China NMPA Drug Inspection - Hebei Yuekang Zhide Pharmaceutical Co., Ltd. - Bupleurum (Northern Bupleurum)

On July 19, 2021, the National Medical Products Administration (NMPA) issued Announcement No. 49, identifying quality failures in 15 batches of drugs produced by 14 different companies. Involved manufacturers include Anhui Jishantang Traditional Chinese Medicine Technology Co., Ltd., Hubei Keyi Pharmaceutical Co., Ltd., and Guangdong Hongying Technology Co., Ltd. Testing conducted by various provincial institutes revealed several significant issues, ranging from physical inconsistencies like improper appearance and excessive moisture to chemical deviations such as high organic impurities and incorrect active ingredient concentrations. Notably, multiple batches of traditional Chinese medicines, including Bupleurum chinense, failed standards due to the presence of external impurities like sand and soil or improper processing techniques. These findings fall under the regulatory framework of the Drug Administration Law of the People's Republic of China. Consequently, the NMPA has mandated immediate risk control measures, requiring companies to suspend sales, stop product use, and initiate recalls of all affected batches. Manufacturers must also investigate the root causes of these failures and implement corrective actions. Provincial regulatory authorities have been tasked with overseeing these investigations and are required to publicly disclose the results of legal proceedings regarding the manufacture of substandard pharmaceuticals.