China NMPA Drug Inspection - Minxian Guiqitang Pharmaceutical Co., Ltd. - Angelica sinensis

This announcement from the Henan Provincial Drug Administration, published on January 18, 2019, details findings from inspections revealing five batches of substandard drugs from four manufacturers. The inspections, conducted by various municipal and county drug inspection institutes, identified significant quality control issues.

Yunnan Longrun Pharmaceutical Co., Ltd. was cited for Weikangling Capsules containing Auramine O, a prohibited substance. Hubei Tongren Hengkang Traditional Chinese Medicine Pieces Co., Ltd.'s Cistanche deserticola failed standards for appearance, moisture, and total ash. Minxian Guiqitang Pharmaceutical Co., Ltd.'s Angelica sinensis and Henan Baiyuankang Pharmaceutical Co., Ltd.'s Angelica dahurica both exhibited unsatisfactory appearance, including insect infestation. Additionally, Henan Baiyuankang Pharmaceutical Co., Ltd.'s Amomum villosum contained unacceptable impurities.

The regulatory framework underpinning these inspections is primarily the Chinese Pharmacopoeia 2015 Edition, alongside specific supplementary test methods for certain items. In response to these violations, the Henan Provincial Drug Administration mandated immediate risk control measures. These include sealing and seizing the affected products, suspending their sale, and initiating legal investigations and penalties against the implicated manufacturing companies to ensure public health and drug quality.