"We are not targeting Indian companies. We are undertaking our required regulatory activities. We inspect and take appropriate action against companies within United States," Hamburg told reporters during a conference call.

"When products are sold in United States for use by American citizens, then those products have to meet our regulatory standards and requirements and we inspect those facilities in other countries as well," she told reporters after her first official trip to India, where she met with government and industry leaders earlier this month.
"Inspections are routine part of our regulatory process. So what happens in India is consistent with what happens within US and throughout the world," she said, while responding to a series of questions on the recent actions taken against several Indian pharma companies and Ranbaxy in particular.

Hamburg said the FDA is planning to expand its staff in India to 19 from 12 as it tries to assure the safety of medications from India.
Describing India as a nation which is ‘particularly important’ to US food and drug trade, she said the fact that US has increased its presence in India reflects that New Delhi is a very significant and growing player in US marketplace with respect to both pharmaceutical products and food.

During her over a week-long travel to India from February 10 to 18, the two countries signed their first statement of intent to cooperate in the field of medical products.
Hamburg said US wants to ensure the quality and availability of the products.

"That is our greatest goal and we do think that, the work in India is important to that overall effort because they are such a significant supplier of drugs to this country," Hamburg said.
The FDA chief said she has already visited China twice and other countries as well and plans to continue to engage with other nations.
"India, such an important player, needs to be a full participant at the table," she said in response to a question.

Hamburg said there needs to be a global coalition of regulators as they together try to address the challenges of an increasingly complex globalized world.


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