Terbutoline sulphate
Terbutaline sulphate, organic pharmaceutical compound
HSN 2942 00 22 (Terbutaline sulphate) is subject to dual primary-regulator oversight: the Central Insecticides Board and Registration Committee (CIB&RC) requires registration and an import permit under the Insecticides Act, 1968 where the substance figures in its Schedule, and the Narcotic Drugs and Psychotropic Substances (NDPS) regime governs import for medical and scientific purposes under Chapter VII-A of the NDPS Rules, 1985. Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition 2 of Chapter 29 and Central Board of Indirect Taxes and Customs (CBIC) Circular 23/2023-Cus dated 30-09-2023 apply as additional customs-layer requirements.
- 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.
- 1Verify whether Terbutaline sulphate figures in the Schedule to the Insecticides Act, 1968; if so, obtain a registration certificate and import permit from the secretariat of the Central Insecticides Board and Registration Committee before shipment. Import is permitted only through the restricted places specified 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
- 2Where the substance is being imported for medical or scientific purposes under the NDPS regime, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 (details at http://cbn.nic.in). Imports outside the medical/scientific category are governed by Appendix-I to the ITC (HS) Schedule.Chapter VII-A of the NDPS Rules, 1985 · Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition 2 of Chapter 29
- 3Before filing the bill of entry, upload all mandatory documents in e-Sanchit: certificate of analysis — drug (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc). Ensure Chapter 29 mandatory additional qualifiers are included in the import declaration per CBIC Circular 23/2023-Cus dated 30-09-2023, operative from 15-10-2023.CBIC Circular 23/2023-Cus dated 30-09-2023, Para 4.1 and 4.2
The most common error on this tariff line is treating the drug-regime e-Sanchit document set (0010dc, 0030dc, 0110dc, 101dc1, 9111dc) as the complete clearance and overlooking the independent CIB&RC registration and port-restriction requirement under Rule 45 of the Insecticides Rules, 1971. Where Terbutaline sulphate is scheduled under the Insecticides Act, 1968, absent CIB&RC registration converts the consignment into an unlawful import regardless of drug-licence validity, exposing the importer to detention and seizure at a non-notified port of entry.