China NMPA Drug Inspection - Diqing Development Zone Sanjiang Biological Development Co., Ltd. - Fritillaria cirrhosa

On April 22, 2021, the Yunnan Provincial Drug Administration released its first announcement regarding substandard drug quality based on its 2020 supervision and sampling plan. The report identifies several pharmaceutical companies involved in the production and distribution of non-compliant Traditional Chinese Medicine (TCM) products. Key companies named include Yunnan Houkang Times Pharmaceutical Co., Ltd., Anhui Qiangzheng Traditional Chinese Medicine Pieces Co., Ltd., and Yunnan Zongshun Biotechnology Co., Ltd. The primary issues cited across the sampled batches involve failures in microbial safety, improper product properties, and inadequate levels of active ingredients or extractives. Notably, Anhui Qiangzheng denied the production of a sampled batch of Drynaria fortunei, suggesting potential issues with counterfeit products. These inspections were conducted under the regulatory framework of the 2015 Chinese Pharmacopoeia and the 2005 Yunnan Provincial Standards for TCM Pieces. As a result of these findings, regulatory departments are required to verify the inspection results and take necessary enforcement actions to ensure public safety and prevent the use of substandard medications in healthcare facilities.