THE US Food and Drug Administration has opened its offices in New Delhi
and Mumbai. The office will regulate the quality of medicines from
Indian drugmakers sold in the US. The office would also expedite the
process for getting FDA’s approval for Indian drugmarkers interested in
exporting their medicines the US. “Through these offices, we can work
more closely with manufactures to share best practices and ensure that
the producers build quality and safety into food and medical products,”
US health and human services secretary Mike Leavitt said.
As part of its Beyond Our Borders initiative, the US department will send 10 USFDA officials to India, besides 14 other locations around the world, including China, Europe and Latin America.
The officials will inspect the facilities that export medicines to the US and work with the government and the pharmaceutical industry to develop certification programmes to further enhance trading relationship between the two countries. At present, USFDA officials are in India for the same. While USFDA offices in the country would mean fast approvals for Indian drugmakers, this may also bring in stricter and more frequent inspections of their facilities. India is the fourth largest supplier of drugs and biologics to the United States.
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