China NMPA Drug Inspection - Anhui Zhongmeitang Traditional Chinese Medicine Pieces Co., Ltd. - Bupleurum chinense

On August 1, 2018, the Guangxi Zhuang Autonomous Region Food and Drug Administration, operating under the National Medical Products Administration (NMPA) framework, released its 7th Drug Quality Announcement. This regulatory action aimed to enhance drug quality supervision and safeguard public health through comprehensive sampling inspections across drug production, distribution enterprises, and medical institutions within its jurisdiction. The inspections identified 11 batches of traditional Chinese medicine pieces that failed to meet established quality standards. Multiple manufacturers were implicated, including Jiangxi Zhangshu Chengfang Traditional Chinese Medicine Pieces Co., Ltd., Guangxi Tianxiakang Pharmaceutical Co., Ltd., Nanning Jingchang Traditional Chinese Medicine Pieces Co., Ltd., Guangxi Guigang Lvzhiyuan Planting and Breeding Development Co., Ltd., Guangxi Deruntang Traditional Chinese Medicine Technology Co., Ltd., Guangxi Wuzhou Jiexun Pharmaceutical Co., Ltd., and Guangxi Zhangyitang Chinese Herbal Slices Co., Ltd. The primary violations, assessed against the Chinese Pharmacopoeia (2010 and 2015 versions), included failures in drug properties, identification tests (such as thin film chromatography and chemical reactions), content determination, and macroscopic appearance. These issues indicate significant deficiencies in manufacturing quality control for herbal ingredients. In response, the Guangxi Food and Drug Administration mandated immediate control measures, including sealing, seizing, and suspending sales of the substandard drugs. Furthermore, investigations were initiated against the responsible source units to ensure legal compliance and accountability. This comprehensive approach underscores the administration's commitment to upholding drug quality and patient safety.