Monday, January 21, 2008

FDA considering establishing Indian presence

Can this even be considered out-sourcing???...

The US Food and Drug Administration (FDA) is considering establishing a presence in India, amidst the country's growing ties with the US pharma industry.

FDA commissioner Andrew Von Eschenbach and US Health and Human Service (HHS) secretary Michael Leavitt have been visiting India to assess the manufacturing practices at some of the facilities there. The visit was largely initiated in response to mounting apprehension over the quality of both food and drugs and related ingredients being imported into the US. The current import protection system was described by Leavitt as "inadequate."

Some Indian media reports have also claimed that the visit was made because the FDA is planning on setting up an office in the country. On the flip side, other media reports have said that the FDA is not planning such a move. confirmed with an FDA spokesperson that at this point the agency is just offering advice and guidance to the Indian authorities who are looking at setting up a regulatory body that is comparable to that of the FDA.

During his trip to India last week, Leavitt stated: "Basically, we would be glad to try to provide technical assistance to the Indian government as it further develops its new regulatory agency/ies."

He also said that "we are considering trying to establish an FDA presence/office in India," although no decision has been made as yet, the spokesperson advised.

link to full article

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