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China To Review Use Of Chinese Herbal Injections

This article was originally published in PharmAsia News

Executive Summary

China's Ministry of Health has held an emergency videoconference to announce the adverse reactions of four newborn babies who were injected with Yinzhihuang herbal medicine. The drug produced by Shanxi Taihang Pharmaceutical has caused one death and the authorities are calling for an immediate recall. From Yuxingcao and Ciwujia to Yinzihuang, controversy and drug safety incidents have been plaguing Chinese herbal injections since they emerged as a new profit stream in the pharmaceutical industry. Experts note that to ensure such products' safety and quality, China's State FDA issued basic technical requirements for traditional Chinese medicine and natural medicine injections last December but the regulations have not been fully implemented. To prevent further incidents, the government should expand more clinical trial coverage and establish an effective adverse drug reaction reporting system. (Click here for more - Chinese Language)

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According to Shanxi FDA, Shanxi Taihang Pharmaceutical-produced Yinzhihuang herbal medicine has been examined and proven to comply with China's national drug standards. The herbal medicine caused adverse reactions in four newborn babies in October 2008, resulting in one death (PharmAsia News, Oct. 27, 2008). Subsequently, experts appointed by the state and provincial FDA inspected the company's GMP implementation. In addition, the National Institute for the Control of Pharmaceutical and Biological Products and Shanxi Institute for Drug Control each tested the suspected batch and the results conformed to the national standards. A Shanxi Taihang insider says the company has announced the testing report on its website but resumption ofYinzhihuang sales will depend on the decision of the authorities. (Click here for more - Chinese Language)

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