New Delhi: The US Food and Drug Administration opened an office in New Delhi on Thursday, and would shortly start another in Mumbai.
Outreach opportunities: (left) Secretary of the ministry of health Naresh Dayal with US embassy’s deputy chief of mission Steven J. White at the press conference in New Delhi. Harikrishna Katragadda / Mint
The move is part of a US programme—called Beyond the Borders Initiative—that aims at ensuring safety and quality of medicines and food imports by expanding FDA’s outreach.
A US government audit last year said the FDA’s infrastructure was inadequate to inspect factories that export drugs to the US.
The two offices in India would add to the five opened by FDA overseas, including China, in the last few months.
“The opening of these offices in India will help safeguard citizens in both countries amid the growing volume of trade,” said Mike Leavitt, secretary of US department of health and human services that oversees FDA.
“Through these offices, we can work more closely with manufacturers to share best practices and ensure producers build quality and safety into food and medical products,” he said.
He added that the FDA is prepared to work with India as its government strengthens regulatory institutions.
‘Mint’ had reported on 21 December that FDA will open an office in New Delhi in January after the Union government approved the proposal.
Four FDA officials will join the India office now, with the number eventually going up to 10.
India is the fourth largest exporter by volume of drugs and biologics, especially generics, to the US.
“This office will be a portal to work directly and more effectively with the (Indian) producers and FDA in the US,” Leavitt said.
“We must ensure that Indian manufacturers have the best standards of vigilance at their plants,” Naresh Dayal, secretary, ministry of health and family welfare, told the media.