China NMPA Drug Inspection - Hebei Union Pharmaceutical CO., LTD. - yam

The Ningxia Drug Quality Sampling Inspection Announcement (No. 02, 2018), published on May 11, 2018, detailed the results of a region-wide drug quality surveillance program conducted by Ningxia's drug regulatory authorities. The inspection encompassed 95 batches across 58 drug varieties, including chemical drugs, traditional Chinese medicines, and traditional Chinese medicine decoction pieces. The key finding was that 16 batches, representing 6 varieties, failed to meet required quality standards. These non-compliant products were primarily Traditional Chinese Medicine (TCM) decoction pieces. Specific issues identified included failures in content determination, excessive total ash content, elevated sulfur dioxide residue, and non-conforming appearance or extractive levels. Notable manufacturers involved in these non-compliant batches included Pingliang Yongcheng Pharmaceutical Co., Ltd., Anhui Yiyuan Pharmaceutical Co., Ltd., and Pingliang Zhukang Traditional Chinese Medicine Pieces Co., Ltd., among others. One manufacturer, Anhui Bozhou Jinshaotang Traditional Chinese Medicine Pieces Co., Ltd., denied producing a non-compliant batch. Another, Lanzhou Xukang Pharmaceutical Co., Ltd., was noted as bankrupt. The regulatory framework for these inspections was primarily the Chinese Pharmacopoeia 2015 Edition, Part I, particularly for TCM products. In response to these findings, the relevant municipal and county market supervision administrations were tasked with investigating and addressing the non-compliant drugs in accordance with applicable laws. The announcement emphasizes the ongoing commitment to ensuring drug quality and safety within the region under the National Medical Products Administration's oversight.