China NMPA Drug Inspection - Hubei Kangyuan Pharmaceutical Co., Ltd. - Motherwort paste

The Chinese State Food and Drug Administration (SFDA) published its National Drug Quality Bulletin (2011, No. 2) on July 25, 2011, detailing the results of nationwide sampling inspections. Conducted as part of a national plan to enhance drug supervision and ensure public safety, the inspection covered 2,661 batches across 21 essential and other drug varieties. The overall quality was deemed good, with 2,652 batches meeting standards.

However, nine batches from five companies were found to be non-compliant with established drug quality standards, including the Ministry of Health's "Drug Standards" and the "Chinese Pharmacopoeia 2005 Edition." Violations primarily involved glycerin suppositories and Motherwort preparations. Anqing Yongsheng Pharmaceutical Co., Ltd. had one batch of glycerin suppositories fail for appearance and microbial limits. Jinzhou Bentian Pharmaceutical Co., Ltd. had two batches of glycerin suppositories fail due to appearance issues, while Anshan Jiutian Pharmaceutical Co., Ltd.'s glycerin suppositories failed content determination. Regarding Motherwort preparations, Guangxi Lingfeng Pharmaceutical Co., Ltd. had two batches of Motherwort Granules exceed bacterial limits. Laiyang Jiangbo Pharmaceutical Co., Ltd., Wuhan Ezhong Pharmaceutical Co., Ltd., and Hubei Kangyuan Pharmaceutical Co., Ltd. each had one batch of Motherwort Paste or Granules fail content determination.

In response, provincial food and drug administration departments were mandated to investigate and handle these non-compliant drugs and manufacturers. They were required to submit their investigation results to the SFDA's Inspection Bureau by the end of September 2011, with a copy to the Drug Market Supervision Office, ensuring accountability and corrective measures.