China’s State Food And Drug Administration has ordered local authorities to tighten controls on production of pharmaceutical products, not least of heparin, the blood-thinner recently linked to 19 deaths in the United States, and to hundreds of allergic reactions in the USA, Japan and Germany.

Investigations have prompted a state crackdown on small unlicensed and unregistered workshops as well as on larger manufacturers.

According to the Chinese People’s Daily, producers must now source their raw heparin only from registered suppliers, and improve their monitoring of raw materials.

Manufacturers must closely follow the clinical effect of their products and those who have problems in the production chain must immediately halt production. Products must now be recalled if there are any safety questions raised.

China’s Ministry of Commerce is particularly concerned about the suspect ingredient detected in heparin products exported to the USA from a supplier in Changzhou, Jiangsu Province.

Both the SFDA and the US Food and Drug Administration have reportedly identified the contaminant as hypersulphated chondroitin sulphate and the Changzhou Kaipu Biochemical Co is one link in a long production chain. The US-based company Scientific Protein Laboratories imported the raw heparin from the Chinese factory and supplied it to Baxter International in the United States. Because the Changzhou facility is a chemical plant, not a drug manufacturer, it has apparently not been registered with the SFDA.

An explosion of Chinese production capacity has resulted in numerous reports of adulterated, counterfeit and otherwise unsafe pharmaceuticals.

Meantime, according to the Xinhua News Agency, the Central Commission for Discipline Inspection of the Communist Party, announced it had uncovered more than a thousand commercial bribery cases in China’s healthcare sector in the last year. Zheng Xiaoyu, head of the SFDA, was executed for taking $850,000 in bribes. By Steve Ainsworth









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