Other antitubercular drugs

Antitubercular medicaments in retail or measured-dose packing

MEFCC CLEARANCE

HSN 3004 90 57 (Other antitubercular drugs) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under policy controls, and an import prohibition applies specifically to oxytocin under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, though oxytocin reference standards remain permissible for test and analysis under a DGCI/CDSCO test licence.

What this is

HSN code

3004 90 57

Chapter

30 · Pharmaceutical products

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Certificate of Analysis from manufacturer

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 an import licence for drugs (document code 9111dc) from CDSCO before the consignment is dispatched. Both documents, along with the batch release certificate (document code 0030dc), label of consignment (document code 0110dc), and Certificate of Analysis — Drug (document code 0010dc), must be uploaded in e-Sanchit before customs out-of-charge is granted.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1, 9111dc, 0030dc, 0110dc, 0010dc
2
Verify that the active substance(s) in the antitubercular formulation do not include oxytocin, which is prohibited for import under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. Oxytocin reference standards are the sole permissible exception, and only where a test licence issued by DGCI/CDSCO exclusively for test and analysis purposes is submitted 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 single most common error on this tariff line is filing at the bill-of-entry stage without all five mandatory e-Sanchit uploads in place. Customs proper officers are instructed to verify the presence of document codes 0010dc, 0030dc, 0110dc, 101dc1, and 9111dc before granting out-of-charge; a consignment with even one missing code is detained, accruing demurrage and ground rent while the document is retrieved retrospectively. Pre-clearance audit of e-Sanchit uploads against the document-code checklist is the single most effective preventive measure.

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Frequently asked

Does HSN 3004 90 57 require BIS certification?

No. No BIS Quality Control Order covers antitubercular medicaments. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, requiring drug registration, an import licence, and the full suite of e-Sanchit document uploads before out-of-charge.

Which five document codes must be uploaded in e-Sanchit at the bill of entry for this tariff line?

The mandatory documents are: Certificate of Analysis — Drug (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 granted.

Can oxytocin reference standards be imported under HSN 3004 90 57?

Yes, but only for test and analysis purposes, subject to submission of a test licence issued by DGCI/CDSCO; general import of oxytocin remains prohibited under 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.