Norfloxacin and its salts

Norfloxacin and its salts, antibiotic active pharmaceutical ingredient

NDPS CLEARANCE

HSN 2941 90 60 (Norfloxacin and its salts) is subject to Narcotic Drugs and Psychotropic Substances (NDPS) import certificate requirements under Chapter VII-A of the NDPS Rules, 1985, with medical and scientific-purpose imports permitted after obtaining a certificate under Rule 53 of the NDPS Rules. Imports outside the medical and scientific category are governed by Appendix-I to the ITC (HS) Schedule per ITC (HS) policy condition 2 to Chapter 29, administered by the Directorate General of Foreign Trade (DGFT). Central Board of Indirect Taxes and Customs (CBIC) mandatory Chapter 29 qualifiers in import declarations apply with effect from 15 October 2023.

What this is

HSN code

2941 90 60

Chapter

29 · Organic chemicals

Primary regulator

NDPS · NDPS Rules, 1985 (Chapter VII-A, Rule 53 import certificate)

Customs documentation

Import certificate from NDPS
Registration certificate from CDSCO
Import licence for drugs from CDSCO

Applicable Partner Government Agencies

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
Obtain an import certificate under Rule 53 of the NDPS Rules, 1985 from the Central Bureau of Narcotics (cbn.nic.in) for each consignment imported for medical or scientific purposes under Chapter VII-A of the NDPS Rules. Imports outside this category must comply with Appendix-I to the ITC (HS) Schedule per ITC (HS) policy condition 2 to Chapter 29.
Rule 53 of the NDPS Rules, 1985 · Chapter VII-A of the NDPS Rules, 1985 · ITC (HS) policy condition 2 to Chapter 29
2
Upload 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). The proper officer will verify these codes before granting out-of-charge.
CBIC e-Sanchit mandatory document codes: 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Ensure the import declaration includes the mandatory additional qualifiers for Chapter 29 commodities as stipulated in paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus dated 30-09-2023, applicable with effect from 15 October 2023. Non-compliance with the qualifier requirement delays out-of-charge and may attract a misdeclaration finding.
CBIC Circular 23/2023-Cus dated 30-09-2023, paragraphs 4.1 and 4.2

A word of counsel

The most common error on this tariff line is treating the drug registration certificate and import licence as sufficient and filing the bill of entry without the NDPS Rule 53 import certificate — a distinct instrument issued by the Central Bureau of Narcotics, not by CDSCO. An absent or expired NDPS import certificate renders the consignment liable to detention and seizure regardless of drug-licence currency; the two regulatory tracks operate independently and both must be satisfied before out-of-charge.

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Frequently asked

Does HSN 2941 90 60 require BIS certification?

No, no BIS Quality Control Order covers Norfloxacin or its salts. Import is governed by the Narcotic Drugs and Psychotropic Substances Rules, 1985 — specifically Rule 53 for the import certificate — alongside DGFT ITC (HS) policy condition 2 to Chapter 29 and CBIC Chapter 29 declaration qualifiers.

What document codes must be uploaded in e-Sanchit for this tariff line?

Five codes are mandatory: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc); all must be present before customs out-of-charge.

Can Norfloxacin be imported for purposes other than medical or scientific use?

Imports outside the medical and scientific category are not covered by Chapter VII-A of the NDPS Rules and must instead comply with Appendix-I to the ITC (HS) Schedule under ITC (HS) policy condition 2 to Chapter 29, which carries a separate and more restrictive import-authorisation pathway.

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