Of Unani system

Unani system medicaments in measured doses or retail packing

MEFCC CLEARANCE

HSN 3004 90 12 (Of Unani system) is subject to Ministry of Environment, Forest and Climate Change (MEFCC) conditions and the Directorate General of Foreign Trade (DGFT) Restricted-import policy under ITC (HS) Chapter 30 controls. Import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, with a narrow carve-out permitting oxytocin reference standards exclusively for test and analysis against a DCGI/CDSCO test licence.

What this is

HSN code

3004 90 12

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · ITC (HS) Restricted import policy, Chapter 30 (DGFT Notification 09/2015-2020)

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
Verify that the consignment does not contain oxytocin in any formulation other than reference standards intended exclusively for test and analysis. If the consignment is oxytocin reference standards, obtain the test licence issued by DCGI/CDSCO and present it at the bill of entry; import of oxytocin in any other form is prohibited.
S.O. 2357(E) · DGFT Notification 09/2015-2020 both dated 23-05-2022
2
Upload in e-Sanchit the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) before filing the bill of entry. The Proper Officer must confirm all three documents are present before granting out-of-charge.
CCR document codes 0010dc, 0030dc, 0110dc · e-Sanchit mandatory-document verification requirement

A word of counsel

The prohibition on oxytocin is absolute for finished formulations; the sole exception is reference-standard material for test and analysis, and that exception is conditional on a current DCGI/CDSCO test licence being uploaded in e-Sanchit at the time of filing. Importers who attempt to clear reference standards without the test licence — or who misclassify a finished Unani medicament containing oxytocin as a reference standard — face outright confiscation and prosecution under the Drugs and Cosmetics Act, 1940, in addition to DGFT Restricted-import enforcement.

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Frequently asked

Does HSN 3004 90 12 require BIS certification?

No, Unani system medicaments are not within the BIS Quality Control Order regime. Import is governed by MEFCC conditions and DGFT Restricted-import policy under S.O. 2357(E) and DGFT Notification 09/2015-2020, with mandatory e-Sanchit documentation including a Certificate of Analysis and Batch Release Certificate.

Which document codes must be uploaded in e-Sanchit for this tariff line?

Three documents are mandatory: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc); out-of-charge will not be granted until all three are verified in e-Sanchit.

Is any import of oxytocin permitted under this HSN?

Only oxytocin reference standards for test and analysis are permitted, subject to submission of a test licence issued by DCGI/CDSCO; all other forms of oxytocin are 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.