Methotrexate, 5-fluorouracil(5-FU) and ftorafur

Antineoplastic medicaments (methotrexate, 5-fluorouracil, ftorafur)

MEFCC CLEARANCE

HSN 3004 90 42 (Methotrexate, 5-fluorouracil and ftorafur) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under ITC (HS) import policy controls, and an oxytocin-prohibition overlay under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies to related drug substances in this chapter.

What this is

HSN code

3004 90 42

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

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 and an import licence for drugs from the Central Drugs Standard Control Organisation before filing the bill of entry. Upload the registration certificate (document code 101dc1) and the import licence (document code 9111dc) in e-Sanchit; out-of-charge will not be granted without both documents present.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc · e-Sanchit mandatory-document verification
2
Upload the Certificate of Analysis (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. The proper officer is required to verify all five mandatory document codes before granting out-of-charge on PGA-facilitated bills.
CCR mandatory-document requirement · document codes 0010dc, 0030dc, 0110dc
3
Confirm the consignment does not contain oxytocin in any form other than a reference standard for test and analysis. Import of oxytocin is prohibited; import of oxytocin reference standards is permitted only upon submission of a test licence issued by DGCI/CDSCO.
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 filing the bill of entry with the registration certificate alone and omitting one or more of the batch-level documents — Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc). All five document codes must be present in e-Sanchit simultaneously; a single missing upload triggers detention and demurrage at the port of import, as the proper officer has no discretion to grant out-of-charge on an incomplete document set.

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Frequently asked

Does HSN 3004 90 42 require BIS certification?

No. Antineoplastic medicaments including methotrexate, 5-fluorouracil and ftorafur are not covered by any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with ITC (HS) policy controls administered by the Directorate General of Foreign Trade.

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

Is the import of oxytocin under Chapter 30 completely prohibited?

Import of oxytocin as a finished formulation 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 requires a test licence from DGCI/CDSCO.

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