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Drug Warning (India)

This article was originally published in PharmAsia News

Executive Summary

India's drug authorities may have a problem on their hands due to a series of drugs approved by the U.S. FDA being recalled recently, as well as alerts being issued on others. Several drugs are marketed in India solely on the strength of the U.S. FDA having approved them. Should the FDA's clearances themselves come under a cloud, so will the drug clearance process in India. Additionally, drug controllers in India must weigh what to do when the FDA recalls a drug or issues alerts about possible problems with the drug, as in the case of GlaxoSmithKline's Avandia, where the publication of a study in New England Journal of Medicine by a prominent U.S. cardiologist suggested that patients taking the drug had a higher chance of suffering a heart attack. While in some situations, such as when Merck's Vioxx and Pfizer's Bextra were withdrawn in the U.S. market, India followed up by banning them as well, in other recalls, like for drugs Zelnorm and Permax, the authorities in India have not banned them. Finally, even those medicines banned in India are not necessarily fully withdrawn from the market. One case is Nimesulide, which India banned more than a year ago, yet Nimulid doses are still available for children. One hindrance is the shortage of drug inspectors who are supposed to ensure that chemists do not stock banned medicines. Meanwhile, estimates of counterfeit drugs in the country vary from a fourth to 40 percent of the industry's turnover. Just a handful of government laboratories are authorized to check counterfeit drugs. India's counterfeiting problem is serious enough to have been put on the U.S. list of countries with poor intellectual property right protection. (Click here for more
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