Other

Antibiotic medicaments in retail packs, other formulations

MEFCC CLEARANCE

HSN 3004 20 39 (Other antibiotic medicaments in measured doses or retail packs) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under restricted ITC (HS) import policy; import of oxytocin is prohibited outright, with a narrow exemption for reference standards used for test and analysis under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

What this is

HSN code

3004 20 39

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 drug registration certificate and an import licence for drugs from the Central Drugs Standard Control Organisation before filing the bill of entry. Upload both documents in e-Sanchit under document codes 101dc1 (registration certificate, drugs) and 9111dc (import licence for drugs) respectively.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc per CCR e-Sanchit mandatory document list
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 customs out-of-charge. The proper officer will verify all five mandatory documents on PGA-facilitated bills prior to granting out-of-charge.
CCR e-Sanchit mandatory document list · document codes 0010dc, 0030dc, 0110dc
3
If the antibiotic formulation contains oxytocin, note that import is prohibited; the sole exemption is for oxytocin reference standards imported exclusively for test and analysis, subject to submission of a test licence issued by the DGCI/CDSCO 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 alone while the batch release certificate and Certificate of Analysis remain outstanding. All five e-Sanchit documents — registration certificate (101dc1), import licence (9111dc), Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc) — must be uploaded before the proper officer can grant out-of-charge; a single missing document triggers detention, demurrage, and ground rent liability with no administrative remedy short of document rectification.

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Frequently asked

Does HSN 3004 20 39 require BIS certification?

No, antibiotic medicaments in retail packs 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, with DGFT restricted-import policy controls applying as an overlay.

Which five documents must be uploaded in e-Sanchit for antibiotic medicament imports under this HSN?

The mandatory e-Sanchit documents are: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for drugs (101dc1), and Import Licence for drugs (9111dc); all five must be present before customs out-of-charge.

Is there any permitted import of oxytocin under this tariff line given the general prohibition?

Yes, but only narrowly: oxytocin reference standards may be imported exclusively for test and analysis purposes, provided a test licence issued by the DGCI/CDSCO is submitted at the bill of entry, per S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

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