Chloroquine, amodiaquine, mefloquine, quinine, chloroguamide, pyrimethamine

Antimalarial medicaments (chloroquine, mefloquine, quinine, pyrimethamine)

MEFCC CLEARANCE

HSN 3004 90 56 covers antimalarial medicaments including chloroquine, amodiaquine, mefloquine, quinine, chloroguamide, and pyrimethamine, and is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. Directorate General of Foreign Trade (DGFT) policy controls apply as an overlay, and mandatory documents including the registration certificate and import licence must be uploaded in e-Sanchit before out-of-charge.

What this is

HSN code

3004 90 56

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence 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, along with the Certificate of Analysis (document code 0010dc), batch release certificate (document code 0030dc), and label of consignment (document code 0110dc).
Drugs and Cosmetics Act, 1940 · e-Sanchit mandatory document codes 101dc1, 9111dc, 0010dc, 0030dc, 0110dc
2
Confirm the consignment does not contain oxytocin, the import of which is prohibited; oxytocin reference standards are permissible only for test and analysis purposes, subject to submission of a test licence issued by the 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 presenting a registration certificate that covers a different drug formulation or strength than the consignment being imported — CDSCO registration is product-specific, and a certificate issued for one salt or concentration does not extend to a related compound in the same antimalarial class. A mismatch between the registered product and the bill of entry description triggers detention and may necessitate re-export, as the consignment cannot be regularised by retrospective amendment of the registration.

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Frequently asked

Does HSN 3004 90 56 require BIS certification?

No, this tariff line falls outside the BIS Quality Control Order regime; no BIS QCO covers antimalarial medicaments. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT policy controls as an additional overlay.

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

Five documents must be uploaded: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc); out-of-charge will not be granted until all five are verified.

Is the import of oxytocin permitted under this HSN?

Import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; the sole exception is oxytocin reference standards imported exclusively for test and analysis, which require a test licence issued by DGCI/CDSCO.

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