China Washes Hands on Heparin Purity

-Wall Street Journal

02/27/2008 - If the U.S. is concerned about the quality of raw heparin imported from China, the Americans need to make sure the proper controls are in place, China’s State Food and Drug Administration said today.

The Chinese FDA said it works with foreign regulators to monitor factories, but the ultimate responsibility for “safeguarding the legality, quality and safety of active pharmaceutical ingredients” lies with the importing nation, the WSJ’s Gordon Fairclough reports.

A version of the blood thinner heparin, sold by Baxter International, has been associated with illnesses and deaths in this country. Some of the key raw ingredient for the drug comes from China. In today’s statement, China’s FDA put concerns about the Chinese product at arm’s length, noting that the Chinese manufacturer that supplied the raw heparin is majority U.S. owned, its production technology was supplied by an American firm and all of its output was exported to the U.S.

Chinese producers of active pharmaceutical ingredients must be drug companies that are “registered and certified” by the Chinese FDA, an agency spokeswoman told the WSJ. Foreign buyers should confirm this certification and importing countries “should make strict tests” on ingredients. The company that sold the raw heparin used by Baxter wasn’t certified by the Chinese FDA because it was registered as a chemical company, not a drug company.


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