Sulphamoxole
Sulphamoxole sulphonamide active pharmaceutical ingredient
HSN 2935 90 23 (Sulphamoxole) 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 import restricted to notified places under Rule 45 of the Insecticides Rules, 1971. Narcotic Drugs and Psychotropic Substances (NDPS) import certificate requirements under Chapter VII-A of the NDPS Rules, 1985 and the Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition 2 of Chapter 29 apply as additional overlays, alongside mandatory Chapter 29 qualifiers under Central Board of Indirect Taxes and Customs (CBIC) Circular 23/2023-Cus.
- 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.
- 1Confirm whether Sulphamoxole figures in the Schedule to the Insecticides Act, 1968. If it does, obtain both registration and an import permit from the Secretariat of the Central Insecticides Board and Registration Committee, and route the consignment only through places notified under Rule 45 of the Insecticides Rules, 1971.Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · ITC (HS) policy condition 2 of Chapter 29
- 2Upload all mandatory 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). The proper officer will verify upload before granting out-of-charge.CBIC Instruction — e-Sanchit mandatory document upload requirement (PGA-facilitated bills)
- 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, with effect from 15 October 2023. If the substance qualifies as an NDPS substance, additionally obtain an import certificate under Rule 53 of the NDPS Rules, 1985 for medical and scientific purposes, or demonstrate compliance with Appendix-I to the ITC (HS) Schedule for other categories.CBIC Circular 23/2023-Cus dated 30-09-2023 · Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition 2 of Chapter 29
The most common error on this tariff line is assuming that drug-registration documents (101dc1, 9111dc) satisfy the CIB&RC requirement when Sulphamoxole appears in the Schedule to the Insecticides Act, 1968 — the two regimes are independent, and CIB&RC registration and an import permit are required in addition to the drug-import documentation. Furthermore, importers frequently overlook that import is restricted to notified places under Rule 45 of the Insecticides Rules, 1971; consignments arriving at a non-notified port are liable to detention regardless of document completeness.