In a global economy, there is both good news and bad news.
The good news is the possibility to increase economies of scale as well as breaking down barriers allowing companies to benefit from the largest and cheapest workforces, raw materials, and technology.
That's also the bad news.
Where's the quality control? Who's minding the store and the regulatory problems?
A perfect example is heparin.
The active ingredient is made in China without any regulatory oversight. The US Federal Drug Administration (FDA) doesn't have a handle on it and neither does its Chinese equivalent.
More than 50 percent of drug active ingredients are produced in China and India. Who's paying attention?
In regard to heparin, the FDA admitted to insufficient inspection of an American-owned production facility in China, prior to approving the drug for market.
On the good news side, a permanent FDA office is scheduled to open in China by October 2008 and pharmaceutical manufacturers there will be subjected to stricter scrutiny.
What about India?
Unfortunately, it's too late for the people who have already died from heparin.
Wednesday, August 13, 2008
Good news, bad news, raw material, heparin
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