Other, containing antimalarial active principles described in Sub-heading Note 2 to this Chapter

Antimalarial medicaments, bulk mixed formulations not for retail

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3003 60 00 (antimalarial medicaments containing active principles described in Sub-heading Note 2 to Chapter 30) is governed by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940, requiring a valid import licence and drug registration before a bill of entry can be filed. Five mandatory documents — including a Certificate of Analysis, batch release certificate, and specimen label — must be uploaded in e-Sanchit before customs out-of-charge is granted.

What this is

HSN code

3003 60 00

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Import licence from CDSCO
Registration certificate from CDSCO
Batch release certificate from manufacturer

Compliance steps

1
Secure a valid drug import licence (document code 9111dc) and a current registration certificate for the drug (document code 101dc1) from the Central Drugs Standard Control Organisation before shipment is dispatched. Both documents must be uploaded in e-Sanchit and cover the specific antimalarial formulation being imported.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 9111dc and 101dc1
2
Upload the Certificate of Analysis (document code 0010dc), batch release certificate (document code 0030dc), and consignment label (document code 0110dc) in e-Sanchit prior to filing the bill of entry. The customs proper officer will verify all five mandatory documents before granting out-of-charge.
e-Sanchit document codes 0010dc, 0030dc, 0110dc · Drugs and Cosmetics Act, 1940

A word of counsel

The single most common failure on this tariff line is uploading an import licence that does not specifically cover the antimalarial active principles enumerated in Sub-heading Note 2 to Chapter 30. A generic drug import licence that does not identify the scheduled antimalarial active ingredient is treated as non-compliant at the bill of entry stage, resulting in consignment detention, accruing demurrage and ground rent, until a correctly scoped licence is produced.

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Frequently asked

Does HSN 3003 60 00 require BIS certification?

No, bulk antimalarial medicament formulations are not within the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, requiring a drug import licence, registration certificate, and supporting analytical documents uploaded in e-Sanchit.

Are all five e-Sanchit documents mandatory even when the bill is PGA-facilitated?

Yes. The customs proper officer is required to verify that document codes 0010dc, 0030dc, 0110dc, 101dc1, and 9111dc have all been uploaded in e-Sanchit before granting out-of-charge, regardless of whether the bill was routed through the PGA for NOC.

Does the medicament need to be in retail packaging to fall under this HSN?

No. HSN 3003 60 00 covers mixed antimalarial formulations that are NOT put up in measured doses or in forms or packings for retail sale; products in retail-ready measured doses or retail packs fall under heading 3004 and attract a separate import regime.

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