Feb 5 The commissioner of the U.S. Food and Drug
Administration, Dr. Margaret Hamburg, plans to visit India for
the first time in an official capacity next week as the agency
works to keep sub-standard food and drugs from entering the
The FDA's Wednesday announcement of the visit, planned for
Feb. 10-18, comes less than two weeks after the FDA banned
products from a fourth facility owned by Indian drugmaker
Ranbaxy Laboratories Ltd due to manufacturing
violations, effectively shutting the company out of the U.S.
market for the foreseeable future.
India is the second-largest exporter of drugs to the United
States after Canada and the eighth-largest food exporter. Indian
companies supply 40 percent of all drugs consumed in the United
States, yet quality control problems have been rampant.
Hamburg said the purpose of her visit is to "connect with my
counterparts in the regulatory agencies as well as have a chance
to talk with industry leaders who are important stakeholders in
terms of our activities."
She plans to visit Delhi, Mumbai and Cochin, where she will
attend the World Spice Congress which runs from Feb. 16-19. She
will also visit a seafood processing facility and a spices
India accounted for 16 percent of U.S. spice imports by
value in 2010 according to a recent FDA report, more than any
other country. However, spice imports have been a source of food
In October the FDA released figures showing that nearly 7
percent of all spice imports examined between 2007 and 2009 were
contaminated with salmonella, while 12 percent of imported
spices were contaminated with insects, hair and other filth.
Mexico and India accounted for the highest percentage of
Hamburg said she wants to build both professional
relationships with her counterparts "and build the personal
bonds as well."
"We plan to sign a fairly broad memorandum of understanding
to strengthen the ongoing working relationship," she said. "It
will be a fairly broad umbrella framework but will be important
both practically and symbolically."
She said she will not be visiting individual drug companies,
but will have a round-table discussion with drug company chief
executives. Part of the discussion will focus on quality
"We have made it very clear that we have a set of quality
standards that we will adhere to," Hamburg said, adding that the
message will be reiterated. "It needs to be a very clear
message, but it is a message they will not be surprised by."
In December Jubilant Life Sciences Ltd received a
warning letter from the FDA over manufacturing practices at one
of its U.S. facilities. In November the FDA effectively banned
products from a second plant operated by Wockhardt Ltd
"We have a responsibility to ensure quality, whether of
drugs manufactured in this country or outside our borders,"