Antibacterial formulations, not elsewhere specified or included

Antibacterial medicament formulations, not elsewhere specified

MOHFW CLEARANCE · MEFCC CLEARANCE

HSN 3004 90 87 (Antibacterial formulations, not elsewhere specified or included) is subject to Ministry of Health and Family Welfare (MOHFW) import licensing and registration under the Drugs and Cosmetics Act, 1940, including substance-specific prohibitions on chloramphenicol, nitrofurans, and oxytocin formulations. The Ministry of Environment, Forest and Climate Change (MEFCC) overlay governs any used or refurbished equipment in the consignment, and the Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy conditions applicable to this tariff line.

What this is

HSN code

3004 90 87

Chapter

30 · Pharmaceutical products

Primary regulator

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

Customs documentation

Import licence for drugs from MOHFW
Registration certificate from MOHFW
Batch release certificate from MOHFW

Applicable Partner Government Agencies

MOHFWMOHFW·Ministry of Health and Family Welfare

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.

Compliance steps

1
Ensure the drug is registered and that a valid import licence for drugs (document code 9111dc) and a registration certificate for drugs (document code 101dc1) have been obtained from the MOHFW/DGCI before filing the bill of entry. Verify that the specific antibacterial formulation is not a prohibited substance: import of chloramphenicol and its formulations and nitrofurans and its formulations for use in any food-producing animal rearing system is prohibited with immediate effect.
S.O. 1158(E) dated 12-03-2025 issued by Ministry of Health and Family Welfare
2
Upload all mandatory documents in e-Sanchit before customs out-of-charge: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). Bills not routed through the PGA for NOC are subject to document verification by the proper officer before out-of-charge is granted.
CBIC e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
If the consignment includes oxytocin, import is prohibited unless the oxytocin is a reference standard imported exclusively for test and analysis, in which case a test licence issued by DGCI/CDSCO must be submitted. Confirm this carve-out applies before shipment, as consignments outside the reference-standard exemption are liable to seizure.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most frequent error on this tariff line is treating the import licence and registration certificate as the complete compliance set without screening the specific active substance against MOHFW prohibition notifications. Chloramphenicol and nitrofuran formulations destined for food-animal use, and oxytocin in non-reference-standard form, are absolutely prohibited at the bill of entry stage — a consignment carrying these substances is liable to confiscation and criminal prosecution under the Drugs and Cosmetics Act, 1940, regardless of whether all other documents are current and correctly uploaded in e-Sanchit.

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Frequently asked

Does HSN 3004 90 87 require BIS certification?

No, no BIS Quality Control Order covers antibacterial medicament formulations. Import is governed by the Ministry of Health and Family Welfare under the Drugs and Cosmetics Act, 1940, with substance-specific prohibitions on chloramphenicol, nitrofurans, and oxytocin formulations enforced through MOHFW notifications.

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

Five documents are mandatory: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc); out-of-charge will not be granted until all five are verified in e-Sanchit.

Is there any circumstance under which oxytocin may be imported under this HSN?

Yes, but only as a reference standard imported exclusively for test and analysis, and only on submission of a test licence issued by DGCI/CDSCO, as permitted under S.O. 2357(E) and DGFT Notification 09/2015-2020 both dated 23-05-2022; commercial or therapeutic use imports remain absolutely prohibited.

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