Food and Drug Safety Administration newly designates 7 substances as 'narcotics' to prevent misuse

[Financial News] The Ministry of Food and Drug Safety has newly designated a total of 7 substances, including the general anesthesia inducer 'Etomidate', as 'narcotics'. The Ministry of Food and Drug Safety announced on the 12th the revision and promulgation of the Enforcement Decree of the Narcotics Control Act for the designation of new narcotics.
This revision is a measure to preemptively block the illegal distribution and administration of pharmaceuticals with high potential for misuse and to reflect the international regulatory standards of the United Nations (UN) Commission on Narcotic Drugs (CND) domestically.
The 7 substances newly designated as narcotics include Etomidate and Lemborexant, which have been recognized by the Domestic Narcotics Safety Management Deliberation Committee as requiring management as psychotropic drugs, and 4 narcotics designated by the UN CND, including N-Pyrrolidino Protonitazen, as well as the psychotropic drug Hexahydrocannabinol.
Among them, Etomidate is particularly noteworthy as it has been managed as a 'drug of concern for misuse' since 2020 as a drug that induces general anesthesia.
However, even after that, cases of illegal administration or misuse of Etomidate as an alternative drug to Propofol, which is designated as a narcotic, have continued to occur in some medical institutions, leading to ongoing social controversy.
The Ministry of Food and Drug Safety stated that since Propofol will be prohibited from self-prescription by doctors from February 2025, they have proactively decided to designate it as a narcotic to prevent the spread of illegal administration for similar purposes.
When Etomidate is designated as a narcotic, an obligation to report handling is imposed throughout the entire process of import, manufacture, distribution, and administration of pharmaceuticals, enabling the government to monitor in real-time. This is expected to have a significant deterrent effect on illegal activities by quickly detecting and investigating abnormal distribution or administration patterns.
However, since Etomidate is also used in legitimate medical settings, the Ministry of Food and Drug Safety plans to closely cooperate with importers to ensure that there are no supply disruptions. They plan to coordinate to ensure that medical institutions can stably receive the necessary pharmaceuticals during the implementation of this designation.
Etomidate has not yet been designated as a narcotic in major countries such as the United States, United Kingdom, France, and Japan. The Ministry of Food and Drug Safety's decision is a preemptive regulation ahead of international standards.
Oh Yu-gyeong, Director of the Ministry of Food and Drug Safety, stated, "We have pursued this designation with the highest priority on public health and safety," and added, "We will continue to strengthen narcotics management policies by comprehensively reflecting international trends and domestic situations."

vrdw88@fnnews.com Kang Jung-mo Reporter