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HomeHSNChapter 30HSN 3004 39 13

Dexamethasone

Dexamethasone medicaments in measured doses for retail

MEFCC CLEARANCE

HSN 3004 39 13 (Dexamethasone) is subject to drug import registration and licensing under the Drugs and Cosmetics Act, 1940, with the Central Drugs Standard Control Organisation (CDSCO) requiring a Registration Certificate and Import Licence before the bill of entry is filed. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under the ITC (HS) policy framework, and mandatory documents including Certificate of Analysis and Batch Release Certificate must be uploaded in e-Sanchit prior to out-of-charge.

What this is
HSN code
3004 39 13
Chapter
30 · Pharmaceutical products
Primary regulator
CDSCO · Drugs and Cosmetics Act, 1940 (drug import registration and licence)
Customs documentation
  • Registration certificate from CDSCO
  • Import licence 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. 1
    Obtain a Registration Certificate (Drugs) under document code 101dc1 and an Import Licence for Drugs under document code 9111dc from CDSCO before shipment. Both documents must be current and uploaded in e-Sanchit at the time of filing the bill of entry.
    Drugs and Cosmetics Act, 1940 · document codes 101dc1, 9111dc · e-Sanchit mandatory upload requirement
  2. 2
    Upload the Certificate of Analysis (Drugs) under document code 0010dc, the Batch Release Certificate under document code 0030dc, and the Label of Consignment under document code 0110dc in e-Sanchit prior to customs out-of-charge. Consignments lacking any of these documents are detained pending upload.
    CDSCO mandatory document codes 0010dc, 0030dc, 0110dc · e-Sanchit out-of-charge requirement
A word of counsel

The most common error on this tariff line is treating the Import Licence alone as sufficient clearance and overlooking the Batch Release Certificate and Certificate of Analysis as independent mandatory uploads. A consignment with a valid Registration Certificate and Import Licence but missing either batch-level document will be detained at port pending e-Sanchit remediation, attracting demurrage and ground rent while CDSCO verification is outstanding.

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Frequently asked
Does HSN 3004 39 13 require BIS certification?
No, Dexamethasone medicaments are not within the BIS Quality Control Order regime. Import is governed by the Drugs and Cosmetics Act, 1940 administered through CDSCO, which requires a Registration Certificate, Import Licence, Certificate of Analysis, and Batch Release Certificate at the bill of entry.
Which document codes must be uploaded 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 customs out-of-charge is granted.
Does the oxytocin import prohibition referenced in the CCR affect Dexamethasone imports?
No. The prohibition on oxytocin under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies specifically to oxytocin, not to Dexamethasone; however, importers should ensure classification is correctly recorded at the bill of entry to avoid misdeclaration scrutiny.
Last verified against gazette notifications: 2026-05-16. Source: MEFCC / DGFT / Indian Customs CUSDATA.
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