US FDA to set up Indian offices by '09

Under fire from some United States senators for allegedly taking lenient positions in granting product approvals to generic companies from countries like India, the US FDA is planning to speed up its plans to set up offices in India by 2009. FDA, in its latest newsletter dated July 21, has said that the agency will set up offices in Mumbai and Delhi to intensify its monitoring efforts.

The offices are part of the authority's FDA With Borders Initiative announced few months ago.

The FDA "believes we can better help assure the safety and manufacturing quality of these products by having FDA personnel full time in India to work with our counterpart agencies there," the newsletter quoted Christopher Kelly, a spokesman for the FDA's Office of International Programs.

Kelly said the offices will help the agency make better, more risk-based decisions on where to use its inspection resources - both in the field and at the US borders.

Responding to the allegations made by the FDA against Ranbaxy in a legal motion moved by the government on July 3, senators John Dingell and Bart Stupak had yesterday said that they would like to know "whether FDA officials knew about these allegations and what, if any, action was taken".

The Indian Pharmaceutical Alliance, the representative body of leading Indian drug firms, has welcomed the FDA move.

"The agency had earlier informed of its plans to set up three offices - in Delhi, Mumbai and Hyderabad - in India. We feel that the FDA decision will help the Indian drug industry in the long run. It will clear all doubts and suspicions about the quality of Indian medicines and also help mid-sized Indian companies to comply with US FDA norms and explore US markets," D G Shah, secretary general, IPA said.

The FDA also is in the process of finalising an agreement with the Chinese government to open three offices there and hopes to have agency officials in Beijing, Shanghai and Guangzhou by the end of September, the newsletter informed.