US to conduct intl pharma inspections in India, China

The US will team up with Australia and European Union to conduct international pharmaceutical inspections in countries like India and China that make an increasing share of the active ingredients in medications.

"... Food and Drug Administration will work more closely with foreign regulators who have systems of inspection and regulation we trust. The principle will be collaborative information gathering and individual decision making," Secretary of Health and Human Services Michael Leavitt said at an Import Safety Summit Washington.

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

The process will begin with inspections of active pharmaceutical ingredient manufacturing. These are the 'starting products' of many of the medicines we all use," he added.

"These strong, action-oriented documents call for specific steps and set clear deadlines for achieving them.

Once implemented, they will enhance the safety of scores of items the Americans consume on a daily basis. We recently signed a MoU with the Vietnam and we are working with Indian authorities to support their pharmaceutical regulatory priorities," Leavitt said. 

Leavitt said, while the US will be inspecting some, the Australians others, the European Union still others. We will then share information. "Facilities will be inspected more often and we can all focus more resources on those products that present higher risk."

The top official added that the FDA is opening an office in China with staff in three cities: Beijing, Shanghai and Guangzhou.

"We are currently negotiating to do the same in India," he said.

"I met with leaders from India, Vietnam, China, Australia, Mexico, Canada, El Salvador, Costa Rica, Panama, Nicaragua, Guatemala, Honduras, Singapore, the largest economies of the European Union and the European Commission to discuss import safety. The scale and complexity of global commerce amazed me. So did the need for change," Leavitt said.

"...as long as Americans want to enjoy fresh produce from around the world, buy needed medicines, wear low-cost clothing, drive foreign-made cars, use electronic products designed and built off our shores, purchase affordable furniture, and otherwise participate in the bounties of a global economy, our import system will become increasingly complex," he said.

The United States imported more than $2 trillion worth of products last year, an amount that exceeds the entire GDP of France and approximately $6,500 for every man, woman, and child in the US.