China NMPA Drug Inspection - Xichang Jingkang High-Tech Industrial Development Co., Ltd. - yam

On December 18, 2020, the Sichuan Provincial Drug Administration issued Announcement No. 9 of 2020, reporting that 16 batches of pharmaceutical products from 16 different companies failed to meet quality standards. Key manufacturers cited in the report include Guizhou Hanfang Pharmaceutical Co., Ltd., Chengdu Stomach Disease Hospital, and Sichuan Daqian Pharmaceutical Co., Ltd., along with several traditional Chinese medicine producers such as Sichuan Yunbotang Pharmaceutical and Sichuan Juyuan Pharmaceutical Group.

The inspections revealed various quality violations. Major issues included physical defects like poor appearance and improper disintegration times for capsules. Other batches failed due to excessive weight variation, the presence of impurities, and high levels of sulfur dioxide residue. Additionally, several traditional medicinal herbs failed technical tests for microscopic identification and content determination, meaning they did not meet the required concentration of active ingredients or were incorrectly identified at the microscopic level.

Governed by the Drug Administration Law of the People's Republic of China and the Chinese Pharmacopoeia, the regulatory authority has mandated immediate action. The involved companies must implement risk control measures, including the suspension of all sales and the recall of substandard products. Manufacturers are required to investigate the root causes of these failures and perform effective rectifications. Furthermore, local regulatory departments will conduct formal investigations into the production of these substandard drugs, with results to be disclosed publicly.