Amid fresh concerns about quality control in China, drug and device makers continue to step up their manufacturing there. Is the risk overblown? Or is it simply that the economic tide can't be turned? The Boston Globe takes a look today, and predictably, the companies say problems such as the recent heparin recalls in the U.S. and Germany and the tainted leukemia drugs found in China are isolated incidents. They say they have the same quality-control standards in China as they do in other countries.
But patient advocates, also predictably, say that a scarcity of regulation and oversight ensures that more drug and drug-ingredient imports will cause safety problems. And the more manufacturing that moves there and the more active ingredients are sourced there, the more likely problems become.
We were most interested by the middle-of-the-road comments. One consultant to a Chinese contract manufacturer said that the contaminated heparin should have been caught before it hit the market; U.S. companies are supposed to make sure their suppliers meet FDA standards. "This was just poor business practice, whatever the source was," the consultant told the Globe. A corporate lawyer acknowledged that quality standards are uneven in China, saying that companies should spend extra money on quality control, even if that means they save less by operating there. Let's hope that drug makers are listening.
- read the article in the Globe
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