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China Urges Enhanced Quality Control over Heparin Production

China's drug watchdog on Thursday urged its local bureaux to step up supervision and inspection on blood-thinner heparin production to ensure quality and safety.

The State Food and Drug Administration (SFDA) said in a circular on its website that the local offices should strengthen their role in supervising heparin manufacturers' production, and urge the companies to produce in accordance with the approved technics.

Blood-thinner heparin producers must source their raw heparin from registered suppliers, while raw heparin suppliers must also beef up their management and check-up of raw and supplementary materials, the SFDA urged.

The manufacturers must closely follow the clinic effect of their products and those who have problems with their production links must immediately halt their production, the administration said. Products circulating in markets must be recalled if they have any possible safety problems, it added.

Meanwhile, China's Ministry of Commerce also announced on Thursday it is highly concerned about the suspect drug ingredient detected from the heparin products exported to the US.

A ministry spokesperson said the ministry had circulated emergency notifications to heparin exporters nationwide, demanding stricter monitoring on drug quality.

The move follows reports that heparin blood-thinner products, with a suspected contaminated ingredient from a supplier in Changzhou, in east China's Jiangsu Province, have caused serious reactions and deaths in the United States. The drugs were recalled February 28 this year.

The SFDA said Wednesday night it had detected an ingredient called Hypersulphated Chondroitin Sulphate from the heparin products exported to the United States. The finding was basically the same as that of the US Food and Drug Administration, it said.

Neither administration, however, could be certain whether the ingredient was to blame for the adverse reactions that heparin products had caused in the United States. Further investigations are still going on.

The Changzhou Kaipu Biochemical Co. is one link in a long production chain of heparin, according to the administration. The factory's share-holder, Scientific Protein Laboratories (SPL), imports the raw heparin from the Chinese factory and supplies it to Baxter International, one of the major heparin producers in the United States.

The Changzhou factory, a chemical plant but not a drugmaker, is not registered within the SFDA and its raw heparin is subjected to quality checks both by itself and SPL, the administration said.

(Xinhua News Agency March 21, 2008)


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