China NMPA Drug Inspection - Shaohuatang Chinese Medicine Co., Ltd. - Gastrodia elata

The Yunnan Provincial Drug Administration released its first drug quality announcement of 2020 on May 22, detailing substandard results from inspections conducted during the first quarter. The report identifies several manufacturers and suppliers, including Yunnan Suimin Biotechnology Development Co., Ltd., Yibin Renhe Traditional Chinese Medicine Pieces Co., Ltd., and Chongqing Kangdi Pharmaceutical Co., Ltd. The primary issues discovered involve significant quality failures and regulatory non-compliance under the 2015 Chinese Pharmacopoeia standards. Key violations include the distribution of counterfeit products where the medicine was not produced by the labeled manufacturer, specifically affecting batches of Gleditsia thorns and Tianma. Other technical failures included excessive sulfur dioxide residues in chrysanthemum samples, incorrect physical appearances in Trichosanthes seeds, and failed chemical content tests for Epimedium and Schisandra. Some listed suppliers were also discovered to be untraceable or non-existent entities. The regulatory framework used for these assessments was the 2015 Chinese Pharmacopoeia. To ensure public safety, the administration has publicized these findings, requiring medical institutions and pharmacies to identify and remove the non-compliant batches from their inventories. These actions aim to strengthen drug supervision and prevent the use of substandard traditional Chinese medicines across the province.