US undertaking required regulatory activities: FDA chief

FDA chief also said that United States is "not targeting" Indian companies, but has a strict quality control regime for all products

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 said today.

"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," US Food and Drug Administration (FDA) Commissioner Margaret Hamburg told reporters during a conference call.

"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 told reporters after her first official trip to India, where she met with government and industry leaders earlier this month.

Her remarks came as the FDA for the first time banned the sale and import of "bidi" products made by Pune-based Jash International, citing lack of regulatory standards.

In recent months, the US regulators have banned drugs and drug ingredients from Ranbaxy Laboratories Ltd and Wockhardt Ltd, citing quality concerns.

"Inspections are 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 pharma companies, 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 of "particularly important" to US food and drug 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 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 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, 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.