Famotidine
Famotidine, organic compound for pharmaceutical use
HSN 2942 00 34 (Famotidine) is subject to Central Insecticides Board and Registration Committee (CIB&RC) registration and import permit requirements under the Insecticides Act, 1968, where the substance figures in the Schedule to that Act, with restricted import ports under Rule 45 of the Insecticides Rules, 1971. Narcotic Drugs and Psychotropic Substances (NDPS) import-certificate requirements under Rule 53 of the NDPS Rules, 1985 apply as a concurrent overlay, and mandatory Chapter 29 additional qualifiers must be declared at the bill of entry per CBIC Circular 23/2023-Cus dated 30-09-2023.
- 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 Famotidine figures in 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 ports at which insecticides may be imported under Rule 45 of the Insecticides Rules, 1971.Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · ITC (HS) policy condition 2 to Chapter 29
- 2Where the substance attracts NDPS controls, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 before importation. Imports for medical and scientific purposes proceed under Chapter VII-A of the NDPS Rules, 1985; all other imports are governed by Appendix-I to the ITC (HS) Schedule.Rule 53 and Chapter VII-A of the NDPS Rules, 1985 · ITC (HS) policy condition 2 to Chapter 29
- 3Upload 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, declare the mandatory Chapter 29 additional qualifiers in the import declaration per CBIC Circular 23/2023-Cus with effect from 15-10-2023.CBIC Circular 23/2023-Cus dated 30-09-2023 · Document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
The most common error on this tariff line is treating CIB&RC registration as the only applicable PGA clearance and overlooking the independent NDPS import-certificate track. The two regimes operate in parallel: CIB&RC registration governs the insecticide-schedule angle, while the NDPS import certificate under Rule 53 of the NDPS Rules, 1985 is a separate pre-shipment obligation that customs will verify at the bill of entry regardless of CIB&RC status. Failure to upload all five e-Sanchit document codes before out-of-charge will result in consignment detention irrespective of which PGA clearances are otherwise in order.