FDA Announces New Food and Drug Safety Efforts in India
The Food and Drug Administration announced several new initiatives during Commissioner Margaret Hamburg’s recent trip to India, in a bid to build capacity and boost food and drug safety in the country. FDA is in the process of expanding its offices in India to include new staff, said an agency spokesman. During the trip, Hamburg also signed an agreement to work more closely with Indian food and drug regulators.
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India is currently the second largest exporter of drugs to the U.S., and the eighth largest exporter of food. “Unfortunately the many Indian companies that understand good manufacturing and quality processes have been overshadowed by recent lapses in quality at a handful of pharmaceutical firms,” said Hamburg in a blog post on Feb. 11 (here). “While the FDA will take appropriate action against any company that doesn’t meet our requirements, we are also willing to work with them to address their issues. All consumers deserve access to safe and affordable drugs and should not have to sacrifice quality to get that,” she said. “Officials at India’s Ministry of Health and Family Welfare share this goal.”
Under the memorandum of understanding between FDA and the Indian Ministry of Health and Family Welfare (here), the two agencies will share information on noncompliant companies in each country. Each regulator will also inform its counterpart before undertaking inspections, so that the other country may join the inspection as an observer. The agencies agreed to meet by teleconference every three months to discuss their collaborative efforts.
FDA will also increase its own inspection capacity in India, the FDA spokesman confirmed. FDA inspected 160 Indian drug plants last year, which is three times the number inspected in 2009, he said. To meet this burden, FDA is in the process of adding seven new inspectors to the 12 already stationed in India. In total, 10 of the 19 FDA inspectors will focus on drugs, said the spokesman.