China NMPA Drug Inspection - Hubei Ruizhe Pharmaceutical Co., Ltd. - Andrographis paniculata slices

The National Medical Products Administration (NMPA) of China announced on May 16, 2018, that four batches of drugs from multiple companies failed to meet regulatory standards based on tests by provincial drug control institutes. The announcement, dated May 15, 2018, detailed non-compliance from several manufacturers. Shaohuatang Pharmaceutical Co., Ltd., along with another company, produced Angelica dahurica found to have excessive sulfur dioxide residue. Additionally, Hubei Renyue Pharmaceutical Co., Ltd.'s Andrographis paniculata tablets and Jilin Shuangxing Pharmaceutical Co., Ltd.'s Acanthopanax senticosus tablets both failed content determination, indicating issues with their active ingredient levels. In response, regulatory authorities initiated immediate control measures, including product sealing and seizure. The affected companies were mandated to halt sales, recall products, and implement corrective actions. Operating under the *Drug Administration Law of the People's Republic of China* (Articles 73, 74, 75), the NMPA directed provincial drug regulatory bodies to investigate these companies for potential illegal activities related to producing or selling substandard drugs. These investigations are required to be completed, and their findings made public, within three months of receiving the inspection reports. The announcement also outlines procedures for companies to object to product authenticity and for authorities to trace problematic product sources.