China says drug checks are up to importers

China’s drug-safety agency, responding to questions about oversight of an exported blood-thinning compound, said checks of pharmaceutical ingredients made in China are ultimately the responsibility of countries that buy them.

The State Food and Drug Administration said it works with foreign counterparts to monitor drug-ingredient production. But it said that based on international practice, "safeguarding the legality, quality and safety of active pharmaceutical ingredients" is up to importing countries.

In its statement, the agency also said it is cooperating with the U.S. Food and Drug Administration in the regulator’s investigation of 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.

China’s food and drug agency noted that the company in question is majority U.S.-owned, its production technology was supplied by Scientific Protein and all of its output was exported to the U.S. It also said that U.S. regulators "verified" in 2004 that Scientific Protein’s China venture, Changzhou SPL, was supplying heparin.

It remains unclear if the heparin produced in China is connected in any way to the adverse reactions linked to the Baxter drug. Even so, the heparin case highlights regulatory gaps that have opened as drug companies have become increasingly global in their purchase of ingredients. China is supplying more of the international pharmaceutical industry’s raw materials.

Lembit Rago, head of drug safety for the World Health Organization, says many Chinese manufacturers don’t "have an understanding of international regulations or the training" to comply with them. Consumers in the U.S. and European nations are protected in part by their own regulatory agencies, Dr. Rago says. For other countries without the capacity to check drug quality, "it’s a much bigger problem."

Yan Jiangying, spokeswoman for the State Food and Drug Administration, said that in China, producers of active pharmaceutical ingredients must be drug companies that are "registered and certified" by her agency. She said foreign buyers should check this certification and importing countries "should make strict tests" on ingredients and drugs.

Ms. Yan also says that her agency is working to "further strengthen cooperation" with the U.S. FDA on the monitoring of exports of active pharmaceutical ingredients. Andrew von Eschenbach, the FDA’s commissioner, has said his agency needs a bigger budget to fulfill its responsibilities. Among its biggest challenges: coping with a rising number of drug imports.

Makers of crude heparin — who extract the chemical from pig intestines, often in small workshops, and supply this raw material to companies such as Changzhou SPL and other producers of refined heparin — say that they face little oversight from Chinese health authorities.

(Source: Gordon Fairclough: Wall Street Journal: March 2008)