China NMPA Drug Inspection - Ningxia Bauhinia Pharmaceutical Co., Ltd. - Total alkaloids of Sophora flavescens

The Ningxia Drug Administration issued an announcement on January 22, 2020, detailing drug sampling inspection results from 2019. Operating under the "Drug Administration Law of the People's Republic of China" and "Regulations on the Administration of Drug Quality Sampling Inspection," the inspections covered 137 batches from 76 drug varieties, encompassing chemical drugs, traditional Chinese medicine preparations, and decoction pieces. A total of 20 batches across 16 varieties were found to be non-compliant with quality standards. Primary violations focused on Traditional Chinese Medicine (TCM) pieces, highlighting issues such as substandard appearance, incorrect identification, failures in thin-layer chromatography, inaccurate content determination, and excessive sulfur dioxide levels. Several manufacturers, including Anhui Meiyu Traditional Chinese Medicine Pieces Co., Ltd., Bozhou Jinshaotang Traditional Chinese Medicine Pieces Co., Ltd., and Ningxia Mingde Traditional Chinese Medicine Pieces Co., Ltd., had products cited. Significantly, some implicated manufacturers denied producing the non-compliant batches, and one company had its Good Manufacturing Practice (GMP) certificate revoked. Adherence to the Chinese Pharmacopoeia 2015 Edition and other national drug standards formed the regulatory basis for evaluation. Authorities have initiated investigations and legal actions through relevant municipal and county market supervision administrations to address the non-compliant drugs.