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New FDA import ban hits Indian drug-making industry

April 07, 2014
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The U.S. Food and Drug Administration's (FDA) campaign against substandard pharmaceutical products manufactured in India is continuing with a new import ban, this time imposed on drugs produced at a Bangalore facility owned and operated by Canadian company Apotex Inc.

Products manufactured at the facility will now be detained without physical examination and will not be allowed to reach the U.S. market under any form. The reason for this enforcement action is the FDA's finding that the facility does not meet good manufacturing practices. However, the sanction excludes Riluzole, a medicine used to treat amyotrophic lateral sclerosis, also known as Lou Gehrig's disease, media reports have said.

The move comes on the heels of import bans on a number of Indian drug producers, as the FDA has been keeping a close eye on drugs imported from the Asian country. Some of the largest pharmaceutical companies have also been affected by import alerts issued by the U.S. regulator, including Ranbaxy Laboratories and Sun Pharmaceuticals.

The reason for the tighter control over Indian drug products is the rapidly growing market share of Indian companies on the American market. Currently, about 40 percent of all generic drugs and over-the-counter medicines sold in the United States come from India, which means that exposure of U.S. consumers to these products is greater, calling for increased oversight, the regulator explained.

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