Insulin injection

Insulin injection medicaments containing insulin

MEFCC CLEARANCE

HSN 3004 31 10 (Insulin injection) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. Mandatory documents including the Registration Certificate, Import Licence, Batch Release Certificate, Certificate of Analysis, and label declaration must be uploaded in e-Sanchit before customs out-of-charge. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy applicable to this tariff line.

What this is

HSN code

3004 31 10

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Batch release certificate from CDSCO

Applicable Partner Government Agencies

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.

Compliance steps

1
Obtain a valid Registration Certificate for the drug (document code 101dc1) and an Import Licence for Drugs (document code 9111dc) from CDSCO before shipment. Both documents must be current and uploaded in e-Sanchit prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1, 9111dc
2
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit before out-of-charge. The proper officer must verify all five mandatory documents are present on any PGA-facilitated bill of entry not routed through the PGA for NOC.
CCR mandatory-document requirement · e-Sanchit document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is submitting a Registration Certificate and Import Licence that are valid on their face but missing the Batch Release Certificate or Certificate of Analysis specific to the shipment lot. Customs out-of-charge is withheld until all five e-Sanchit document codes — 101dc1, 9111dc, 0010dc, 0030dc, and 0110dc — are verified; a missing batch-level document causes consignment detention and demurrage regardless of the currency of the drug registration.

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Frequently asked

Does HSN 3004 31 10 require BIS certification?

No, insulin injection medicaments are not within the BIS Quality Control Order regime. Import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, requiring a Registration Certificate and Import Licence, with ITC (HS) policy administered by DGFT.

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

Five documents must be uploaded: Registration Certificate for drugs (101dc1), Import Licence for drugs (9111dc), Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc); the proper officer withholds out-of-charge if any one is absent.

Does the CCR prohibition on oxytocin affect import of insulin injections under this HSN?

No. The prohibition on oxytocin under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies to oxytocin, not to insulin; insulin injections are a distinct product and the standard CDSCO registration and import-licence regime applies.

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