China NMPA Drug Inspection - Gansu Bencaoyuan Agricultural Technology Co., Ltd. - Sophora tonkinensis

The Gansu Provincial Food and Drug Administration (China NMPA) published a drug quality announcement on January 10, 2018, detailing supervision and sampling inspections of essential drugs and traditional Chinese medicine decoction pieces across the province. The inspections, conducted under the "Drug Administration Law of the People's Republic of China" and its implementing regulations, involved 734 batches of drugs. Out of these, 15 batches failed to meet quality standards.

Multiple manufacturers were identified with substandard products, including Aimin Pharmaceutical Group, Gansu Yalan Pharmaceutical, Lanzhou Fuxinghou Medicinal Materials, Gansu Heshunyuan Traditional Chinese Medicine Pieces, Qingyang Shenzhou Tongtai Pharmaceutical, Lanzhou Xukang Pharmaceutical, Gansu Kangle Pharmaceutical, Zhangye Guangtai Medicinal Materials, and Gansu Bencaoyuan Agricultural Technology. The primary issues varied but included failures in ethanol content, microscopic characteristics, identification, appearance, acid-insoluble ash, properties, and content determination, as measured against the Chinese Pharmacopoeia (2010 and 2015 Editions).

As a result, regulatory authorities implemented immediate control measures, such as sealing and seizing the unqualified products and mandating that sampled units suspend their sale and use while rectifying the issues. Furthermore, municipal and prefecture-level food and drug administration departments were instructed to investigate and prosecute illegal activities related to producing and selling substandard drugs, citing Articles 73, 74, and 75 of the Drug Administration Law. The handling outcomes for the responsible enterprises must be publicly disclosed within three months and reported to the Provincial Bureau.