China NMPA Drug Inspection - Sichuan Tianzhi Traditional Chinese Medicine Co., Ltd. - yam

On December 18, 2020, the Sichuan Provincial Drug Administration released Announcement No. 9 of 2020, detailing quality failures in 16 batches of drugs across 16 pharmaceutical companies. Key manufacturers identified include Guizhou Hanfang Pharmaceutical Co., Ltd., Chengdu Stomach Disease Hospital, Sichuan Daqian Pharmaceutical Co., Ltd., and several traditional Chinese medicine providers such as Sichuan Yunbotang Pharmaceutical Co., Ltd. and Yibin Renhe Traditional Chinese Medicine Pieces Co., Ltd.

Inspections conducted by municipal and provincial testing centers revealed several critical quality issues. Violations included physical defects like improper disintegration times and appearance inconsistencies, weight variations in capsules and pills, and significant chemical failures. Specifically, several herbal products failed microscopic identification tests, contained excessive sulfur dioxide residues, or lacked the required concentration of active medicinal ingredients. These findings indicate potential lapses in manufacturing consistency and raw material sourcing.

Operating under the regulatory framework of the Drug Administration Law of the People's Republic of China and the 2015 Chinese Pharmacopoeia, the administration has mandated immediate corrective actions. The involved companies are required to suspend the sale and use of all affected products and initiate formal recalls. Furthermore, enterprises must conduct thorough investigations into the root causes of these failures and implement effective rectifications. Regulatory departments will pursue administrative investigations into the production and sale of these substandard medicines, with all final enforcement results to be publicly disclosed.