Other antimalarial drugs

Other antimalarial medicaments in measured doses

MEFCC CLEARANCE · NDPS CLEARANCE

HSN 3004 90 59 (Other antimalarial drugs) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940, with mandatory document verification at the bill-of-entry stage. Narcotic Drugs and Psychotropic Substances (NDPS) controls apply where a scheduled psychotropic substance — notably tramadol — is present in the formulation, and the Directorate General of Foreign Trade (DGFT) administers additional ITC (HS) policy conditions including a prohibition on oxytocin imports.

What this is

HSN code

3004 90 59

Chapter

30 · Pharmaceutical products

Primary regulator

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

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

NDPSNDPS·Narcotics Control Bureau

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.

Compliance steps

1
Obtain a valid drug registration certificate and import licence from the Central Drugs Standard Control Organisation before filing the bill of entry. Upload the registration certificate (document code 101dc1), import licence for drugs (document code 9111dc), certificate of analysis (document code 0010dc), batch release certificate (document code 0030dc), and label of consignment (document code 0110dc) in e-Sanchit prior to out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1, 9111dc, 0010dc, 0030dc, 0110dc
2
Where the formulation contains tramadol or any other scheduled psychotropic substance, produce an import certificate issued by the Narcotics Commissioner before the consignment is released. Import of tramadol without this certificate is prohibited under Rule 53 of the NDPS Rules.
Rule 53 of the NDPS Rules · S.O. 1761(E) dated 26-04-2018, Department of Revenue
3
Confirm the consignment does not contain oxytocin — imports of oxytocin are prohibited, except for oxytocin reference standards imported exclusively for test and analysis on production of a test licence issued by DGCI/CDSCO. Non-compliant consignments are liable to detention and confiscation.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is assuming that a current CDSCO drug registration and import licence cover all formulations classified under 3004 90 59, without separately checking whether any active pharmaceutical ingredient triggers an NDPS import-certificate requirement or an outright prohibition. Tramadol is prohibited unless the Narcotics Commissioner's import certificate is produced; oxytocin is prohibited entirely except for reference-standard quantities under a DGCI/CDSCO test licence. A missing NDPS certificate results in consignment detention and potential criminal liability under the Narcotic Drugs and Psychotropic Substances Act, 1985.

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 90 59 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 CDSCO under the Drugs and Cosmetics Act, 1940, with NDPS controls applying to any scheduled psychotropic substance present in the formulation.

Which document codes must be uploaded in e-Sanchit before out-of-charge 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 to be uploaded in e-Sanchit before the proper officer grants out-of-charge.

Is oxytocin absolutely prohibited under this tariff line, or are there exemptions?

Import of oxytocin is prohibited as a general rule; the sole exemption covers oxytocin reference standards imported exclusively for test and analysis, subject to submission of a test licence issued by DGCI/CDSCO, per S.O. 2357(E) and DGFT Notification 09/2015-2020 both dated 23-05-2022.

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