The State Food and Drug Administration recently issued a notice stating that 15 batches of drugs, including Wuwei Qingzhuo Pills produced by 15 companies including Ulanhot Zhongmeng Pharmaceutical Co., Ltd., were inspected by three drug inspection agencies including the China Institute for Food and Drug Control and were found to be non-compliant.
According to the notice, after inspection by the China Institute of Food and Drug Control, one batch of Wuwei Qingzhuo pills labeled as produced by Ulanhot Sino-Mongolian Pharmaceutical Co., Ltd. did not meet the regulations. The item that did not meet the regulations was the dissolution time limit. The dissolution time limit refers to the time for the pills to disintegrate, dissolve or break into granules. The reasons for non-compliance may be related to improper prescription and process control.
After inspection by the Qinghai Provincial Drug Inspection and Testing Institute, the products are labeled as Hangzhou Huadong Traditional Chinese Medicine Pieces Co., Ltd., Anhui Hansheng Pharmaceutical Co., Ltd., Anhui Yaozhiyuan Traditional Chinese Medicine Pieces Co., Ltd., Anhui Jiayou Traditional Chinese Medicine Pieces Co., Ltd., Hubei Gongshengtang Traditional Chinese Medicine Pieces Co., Ltd., Nine batches of Zhigancao produced by Huazhou Huayi Traditional Chinese Medicine Pieces Co., Ltd., Guiyang Daosheng Health Industry Co., Ltd., Guizhou Yuyuan Traditional Chinese Medicine Development Co., Ltd., and Linxia Yisheng Traditional Chinese Medicine Pieces Co., Ltd. did not meet the regulations and did not meet the regulations. The project is content determination.
After inspection by the China Institute of Food and Drug Control, three batches of Ligustrum lucidum labeled as Shunquanlong (Anguo) Pharmaceutical Co., Ltd., Henan Huaxia Medicinal Materials Co., Ltd., and Hubei Daodi Medicinal Materials Technology Co., Ltd. did not meet the regulations and did not comply with the regulations. The item is moisture. Moisture refers to the water content in drugs. High moisture content is usually related to factors such as improper craftsmanship, packaging, and storage and transportation environment.
After inspection by the Zhejiang Provincial Food and Drug Inspection Institute, two batches of fried wild jujube kernels labeled as produced by Beijing Heyanling Pharmaceutical Development Co., Ltd. and Liangshan Xinxin Traditional Chinese Medicine Pieces Co., Ltd. did not meet the regulations. The items that did not meet the regulations included properties, identification, Content determination.
It is reported that the properties of traditional Chinese medicine pieces do not meet the regulations, which may involve deviations in the species of medicinal materials, defects in the processing technology, improper storage, etc. The identification item is mainly used to distinguish the characteristics of the drug. Content determination refers to the determination of the content of active ingredients in raw materials and preparations using prescribed test methods.
The State Food and Drug Administration stated that for the above-mentioned non-compliant drugs, the drug regulatory department has required relevant companies and units to take risk control measures such as suspending sales and use, recalling, etc., to investigate the reasons for non-compliance, and to make practical rectifications. The State Food and Drug Administration requires relevant provincial drug regulatory authorities to organize investigations into suspected illegal activities of the above-mentioned enterprises and units in accordance with the “Drug Administration Law of the People’s Republic of China” and make the results of the investigations public in accordance with regulations.
Screenshot of the official website of the State Food and Drug Administration