Azithromycin

Azithromycin antibiotic medicaments in retail packs

MEFCC CLEARANCE

HSN 3004 20 64 (Azithromycin) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. Mandatory documents including a Registration Certificate for Drugs (document code 101dc1) and an Import Licence for Drugs (document code 9111dc) must be uploaded in e-Sanchit before customs out-of-charge. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) policy overlay applicable to this tariff line.

What this is

HSN code

3004 20 64

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 and an Import Licence for Drugs from CDSCO before filing the bill of entry. Upload both documents in e-Sanchit under document codes 101dc1 (registration certificate) and 9111dc (import licence) respectively; customs out-of-charge will not be granted without these uploads.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc · CDSCO import licensing regime
2
Upload the Certificate of Analysis for the drug batch (document code 0010dc), the Batch Release Certificate (document code 0030dc), and the Label of Consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. The proper officer will verify each document code before granting out-of-charge.
Document codes 0010dc, 0030dc, 0110dc · e-Sanchit mandatory upload requirement per CCR

A word of counsel

The most common error on this tariff line is treating the Import Licence for Drugs as sufficient and overlooking the Batch Release Certificate and Certificate of Analysis as separate, independently mandatory uploads. A consignment carrying a current CDSCO Import Licence but missing either 0010dc or 0030dc in e-Sanchit will be detained at the port of entry; neither document can be retrofitted after the bill of entry is filed without incurring demurrage and ground rent while the proper officer awaits re-submission.

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Frequently asked

Does HSN 3004 20 64 require BIS certification?

No, Azithromycin medicaments are not within the BIS Quality Control Order regime; no BIS QCO covers antibiotic pharmaceutical products. Import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, with the DGFT ITC (HS) policy overlay applicable at the bill of entry.

Which e-Sanchit document codes are mandatory for Azithromycin imports?

Five document codes 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); all must be present before out-of-charge is granted.

Does the oxytocin import prohibition affect Azithromycin classified under this HSN?

No. The prohibition on oxytocin under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies solely to oxytocin formulations; Azithromycin is a macrolide antibiotic in a distinct drug class and is not subject to that prohibition.

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