Insulin and its salts

Insulin and its salts for medical or scientific use

NDPS CLEARANCE

HSN 2937 12 00 (Insulin and its salts) is subject to import certificate requirements under Rule 53 of the Narcotic Drugs and Psychotropic Substances Rules, 1985, administered by the Narcotic Drugs and Psychotropic Substances (NDPS) authority, for imports intended for medical and scientific purposes under Chapter VII-A of those Rules. Imports outside that medical-and-scientific carve-out 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 qualifiers in the import declaration for all Chapter 29 commodities.

What this is

HSN code

2937 12 00

Chapter

29 · Organic chemicals

Primary regulator

NDPS · Narcotic Drugs and Psychotropic Substances Rules, 1985 (Rule 53 import certificate)

Customs documentation

Import certificate from NDPS
Registration certificate from CDSCO
Import licence for drugs from DGFT

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 Narcotic Drugs and Psychotropic Substances Rules, 1985 before shipment, confirming the import falls within the medical and scientific purposes category of Chapter VII-A. Upload this certificate in e-Sanchit; consignments without a valid import certificate cannot obtain out-of-charge.
Rule 53 and Chapter VII-A of the NDPS Rules, 1985 · ITC (HS) policy condition 2 to Chapter 29
2
Ensure the following documents are uploaded in e-Sanchit at the bill of entry stage before 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].
CBIC e-Sanchit 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, with effect from 15 October 2023. Non-compliance with the qualifier requirement attracts detention of the bill of entry.
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 filing under the NDPS medical-and-scientific carve-out without first confirming that the importing entity holds a current drug registration certificate and import licence covering insulin specifically. The NDPS import certificate and the CDSCO drug registration are parallel, independent requirements: a valid NDPS certificate does not substitute for the drug registration under the drugs regime, and a missing [101dc1] or [9111dc] upload in e-Sanchit will trigger detention and demurrage even where the NDPS certificate is in order.

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Frequently asked

Does HSN 2937 12 00 require BIS certification?

No; no BIS Quality Control Order covers insulin or its salts. Import is governed by the Narcotic Drugs and Psychotropic Substances Rules, 1985 (Rule 53 import certificate) for medical and scientific purposes, with the ITC (HS) Appendix-I policy condition 2 to Chapter 29 applying to imports outside that category.

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

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]; out-of-charge will not be granted until all five are present in e-Sanchit.

What governs imports of insulin that fall outside the medical and scientific purposes category?

Imports not qualifying under Chapter VII-A of the NDPS Rules, 1985 are governed by Appendix-I to the ITC (HS) Schedule under policy condition 2 to Chapter 29 administered by DGFT, and are subject to the applicable Restricted or prohibited import regime set out therein.

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