Other

Antibiotic medicaments in measured doses, retail packs

MEFCC CLEARANCE

HSN 3004 20 49 (Other antibiotic medicaments) is subject to drug import registration and licensing under the Drugs and Cosmetics Act, 1940, with the Central Drugs Standard Control Organisation (CDSCO) registration certificate and import licence as the binding pre-clearance requirements. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under a restricted import policy with prohibition on oxytocin imports and a carve-out permitting oxytocin reference standards exclusively for test and analysis under a DCGI-issued test licence.

What this is

HSN code

3004 20 49

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Drugs and Cosmetics Act, 1940 (CDSCO drug import registration and licensing 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 valid drug registration certificate (document code 101dc1) and import licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before shipment. Ensure the registration covers the specific antibiotic formulation being imported; an import licence covering a different formulation or strength does not extend to this product.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
2
Upload all five mandatory documents in e-Sanchit at the bill of entry 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). Any missing upload results in detention pending PGA-routed NOC verification.
CBIC e-Sanchit PGA-facilitated bill requirement · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
If the consignment contains oxytocin (in any form other than reference standards for test and analysis), treat the import as prohibited. For oxytocin reference standards, the DCGI/CDSCO-issued test licence must be uploaded as supporting documentation and the restricted-import status declared on 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 residual antibiotic tariff line is filing under the broad 3004 20 49 residual code without ensuring the CDSCO registration certificate precisely matches the imported formulation — a certificate issued for a branded or innovator product does not cover a parallel-imported or differently-branded variant of the same active ingredient. A mismatch between the registered product name and the import consignment description is treated as importation of an unregistered drug, attracting seizure and prosecution under the Drugs and Cosmetics Act, 1940, irrespective of whether the active antibiotic is otherwise licensed.

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Frequently asked

Does HSN 3004 20 49 require BIS certification?

No, antibiotic medicaments in measured doses are not within the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, requiring a drug registration certificate and import licence, with DGFT restricted-import policy controls applicable.

Are oxytocin-containing products under this HSN permitted for import?

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

What happens if the batch release certificate is missing from the e-Sanchit upload at the bill of entry?

The consignment will not receive out-of-charge; the proper officer must verify all five mandatory documents (0010dc, 0030dc, 0110dc, 101dc1, 9111dc) are uploaded in e-Sanchit, and absence of any one document routes the bill for PGA-NOC verification, resulting in detention and potential demurrage.

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