Danazol

Danazol medicament, measured-dose pharmaceutical preparation

MEFCC CLEARANCE

HSN 3004 39 14 (Danazol) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration requirements under the Drugs and Cosmetics Act, 1940. Mandatory documents including a Registration Certificate for drugs, Import Licence for drugs, Certificate of Analysis, Batch Release Certificate, and Label of Consignment must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3004 39 14

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 shipment. Both documents must be uploaded in e-Sanchit at the bill of entry prior to out-of-charge.
Drugs and Cosmetics Act, 1940 · document codes 101dc1, 9111dc · e-Sanchit mandatory upload requirement
2
Upload the Certificate of Analysis for drugs (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit before filing the bill of entry. Customs officers verify these documents for PGA-facilitated bills not routed through the PGA for NOC.
Document codes 0010dc, 0030dc, 0110dc · e-Sanchit mandatory upload requirement

A word of counsel

The most common error on this tariff line is conflating the drug Registration Certificate (101dc1) with the Import Licence (9111dc) and uploading only one of the two. Both are independently mandatory at the bill of entry; a missing Registration Certificate results in consignment detention and demurrage even where the Import Licence is current and uploaded. Confirm both document codes are present in e-Sanchit before vessel arrival at the designated port.

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Frequently asked

Does HSN 3004 39 14 require BIS certification?

No, Danazol medicament falls outside the BIS Quality Control Order regime; no BIS QCO covers this pharmaceutical product family. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT ITC (HS) policy controls as an additional overlay.

Which e-Sanchit document codes are mandatory for Danazol imports at the bill of entry?

Five documents are mandatory: Certificate of Analysis for drugs (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 customs out-of-charge.

Does the oxytocin import prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 affect the import of Danazol under this HSN?

No, the oxytocin prohibition applies to oxytocin formulations under the same chapter heading and does not govern Danazol; Danazol imports remain subject to standard CDSCO registration and licensing requirements without the oxytocin-specific restriction.

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