Albendazole
Albendazole, anthelmintic active pharmaceutical ingredient
HSN 2933 29 50 (Albendazole) is subject to Central Insecticides Board and Registration Committee (CIB&RC) registration and import permit under the Insecticides Act, 1968, where the substance figures in the Schedule to that Act, with port-of-import restricted to places notified under Rule 45 of the Insecticides Rules, 1971. Narcotic Drugs and Psychotropic Substances (NDPS) import-certificate conditions under Chapter VII-A of the NDPS Rules, 1985 and Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition No. 2 to Chapter 29 apply as additional clearance requirements.
- Registration certificate from CIB&RC
- Import permit 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 registration and an import permit from the Secretariat of the Central Insecticides Board and Registration Committee before shipment, where Albendazole figures in the Schedule to the Insecticides Act, 1968. Route the consignment only through a port notified under Rule 45 of the Insecticides Rules, 1971; import through an unnotified port is prohibited.Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · ITC (HS) policy condition No. 2 to Chapter 29
- 2Upload all mandatory documents in e-Sanchit before filing the bill of entry: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). The proper officer will verify these uploads before granting out-of-charge.CBIC e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc · ITC (HS) policy condition No. 2 to Chapter 29
- 3Include mandatory additional qualifiers in the import declaration for Chapter 29 commodities as stipulated in paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus dated 30-09-2023, with effect from 15 October 2023. Where the substance falls under NDPS Schedule provisions, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 for medical or scientific-purpose imports per Chapter VII-A.CBIC Circular 23/2023-Cus dated 30-09-2023 · Rule 53 of the NDPS Rules, 1985 · Appendix-I to ITC (HS) Schedule
The most common error on this tariff line is conflating the drug-registration documents (101dc1, 9111dc) with the CIB&RC insecticide-registration requirement — these are parallel obligations that apply independently depending on the end-use classification of the consignment. Albendazole's dual characterisation as an anthelmintic pharmaceutical and a potential scheduled insecticide means both the CDSCO drug pathway and the CIB&RC pesticide pathway can be triggered simultaneously, and a consignment cleared under only one regime remains non-compliant under the other. Additionally, the public-liability insurance obligation under S.O. 227(E) dated 24-03-1992 applies when the imported quantity of the specified hazardous substance exceeds the notified threshold.