Imipramine HCl
Imipramine hydrochloride, tricyclic antidepressant drug substance
HSN 2942 00 24 (Imipramine HCl) is subject to dual primary regulation: the Narcotic Drugs and Psychotropic Substances (NDPS) Rules, 1985 govern import under Chapter VII-A for medical and scientific purposes, requiring an import certificate under Rule 53, while the Central Insecticides Board and Registration Committee (CIB&RC) regime under the Insecticides Act, 1968 applies if this substance figures in the Schedule to that Act. The Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition 2 of Chapter 29 and mandatory Chapter 29 qualifiers under CBIC Circular 23/2023-Cus dated 30-09-2023 apply as additional clearance requirements.
- Import certificate from NDPS
- Registration certificate from CIB&RC
- Chapter 29 qualifiers from CBIC
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.
- 1Obtain an import certificate under Rule 53 of the NDPS Rules, 1985 for imports of Imipramine HCl for medical or scientific purposes as specified under Chapter VII-A. Imports outside this category are governed by Appendix-I to the ITC (HS) Schedule per ITC (HS) policy condition 2 of Chapter 29 and are subject to DGFT authorisation.NDPS Rules, 1985 — Rule 53, Chapter VII-A; ITC (HS) policy condition 2, Chapter 29
- 2If the substance figures in the Schedule to the Insecticides Act, 1968, obtain registration and an import permit from the secretariat of CIB&RC before shipment. Note that ports at which insecticides may be imported are restricted under Rule 45 of the Insecticides Rules, 1971.Insecticides Act, 1968; Rule 45 of the Insecticides Rules, 1971
- 3Upload all mandatory documents in e-Sanchit at the bill of entry: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc). Also ensure mandatory Chapter 29 additional qualifiers are included 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; e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
The most common error on this tariff line is treating the NDPS import certificate and the drug-registration documents as mutually exclusive tracks. Imipramine HCl is a psychotropic substance and a listed drug substance simultaneously — customs will verify both the NDPS Rule 53 import certificate and the drug registration documents (101dc1 and 9111dc) in e-Sanchit before granting out-of-charge. A consignment carrying only the drug-channel documents but lacking the NDPS import certificate will be detained, attracting demurrage and potential confiscation under the NDPS Act, 1985.