Chloramphenicol

Chloramphenicol antibiotic medicaments, measured-dose formulations

MOHFW CLEARANCE · MEFCC CLEARANCE

HSN 3004 20 50 (Chloramphenicol) is governed by the Ministry of Health and Family Welfare (MOHFW), which prohibits import of chloramphenicol and its formulations for use in any food-producing animal rearing system under S.O. 1158(E) dated 12-03-2025. Non-prohibited imports require a valid drug registration certificate and import licence under the Drugs and Cosmetics Act, 1940, with the Directorate General of Foreign Trade (DGFT) administering the ITC (HS) policy overlay.

What this is

HSN code

3004 20 50

Chapter

30 · Pharmaceutical products

Primary regulator

MOHFW · S.O. 1158(E) dated 12-03-2025; Drugs and Cosmetics Act, 1940

Customs documentation

Import licence for drugs from CDSCO
Registration certificate from CDSCO
Batch release certificate from exporter

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
Verify that the consignment does not constitute chloramphenicol or its formulations intended for use in any food-producing animal rearing system, which are categorically prohibited under S.O. 1158(E) dated 12-03-2025 issued by MOHFW. A consignment of prohibited formulations is liable to outright rejection and confiscation at the bill of entry.
S.O. 1158(E) dated 12-03-2025 · Ministry of Health and Family Welfare
2
Upload all mandatory documents in e-Sanchit before filing the bill of entry: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), Label of Consignment (document code 0110dc), Registration Certificate for Drugs (document code 101dc1), and Import Licence for Drugs (document code 9111dc). Out-of-charge will not be granted until these five documents are verified in e-Sanchit.
CBIC e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc

A word of counsel

The most frequent error on this tariff line is importing chloramphenicol formulations without confirming the end-use declaration: the S.O. 1158(E) prohibition is use-specific, not product-specific, meaning a consignment destined for veterinary or aquaculture application in a food-producing animal system is prohibited even if the drug registration certificate is otherwise valid. A missing or ambiguous end-use declaration at the bill of entry is sufficient grounds for detention pending MOHFW clarification, and the importer bears the burden of establishing non-prohibited end use before out-of-charge is granted.

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Frequently asked

Does HSN 3004 20 50 require BIS certification?

No, chloramphenicol medicaments are not within the BIS Quality Control Order regime. Import is governed by the Ministry of Health and Family Welfare under S.O. 1158(E) dated 12-03-2025 and the Drugs and Cosmetics Act, 1940, with mandatory drug registration and import licence requirements administered by CDSCO.

Which document codes are mandatory in e-Sanchit for this tariff line?

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

Does the MOHFW prohibition on chloramphenicol apply to all formulations or only veterinary use?

The prohibition under S.O. 1158(E) dated 12-03-2025 applies specifically to chloramphenicol and its formulations for use in any food-producing animal rearing system; formulations for other permitted therapeutic uses remain subject to the standard drug registration and import licence regime.

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