Frusemide
Frusemide, amino-compounds with oxygen function
HSN 2922 50 21 (Frusemide) is subject to dual primary regulation: import as a drug requires registration and an import licence under the Drugs and Cosmetics Act framework enforced at the bill-of-entry stage, while any classification of this substance under the Schedule to the Insecticides Act, 1968 triggers registration and a permit from the Central Insecticides Board and Registration Committee (CIB&RC) under the Insecticides Rules, 1971. Narcotic Drugs and Psychotropic Substances (NDPS) rules apply where the substance falls within the NDPS framework, and Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition 2 of Chapter 29 governs residual import controls.
- Registration certificate from CIB&RC
- Import licence for drugs from CDSCO
- Certificate of analysis from drug supplier
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 under the Schedule to the Insecticides Act, 1968; if so, obtain registration and an import permit from the secretariat of CIB&RC before shipment. Importation of scheduled insecticides is restricted to places notified under Rule 45 of the Insecticides Rules, 1971 — diversion to an unnotified port renders the consignment liable to seizure.Insecticides Act, 1968 (Schedule) · Rule 45 of the Insecticides Rules, 1971 · ITC (HS) policy condition 2 of Chapter 29
- 2If importing for medical or scientific purposes under the NDPS framework, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 via Chapter VII-A of those Rules before the bill of entry is filed. Imports outside the medical/scientific category are governed by Appendix-I to the ITC (HS) Schedule.Rule 53 of the NDPS Rules, 1985 · Chapter VII-A of the NDPS Rules, 1985 · ITC (HS) policy condition 2 of Chapter 29
- 3Upload all mandatory e-Sanchit documents before customs 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). Also ensure compliance with CBIC Circular 23/2023-Cus dated 30-09-2023 for mandatory Chapter 29 additional qualifiers in the import declaration, effective 15 October 2023.CBIC Circular 23/2023-Cus dated 30-09-2023 (Para 4.1 and 4.2) · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
The most common error on this tariff line is treating Frusemide as a pure pharmaceutical import and overlooking the CIB&RC and NDPS overlays. Where the substance is scheduled under the Insecticides Act, 1968, the drug-import document set alone is insufficient — a separate CIB&RC permit and notified-port compliance under Rule 45 of the Insecticides Rules, 1971 are independently required, and failure to produce either results in consignment detention and potential confiscation irrespective of the drug registration being current. Verify the applicable schedule classification with the exporter before purchase-order finalisation.