Norfloxacin

Norfloxacin antibiotic medicaments in measured doses

MEFCC CLEARANCE

HSN 3004 20 31 (Norfloxacin) is subject to the Central Drugs Standard Control Organisation (CDSCO) registration and import-licence regime under the Drugs and Cosmetics Act, 1940, with mandatory documentation including a Registration Certificate for Drugs and an Import Licence for Drugs at the bill-of-entry stage. The Directorate General of Foreign Trade (DGFT) administers the applicable ITC (HS) policy overlay, and all mandatory documents must be uploaded in e-Sanchit before out-of-charge.

What this is

HSN code

3004 20 31

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Batch release certificate from CDSCO

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
Obtain a valid Registration Certificate for Drugs (document code 101dc1) and an Import Licence for Drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before filing the bill of entry. Both must be uploaded in e-Sanchit; a missing or expired registration triggers detention at the port and denial of out-of-charge.
Drugs and Cosmetics Act, 1940 · CDSCO import-licence regime · document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis for Drugs (document code 0010dc), the Batch Release Certificate (document code 0030dc), and the Label of Consignment (document code 0110dc) in e-Sanchit before the bill of entry is assessed. The proper officer will verify all five mandatory documents prior to granting out-of-charge on PGA-facilitated bills.
e-Sanchit mandatory-document verification · document codes 0010dc, 0030dc, 0110dc

A word of counsel

The single most common error on this tariff line is uploading the Registration Certificate without ensuring the Batch Release Certificate and Certificate of Analysis correspond to the specific batch being imported. A registration that is current but paired with documents from a different batch or manufacturing site will fail the proper officer's e-Sanchit verification, resulting in consignment detention and accumulating demurrage, not merely a paperwork query.

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Frequently asked

Does HSN 3004 20 31 require BIS certification?

No. No BIS Quality Control Order covers antibiotic medicaments under this tariff line. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with an ITC (HS) policy overlay administered by the Directorate General of Foreign Trade.

Which document codes must be uploaded in e-Sanchit for a Norfloxacin consignment?

Five documents are mandatory: Certificate of Analysis for Drugs (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc). All five must be present in e-Sanchit before the proper officer grants out-of-charge.

Does the CCR note about oxytocin prohibition affect imports of Norfloxacin under this HSN?

No. The oxytocin prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 is specific to oxytocin formulations; Norfloxacin is a distinct antibiotic not covered by that prohibition, and the standard CDSCO registration and import-licence requirements govern its import.

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