FRIDAY, Feb. 21, 2014 (HealthDay News) -- The head of the U.S.
Food and Drug Administration said Friday that her agency would
increase monitoring of drugs from pharmaceutical companies in
As the second largest supplier of over-the-counter and
prescription drugs sold in the United States, India "stands out as
particularly important," FDA Commissioner Dr. Margaret Hamburg said
during an afternoon news conference.
Commenting on her recent trip to India, Hamburg said she signed
a non-binding "statement of intent" with Indian government
officials that will lead to more cooperation between the FDA and
its Indian counterpart.
As the amount of drugs made in India has increased, problems
with quality have increased and the FDA has sent warning letters to
several Indian drug makers in recent years, according to published
"If products are sold in the United States for use by American citizens, then those products do have to meet our standards," Hamburg said.
During the press briefing, Hamburg was asked repeatedly if the
FDA was singling out India.
"The fact that we have increased our presence in India is true, but it reflects the fact that India is a very significant and growing player in the U.S. marketplace," she said.
Currently, there are 12 FDA inspectors in India, and that number
is expected to grow, Hamburg said.
She added that the FDA's efforts in India aren't any different
from those in the United States or other countries.
"If a company is manufacturing a product for sale within the United States, they have to meet our regulatory standards and requirements," she said. "What's happening in India is consistent with what happens within the United States and throughout the world."
In 2012, India's Ranbaxy Laboratories had to recall dozens of
batches of its generic version of the cholesterol-lowering drug
Lipitor after the discovery of glass particles among the
ingredients used in production. And last May the company's U.S.
subsidiary agreed to pay $500 million in fines and penalties for
selling adulterated drugs and lying to federal regulators, the
For more on FDA drug regulations, visit the
U.S. Food and Drug Administration.
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