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U.S. FDA Investigation Of Ranbaxy Exposes Lax Drug Regulation In India

This article was originally published in PharmAsia News

Executive Summary

Questions raised by the U.S. FDA about whether Ranbaxy Laboratories manufactures generics made from bulk drugs obtained from unapproved sources exposes lax regulatory oversight in undeveloped countries. India's regulatory standards are "abysmal," says an article in the Economic Times, with offenses often unreported or unpunished. The country has no credible way of monitoring adverse drug reactions, so the danger of sub-standard drugs in India is barely recognized, the newspaper said, despite the presence of more than 80 plants that have U.S. FDA approval. India has more than 20,000 other manufacturing units. (Click here for more
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