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May 25, 2006

BUSINESS

More Deaths From Chinese Drug

Chinese government tells regulators to step up enforcement

Jean-François Tremblay

China's government reports that a faulty drug aimed at treating gall bladder and gastric conditions has now killed nine people. The injectable drug, armillarisin A, was administered to patients at a hospital affiliated with Sun Yat-sen University, in Guangzhou (C&EN, May 22, page 11).

A news item posted on the official website of the Chinese government reports that out of 18 people who died after receiving the drug, nine were killed by the injection. The others died from other causes.

China's State Food & Drug Administration issued a notice on May 18 requiring drug regulatory departments at the state and municipal levels to strengthen their supervision of drug manufacturers. SFDA also said that companies should "improve the product quality-assurance system according to the requirements of Good Manufacturing Practices."

An executive with a foreign manufacturer of pharmaceutical ingredients who is familiar with China???s drug industry tells C&EN that "it is well-known that the Chinese GMP guidelines and site inspections still need a lot of improvement before they can ensure product quality."

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