Dept Of Revenue Notifies 4 New Synthetic Opioid Substances As Manufactured Drugs

New Delhi: The Department of Revenue has notified four synthetic opioid substances as manufactured drugs and three other substances as psychotropic substances under the Narcotic Drugs and Psychotropic Substances Act, 1985. The Department also notified the small quantity and commercial quantity of these substances, as part of bringing them under the provisions of the Act.

The Department through a notification has declared the substances, salts and preparations thereof of 2-Methyl-AP-237, etazene, etonitazepyne, and protonitazene to be manufactured drugs under the Act.

According to the Act, manufactured drug means all coca derivatives, medicinal cannabis, opium derivatives and poppy straw concentrate and any other narcotic substance or preparation which the Central Government may notify.

2-Methyl-AP-237 is a novel synthetic drug with opioid agonist-like activity and according to US Drug Enforcement Administration, the substance emerged on the illicit synthetic drug market from 2019, resulting in adverse health effects including death. The substance is an analogue of buccinnazine (AP-237), an opioid used therapeutically in countries like China as an analgesic for cancer patients.

Etazene, also known as etodesnitazene, is a benzimidazole-derived synthetic opioid with a chemical structure and pharmacological similarities to drugs under Schedule I (under the 1961 United Nations Conventions) such as clonitazene, etonitazene and isotonitazene, according to the World Health Organisation (WHO). It has a higher potency at the opioid receptors than morphine, but less than fentanyl, it says.

Etonitazepyne, according to the WHO, is a benzimidazole-derived synthetic opioid with a chemical structure and pharmacological similarities to Schedule I drugs (under the 1961 United Nations Conventions) such as etonitazene. In critical review reports released by the WHO in October, 2022, it said that no medical use of these drugs were identified.

Another critical review of the WHO during the time said, “Protonitazene and several other “nitazenes” or benzimidazole-subclass opioids were first synthesized in the late 1950s by a Swiss chemical company as novel opioid alternatives to morphine. Although they were found to have potent analgesic effects, clinical development of benzimidazole opioids was abandoned because of an increased risk of adverse events. Currently, no drugs in this class are approved for medicinal use”.

In another notification, the Department declared ADB-Butinaca, a synthetic cannabinoid compound, Alpha-PiHP, a synthetic cathinone that is known as a psychomotor stimulant, and 3-Methylmethcathinone, also known as 3-MMC, a synthetic cathinone which is believed to be first appeared a few decades back and has become one of the substances that has been smuggled illicitly for misuse across the markets. These drugs, labelled as novel psychoactive substances, have been in the radar of narcotic substances control agencies across the regulated markets in the recent past.

The Department also issued another notification specifying the small quantity, which is grams, and the commercial quantity in grams and kilograms, in order to bring better regulatory structure for the monitoring against misuse of these drugs.

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