China NMPA Drug Inspection - Jilin Shuangyao Pharmaceutical Group Co., Ltd. - Artificial bezoar metronidazole capsules

On November 17, 2017, China's State Administration for Market Regulation issued Announcement No. 186, disclosing compliance deficiencies in drug products. Inspections conducted by national drug testing institutions identified 39 batches of substandard drugs from eight manufacturers. Key companies cited include Guangxi Chunzhengtang Pharmaceutical Co., Ltd., Guangxi Jinye Pharmaceutical Co., Ltd., Jiangsu Puhua Kesheng Pharmaceutical Co., Ltd., Jilin Shuangyao Pharmaceutical Group Co., Ltd., Gansu Minhai Pharmaceutical Co., Ltd., Guangxi Shengte Pharmaceutical Co., Ltd., and Youhua Pharmaceutical (Leshan) Co., Ltd. The principal violations encompassed critical quality parameters such as insufficient content of active ingredients (e.g., Ficus microcarpa dry extract, Bilirubin), inadequate product solubility, and contamination exceeding microbial limits. These non-compliances were determined against established national drug standards, including the *Pharmacopoeia of the People's Republic of China*. For instance, numerous batches of Guaifenesin Pentotropin Promethazine Granules from Guangxi Chunzhengtang failed solubility tests, while Gansu Minhai's Anti-inflammatory and Antipyretic Granules exhibited microbial limit issues. In response, provincial drug administration departments promptly implemented control measures, including product sealing, seizure, suspension of sales, and mandatory recalls. Furthermore, the national administration directed provincial authorities to investigate these illicit activities thoroughly, adhering to Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*. The provincial departments are required to publicize investigation outcomes within three months and report their findings to the national body, underscoring a commitment to public health and pharmaceutical integrity.