Sodium stibogluconate

Sodium stibogluconate medicament, antimonial antiparasitic drug

MEFCC CLEARANCE

HSN 3004 90 26 (Sodium stibogluconate) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940, with mandatory document verification at the bill-of-entry stage. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy overlay applicable to pharmaceutical products under Chapter 30.

What this is

HSN code

3004 90 26

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Import licence for drugs from CDSCO
Registration certificate 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 import licence for drugs (document code 9111dc) and a registration certificate for drugs (document code 101dc1) from CDSCO before shipment. Both documents must be uploaded in e-Sanchit prior to filing the bill of entry; the proper officer will verify these before granting out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 9111dc and 101dc1
2
Upload the Certificate of Analysis for drugs (document code 0010dc), Batch Release Certificate (document code 0030dc), and the label of consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. Absence of any of these three documents will prevent customs out-of-charge.
e-Sanchit document codes 0010dc, 0030dc, 0110dc · CDSCO import documentation requirements

A word of counsel

The most common error on this tariff line is conflating the drug import licence (9111dc) with the drug registration certificate (101dc1) and uploading only one of the two in e-Sanchit. Both are independently mandatory, and the customs proper officer is instructed to verify each document code separately before out-of-charge; a consignment with a current licence but without a valid registration certificate — or vice versa — will be detained, accruing demurrage and ground rent until the missing document is produced.

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Frequently asked

Does HSN 3004 90 26 require BIS certification?

No. No BIS Quality Control Order covers sodium stibogluconate or this pharmaceutical product family. Import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, with the ITC (HS) import policy administered by the Directorate General of Foreign Trade as the policy overlay.

Which document codes must be uploaded in e-Sanchit for this tariff line?

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 present before the proper officer grants out-of-charge.

Does the oxytocin import prohibition noted in the CCR affect sodium stibogluconate consignments?

No. The prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies specifically to oxytocin, a distinct drug; sodium stibogluconate is an antimonial antiparasitic and is not subject to that prohibition, though the full CDSCO licensing and registration regime applies.

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