Ofloxacin

Ofloxacin antibiotic medicaments in measured doses

MEFCC CLEARANCE

HSN 3004 20 34 (Ofloxacin) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940. Directorate General of Foreign Trade (DGFT) policy controls apply as an overlay, and mandatory documents including a Registration Certificate and Import Licence for drugs must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3004 20 34

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940 (drug import licensing and registration)

Customs documentation

Registration certificate from CDSCO
Import Licence for drugs 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 drug import licence and registration certificate from the Central Drugs Standard Control Organisation before the consignment is dispatched. Upload the Registration Certificate (document code 101dc1) and the Import Licence for drugs (document code 9111dc) in e-Sanchit at the bill of entry stage.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
2
Ensure the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) are uploaded in e-Sanchit before the bill of entry is assessed. The proper officer must verify all five mandatory documents before granting out-of-charge.
CDSCO e-Sanchit mandatory document requirements · document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is conflating Ofloxacin medicaments with oxytocin-related prohibitions present in the broader Chapter 30 CCR: the oxytocin prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies to oxytocin formulations, not to fluoroquinolone antibiotics such as Ofloxacin. However, all five CDSCO e-Sanchit document codes (101dc1, 9111dc, 0010dc, 0030dc, 0110dc) remain mandatory for this tariff line, and an incomplete upload — even of a single code — will result in consignment detention pending rectification.

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Frequently asked

Does HSN 3004 20 34 require BIS certification?

No, Ofloxacin antibiotic medicaments are not within the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT policy controls as an overlay.

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

Five documents are mandatory: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for drugs (101dc1), and Import Licence for drugs (9111dc) — all must be present in e-Sanchit before out-of-charge.

Does the oxytocin import prohibition under S.O. 2357(E) affect Ofloxacin consignments?

No. The prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies specifically to oxytocin formulations; Ofloxacin is a fluoroquinolone antibiotic and is governed by the standard CDSCO drug-import licensing regime.

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