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

Antimalarial medicaments in measured doses for retail sale

MEFCC CLEARANCE

HSN 3004 60 00 (antimalarial medicaments containing active principles described in Sub-heading Note 2 to Chapter 30) requires Central Drugs Standard Control Organisation (CDSCO) drug registration and an Import Licence for Drugs under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies this tariff line as subject to ITC (HS) policy controls, and import of oxytocin — where it falls within this heading — is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, with the sole exception of oxytocin reference standards for test and analysis.

What this is

HSN code

3004 60 00

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940 (drug registration and import licence regime)

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 filing the bill of entry. Both documents must be uploaded in e-Sanchit; customs out-of-charge will not be granted until the proper officer verifies their presence.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc (CCR e-Sanchit mandate)
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 at the bill of entry stage. These are mandatory pre-out-of-charge documents regardless of whether the bill is PGA-facilitated.
CCR e-Sanchit mandate · document codes 0010dc, 0030dc, 0110dc
3
Confirm the active principle being imported is not oxytocin: import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. The sole permitted exception is import of oxytocin reference standards exclusively for test and analysis, conditional on submission of a test licence issued by DGCI/CDSCO.
S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is failing to verify the precise active principle against the Sub-heading Note 2 scope before classification — antimalarial medicaments falling under 3004 60 00 must contain only the active principles enumerated in Sub-heading Note 2, and any misclassification that obscures an oxytocin-containing product (which is prohibited) exposes the importer to confiscation and prosecution. Where the consignment contains oxytocin reference standards, the DGCI/CDSCO-issued test licence is a hard documentary precondition; absence of that licence at the bill of entry renders the import unlawful, not merely procedurally deficient.

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 60 00 require BIS certification?

No, antimalarial medicaments are not within the BIS Quality Control Order regime; no BIS QCO covers pharmaceutical products under Chapter 30. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT ITC (HS) policy controls and a specific prohibition on oxytocin under S.O. 2357(E).

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

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 in e-Sanchit before out-of-charge is granted.

Can oxytocin reference standards be imported under this tariff line?

Yes, but only for test and analysis purposes, and exclusively on submission of a test licence issued by DGCI/CDSCO; general commercial import of oxytocin is prohibited under DGFT Notification 09/2015-2020 and S.O. 2357(E), both dated 23-05-2022.

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