China, India loom large on FDA to-do list

If you're the type who has to see things to believe them, tool on over to In-Pharma Technologist and have a look-see at their graphics. Somehow the globalization of pharma--and the rise of developing-nation drug-making--is much more graspable in visual form. Two big circles representing China and India loom over a handful of much smaller ones, eloquently showing that when it comes to drug exports to the U.S., Asia's where it's at these days.

Said graphic was designed to illustrate the almost-scary magnitude of the regulatory task the FDA faces. As we all learned last year with the tracking of heparin from China to the U.S., the agency has been way, way behind on inspecting overseas manufacturing facilities. Even with untold millions added to its budget, the FDA will be playing catch-up for years to come.

The agency conducted 452 overseas inspections last year, with plans to do 566 more in 2009 and 2010, In-Pharma reports. Coincidentally, in In-Pharma's count of ex-U.S. plants, China boasts 566, the most in the world. Second-place finisher India has 299. Coming in a distant third is Canada with 152. Obviously, the FDA has lots of work to do in this area -- and it's probably going to have to come up with a few creative ways to leverage its dollars and staff to make that happen.

- read the In-Pharma story