Gentamycin and its salts

Gentamicin and its salts, aminoglycoside antibiotics

NDPS CLEARANCE

HSN 2941 90 40 (Gentamycin and its salts) is subject to Narcotic Drugs and Psychotropic Substances (NDPS) import controls under Chapter VII-A of the NDPS Rules, 1985, requiring an import certificate under Rule 53 before shipment. The Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition 2 of Chapter 29 governs imports outside the medical and scientific purpose track, and Central Board of Indirect Taxes and Customs (CBIC) Circular 23/2023-Cus mandates additional Chapter 29 qualifiers in the import declaration with effect from 15 October 2023.

What this is

HSN code

2941 90 40

Chapter

29 · Organic chemicals

Primary regulator

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

Customs documentation

Import certificate from NDPS
Import licence for drugs from CDSCO
Registration certificate 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) before shipment. This certificate is mandatory for imports of NDPS substances for medical and scientific purposes under Chapter VII-A of the NDPS Rules, and must be uploaded in e-Sanchit before the bill of entry is filed.
Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition 2 of Chapter 29
2
Upload all five mandatory documents 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). Consignments on PGA-facilitated bills must be verified by the proper officer for these uploads before out-of-charge is granted.
CCR document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc · CBIC e-Sanchit mandatory-document requirement
3
Include the mandatory additional qualifiers in the import declaration for Chapter 29 commodities as stipulated in paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus, operative from 15 October 2023. Declarations filed without the required Chapter 29 qualifiers are liable to detention at assessment.
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 drugs-registration track (CDSCO import licence and registration certificate) as the sole compliance requirement and overlooking the independent NDPS import certificate under Rule 53 of the NDPS Rules, 1985. These are two parallel and non-substitutable clearances: a current CDSCO import licence does not discharge the NDPS obligation, and a consignment presented without a valid Rule 53 certificate is liable to seizure under the NDPS Act, 1985 regardless of drug-registration status.

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Frequently asked

Does HSN 2941 90 40 require BIS certification?

No, gentamycin and its salts are not covered by any BIS Quality Control Order. Import is governed by the Narcotic Drugs and Psychotropic Substances regime under Rule 53 of the NDPS Rules, 1985, with the DGFT ITC (HS) policy condition 2 of Chapter 29 and the CDSCO drug-registration overlay applying concurrently.

Which document codes must be uploaded in e-Sanchit at the bill of entry for this tariff line?

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

What governs imports of gentamycin that fall outside the medical and scientific purpose track?

Imports outside the medical and scientific purpose category are governed by Appendix-I to the ITC (HS) Schedule, as referenced under ITC (HS) policy condition 2 of Chapter 29, administered by the Directorate General of Foreign Trade.

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