Containing corticosteroid hormones, their derivatives or structural analogues

Medicaments containing corticosteroid hormones or structural analogues

MEFCC CLEARANCE

HSN 3004 32 00 (corticosteroid-containing medicaments) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration, import licensing, and batch-release clearance under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies the import as Restricted under the ITC (HS) policy, with a specific prohibition on oxytocin imports except as a reference standard for test and analysis under a DGCI/CDSCO test licence. Used or refurbished high-end medical equipment under this heading is subject to additional conditions notified by the Ministry of Environment, Forest and Climate Change.

What this is

HSN code

3004 32 00

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940 (drug registration and import licence regime)

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 drug registration certificate (document code 101dc1) and an import licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before filing the bill of entry. Both documents must be uploaded in e-Sanchit; out-of-charge will not be granted without verified uploads of all mandatory documents.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc per CCR
2
Upload the Certificate of Analysis for drugs (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. The proper officer will verify all five mandatory document codes — 0010dc, 0030dc, 0110dc, 101dc1, and 9111dc — before granting out-of-charge.
CCR mandatory document list · e-Sanchit upload requirement
3
Confirm the specific active substance is not oxytocin: import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, except as a reference standard for test and analysis under a test licence issued by DGCI/CDSCO. Any corticosteroid consignment involving oxytocin reference standards must carry the test licence at the bill of entry.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is filing the bill of entry with the registration certificate and import licence in place but omitting one or more of the three product-level documents — Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), or Label of Consignment (0110dc). All five document codes are verified individually by the proper officer before out-of-charge; a single missing upload triggers detention and demurrage regardless of the validity of the CDSCO registration.

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 3004 32 00 require BIS certification?

No. No BIS Quality Control Order covers corticosteroid medicaments. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with drug registration, import licensing, and batch-release clearance as the binding requirements at the bill of entry.

Which five e-Sanchit document codes are mandatory for this tariff line?

The proper officer verifies document codes 0010dc (Certificate of Analysis), 0030dc (Batch Release Certificate), 0110dc (Label of Consignment), 101dc1 (Registration Certificate for drugs), and 9111dc (Import Licence for drugs) before granting out-of-charge.

Is oxytocin import permitted under this HSN for any purpose?

Import of oxytocin is prohibited as a general rule under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; the sole permitted exception is import of oxytocin reference standards exclusively for test and analysis, subject to a test licence issued by DGCI/CDSCO.

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