China NMPA Drug Inspection - Jilin Jiuyang Pharmaceutical Co., Ltd. - Diclofenac sodium enteric-coated tablets

On October 10, 2020, the Sichuan Provincial Drug Administration issued an official notice regarding four batches of pharmaceutical products that failed to comply with national quality regulations. The announcement identified violations involving four manufacturers: Jilin Jiuyang Pharmaceutical Co., Ltd., Sichuan Fufeng Pharmaceutical Co., Ltd., Sichuan Xinrentai Pharmaceutical Co., Ltd., and Sichuan Yunbotang Pharmaceutical Co., Ltd.

Inspection results, based on the 2015 Chinese Pharmacopoeia, revealed several quality failures. Jilin Jiuyang’s diclofenac sodium tablets showed issues with weight variation and excessive related substances. Traditional Chinese medicine pieces from the other firms failed due to insufficient extractives, high levels of acid-insoluble ash, and excessive pesticide residues—specifically in American ginseng produced by Sichuan Yunbotang.

Governed by the Drug Administration Law of the People's Republic of China, the authorities have mandated immediate risk control measures. The involved companies must suspend the sale and use of the non-compliant batches and initiate comprehensive product recalls. Furthermore, the manufacturers are required to investigate the root causes of these quality failures and implement effective rectification plans. The Sichuan Provincial Drug Administration has directed local departments to investigate potential illegal production and distribution of substandard drugs and has committed to publicly disclosing the results of these investigations.