The US Food and Drug Administration is “considering trying to establish” a presence or office in India, US Health and Human Services Secretary Michael Leavitt is reported to have said during his visit to the country with FDA Commissioner Andrew von Eschenbach this month.

The issue was raised during Sec Leavitt’s discussions in New Delhi with Indian Union ministers including Health Minister Anbumani Ramadoss, who earlier this month announced plans to establish a Central Drug Authority of India (CDAI) based on the FDA.

The US agency “would be glad to try to provide technical assistance” to India in these regulatory developments, said Sec Leavitt. Moreover, the FDA is “open” to the Indian government “bringing people down to Washington and other places where FDA works, and we have signalled the willingness to even talk about having an FDA person here,” he told the Indian business newspaper Mint. However, he added, the two governments are still “in the early stages of the conversation.”

Sec Leavitt’s visit to India has followed swiftly on from his December trip to China, where he signed an agreement with officials there aimed at improving the safety of drugs, medical devices and foods imported into the USA from China. However, the FDA is not seeking a similar agreement with New Delhi, he said. Commissioner von Eschenbach added that they were visiting India not “because there is a problem. We are here because there is a possibility”.

Sec Leavitt chairs President George W Bush’s Cabinet-level Import Safety Working Group, which last November delivered its Action Plan aimed at improving the safety of imported products, including heightened interactions with exporting nations among its recommendations.

The Group’s work revealed that while the US has a good system for assuring the safety of imports today, it is not adequate for the future, said Sec Leavitt. Last year, the US imported nearly $2 trillion-worth of goods through more than 825,000 importers, and experts project that the value of imports will triple by 2015. “To keep up with the pace of global commerce, we need a fundamental shift, from trying to catch unsafe products as they come in, to building quality and safety into products before they reach our borders,” he said.

Also last November, a damning report from the US Government Accountability Office (GAO) revealed that each year the FDA inspects only around 7% of the total number of foreign drug manufacturers believed to be supplying the domestic market. Moreover, the agency was unable to provide inspection records for two-thirds of the 3,250 facilities worldwide that provide pharmaceutical ingredients to the US, it said.

Speaking in India, Sec Leavitt said the US was exploring the possibility of placing its representatives in various countries, as part of a new strategy of building safety into every product and developing commonly-shared standards. Commissioner von Eschenbach added that while the agency already has multilateral and bilateral agreements in place, this was different to having an FDA presence outside of the US on a continuous, ongoing basis. “We look to put at least five of these kinds of opportunities around of the world,” he said.

Indian parliament views “FDA” bill
Meantime, India’s Parliamentary Standing Committee on Health and Family Welfare has this month begun its scrutiny of the Drugs and Cosmetics (Amendment) Bill 2007, which is the enabling legislation for setting up the CDAI.

One proposal for the new Authority is that it would be responsible for all drug manufacturing and sales licenses issued in India; currently, these are issued by the drug control authorities of each individual state, which makes them difficult to track. However, the state authorities have expressed concern at losing license fee income and enforcement powers under a centralised system.