Domperidone
Domperidone, an oxygen-function amino-compound active pharmaceutical ingredient
HSN 2922 50 24 (Domperidone) is subject to Central Board of Indirect Taxes and Customs (CBIC) drug-document verification requirements at the bill of entry, with mandatory e-Sanchit upload of five document codes, and is additionally governed by Narcotic Drugs and Psychotropic Substances (NDPS) Rules, 1985 import certificate conditions under Chapter VII-A. Central Insecticides Board and Registration Committee (CIB&RC) registration and permit apply where Domperidone figures in the Schedule to the Insecticides Act, 1968, and the Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition 2 of Chapter 29 applies as the overarching import-policy overlay.
- Import certificate from NDPS
- Registration certificate from CIB&RC
- Import licence for drugs from CBIC
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.
- 1Where Domperidone is imported for medical or scientific purposes, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 (Chapter VII-A). For all other imports, comply with Appendix-I to the ITC (HS) Schedule as directed by ITC (HS) policy condition 2 of Chapter 29.NDPS Rules, 1985 · Rule 53 · ITC (HS) policy condition 2 of Chapter 29
- 2Upload all five mandatory drug-import documents in e-Sanchit before filing the bill of entry: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). Customs out-of-charge will not be granted until all five codes are verified.CBIC CCR mandatory-document requirement · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
- 3Ensure the bill of entry includes the mandatory Chapter 29 additional qualifiers in the import declaration as required by CBIC Circular 23/2023-Cus dated 30-09-2023, with effect from 15 October 2023. Where Domperidone falls within the Schedule to the Insecticides Act, 1968, confirm CIB&RC registration and import permit, noting that the places of import for insecticides are restricted under Rule 45 of the Insecticides Rules, 1971.CBIC Circular 23/2023-Cus dated 30-09-2023 · Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971
The most common error on this tariff line is treating Domperidone solely as a pharmaceutical drug entry and overlooking the parallel CIB&RC insecticide-schedule check: if the specific formulation figures in the Schedule to the Insecticides Act, 1968, registration and a port-restricted import permit from CIB&RC are independently required, and arrival at an unrestricted port will result in consignment detention regardless of NDPS and drug-licence compliance. Additionally, importers who exceed specified hazardous-substance quantities must take out an insurance policy under the Public Liability Insurance Act, 1991 per S.O. 227(E) dated 24-03-1992 — a requirement that is frequently missed at the documentation stage.