China NMPA Drug Inspection - Qianjiang City Traditional Chinese Medicine Hospital - Fritillaria thunbergii

The National Medical Products Administration (NMPA), formerly the State Food and Drug Administration (SFDA), issued an announcement on October 31, 2019, detailing investigations and resolutions regarding substandard Traditional Chinese Medicine (TCM) materials. This announcement specifically highlights two cases in Hubei province, stemming from a broader 2017 report on unqualified TCM batches.

Ezhou Central Hospital faced inspection following a July 21, 2016, sampling. Zhejiang Fritillaria, labeled as manufactured by Anhui People's Traditional Chinese Medicine Pieces Co., Ltd., was found to have sulfur dioxide residue exceeding regulatory limits. This violation of Article 49 of the "Drug Administration Law of the People's Republic of China" led to a penalty of 2004.5 yuan, including confiscated illegal profit and a fine, imposed by the Ezhou Municipal Food and Drug Administration. The case concluded on December 7, 2016.

Similarly, Xianning Municipal Traditional Chinese Medicine Hospital was inspected after a June 22, 2016, sampling of Zhejiang Fritillaria, labeled from Shaanxi Longli Pharmaceutical Co., Ltd. This batch also contained excessive sulfur dioxide. Further investigation uncovered discrepancies in product documentation, suggesting a potentially illicit source. The Xianning Municipal Food and Drug Administration, referencing the "Drug Administration Law" and Hubei provincial regulations, imposed a total penalty of 20979 yuan in fines and confiscations. Additionally, it recommended referring the sales representative to public security for further investigation into the product's origin. This case closed on January 18, 2017. These actions demonstrate China's commitment to ensuring drug quality and compliance.