Penicillins and its salts (e.g. procaine penicillin, penicillin G-potassium)

Penicillins and salts (procaine penicillin, penicillin G-potassium)

NDPS CLEARANCE

HSN 2941 10 10 (Penicillins and its salts) is subject to Narcotic Drugs and Psychotropic Substances (NDPS) import certificate requirements under Chapter VII-A of the NDPS Rules, 1985, for imports destined for medical and scientific purposes. Imports outside that 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). Mandatory Chapter 29 additional qualifiers in import declarations are required under Central Board of Indirect Taxes and Customs (CBIC) Circular 23/2023-Cus dated 30-09-2023, effective 15 October 2023.

What this is

HSN code

2941 10 10

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 (http://cbn.nic.in) before shipment for imports under the special provision for medical and scientific purposes per Chapter VII-A of the NDPS Rules. Imports falling 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 NDPS Rules, 1985 · Chapter VII-A of NDPS Rules, 1985 · ITC (HS) policy condition 2, 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 before granting out-of-charge.
CBIC e-Sanchit mandatory document codes: 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Include mandatory additional qualifiers in the import declaration for all Chapter 29 commodities as stipulated in paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus, effective 15 October 2023. Declarations lacking the required Chapter 29 qualifiers are liable to be held pending correction at the bill-of-entry stage.
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 (Rule 53 of the NDPS Rules, 1985) with the drug registration certificate and import licence required at the bill of entry. These are distinct instruments from different authorities: the NDPS import certificate is issued by the Central Bureau of Narcotics, while the drug-side documents (101dc1 and 9111dc) are drug-regulator credentials — absence of either set independently blocks out-of-charge and attracts consignment detention.

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 10 require BIS certification?

No. No BIS Quality Control Order covers penicillins or their salts. Import is governed by the NDPS Rules, 1985 under Rule 53 for medical and scientific purposes, with the ITC (HS) policy condition 2 of Chapter 29 applying to all other imports.

Which e-Sanchit document codes are mandatory for this tariff line at the bill of entry?

Five documents must be uploaded: 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 not grant out-of-charge until all five are present in e-Sanchit.

What happens if the import falls outside the medical and scientific purposes category under the NDPS Rules?

Imports outside Chapter VII-A of the NDPS Rules, 1985 are governed by Appendix-I to the ITC (HS) Schedule under policy condition 2 of Chapter 29; non-compliance with the applicable Appendix-I conditions exposes the consignment to seizure and NDPS enforcement action.

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