China NMPA Drug Inspection - Li Guishuang - Yam (medicinal herb)

The Chongqing Municipal Drug Administration issued its first Drug Quality Bulletin for 2018, detailing non-compliance discovered during sampling inspections of traditional Chinese medicine (TCM) pieces. Conducted across various regional testing institutes, the investigation targeted numerous manufacturers and pharmacies, including Sichuan Juyuan Traditional Chinese Medicine Pieces Co., Ltd., Sichuan Zhongyong Pharmaceutical Co., Ltd., and Neijiang Lianghui Pharmaceutical Co., Ltd. The inspections were carried out against the regulatory framework of the Chinese Pharmacopoeia 2015 Edition, Part I.

The main violations identified involved failures in product appearance, microscopic and DNA-based identification (such as polymerase chain reaction testing for snake species), and chemical testing for sulfur dioxide residues and ash content. Specifically, products like tortoise shell, kudzu root powder, and various herbs were found to have inaccurate identity markers or insufficient active ingredient levels. Several manufacturers disputed the findings, claiming certain non-compliant batches were counterfeit and not produced by their facilities.

Following these findings, the Chongqing Municipal Drug Administration mandated immediate enforcement actions. Relevant district and county departments were ordered to seal and seize the substandard products, requiring all involved enterprises to suspend sales and use while initiating comprehensive product recalls. Additionally, the bureau pledged to increase the frequency of random sampling inspections and tighten daily oversight to eliminate safety risks and protect public health.