China strengthens safety regulations due to contamination in Heparin

SHANGHAI, China Baxter international has recalled all batches of Heparin, prompting China’s top drug safety agency to order its local bureaus to increase supervision over the manufacturing of the blood-thinning drug, according to the New York Times.

The use of heparin has resulted in about 19 deaths and hundreds of allergic reactions in America, and in Germany, Heparin, provided from another Chinese manufacturer, has also experienced a reported 80 accounts of allergic reactions.

According to the Times, China is the largest supplier of Heparin, and the Food and Drug Administration last week reported that active ingredients from Baxter’s Chinese supplier, Changzhou SPL, were contaminated with a cheaper version of Heparin.

China’s drug agency, the State Food and Drug Administration, has ordered that producers of the active ingredients of Heparin must get their raw materials from registered suppliers, and has strengthened the checks that the raw materials are safe and efficient. Investigations are still continuing on whether the fake material, which was identified as oversulfated chondoitin sulfate, caused the allergic reactions in patients.

The Times also reported that the FDA has ordered that all the imports of Heparin be inspected for contamination. It seems likely that the active ingredient would be contaminated, as much of the production of Heparin occurs in small factories and homes that are unlicensed and unregulated.

Based on the Chinese agency’s order, organizations involved in the health and drug industry are being pushed to create a system to be able to trace back to the raw materials used in order to prevent future health issues.