Sulphacetamide
Sulphacetamide, a sulphonamide active pharmaceutical ingredient
HSN 2935 90 15 (Sulphacetamide) 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. The Narcotic Drugs and Psychotropic Substances (NDPS) regime under Chapter VII-A of the NDPS Rules, 1985 applies as a concurrent overlay, and the Directorate General of Foreign Trade (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 licence for drugs from CDSCO
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.
- 1Determine whether the consignment falls within the Schedule to the Insecticides Act, 1968. If so, obtain registration and an import permit from the Secretariat of CIB&RC before shipment, and ensure import is routed 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 (document code 0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). Consignments PGA-facilitated outside the NOC routing must have all five documents verified by the proper officer before out-of-charge.CBIC e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
- 3Include the mandatory Chapter 29 additional qualifiers in the import declaration in accordance with CBIC Circular 23/2023-Cus dated 30-09-2023, as stipulated in paragraphs 4.1 and 4.2, with effect from 15 October 2023. If the substance is imported as an NDPS for medical or scientific purposes, obtain an import certificate under Rule 53 of the NDPS Rules, 1985.CBIC Circular 23/2023-Cus dated 30-09-2023 · Rule 53 of the NDPS Rules, 1985 · Chapter VII-A of the NDPS Rules, 1985
The most prevalent error on this tariff line is treating the drug-import documentation set (Registration Certificate, Import Licence for Drugs) as exhaustive and overlooking the CIB&RC registration and notified-port obligation where the substance is scheduled under the Insecticides Act, 1968. A consignment arriving at an unnotified place of import is liable to detention and seizure regardless of FSSAI or drug-import licence currency. Verify the CIB&RC schedule applicability and the permissible import locations before booking freight.