Cyclophosphamide

Cyclophosphamide medicaments in measured doses for retail

MEFCC CLEARANCE

HSN 3004 90 41 (Cyclophosphamide) 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 a restricted import policy, and mandatory pre-clearance documents — including a Certificate of Analysis, Batch Release Certificate, and Registration Certificate — must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3004 90 41

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 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 CDSCO before the consignment is shipped. Both documents must be uploaded in e-Sanchit at the bill of entry stage; customs out-of-charge will not be granted until both are verified.
Drugs and Cosmetics Act, 1940 · CDSCO drug registration and import licence regime · document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit before filing the bill of entry. Proper officers are instructed to verify all five mandatory document codes before granting out-of-charge on PGA-facilitated bills.
CDSCO mandatory e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc

A word of counsel

The most frequent error on this tariff line is uploading only the Registration Certificate and Import Licence while omitting the Batch Release Certificate or Certificate of Analysis. All five document codes — 0010dc, 0030dc, 0110dc, 101dc1, and 9111dc — are independently verified by the proper officer on PGA-facilitated bills; a single missing document triggers consignment detention and demurrage, with no provision for post-arrival documentary curing once the bill of entry has been assessed.

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Frequently asked

Does HSN 3004 90 41 require BIS certification?

No, cyclophosphamide medicaments are not within the BIS Quality Control Order regime. Import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, requiring drug registration, an import licence, and batch-level documentation uploaded in e-Sanchit before customs out-of-charge.

Which five documents must be uploaded in e-Sanchit for this tariff line?

Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc); all five must be present before the proper officer grants out-of-charge.

Does the oxytocin import prohibition affect cyclophosphamide imports under this tariff line?

No. The prohibition on oxytocin imports under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies specifically to oxytocin formulations, not to cyclophosphamide; the standard CDSCO registration and import-licence framework governs this HSN.

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