Cephalexin and its salts

Cephalexin and its salts, antibiotic bulk drug

NDPS CLEARANCE

HSN 2941 90 20 (Cephalexin and its salts) is subject to Narcotic Drugs and Psychotropic Substances (NDPS) import certificate requirements under Chapter VII-A of the NDPS Rules, 1985, specifically Rule 53, for imports intended for medical and scientific purposes. The Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition 2 of Chapter 29 governs all other imports, and Central Board of Indirect Taxes and Customs (CBIC) Circular 23/2023-Cus dated 30-09-2023 mandates additional Chapter 29 qualifiers in the import declaration with effect from 15 October 2023.

What this is

HSN code

2941 90 20

Chapter

29 · Organic chemicals

Primary regulator

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

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 filing the bill of entry. This certificate is mandatory for all imports of NDPS substances for medical and scientific purposes under Chapter VII-A of the NDPS Rules, 1985; imports outside this category are governed by Appendix I to the ITC (HS) Schedule.
Rule 53, Chapter VII-A of the NDPS Rules, 1985 · ITC (HS) policy condition 2 of Chapter 29
2
Upload all mandatory documents in e-Sanchit before claiming 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). The proper officer will verify each document code before granting out-of-charge on PGA-facilitated bills.
CBIC e-Sanchit mandatory document list; document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
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. Non-compliance with the qualifier requirement, operative from 15 October 2023, renders the bill of entry deficient and may cause consignment detention.
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 conflating the NDPS import certificate under Rule 53 with the drug import licence uploaded under document code 9111dc — these are two distinct instruments from two distinct authorities, and the absence of either will result in consignment detention and potential seizure under the NDPS Act. Additionally, the Chapter 29 mandatory qualifiers under CBIC Circular 23/2023-Cus are a declaration-level requirement separate from PGA document upload; a bill of entry that omits the qualifiers is non-compliant even when all e-Sanchit documents are correctly uploaded.

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Frequently asked

Does HSN 2941 90 20 require BIS certification?

No, no BIS Quality Control Order covers antibiotic bulk drugs under this tariff line. Import of Cephalexin and its salts is governed by the NDPS Rules, 1985 for medical and scientific purposes, with DGFT ITC (HS) policy condition 2 of Chapter 29 applying to other categories of import.

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

Five document codes 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 the proper officer grants out-of-charge.

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

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

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