Atenolol, propronalol
Atenolol and propranolol beta-blocker active pharmaceutical ingredients
HSN 2942 00 27 (Atenolol, propranolol) is subject to Central Drugs Standard Control Organisation drug-registration and import-licence requirements and, where any substance in the consignment figures in the Schedule to the Insecticide Act, 1968, registration and import permit from the Central Insecticides Board and Registration Committee (CIB&RC) under Rule 45 of the Insecticides Rules, 1971. The Narcotic Drugs and Psychotropic Substances (NDPS) regime applies to any scheduled substance within this tariff line, permitting import only under a certificate obtained under Rule 53 of the NDPS Rules, 1985, with Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition 2 of Chapter 29 governing all other cases.
- Registration certificate from CIB&RC
- Import certificate from NDPS
- 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.
- 1If the consignment contains any substance scheduled under the Insecticide Act, 1968, obtain registration and an import permit from the secretariat of the Central Insecticides Board and Registration Committee. Import is restricted to ports specified under Rule 45 of the Insecticides Rules, 1971; routing through an unspecified port is unlawful regardless of permit validity.Insecticide Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · ITC (HS) policy condition 2 to Chapter 29
- 2Where atenolol or propranolol is classified as an NDPS-scheduled substance, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 before shipment. Imports for medical and scientific purposes are governed by Chapter VII-A of the NDPS Rules, 1985; all other imports are governed by Appendix I to the ITC (HS) Schedule.Chapter VII-A and Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition 2 to Chapter 29
- 3Upload all mandatory drug 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). Also comply with CBIC Circular 23/2023-Cus dated 30-09-2023 by including mandatory additional qualifiers in the import declaration for Chapter 29 commodities, effective 15-10-2023.CBIC Circular 23/2023-Cus dated 30-09-2023 · e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
The most common error on this tariff line is assuming that the drug-import-licence and e-Sanchit document package is the complete compliance obligation, while overlooking that the same consignment may independently trigger the CIB&RC permit requirement if any component figures in the Schedule to the Insecticide Act, 1968, and the NDPS certificate requirement if any substance is psychotropically scheduled — both operating as concurrent, independent obligations. A consignment that is cleared on drug documents alone but carries a scheduled insecticide or NDPS substance is liable to seizure and prosecution under the respective Acts notwithstanding customs out-of-charge.