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Global Processing e-News / Pharmaceutical / North America

FDA's regulatory policy not biased against Indian drug makers

July 17, 2014
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Amid news of regulatory action taken by the U.S. watchdog against pharmaceutical companies, at first glance it would appear that mostly Indian companies have come under fire. But in fact, as the U.S. Food and Drug Administration sets the quality bar higher, warning letters have reached drug makers in the European Union, Australia, China and Canada, as well as many companies in the United States.

This focus on overseas drug manufacturers is not surprising. The United States imports about 40 percent of all finished drugs sold on its market and approximately 80 percent of the active ingredients involved in its own pharmaceutical production. Bearing in mind the fact that imports keep rising, both in terms of volume and value, it is understandable that the FDA remains watchful about the quality of products reaching U.S. consumers, according to the Pharma Letter.

Still, data regarding FDA warning letters over the past five years shows that 114 U.S.-based producers have been reprimanded by the regulator for marketing offences or manufacturing failings, compared to 22 Indian companies over the same period.

According to a recent report from rating agency Crisil, the high number of examples of enforcement action against Indian manufacturers is not a demonstration of anti-Indian bias, but a reflection of the fact that India has the highest number of Abbreviated New Drug Application approvals. Sudip Sural, senior director at Crisil Ratings, said that in terms of generic drug supply, India comes second only to Canada when it comes to imports in the United States.

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