Sulphamethoxazole
Sulphamethoxazole sulphonamide bulk drug substance
HSN 2935 90 11 (Sulphamethoxazole) 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 locations under Rule 45 of the Insecticides Rules, 1971. Narcotic Drugs and Psychotropic Substances (NDPS) rules apply under Chapter VII-A of the NDPS Rules, 1985 where the substance falls within that schedule, and DGFT ITC (HS) policy condition 2 of Chapter 29 governs the residual import framework.
- Registration certificate from CIB&RC
- Import permit from CIB&RC
- Import certificate from NDPS
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.
- 1Confirm whether the consignment falls within the Schedule to the Insecticides Act, 1968; if so, obtain registration and an import permit from the secretariat of the Central Insecticides Board and Registration Committee before shipment. Route the consignment only through locations notified under Rule 45 of the Insecticides Rules, 1971, as import at non-notified points renders the consignment liable to seizure.Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · ITC (HS) policy condition 2 of Chapter 29
- 2If the substance is scheduled under the NDPS regime, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 before filing the bill of entry. Imports for purposes other than medical and scientific use are governed by Appendix I to the ITC (HS) Schedule and require DGFT clearance under ITC (HS) policy condition 2 of Chapter 29.Chapter VII-A of the NDPS Rules, 1985 · Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition 2 to Chapter 29
- 3Upload mandatory documents in e-Sanchit before out-of-charge: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). Ensure Chapter 29 mandatory additional qualifiers are declared in the import entry per CBIC Circular 23/2023-Cus dated 30-09-2023, operative from 15 October 2023.CBIC Circular 23/2023-Cus dated 30-09-2023 · e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
The most common error on this tariff line is treating the drug-regime document set (certificate of analysis, batch release, import licence for drugs) as exhaustive and overlooking the parallel CIB&RC registration obligation where the substance is scheduled under the Insecticides Act, 1968. Both regimes are independently operative; a consignment cleared by CDSCO-linked documentation but lacking CIB&RC registration and a Rule 45-notified port of import is liable to detention and confiscation under the Insecticides Act regardless of drug-licence compliance. Verify schedule status under both Acts before placing the purchase order.