More reports on: Pharmaceuticals

Not targeting India, but US standards must be met: FDA's Hamburg

22 February 2014

The United States is "not targeting" Indian companies, but has a strict quality control regime for all products being imported into America, the head of the US Food and Drug Administration Margaret Hamburg told reporters during a conference call today, soon after a week-long visit to India.

''We are not targeting Indian companies. We are undertaking our required regulatory activities. We inspect and take appropriate action against companies within the United States,'' the FDA commissioner said.

''When products are sold in the 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 said after her first official visit to India from 10-18 February, when she met government and industry leaders as well as personally visited plants of Indian generic drug manufacturers.

''Inspections are a routine part of our regulatory process. So what happens in India is consistent with what happens within the US and throughout the world,'' she said, responding to a series of questions on the recent actions taken against several Indian pharmaceutical companies, including Ranbaxy Laboratories and Wockhardt, in the recent past.

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 made in India.

Describing India as a nation which is of ''particularly important'' to the US food and drugs trade, she said the fact that the US has increased its presence in India reflects that India is a very significant and growing player in the American marketplace with respect to both pharmaceutical products and food.

During her visit, the two countries signed their first statement of intent to cooperate in the field of medical products.

Hamburg said the 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.''

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, it 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 globalised world.

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