Tamoxifen

Tamoxifen medicament, retail-packed pharmaceutical preparation

MEFCC CLEARANCE

HSN 3004 90 48 (Tamoxifen) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940, with mandatory pre-clearance documents verified at the bill-of-entry stage. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) policy overlay, and consignments require a current registration certificate, import licence, batch release certificate, and certificate of analysis uploaded in e-Sanchit before out-of-charge.

What this is

HSN code

3004 90 48

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 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 registration certificate (document code 101dc1) and an import licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before the consignment is dispatched. Both must be current and cover the specific Tamoxifen formulation, pack size, and quantity being imported.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
Upload all five mandatory documents in e-Sanchit at the bill of entry before requesting out-of-charge: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). Customs will verify e-Sanchit completeness on PGA-facilitated bills before granting out-of-charge.
e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc · CDSCO import procedure

A word of counsel

The most common error on this tariff line is uploading an import licence that covers the active pharmaceutical ingredient but not the finished retail-packed formulation — Tamoxifen medicaments in measured doses for retail sale require registration and licensing of the finished dosage form, not merely the bulk drug. A mismatch between the registered pack size or strength and the arriving consignment is treated as an unlicensed import under the Drugs and Cosmetics Act, 1940, and exposes the consignment to detention, seizure, and potential confiscation pending regularisation.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 3004 90 48 require BIS certification?

No, Tamoxifen medicaments are not within the BIS Quality Control Order regime; no BIS QCO covers pharmaceutical preparations under Chapter 30. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT administering the ITC (HS) policy overlay.

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

Five documents must be uploaded: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc); the proper officer verifies all five before granting out-of-charge.

Does the oxytocin import prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 affect Tamoxifen consignments?

No, the prohibition applies specifically to oxytocin; Tamoxifen is a distinct active pharmaceutical ingredient and is not covered by S.O. 2357(E) or DGFT Notification 09/2015-2020 dated 23-05-2022.

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