China NMPA Drug Inspection - Jiangxi Hengkang Pharmaceutical Co., Ltd. - Cough-relieving capsules

On February 25, 2020, the Jiangxi Provincial Drug Administration published its first-quarter inspection report for 2020, detailing the quality supervision of pharmaceutical products across the province. Conducting inspections under the Drug Administration Law and the 2015 Chinese Pharmacopoeia, authorities tested 4,570 batches of drugs. While the majority passed, 22 batches from 20 different product varieties were found to be non-compliant.

Key companies cited for violations include Jiangxi Zhaosheng Traditional Chinese Medicine Pieces Co., Ltd., Jiangxi Hengkang Pharmaceutical Co., Ltd., Guangdong Nanguo Pharmaceutical Co., Ltd., and Nancheng County Jianhong Traditional Chinese Medicine Pieces Factory. The primary issues identified involved failures in physical properties, identification testing, and content determination. Specific violations included the presence of visible foreign matter in injections, excessive microbial levels in capsules, weight variations in tablets, and high ash or moisture content in traditional Chinese medicine pieces. Notably, one instance of a counterfeit Yunnan Baiyao Band-Aid was also recorded.

In response to these findings, the Jiangxi Provincial Drug Administration has mandated immediate regulatory actions. Relevant departments are required to seal, seize, and suspend the sale of all non-compliant batches. Furthermore, manufacturers must initiate product recalls, and both the producers and the units where samples were collected will face formal investigations and legal penalties to ensure public medication safety.