Of Siddha system

Siddha system medicaments in retail packs

MEFCC CLEARANCE

HSN 3004 90 13 (Of Siddha system) is subject to regulatory controls administered by the Ministry of Environment, Forest and Climate Change (MEFCC) and the Directorate General of Foreign Trade (DGFT) under the ITC (HS) import policy. A Certificate of Analysis, Batch Release Certificate, and label of consignment must be uploaded in e-Sanchit before out-of-charge. Import of oxytocin within this tariff line is prohibited except for reference standards for test and analysis under a DGCI/CDSCO test licence.

What this is

HSN code

3004 90 13

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · ITC (HS) import policy, Chapter 30; DGFT Notification 09/2015-2020 dated 23-05-2022

Customs documentation

Certificate of Analysis from drug authority
Batch Release Certificate from manufacturer
Label of consignment from importer

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
Upload the mandatory e-Sanchit documents before filing the bill of entry: Certificate of Analysis – Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc). Out-of-charge will be withheld until all three documents are verified by the proper officer.
CCR e-Sanchit document codes 0010dc, 0030dc, 0110dc
2
If the consignment contains oxytocin, it is prohibited for import except as a reference standard for test and analysis. In that sole exception, submit a test licence issued by DGCI/CDSCO at the bill of entry stage to substantiate the restricted-import claim.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022
3
If the import involves used or refurbished medical equipment classified under this heading, note that high-end and high-value used/refurbished medical equipment (other than critical care equipment recommended by DGHS) is subject to additional conditions and is Restricted. Confirm compliance with the O.M. issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023 before shipment.
O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023

A word of counsel

The most common error on this tariff line is failing to recognise that the oxytocin prohibition is absolute for commercial imports — the narrow carve-out for reference standards requires a current DGCI/CDSCO test licence, not a general import licence or a DGFT condition compliance certificate. Presenting a generic drug import authorisation at the bill of entry for an oxytocin-containing consignment will trigger seizure and prosecution under the Drugs and Cosmetics Act, 1940, regardless of the Siddha-system classification of other products in the same shipment.

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Frequently asked

Does HSN 3004 90 13 require BIS certification?

No, no BIS Quality Control Order covers Siddha system medicaments under this tariff line. Import is governed by controls administered by the Ministry of Environment, Forest and Climate Change and the ITC (HS) import policy under the Directorate General of Foreign Trade, with mandatory e-Sanchit document compliance at the bill of entry.

Which e-Sanchit document codes are mandatory at the bill of entry for this HSN?

Three documents are mandatory: Certificate of Analysis – Drug (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc); all must be uploaded before out-of-charge is granted by the proper officer.

Can oxytocin formulated under the Siddha system be imported under this tariff line?

Import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, with the sole exception being reference standards for test and analysis, which require a test licence from DGCI/CDSCO as a precondition to import.

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