Recently, the National Medical Products Administration (NMPA) and the National Health Commission (NHC) have jointly issued the Circular on Strengthening the Management of Dextromethorphan and Other Drugs (the "Circular").
The Circular specifies that, according to the Announcement of the National Medical Products Administration, the Ministry of Public Security, and the National Health Commission on Adjusting the Catalog of Psychotropic Drugs, dextromethorphan (DXM) (including salts and single preparations, the same below), nalfurafine (including salts, isomers, and single preparations, the same below), lorcaserin (including salts, isomers, and single preparations, the same below), and difenoxin-containing compound preparations will be included in the Category II of psychotropic drugs catalog from July 1, 2024. While midazolam API (including salts and isomers, the same below) and injections will be adjusted from Category II to Category I of psychotropic drugs catalog. Furthermore, the Circular clarifies that from July 1, enterprises without the requisite qualifications for designated manufacturing of specified varieties or production and demand plans are prohibited from manufacturing DXM, nalfurafine, lorcaserin, difenoxin-containing compound preparations, midazolam API and injections. Moreover, the manufacturing of the said varieties shall not be commissioned.