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As quality control violations rise, FDA chief heads to India
1. As quality control violations rise, FDA chief heads to India
By Toni Clarke
Wed Feb 5, 2014 11:12am EST
Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration (FDA), speaks during
the 2013 Reuters Health Summit in New York, May 6, 2013.
Credit: Reuters/Shannon Stapleton
(Reuters) - 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 United States.
The FDA's Wednesday announcement of the visit, planned for February 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
2. runs from February 16-19. She will also visit a seafood processing facility and a spices facility.
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
contamination.
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 contaminated shipments.
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 control.
"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," Hamburg said.
(Reporting by Toni Clarke in Washington; Editing by Meredith Mazzilli)
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