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Indian Pharmas Seen Bearing Brunt Of U.S. FDA Safety Crackdown

This article was originally published in PharmAsia News

Executive Summary

India's pharmaceutical industry is growing concerned over the recent strong actions taken by U.S. FDA against some Indian-made drugs. Although the European Union and India's own drug regulator have stepped in to block certain Indian drugs, local drug makers say they are being singled out by U.S. authorities. The Indian industry has about 75 plants approved by the U.S. agency, but a new emphasis on use of generics in the United States has led its drug-safety agency to increase its efforts to ensure the safety of those types of drugs. Avesthagen founder Villoo Morawela-Patell said Indian pharmas should expect more U.S. FDA inspections of their plants in India. (Click here for more
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