Ciprofloxacin

Ciprofloxacin antibiotic medicaments in measured doses

MEFCC CLEARANCE

HSN 3004 20 13 (Ciprofloxacin) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import-licence requirements under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under its pharmaceutical-import policy overlay, and mandatory e-Sanchit documentation — including a Registration Certificate, Import Licence, Batch Release Certificate, and Certificate of Analysis — must be uploaded before customs out-of-charge.

What this is

HSN code

3004 20 13

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

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

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 CDSCO before the consignment is dispatched. Both documents must be uploaded in e-Sanchit at the bill of entry stage prior to customs out-of-charge.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc (e-Sanchit mandatory uploads)
2
Upload in e-Sanchit the Certificate of Analysis for drugs (document code 0010dc), the Batch Release Certificate (document code 0030dc), and the Label of Consignment (document code 0110dc). The proper officer will verify all five mandatory documents before granting out-of-charge on PGA-facilitated bills.
CDSCO mandatory e-Sanchit document codes 0010dc, 0030dc, 0110dc
3
Note the absolute prohibition on the import of oxytocin; only oxytocin reference standards for test and analysis are permitted, exclusively on production of a test licence issued by DGCI/CDSCO. Ciprofloxacin is a distinct antibiotic, but the same bill of entry must not carry any prohibited oxytocin product.
S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is filing the bill of entry with the Registration Certificate uploaded but omitting either the Batch Release Certificate or the Certificate of Analysis, treating them as optional secondary documents. All five document codes — 101dc1, 9111dc, 0010dc, 0030dc, and 0110dc — are mandatory pre-OOC uploads; a single missing document causes consignment detention and attracts demurrage at the port until the gap is rectified through CDSCO's amendment process.

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Frequently asked

Does HSN 3004 20 13 require BIS certification?

No, ciprofloxacin medicaments are not within the BIS Quality Control Order regime. Import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, with a mandatory registration certificate, import licence, and batch documentation package uploaded in e-Sanchit before customs out-of-charge.

Which document codes are mandatory 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 uploaded before out-of-charge is granted.

Does the oxytocin prohibition under S.O. 2357(E) affect Ciprofloxacin imports?

No — Ciprofloxacin is a fluoroquinolone antibiotic and is not subject to the oxytocin prohibition; however, any co-shipment containing oxytocin (other than reference standards accompanied by a DGCI/CDSCO test licence) will be liable to confiscation under DGFT Notification 09/2015-2020 dated 23-05-2022.

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