Strict control! , State Drug Administration: 13 newly listed narcotic drugs
The reporter learned from the National Medical Products Administration today that the special inspection of psychotropic drugs being carried out nationwide focuses on the management of newly listed varieties such as etomidate and dextromethorphan since 2023. In addition, the National Medical Products Administration, together with relevant departments, has added 13 varieties such as etomidate, dextromethorphan, and compound preparations containing tramadol to the list of narcotic drugs for strict control to curb the spread of drug abuse.
Narcotic drugs and psychotropic drugs are mainly used in the treatment of pain, insomnia and other diseases in clinical practice, and are indispensable in medical practice; however, use for non-medical purposes can lead to addiction in users, and may also cause public health and social problems. In recent years, as my country's people's war on drug control has deepened, it has become more difficult to obtain traditional drugs, and the risk of narcotic drugs for medical use flowing into illegal channels and being abused has increased. In response to the new situation facing regulatory work, the State Food and Drug Administration has continued to strengthen supervision and management, innovate regulatory methods, effectively guarantee the medical demand for narcotic drugs, and resolutely curb the flow of narcotic drugs into illegal channels and abuse.
The State Food and Drug Administration has established and improved management systems and implemented key supervision over production and operation enterprises.
Implement designated management on production and operation enterprises, requiring them to have the ability and conditions to ensure the quality and management safety of narcotic drugs;
The production volume is managed by plan, and the production plan is adjusted in a timely manner according to changes in medical needs;
It is circulated through fixed channels and supplied to medical institutions after being wholesaled at the second level by national and regional wholesale enterprises.
Drug regulatory authorities organize full-coverage inspections of narcotic drug production and operation enterprises according to risk levels, and promptly identify and eliminate potential safety risks. With a problem-oriented approach, special inspections and cause-based inspections are organized to severely investigate and punish illegal and irregular behaviors.
In 2023, a special inspection of narcotic drugs was deployed, and a comprehensive inspection of the safety management of 2,833 narcotic drug production and operation enterprises was carried out. 827 enterprises were ordered to rectify, 11 were investigated and punished, and 95 clues were transferred to relevant departments. In addition, 12 enterprises were inspected for cause. Special inspections of psychotropic drugs are currently being organized, focusing on the management of newly listed varieties such as etomidate and dextromethorphan since 2023.
At the same time, the State Food and Drug Administration actively promoted the construction of an information-based traceability system for narcotic drugs and established a national drug traceability supervision system, covering all narcotic drug production and operation companies, achieving coding of all narcotic drug minimum packaging production lines, dynamic monitoring of the entire flow, and timely warning of malpractice risks, to further improve the effectiveness of narcotic drug supervision.
In addition, the State Food and Drug Administration closely monitors changes in drug abuse, and promptly organizes feasibility assessments and demonstrations on the listing of drugs with prominent abuse problems. It works with relevant departments to add 13 drugs, including etomidate, dextromethorphan, and tramadol-containing compound preparations, to the catalogue of narcotic drugs for strict control, in an effort to curb the spread of drug abuse.
The State Food and Drug Administration reminds the public that the abuse of narcotic drugs can lead to addiction in users. Please use narcotic drugs reasonably under the guidance of a doctor and stay away from drug abuse.
