Pharmaceuticals Export Promotion Council of India.


The deceleration in 2013-14 is principally because of bans imposed by the US, the world's largest drug market, on imports from Indian companies. The US Food and Drug Administration (FDA) has in the past year found manufacturing violations among several plants of generic drug suppliers like Ranbaxy, Wockhardt, Sun Pharma, RPG Life Sciences and Agila Specialities. Some factories are also barred from supplying to other markets like the EU.


"We have not yet arrived at the actual export calculations for 2013-14, but growth is likely to be much lower than expected. While currency fluctuation has had its adverse effect, the major contributor is regulatory actions faced by major companies," PV Appaji, director-general, Pharmaceuticals Export Promotion Council of India (Pharmexcil) told Business Standard.


India has over 200 FDA-approved drug manufacturing facilities and is the largest foreign supplier of generic medicines to the US. During 2012-13, drug exports from India to the US rose 32 per cent to $4.23 billion. Most major Indian drug companies earn 60-80 per cent of their consolidated revenues from exports. Sales in the US make up the largest share at xx per cent. The EU and Africa are also important markets with 18 and 17 per cent share in exports, respectively.


Industry analysts question whether the Indian drug industry can sustain its recent export performance with the regulatory hurdles they confront now.


"The increasing regulatory actions should certainly slow growth by a couple of percentage points," said Kumar Hinduja, senior director for strategy planning and business development at IMS Health, a leading market research agency for the healthcare sector.


Source:- business-standard.com





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