USFDA set to open India office in Jan

USFDA set to open India office in Jan

New Delhi: The US food and drug administration, or FDA, will open an office in New Delhi in January after the Union government approved the proposal.

“The government of India has approved the placement of an FDA acting country director in India and FDA has a staff member currently assigned and in-country," Christopher Kelly, press officer at FDA, told Mint by email. “We anticipate increasing our staff and formalizing the offices in the coming weeks."

The move was confirmed by an Indian health ministry official who said “the FDA office is likely to start functioning by 14 January 2009". He didn’t want to be named.

Initially, the office will have four-five employees with the number eventually going up to 10, US health secretary Mike Leavitt said on 16 October.

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 Indian health ministry and FDA are also discussing having an Indian drugs inspector accompany an FDA inspector for inspections. “We are still formulating the level and detail of the interaction," said Kelly. FDA opened its first overseas offices last month in Beijing, Shanghai and Guangzhou in China. It said it would have two offices in India, marking the regulator’s second overseas presence, with more planned for Latin America, Europe and West Asia.

This year has seen increased scrutiny of some Indian drug-exporting plants, including two Indian units of Ranbaxy Laboratories Ltd and one of Lupin Ltd.

“There has been increased surveillance on Indian drugs manufacturers of late, and the new office will further make these inspections faster, allowing for a close watch on the industry by the FDA," said P.V. Appaji, executive director of state-administered Pharmaceuticals Export Promotion Council.

He said the move will boost quality of medicines and good manufacturing practices of Indian pharma industry.

T.S. Jaishankar, chairman, Confederation of Indian Pharmaceutical Industry, a trade lobby group, said an India-based office will mean “quicker audits" and “an advantage for Indian drugs manufacturers".

Agrees Shoibal Mukharjee, a senior vice-president at GVK Biosciences Pvt. Ltd, noting that some “10% of the total formulations that enter the US market are from India. So, it’s very important that people are convinced of their quality and the FDA office in India will ensure that".

Of the total drug exports from India, 20% go to the US market. Indian companies exported $1.38 billion (Rs6,497 crore) worth of medicines to the US in 2007-08. India has 175 FDA-approved drug-making factories, the largest number of such plants outside the US.