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]