Administration considers establishing FDA office in India

FDA's fight to become a better watchdog over drugs and pharmaceutical ingredients flowing into the United States might land the agency an office in India.

While the talks are preliminary, HHS Secretary Michael Leavitt said last week during a briefing that his visit to India this month set in motion an ongoing consideration of an FDA presence in that nation.

"We clearly have the strategy of putting more U.S. government personnel in other countries where we can build capacity and begin to work more closely with them," Leavitt said, although he added, "No decisions have been made."

Leavitt was careful to point out that a timeline was impossible to give because of India's complicated bureaucracy and the nascence of the talks.

Since import problems became more high-profile over the last year, FDA has worked with China and India to foster better cooperation.

FDA and HHS officials signed agreements recently with Chinese officials to strengthen regulation, but Leavitt would not say if similar agreements are on tap with India.

On his second day in India, Leavitt visited Dr. Reddy's Laboratories Ltd., a major producer of generic products and active pharmaceutical ingredients, chemicals used to produce drugs.

India is emerging as a major player, particularly in production of active pharmaceutical ingredients imported to the United States.

Indian companies filed 30 percent of new drug master files as of September, surpassing leading contenders Italy and China at 18 percent and 11 percent, respectively. Companies provide data on active pharmaceutical ingredients through drug master file submissions.

The draw to India lies in its highly skilled scientific workforce that does not command high wages.

"An HHS scientist working with me estimated the average Indian scientist would be paid around $2,000 a month, which puts them in the top social economic range. A comparable American scientist would demand six figures," Leavitt blogged after visiting Dr. Reddy's.

Leavitt wrote that cost savings in the Indian market save Dr. Reddy's an estimated 25 percent.

Chuck Caprariello, a spokesman for Ranbaxy Laboratories Ltd., said an FDA office in India could speed drug approvals for drugmakers who are stationed there.

Ranbaxy is headquartered in India and makes 65 percent of its products there, Caprariello said.

Drug approval involves not just FDA review of data, but a site visit to inspect the facility. "And sometimes it's a lengthy process because FDA inspectors have to go to India," Caprariello said. "We think if there were an FDA site or an FDA presence [in India] it might expedite the process," he added.

While FDA considers a permanent office there, agency officials also might lend a hand to Indian officials to help them shore up their drug approval process.

"They have indicated an interest in establishing an FDA-like agency; they don't have one. They have indicated an interest to have technical assistance from us, which we have offered," Leavitt said.