Ibuprofane
Ibuprofen bulk drug substance, organic chemical compound
HSN 2942 00 12 (Ibuprofen) is subject to dual primary-regulator oversight: the Central Insecticides Board and Registration Committee (CIB&RC) exercises registration and permit authority under the Insecticides Act, 1968, where the substance figures in the Insecticides Schedule, and the Narcotic Drugs and Psychotropic Substances (NDPS) regime under Chapter VII-A of the NDPS Rules, 1985 governs any NDPS-categorised quantities. The 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 policy overlays requiring mandatory Chapter 29 qualifiers in the import declaration.
- Registration certificate from CIB&RC
- Import certificate from NDPS
- 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.
- 1Determine whether the imported substance falls within the Schedule to the Insecticides Act, 1968. If so, obtain registration and an import permit from the Secretariat of CIB&RC and route the consignment exclusively through ports notified under Rule 45 of the Insecticides Rules, 1971; import at any non-notified port is unlawful.Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · ITC (HS) policy condition 2 of Chapter 29
- 2If the consignment is imported for medical or scientific purposes under the NDPS regime, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 before shipment. Imports outside that 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
- 3Upload 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). Additionally, include the Chapter 29 mandatory qualifiers in the import declaration as required from 15-10-2023.CBIC Circular 23/2023-Cus dated 30-09-2023, Para 4.1 and 4.2 · e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
The most common error on this tariff line is assuming the drug-registration documents (101dc1, 9111dc) satisfy the full clearance obligation and overlooking the CIB&RC permit when the substance falls within the Insecticides Schedule — these are independent regimes and a CIB&RC-scheduled substance imported without the pesticide registration and permit is liable to seizure under the Insecticides Act, 1968 regardless of the drug-import documentation being current. Additionally, importers with consignments of specified hazardous substances exceeding the thresholds under S.O. 227(E) dated 24-03-1992 must hold a public liability insurance policy before clearance.