Core Viewpoint - The incident involving the addition of a controlled substance, diazepam, to a traditional Chinese medicine (TCM) product highlights significant regulatory challenges in the pharmaceutical industry, particularly regarding the classification and oversight of TCM formulations [1][2][7] Regulatory Issues - The Hebei Puzhe Medical Service Co., Ltd. is under investigation for allegedly adding diazepam, a second-class controlled substance, to its TCM product, which raises questions about compliance with existing drug regulations [1][2] - The incident underscores the need for stricter enforcement of laws governing the production and sale of TCM, particularly regarding the classification of products as hospital preparations versus approved formulations [3][4] Legal Framework - According to the Pharmaceutical Administration Law and the TCM Law, medical institutions must obtain a preparation license and approval number for any formulations that include both TCM and chemical drugs, especially those containing controlled substances [2][3] - The lack of proper licensing and the potential for misleading information during the registration process can lead to severe penalties, including fines and criminal charges for responsible parties [3][4] Health Risks - The addition of diazepam to TCM products poses significant health risks, particularly for vulnerable populations such as the elderly, who may develop dependencies on these substances [4][5] - There are documented cases of similar violations across the country, indicating a broader issue of non-compliance and the potential for serious health consequences due to improper drug combinations [4][6] Industry Implications - The incident reflects a larger trend of inappropriate combinations of TCM and Western medicine, which can complicate treatment regimens and lead to adverse drug interactions [5][6] - The need for a comprehensive approach to address these regulatory and safety issues is critical for restoring public trust in the pharmaceutical industry and ensuring patient safety [7]

Group 1 - The core issue involves allegations against Hebei Puzhe Medical and Health Service Co., Ltd. regarding the production and sale of "traditional Chinese medicine liquid" that is suspected of containing sleeping pills [1] - The market supervision administration of Qiaoxi District, Shijiazhuang, has initiated an investigation into the hospital involved in this case [1][2] - The administration emphasizes its commitment to enhancing drug safety supervision to ensure the safety of medication for the public [3]

Core Viewpoint - The article discusses the investigation into a hospital in Shijiazhuang for allegedly selling a traditional Chinese medicine for insomnia that contains the controlled substance diazepam, raising concerns about drug safety and regulatory compliance [1]. Group 1: Investigation and Regulatory Response - The Shijiazhuang Qiaoxi District Market Supervision Administration has initiated an investigation into the Hebei Puzhe Medical and Health Service Co., Ltd. for the alleged addition of sleeping pills in their herbal medicine [1]. - The administration emphasizes its commitment to enhancing drug safety supervision to protect public health [1]. Group 2: Allegations and Consumer Reports - A consumer reported that after purchasing a herbal remedy for insomnia from the hospital, they experienced drowsiness, leading to tests that confirmed the presence of diazepam [1]. - Diazepam is classified as a second-class controlled substance under the Regulations on the Administration of Psychotropic Substances, with risks of dependency and addiction associated with long-term or excessive use [1]. Group 3: Hospital's Response - The on-duty doctor at Puzhe Hospital denied the allegations of adding diazepam to their products when approached by reporters [1].