US, Europe, Australia to jointly inspect Indian drug factories

July 10th, 2008 - 11:53 am ICT by IANS  

By Arun Kumar
Washington, July 10 (IANS) With countries like India and China making an increasing share of the active ingredients in medications, the US is joining Europe and Australia to inspect overseas factories. A pilot programme announced Wednesday will allow regulators to coordinate their inspections and share information, thereby covering a wider territory and more foreign facilities.

“What we are seeing is the maturing of a global market, and we have to invent new tools to deal with a changing environment,” Health and Human Services secretary Michael Leavitt said at an Import Safety Summit here.

The pilot programme will concentrate primarily on facilities in third countries, such as India and China, which produce much of the world’s pharmaceutical raw materials, but are sometimes beyond the reach of US inspectors.

US Food and Drug Administration (FDA) is opening offices in three Chinese cities — Beijing, Shanghai, and Guangzhou, Leavitt said. US is also currently negotiating to do the same in India, with plans for additional FDA offices in multiple areas of Latin American, Europe, and the Middle East.

“We are working with Indian authorities to support their pharmaceutical regulatory priorities,” Leavitt said.

The official said he had met with leaders from India, China, Australia, Mexico, Canada, Singapore, the largest economies of the European Union and the European Commission to discuss import safety as part of a comprehensive review of US import safety practices.

Under the programme announced Wednesday, authorities would share inspection schedules, results and other information. The goal is to try to reduce duplication and identify potential problems more quickly.

“FDA and these trusted colleagues can spread our inspection net wider by leveraging our respective resources,” Leavitt said. “Facilities will be inspected more often, and we can all focus more resources on those products that present higher risk.”

However, the FDA would still retain the option of going into a facility that already has been inspected by another country.

“Just as the volume of trade has changed, so must the strategies to regulate safety. Simply scaling up our current inspection strategy will not work,” Leavitt said.

“This is not a problem unique to the US. It is a fundamental challenge for all nations,” he said. “We need to develop new tools and strategies equal to the new challenges we face.”

Last year, the US imported more than $2 trillion-worth of products. Its biggest trading partners are now Canada, China, and Mexico, in that order. Chinese products made up about one-sixth of all US imports.

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