Other, containing antibiotics

Multi-constituent antibiotic medicaments not in retail packs

MOHFW CLEARANCE

HSN 3003 20 00 (multi-constituent antibiotic medicaments not put up for retail sale) is subject to Ministry of Health and Family Welfare (MOHFW) import controls under the Drugs and Cosmetics Act, 1940, requiring a valid import licence and registration certificate for drugs. A categorical prohibition — effective immediately — bars import of chloramphenicol and its formulations, and nitrofurans and their formulations, for use in any food-producing animal rearing system, per S.O. 1158(E) dated 12-03-2025.

What this is

HSN code

3003 20 00

Chapter

30 · Pharmaceutical products

Primary regulator

MOHFW · Drugs and Cosmetics Act, 1940 — import licence and prohibition regime

Customs documentation

Import licence for drugs from MOHFW
Registration certificate from MOHFW
Certificate of analysis from manufacturer

Applicable Partner Government Agencies

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Verify that the antibiotic formulation is not chloramphenicol, a chloramphenicol formulation, nitrofuran, or a nitrofuran formulation intended for use in food-producing animal rearing. Consignments falling within the prohibition are barred from import with no exemption carve-out; entry is refused and the consignment is liable to re-export or confiscation.
S.O. 1158(E) dated 12-03-2025 issued by the Ministry of Health and Family Welfare
2
Before filing the bill of entry, upload in e-Sanchit the following mandatory documents: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), Label of Consignment (document code 0110dc), Registration Certificate — Drugs (document code 101dc1), and Import Licence for Drugs (document code 9111dc). Out-of-charge will not be granted until all five documents are verified by the proper officer.
MOHFW NOC requirement · e-Sanchit mandatory document list per CCR for HSN 3003 20 00

A word of counsel

The most common error on this tariff line is filing the bill of entry without uploading all five mandatory e-Sanchit document codes — in particular, omitting the Batch Release Certificate (0030dc) or the Registration Certificate (101dc1) on the assumption that the Import Licence (9111dc) alone suffices. Customs proper officers are instructed to withhold out-of-charge until every document code is confirmed present in e-Sanchit; a single missing upload results in consignment detention, accruing demurrage and ground rent until the deficiency is rectified.

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Frequently asked

Does HSN 3003 20 00 require BIS certification?

No, multi-constituent antibiotic medicaments are not covered by any BIS Quality Control Order. Import is governed by the Ministry of Health and Family Welfare under the Drugs and Cosmetics Act, 1940, with a mandatory import licence, drug registration certificate, and a categorical prohibition on chloramphenicol and nitrofuran formulations for food-producing animal use per S.O. 1158(E) dated 12-03-2025.

Which five document codes must be uploaded in e-Sanchit before out-of-charge?

The mandatory uploads are: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc); all must be present before the proper officer can grant out-of-charge.

Does the chloramphenicol and nitrofuran prohibition apply only to veterinary imports?

The prohibition under S.O. 1158(E) dated 12-03-2025 is specifically for use in any food-producing animal rearing system; importers whose formulations are destined for human therapeutic use should nonetheless ensure product labelling and end-use documentation clearly reflect that use to avoid detention.

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