Ampicilline and its salts

Ampicillin and its salts, penicillin-class antibiotic

NDPS CLEARANCE

HSN 2941 10 20 (Ampicillin and its salts) is subject to Narcotic Drugs and Psychotropic Substances (NDPS) import controls under Chapter VII-A of the NDPS Rules, 1985, with import for medical and scientific purposes requiring an import certificate under Rule 53 of those Rules. Imports outside the medical and scientific category are governed by Appendix-I to the ITC (HS) Schedule under policy condition 2 of Chapter 29, administered by the Directorate General of Foreign Trade (DGFT). Central Board of Indirect Taxes and Customs (CBIC) mandatory Chapter 29 chemical qualifiers under CBIC Circular 23/2023-Cus apply at the bill-of-entry stage.

What this is

HSN code

2941 10 20

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) before shipment. This certificate is mandatory for all imports of NDPS-listed substances for medical and scientific purposes under Chapter VII-A of the NDPS Rules, 1985; imports outside this category must comply with Appendix-I to the ITC (HS) Schedule under ITC (HS) policy condition 2 of Chapter 29.
Rule 53 of the NDPS Rules, 1985 · 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 filing the bill of entry: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), Label of Consignment (document code 0110dc), Registration Certificate for Drugs (document code 101dc1), and Import Licence for Drugs (document code 9111dc). The proper officer must verify each upload before granting out-of-charge.
CCR e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Include mandatory additional qualifiers in the import declaration for Chapter 29 commodities as required by paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus. This obligation is operative from 15 October 2023 and applies to all import declarations under Chapters 28, 29, 32, 39 and CTH 3808.
CBIC Circular 23/2023-Cus dated 30-09-2023, paragraphs 4.1 and 4.2, effective 15-10-2023

A word of counsel

The dual-track structure of the NDPS import regime is the most frequent source of error: importers obtain the drug registration and import licence documents correctly but ship without the Rule 53 import certificate from the Central Bureau of Narcotics, treating the CDSCO drug-registration pathway as exhaustive. An absent or expired Rule 53 certificate renders the consignment liable to seizure under the NDPS Act regardless of the validity of CDSCO documentation; the two clearances are independent obligations and neither substitutes for the other.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 2941 10 20 require BIS certification?

No. No BIS Quality Control Order covers ampicillin or penicillin-class antibiotics. Import is governed by the NDPS Rules, 1985 under the NDPS regime, with DGFT ITC (HS) policy condition 2 of Chapter 29 and CBIC Circular 23/2023-Cus Chapter 29 qualifier requirements as additional overlays.

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

Five documents 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 uploaded before the proper officer grants out-of-charge.

What governs imports of ampicillin that fall outside the medical and scientific purpose category?

Such imports are governed by Appendix-I to the ITC (HS) Schedule under ITC (HS) policy condition 2 of Chapter 29 administered by DGFT; the Rule 53 medical-and-scientific-purpose pathway under Chapter VII-A of the NDPS Rules, 1985 is not available for those categories.

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