Loprazolam (INN), mecloqualone (INN), methaqualone (INN) and zipeprol (INN);salts thereof

Loprazolam, mecloqualone, methaqualone, zipeprol and salts thereof

HSN 2933 55 00 (Loprazolam, mecloqualone, methaqualone and zipeprol; salts thereof) is subject to dual primary regulation: import for medical or scientific use requires an import certificate from the Narcotics Commissioner, Gwalior under the Narcotic Drugs and Psychotropic Substances (NDPS) Rules, 1985, Chapter VII-A, while items falling within the Schedule to the Insecticides Act, 1968 additionally require registration and an import permit from the Central Insecticides Board and Registration Committee (CIB&RC) under Rule 45 of the Insecticides Rules, 1971. Import is otherwise free subject to Policy Condition No. 3 to Chapter 29 of the ITC (HS) administered by the Directorate General of Foreign Trade (DGFT), and CBIC mandatory Chapter 29 additional qualifiers apply at the bill-of-entry stage.

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.

1. 1
   Obtain an import certificate from the Narcotics Commissioner, Gwalior before shipment for any import intended for medical or scientific use under Chapter VII-A of the NDPS Rules, 1985. Imports for other uses must comply with Appendix-I of the ITC (HS) Schedule and Policy Condition No. 2 to Chapter 29; confirm the applicable use-category before filing.
   NDPS Rules, 1985, Chapter VII-A · ITC (HS) Policy Condition No. 3 to Chapter 29 · DGFT Notification 39/2015-2020 dated 03-10-2018
2. 2
   If the substance falls within the Schedule to the Insecticides Act, 1968, obtain registration and an import permit from the secretariat of CIB&RC before import. The consignment must enter only through ports notified under Rule 45 of the Insecticides Rules, 1971; diversion to any non-notified port renders the consignment liable to seizure.
   Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971
3. 3
   Upload in e-Sanchit the Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate (Drugs) (101dc1) and Import Licence for Drugs (9111dc) before customs out-of-charge. Also ensure mandatory Chapter 29 additional qualifiers are declared in the import declaration per CBIC Circular 23/2023-Cus, operative from 15 October 2023.
   CBIC Circular 23/2023-Cus dated 30-09-2023, Para 4.1 and 4.2