Diluxamide furoate

Diloxanide furoate medicament, measured-dose retail packing

MEFCC CLEARANCE

HSN 3004 90 25 (Diloxanide furoate) is subject to drug-import controls administered through the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940, requiring a valid import licence and registration certificate before the bill of entry is filed. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under the ITC (HS) policy with associated pharmaceutical-import conditions. Additionally, the Ministry of Environment, Forest and Climate Change is listed as a notified regulator for this heading.

What this is

HSN code

3004 90 25

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Drug import conditions under Drugs and Cosmetics Act, 1940 (CDSCO-administered)

Customs documentation

Import licence from CDSCO
Registration certificate from CDSCO
Batch release certificate from manufacturer

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 current import licence for drugs (document code 9111dc) and ensure the registration certificate for drugs (document code 101dc1) is valid for the specific formulation of diloxanide furoate. Both must be uploaded in e-Sanchit before the bill of entry is presented for out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 9111dc and 101dc1
2
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and the label of the consignment (document code 0110dc) in e-Sanchit. The proper officer must verify all five mandatory documents are present before granting out-of-charge on PGA-facilitated bills.
CCR mandatory document list · e-Sanchit document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is treating the import licence (9111dc) as sufficient without ensuring the batch-specific documents — Certificate of Analysis (0010dc) and Batch Release Certificate (0030dc) — are uploaded in e-Sanchit for the precise consignment being cleared. A current licence with absent or mismatched batch documentation routinely triggers detention at the port of entry; the proper officer has explicit instruction to verify all five document codes before granting out-of-charge, and a single missing code is treated as non-compliance regardless of the licence status.

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Frequently asked

Does HSN 3004 90 25 require BIS certification?

No. No BIS Quality Control Order covers this pharmaceutical tariff line. Import of diloxanide furoate medicaments is governed by drug-import licensing under the Drugs and Cosmetics Act, 1940, administered through CDSCO, with DGFT ITC (HS) policy conditions applying concurrently.

Which five documents must be uploaded in e-Sanchit at the bill of entry for this HSN?

The mandatory uploads are: 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 present before out-of-charge is granted.

Does the oxytocin import prohibition or the used medical equipment restriction affect diloxanide furoate imports?

No. The oxytocin prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, and the Ministry of Environment, Forest and Climate Change O.M. dated 15-12-2023 on used medical equipment, are separate conditions applicable to distinct product categories within this heading, not to diloxanide furoate formulations.

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