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In a blow to the revenues of India's largest pharmaceiutical manufacturer and one of the world's leading generic companies, the United States Food and Drug Administration (FDA) has blacklisted about 30 generic drugs being manufactured by the company at two of their manufacturing sites, citing failure to adhere to current Good Manufacturing Practices requirements. The US has not sought a ban nor sought withdrawl of the products manufactured from the blacklisted sites, as the FDA's repeated testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of the blacklisted drugs.
There are many who feel that this action by the FDA is unduly harsh and probably protectionist. However, the FDA wants to send a clear signal that drug products intended for use by American consumers must meet their standards of safety and quality. To those around the world who were cursing India for its poor drug regulatory record, the present FDA sanction seemed like divine retribution. It is nevertheless unfortunate that the axe has fallen on a company with a reputation for the affordability and safety of its generic drugs.