FDA commissioner blogs regarding challenges facing Indian drug manufacturers

SILVER SPRING, Md. — In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections. 

"I am happy to report that the FDA is working quickly to fulfil one of our commitments under the Generic Drug User Fee Act — reducing the backlog of generic drug applications that were pending when the new user fee program went into effect on Oct. 2, 2012," Hamburg reported. "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."

Participants of the roundtable meetings last week attended by Hamburg, which were organized by the Federation of Indian Chambers of Commerce and Industries also reported they were challenged by heightened inspectional activities. "I told them that every company supplying the U.S. market has the responsibility of ensuring that their products are safe, effective and of high-quality," Hamburg said. "I am pleased that as a global leader in the pharmaceutical and foods sectors, India will continue partnering with us to ensure that the companies exporting products to the United States adhere to established quality standards," she added. "On the home front, we at the FDA also will continue to increase our focus on quality. One way we are doing this is through the creation of a new Office of Pharmaceutical Quality that will create one voice for drug quality at the FDA and improve our oversight of quality throughout the lifecycle of a pharmaceutical product."




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