China NMPA Drug Inspection - Baoji Hanfang Traditional Chinese Medicine Pieces Co., Ltd. - Borneol

The State Administration for Market Regulation issued Announcement No. 78 on May 18, 2017, detailing findings from drug testing institutions that revealed 71 batches of unqualified Traditional Chinese Medicine (TCM) decoction pieces produced by 62 companies. Investigations identified significant issues, including 40 batches of substandard Eupolyphaga sinensis and 30 batches of substandard borneol, which failed quality parameters such as appearance, content determination, camphor levels, and non-volatile matter. Additionally, one batch of dodder seed from Guangzhou Zhixin Traditional Chinese Medicine Pieces Co., Ltd. was found to have non-compliant content determination.

In response, provincial food and drug administrations were directed to implement immediate control measures, including sealing, seizing, suspending sales, recalling products, and requiring rectification from the implicated enterprises. Operating under the Drug Administration Law of the People's Republic of China, these administrations are mandated to thoroughly investigate the illegal acts of producing and selling non-compliant drugs. They must publicly disclose the results of their investigations and handling of these enterprises within three months, with severe penalties to be imposed on manufacturers confirmed to be responsible for the substandard products. A clear process for handling enterprise objections regarding product authenticity was also established.