FDA concludes Indian visit with pledge to focus on quality

The US Food and Drug Administration’s visit to India concluded with roundtable meetings organized by the Federation of Indian Chambers of Commerce and Industries.

FDA Commissioner Margaret Hamburg met with executives from Indian pharmaceutical companies in order to hear from business leaders about the challenges they are facing as a result of globalization. She said that one of the challenges cited by the pharmaceutical leaders is approval times for abbreviated new drug applications – the applications filed for generic drugs. Commissioner Hamburg said: “I am happy to report that the FDA is working quickly to fulfil one of our commitments under the Generic Drug User Fee Act (GDUFA) – reducing the backlog of generic drug applications that were pending when the new user fee program went into effect on October 2, 2012. As of the end of January 2014, our Center for Drug Evaluation and Research had taken a formal action on 45% of backlogged generic drug applications. In December 2013 alone, the center completed 174 actions, including 30 full approvals for generic drugs.”

Lapses in quality are unacceptable