FDA Commissioner Margaret A Hamburg's India trip was about Taj, quality and pharma

Margaret A Hamburg, US Food and Drug Administration (USFDA) Commissioner on her first official visit to India, has been visiting the Taj Mahal and also writing down her impressions of the meetings she has had in India.  These have been put up on the FDA's official blog.
 
"As I walked, along with hundreds of other visitors, in socked feet (I felt) that those responsible for building the Taj and those that are preserving the centuries' old structure are committed to extraordinary quality," she writes in a piece titled Quality: A Recurring Theme During My Visit to India.  Hamburg then goes on to discuss the meeting with the heads of several Indian pharmaceutical companies that she held recently. "This vision of quality and care remained with me when I met with executives from pharmaceutical and food exporting companies operating in India. The roundtable meetings, organized by the Federation of Indian Chambers of Commerce and Industries, were an opportunity for me to learn about two of the largest business sectors in India and to hear from business leaders about the challenges they are facing as a result of globalization," she says.
 
She adds: "One of the challenges cited by the pharmaceutical leaders is approval times for abbreviated new drug applications - the applications filed for generic drugs. 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 Oct. 2, 2012.  As of the end of January 2014, our Center for Drug Evaluation and Research had taken a formal action on 45 percent of backlogged generic drug applications. In December 2013 alone, the center completed 174 actions, including 30 full approvals for generic drugs."
 
Referring to her talks with the Indian drug regulators, she says: "In my talks with regulators and companies here in India I have placed a great deal of emphasis on why quality matters. As I explained, quality is linked to product safety and without a direct focus on quality, the potential for patient harm increases significantly."