Salbutamol sulphate

Salbutamol sulphate, pharmaceutical-grade butanol derivative

CIB&RC CLEARANCE · NDPS CLEARANCE

HSN 2905 14 20 (Salbutamol sulphate) is subject to dual primary oversight: Narcotic Drugs and Psychotropic Substances (NDPS) import certificate requirements under Chapter VII-A of the NDPS Rules, 1985, and Central Insecticides Board and Registration Committee (CIB&RC) registration and permit obligations under the Insecticides Act, 1968, where the substance figures in the schedule to that Act. 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.

What this is

HSN code

2905 14 20

Chapter

29 · Organic chemicals

Primary regulator

NDPS · NDPS Rules, 1985 (Chapter VII-A) · CIB&RC · Insecticides Act, 1968

Customs documentation

Import certificate from NDPS
Registration certificate from CIB&RC
Import licence for drugs from CDSCO

Applicable Partner Government Agencies

CIB&RCCIB&RC·Central Insecticides Board and Registration Committee

NDPSNDPS·Narcotics Control Bureau

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.

Compliance steps

1
Where salbutamol sulphate is imported for medical or scientific purposes, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 as per Chapter VII-A of those Rules. Upload the certificate in e-Sanchit before filing the bill of entry; imports outside this category are governed by Appendix-I of the ITC (HS) Schedule per policy condition 2 of Chapter 29.
Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition 2 to Chapter 29
2
If the substance figures in the schedule to the Insecticides Act, 1968, obtain registration and an import permit from the Secretariat of CIB&RC before shipment. Note that the places through which insecticides may be imported are restricted; refer Rule 45 of the Insecticides Rules, 1971 for the notified ports of import.
Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971
3
Upload all mandatory e-Sanchit documents before 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). Additionally, ensure mandatory Chapter 29 additional qualifiers in the import declaration are included per CBIC Circular 23/2023-Cus with effect 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

A word of counsel

The most common error on this tariff line is treating salbutamol sulphate as a straightforward pharmaceutical import and overlooking the NDPS overlay: the medical-use carve-out under Chapter VII-A is not automatic — a valid import certificate under Rule 53 of the NDPS Rules, 1985 must be in hand before the consignment is dispatched. Presenting only the drug Registration Certificate (101dc1) and Import Licence (9111dc) without the NDPS import certificate will result in consignment detention pending NDPS clearance, attracting demurrage and potential ground rent at the port.

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Frequently asked

Does HSN 2905 14 20 require BIS certification?

No. Salbutamol sulphate is not within any BIS Quality Control Order regime. Import is governed by the NDPS Rules, 1985 (Chapter VII-A import certificate under Rule 53) and, where the substance falls within the schedule to the Insecticides Act, 1968, by Central Insecticides Board and Registration Committee registration and permit requirements.

Which e-Sanchit documents are mandatory at the bill of entry for this tariff line?

Five documents must be uploaded in e-Sanchit before 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); absence of any one document will prevent the proper officer from granting out-of-charge.

Does the Public Liability Insurance Act, 1991 apply to imports of salbutamol sulphate?

Yes, where imports of specified hazardous substances exceed the quantities prescribed under S.O. 227(E) dated 24-03-1992 issued by the Ministry of Environment and Forests, the owner must take out an insurance policy as per the provisions of the Public Liability Insurance Act, 1991.

Last verified against gazette notifications: 2026-05-16. Source: CIB&RC / NDPS / DGFT / CBIC / Indian Customs CUSDATA.