China NMPA Drug Inspection - China (Bozhou) Shanghai Lei Yunshang Traditional Chinese Medicine Pieces Factory - Tetrapanax papyriferus

On July 18, 2016, the Henan Provincial Food and Drug Administration, under China's National Medical Products Administration, issued Drug Quality Announcement No. 40. This announcement was part of a provincial effort to strengthen drug quality supervision and protect public health through comprehensive sampling inspections. The inspections identified 25 batches of drugs and traditional Chinese medicine (TCM) products that did not meet regulatory standards.

Several manufacturers were implicated, including Taikang Haien Pharmaceutical, Nanyang Pukang Pharmaceutical, Jiyuan Jishi Pharmaceutical, Shandong Juancheng Zhiyuan Traditional Chinese Medicine Pieces Co., Ltd., and Anhui Jin Furong Traditional Chinese Medicine Pieces Co., Ltd. The main violations encompassed a range of quality issues: failures in dissolution tests for drugs like Metronidazole Tablets, incorrect content determination in products such as Berberine Hydrochloride Tablets and various TCMs, and deviations in the properties or identification of herbal ingredients like Ginseng and Tetrapanax papyriferus. A significant recurring issue for multiple TCM items, including Yam and Dried Ginger, was the presence of excessive sulfur dioxide residue. Additionally, unauthorized coloring agents like Lemon Yellow and Auramine O were detected in some herbal medicines.

These findings were processed under the "Drug Administration Law of the People's Republic of China." All local authorities were instructed to investigate these substandard products thoroughly and implement appropriate corrective and enforcement actions to ensure adherence to quality standards and safeguard consumer medication safety.