China NMPA Drug Inspection - Hebei Huarong Pharmaceutical Co., Ltd. - Pinellia ternata

The Hebei Province Drug Quality Announcement (2019 Drug Supervision and Sampling Inspection No. 3), issued on October 12, 2019, reports findings from drug quality inspections conducted between July and September 2019. These inspections, part of the "2019 Hebei Province Drug Supervision and Sampling Plan," targeted drug manufacturers, distributors, and users across the province.

Several companies were identified for non-compliance. Hebei Qilong Pharmaceutical Co., Ltd., Hebei Quantai Pharmaceutical Co., Ltd., Anguo Yuanguang Pharmaceutical Co., Ltd., and Hebei Shunquanlong Pharmaceutical Co., Ltd. all had drug products, including *Bupleurum chinense*, *Paeonia suffruticosa*, *Papaya*, and *Pinellia ternata*, that failed the "Appearance" specification. Additionally, Ginger Pinellia ternata, manufactured by Anhui Meiyu Traditional Chinese Medicine Pieces Co., Ltd., failed the "Extractives" test.

In response to these violations, regulatory authorities have implemented control measures, such as sealing and seizing the non-compliant drugs. Under Articles 73, 74, and 75 of the "Drug Administration Law of the People's Republic of China," relevant drug regulatory bodies are mandated to investigate these enterprises for producing and selling substandard products. Required actions include publicizing risk control measures within one week and reporting the outcomes of enforcement actions against the involved entities within three months. Furthermore, any suspected counterfeit drugs are to be investigated, with potential criminal cases referred to public security departments.