China NMPA Drug Inspection - Hubei Shian Pharmaceutical Co., Ltd. - Mulberry leaves

In August 2021, the National Medical Products Administration (NMPA) published Announcement No. 59, detailing quality failures in 18 batches of pharmaceuticals involving 17 companies. Notable firms include Shaanxi Lijun Modern Traditional Chinese Medicine Co., Ltd., Inner Mongolia Kaimeng Pharmaceutical Co., Ltd., and Wuhan Dongxin Pharmaceutical Technology Co., Ltd. The testing, conducted by various provincial drug inspection centers, identified significant safety and quality violations. Primary issues included weight variation in tablets, failure to meet dissolution rate standards (which affects drug absorption), and excessive microbial limits. Traditional Chinese medicine products also exhibited failures in identification, excessive impurities, improper appearance, and deviations in active ingredient levels. Operating under the Drug Administration Law of the People’s Republic of China, the NMPA has mandated immediate risk control actions. The implicated enterprises are required to suspend all sales and usage of the non-compliant batches and initiate product recalls. Furthermore, provincial regulatory authorities must investigate these companies for the production and sale of counterfeit or substandard drugs, ensure the implementation of effective rectification plans, and publicly disclose the final investigation results to maintain public safety.