Digoxin

Digoxin, a natural glycoside for medical or scientific import

NDPS CLEARANCE

HSN 2938 90 10 (Digoxin) is subject to import certificate requirements under Rule 53 of the Narcotic Drugs and Psychotropic Substances Rules, 1985 (NDPS Rules), administered by the Narcotic Drugs and Psychotropic Substances (NDPS) authority, for imports made under the special provisions for medical and scientific purposes set out in Chapter VII-A of the NDPS Rules. Imports outside that category are governed by Appendix-I to the ITC (HS) Schedule under policy condition 2 to Chapter 29, administered by the Directorate General of Foreign Trade (DGFT). 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

2938 90 10

Chapter

29 · Organic chemicals

Primary regulator

NDPS · Narcotic Drugs and Psychotropic Substances Rules, 1985 (Chapter VII-A, Rule 53)

Customs documentation

Import certificate from NDPS
Registration certificate from CDSCO
Chapter 29 qualifiers from CBIC

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 before shipment, covering the medical or scientific purpose of the import. Imports that do not qualify under Chapter VII-A of the NDPS Rules must comply with Appendix-I to the ITC (HS) Schedule under policy condition 2 to Chapter 29.
Rule 53 of the NDPS Rules, 1985 · Chapter VII-A of the NDPS Rules, 1985 · ITC (HS) policy condition 2 to 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 for Drugs (101dc1), and Import Licence for Drugs (9111dc). Customs out-of-charge will not be granted until all five document codes are verified in e-Sanchit.
CCR mandatory document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc · e-Sanchit verification requirement
3
Include the 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. Non-inclusion of the prescribed qualifiers renders the declaration deficient and may result in consignment detention pending rectification.
CBIC Circular 23/2023-Cus dated 30-09-2023, paras 4.1 and 4.2

A word of counsel

The most frequent error on this tariff line is treating the drug-registration and import-licence documents (101dc1 and 9111dc) as interchangeable with the NDPS import certificate. The NDPS import certificate under Rule 53 is a separate, purpose-specific instrument issued by the Central Bureau of Narcotics; presenting only the Drugs Controller registration at the bill of entry leaves the NDPS-regime obligation unmet, exposing the consignment to detention and potential seizure under the NDPS Act, 1985.

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 2938 90 10 require BIS certification?

No. Digoxin is not covered by any BIS Quality Control Order. Import is governed by the Narcotic Drugs and Psychotropic Substances Rules, 1985 — specifically Rule 53 and Chapter VII-A — for medical and scientific purposes, with the ITC (HS) Appendix-I policy overlay administered by DGFT for all other imports.

Which e-Sanchit document codes are mandatory at the bill of entry for Digoxin?

Five document codes 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 five must be uploaded and verified before customs out-of-charge is granted.

What happens if the import does not qualify under the medical or scientific purpose provisions of Chapter VII-A of the NDPS Rules?

Imports outside the medical and scientific purpose category are governed by Appendix-I to the ITC (HS) Schedule under policy condition 2 to Chapter 29; absent a qualifying purpose, the consignment is treated as a Restricted import and is subject to DGFT enforcement and potential seizure under the NDPS Act, 1985.

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