Ethambutol

Ethambutol medicaments containing antibiotics, retail packings

MEFCC CLEARANCE

HSN 3004 20 94 (Ethambutol) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. Mandatory documents including the Registration Certificate (drugs), Import Licence, Certificate of Analysis, batch release certificate, and consignment label must be uploaded in e-Sanchit before out-of-charge. The Directorate General of Foreign Trade (DGFT) administers the overarching ITC (HS) import policy applicable to this tariff line.

What this is

HSN code

3004 20 94

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence for drugs from CDSCO
Certificate of Analysis from manufacturer

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 documents must be current and uploaded in e-Sanchit prior to customs out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis for the drug (document code 0010dc), the batch release certificate (document code 0030dc), and the consignment label (document code 0110dc) in e-Sanchit at the bill of entry stage. The proper officer will verify all five mandatory documents before granting out-of-charge.
CDSCO mandatory-document requirement · e-Sanchit document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is filing the bill of entry with the Registration Certificate alone, treating the Import Licence as a secondary document to be furnished on request. All five mandatory documents — Registration Certificate (101dc1), Import Licence (9111dc), Certificate of Analysis (0010dc), batch release certificate (0030dc), and consignment label (0110dc) — must be uploaded in e-Sanchit simultaneously; a missing document code is treated as non-compliance and results in detention of the consignment pending a complete upload.

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Frequently asked

Does HSN 3004 20 94 require BIS certification?

No. Ethambutol medicaments are not covered by any BIS Quality Control Order; no BIS QCO applies to this product family. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT administering the ITC (HS) import policy overlay.

Which e-Sanchit document codes are mandatory at the bill of entry for this HSN?

Five document codes are required: Registration Certificate for drugs (101dc1), Import Licence for drugs (9111dc), Certificate of Analysis (0010dc), batch release certificate (0030dc), and consignment label (0110dc). All five must be uploaded before the proper officer issues out-of-charge.

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

No. The prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies exclusively to oxytocin, a distinct active substance; Ethambutol is an anti-tuberculosis antibiotic and is not within the scope of that prohibition.

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