The US Food Drug Administration banned imports from Indian generic drug maker Sun Pharmaceutical Industries Ltd

US FDA bans imports from Sun Pharma’s Gujarat plant

5:13 AM, 14th March 2014
The US Food and Drug Administration banned imports from Sun Pharmaceutical Industries Lt

WASHINGTON DC, US/KARKHADI, INDIA: The US Food and Drug Administration (FDA) has banned imports from Indian generic drugmaker Sun Pharmaceutical Industries Ltd’s plant at Karkhadi in Gujarat, in the latest quality blow for India’s drug sector. The FDA has imposed a rash of regulatory sanctions on Indian generic makers in the last year, triggering concerns about the quality of the medicines supplied by the $14 billion industry to countries including the United States, the biggest market. India is second only to Canada as a drug exporter to the United States, where it supplies about 40 per cent of generic and over-the-counter drugs.

The ban on the plant underscores growing concerns about the quality of medicines made in India, often referred to as the low-cost ‘pharmacy to the world,’ as demand for generics grows in countries from the United States to Japan. Sun Pharma said it had initiated ‘several corrective steps’ to address the FDA’s concerns, and kept its guidance for consolidated sales for the fiscal year ending this month.

 

© Reuters News

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