China NMPA Drug Inspection - Sichuan Gukang Pharmaceutical Co., Ltd. - Eriocaulon

On May 15, 2020, the Chongqing Municipal Drug Administration published the results of sampling inspections identifying 28 batches of non-compliant drugs produced by 18 pharmaceutical companies. Key manufacturers named in the report include Yibin Renhe Traditional Chinese Medicine Pieces Co., Ltd., Liangshan Xinxin Traditional Chinese Medicine Pieces Co., Ltd., Sichuan Gukang Pharmaceutical Co., Ltd., and Jilin Daojun Pharmaceutical Co., Ltd. The inspections revealed widespread quality failures, most notably regarding ingredient potency (content determination) and failed dissolution tests for Ibuprofen capsules. Several traditional Chinese medicine products also failed physical quality standards due to excessive ash levels, incorrect weight variation, and failed microscopic identification. Specifically, items such as American ginseng and lotus seeds were found to be moldy and insect-infested. These products were evaluated under the regulatory framework of the Chinese Pharmacopoeia (2010 and 2015 editions) and local municipal processing standards. In response to these findings, the Chongqing Municipal Drug Administration has instructed relevant bureaus to implement immediate control measures. These required actions include the sealing and seizing of substandard stock, the suspension of sales, and the formal recall of all affected batches to protect public health and safety.