Erythromycin and its derivatives; salts thereof

Erythromycin and its derivatives, salts thereof

NDPS CLEARANCE

HSN 2941 50 00 (Erythromycin and its derivatives; salts thereof) is subject to Narcotic Drugs and Psychotropic Substances (NDPS) import certificate requirements under Chapter VII-A of the NDPS Rules, 1985, and to the ITC (HS) Restricted-import policy administered by the Directorate General of Foreign Trade (DGFT). Drug registration certificate, import licence, batch release certificate, and Certificate of Analysis must be uploaded in e-Sanchit, with mandatory Chapter 29 additional qualifiers in the import declaration as required by Central Board of Indirect Taxes and Customs (CBIC) Circular 23/2023-Cus.

What this is

HSN code

2941 50 00

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 covers import for medical and scientific purposes under Chapter VII-A of the NDPS Rules; imports outside this category are governed by Appendix-I to the ITC (HS) Schedule under ITC (HS) policy condition 2 to Chapter 29.
Rule 53, Chapter VII-A of the NDPS Rules, 1985 · ITC (HS) policy condition 2 to Chapter 29
2
Upload all mandatory documents in e-Sanchit prior to 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). Customs out-of-charge will not be granted until all five documents are verified in e-Sanchit.
CBIC e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Ensure mandatory additional qualifiers for Chapter 29 commodities are included in the import declaration in accordance with paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus, with effect from 15 October 2023. Missing qualifiers attract consignment detention pending a revised declaration.
CBIC Circular 23/2023-Cus dated 30-09-2023, paras 4.1 and 4.2

A word of counsel

The most common error on this tariff line is treating the drug import licence (9111dc) as the sole NDPS gateway and overlooking the separate import certificate required under Rule 53 of the NDPS Rules, 1985. These are distinct authorisations: the drug import licence is a pharmaceutical-regime document, while the NDPS import certificate is issued by the Central Bureau of Narcotics under narcotics-control law. Arriving at customs with one but not the other results in detention and referral to the Central Bureau of Narcotics for adjudication.

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Frequently asked

Does HSN 2941 50 00 require BIS certification?

No, erythromycin and its derivatives fall outside the BIS Quality Control Order regime; no BIS QCO covers this antibiotic product family. Import is governed by the NDPS Rules, 1985 (Rule 53 import certificate) and the ITC (HS) Restricted-import policy administered by DGFT, with five mandatory e-Sanchit document uploads required at the bill of entry.

What are the five mandatory e-Sanchit documents for this tariff line?

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

What governs imports of erythromycin that are not for medical or scientific purposes?

Imports outside the medical and scientific purposes category under Chapter VII-A of the NDPS Rules, 1985 are governed by Appendix-I to the ITC (HS) Schedule under ITC (HS) policy condition 2 to Chapter 29, administered by DGFT.

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