The general anesthetic induction agent "etomidate" has been newly designated as a controlled substance. Consequently, management in medical settings will be significantly strengthened starting next year.
The Ministry of Food and Drug Safety noted on the 12th that it will amend and announce a revision of the Enforcement Decree of the Narcotics Control Act, designating a total of seven substances as controlled substances, including those substances subject to misuse concerns and those designated by the 68th United Nations Commission on Narcotic Drugs (CND).
Two substances, including etomidate and lemborexant, which were determined to require management as psychotropic drugs by the Narcotics Safety Management Advisory Committee, along with five substances designated as controlled substances by the UN, have been classified as narcotics.
The general anesthetic induction agent etomidate has been designated and managed as a substance of concern for misuse since 2020. However, issues of illegal administration and misuse as a substitute for propofol in some medical institutions have continued, leading to its classification as a controlled substance.
Controlled substances must be reported at all stages, from importation to administration.
The government can monitor in real time and will conduct prompt investigations and crackdowns if misuse concerns are detected. The Ministry of Food and Drug Safety expects that this will suppress illegal distribution and administration.
Meanwhile, there have been opposing opinions within the medical community regarding the classification of etomidate as a controlled substance. The reasoning is that there is insufficient scientific and clinical evidence to classify it as such. Major countries including the United States, the United Kingdom, France, and Japan also do not classify it as a controlled substance.