China States Importing Countries Responsible for Drug Safety

Shannon Weidemann

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The agency responsible for drug safety in China has stated that it is the responsiblity of importing countries and companies to inspect and certify drugs are safe. The statement follows a recall by Baxter for the blood-thinning drug heparin. Four people have died and there have been hundreds of reports of adverse reactions following the use of the drug.

"We attach high importance to this," the agency said in its first comment on the heparin recall. SFDA officials have not responded to repeated inquiries about the case.

But the SFDA said that based on international practice, "safeguarding the legality, safety and quality of raw materials imported for use in pharmaceuticals is the responsibility of the importing country."

The U.S. Food and Drug Administration (FDA) is holding inspections of the manufacturing facilities where heparin is made, both in the United States and China. It is unknown what about the heparin is causing the reactions. The U.S. and China signed an agreement in December for greater access in drug and food safety cases. The plant in China was labeled as a chemical manufacturer and was never inspected by the FDA or China's FDA.