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India’s Generics Fear Backlash From New WHO Counterfeit Definition

This article was originally published in PharmAsia News

Executive Summary

Indian generics makers are wary of a new United Nations definition of what constitutes a counterfeit drug. The firms say the World Health Organization's new definition is being used to erect barriers to generic drugs in the United States, European Union and Japan where drugs are highly regulated. The Indian industry worries the use of the anti-counterfeit program already has led to reviews of Indian manufacturing standards already certified by U.S. FDA. The U.S. legal action against Ranbaxy Laboratories for marketing drugs based on ingredients from unapproved sources is interpreted as increased diligence in ensuring quality. (Click here for more
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