Of Bio-chemic system

Biochemic system medicaments, measured-dose therapeutic preparations

MEFCC CLEARANCE

HSN 3004 90 15 (Of Bio-chemic system) is subject to regulatory controls administered by the Ministry of Environment, Forest and Climate Change (MEFCC) and import-policy conditions issued by the Directorate General of Foreign Trade (DGFT) under ITC (HS) policy. Import of oxytocin under this tariff line is prohibited; import of oxytocin reference standards is permitted exclusively for test and analysis subject to a test licence from DGCI/CDSCO under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

What this is

HSN code

3004 90 15

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Ministry of Environment, Forest and Climate Change (O.M. dated 15-12-2023); DGFT · ITC (HS) Restricted import policy, Chapter 30

Customs documentation

Certificate of Analysis from DGCI/CDSCO
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 product to be imported is not oxytocin in formulated/finished form — such import is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. If importing oxytocin reference standards for test and analysis only, obtain a valid test licence from DGCI/CDSCO before filing the bill of entry.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022
2
Upload the mandatory e-Sanchit documents before out-of-charge: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc). Bills not routed through the PGA for NOC are subject to verification by the proper officer at the bill-of-entry stage.
CBIC e-Sanchit document codes 0010dc, 0030dc, 0110dc · CCR customs-officer instruction
3
Where importing used or refurbished medical equipment of high-end or high-value categories under this heading, comply with the conditions prescribed by MEFCC in the O.M. dated 15-12-2023; such imports are Restricted and subject to DGHS-specified conditions that are additional to the standard PGA document set.
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 conflating the oxytocin prohibition with the broader biochemic-system product category. The prohibition applies specifically to oxytocin in its finished/formulated form; oxytocin reference standards for test and analysis remain permissible but require a DGCI/CDSCO test licence uploaded in e-Sanchit — absent that licence, the consignment will be detained and risks confiscation as a prohibited import, regardless of the general biochemic-medicament classification of the tariff line.

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Frequently asked

Does HSN 3004 90 15 require BIS certification?

No, biochemic system medicaments are not within the BIS Quality Control Order regime. Import is governed by the Ministry of Environment, Forest and Climate Change and the ITC (HS) Restricted-import policy administered by DGFT, with DGCI/CDSCO test-licence controls for oxytocin reference standards under S.O. 2357(E).

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

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

Is any import of oxytocin permitted under this HSN?

Import of oxytocin in finished or formulated form is prohibited; import of oxytocin reference standards is allowed exclusively for test and analysis purposes, subject to prior submission of a test licence issued by DGCI/CDSCO, 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.