China NMPA Drug Inspection - Shanxi Guotai Traditional Chinese Medicine Co., Ltd. - yam

The National Medical Products Administration (NMPA) issued Announcement No. 58 on July 13, 2018, reporting that 42 batches of drugs from 37 companies failed to meet regulatory standards. Various provincial drug testing institutions identified critical quality issues across a range of pharmaceutical products, including traditional Chinese medicines and injectable preparations, from companies like Sichuan Fuqing Pharmaceutical Co., Ltd. and Wuhan Pusheng Pharmaceutical Co., Ltd.

Key violations included substandard content determination, affecting drug efficacy, and issues with total ash, acid-insoluble ash, and extractives in traditional Chinese medicine ingredients such as Rehmannia glutinosa and Chinese yam, indicating impurities or improper processing. Concerns regarding drug purity and safety were raised by failures in "related substances" for Omeprazole Sodium for Injection, suggesting impurities from manufacturing or degradation. Additionally, excessive sulfur dioxide residue in Chinese yam highlighted improper preservation practices, and incorrect fill weight for Lincomycin Lidocaine Gel pointed to manufacturing control issues.

In response, regulatory authorities implemented immediate control measures, including product sealing, seizure, sales suspension, and recalls, requiring companies to rectify the identified problems. Under Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*, provincial drug regulatory bodies were mandated to investigate these companies for illegal production and sale of non-compliant drugs. The NMPA required these investigations and their public disclosure within three months, emphasizing the administration's commitment to ensuring drug quality and public safety.