China’s State Food and Drug Administration said in a recent released statement that it is the receiving country’s responsibility to ensure the safety of pharmaceutical ingredients they import from other countries.
The statement was perhaps an effort to exonerate China’s Food and Drug Administration from the heparin situation. The agency also said it is cooperating with the U.S. Food and Drug Administration in their currently investigation into the deaths and illnesses possibly related to the anticlotting medicine heparin sold in the U.S. by Baxter International Inc. of Deerfield, Ill. Some of the heparin used in Baxter’s drugs was made by a Chinese joint venture of Scientific Protein Laboratories, a Wisconsin company that also makes heparin in the U.S. Scientific Protein owns 55% of the joint venture; its Chinese partner owns the rest.
The statement also said that the U.S. FDA “verified” in 2004 that Scientific Protein’s China venture, Changzhou SPL, was supplying heparin. The FDA said that because of a mix-up it never inspected Changzhou SPL’s plant, as it was supposed to do. FDA inspectors along with Chinese authorities visited the plant last week.
It remains unclear if the heparin produced in China is connected in any way to the adverse reactions linked to the Baxter drug. However, the heparin case highlights regulatory gaps that have opened as drug companies become increasingly global in their purchase of ingredients.
Source: WSJ