Pentamidine

Pentamidine medicament, retail-packed therapeutic preparation

MEFCC CLEARANCE

HSN 3004 90 27 (Pentamidine) is subject to drug import licensing and registration under the Drugs and Cosmetics Act, 1940, administered by the Central Drugs Standard Control Organisation (CDSCO), with mandatory e-Sanchit documentation including a Registration Certificate and Import Licence for drugs. The Ministry of Environment, Forest and Climate Change (MEFCC) overlay and Directorate General of Foreign Trade (DGFT) policy conditions apply as additional clearance requirements at the bill-of-entry stage.

What this is

HSN code

3004 90 27

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Ministry of Environment, Forest and Climate Change (legacy code) · 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 Registration Certificate for drugs (document code 101dc1) and an Import Licence for drugs (document code 9111dc) from CDSCO before filing the bill of entry. Both documents must be uploaded in e-Sanchit prior to customs out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis for drugs (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 will verify all five mandatory documents before granting out-of-charge.
CDSCO e-Sanchit mandatory document set · document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is uploading the Registration Certificate and Import Licence while omitting one of the three product-level documents — Certificate of Analysis, Batch Release Certificate, or Label of Consignment — treating them as secondary. All five document codes (0010dc, 0030dc, 0110dc, 101dc1, 9111dc) are mandatory; a missing entry in e-Sanchit is sufficient grounds for the proper officer to withhold out-of-charge, resulting in consignment detention and accruing demurrage.

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Frequently asked

Does HSN 3004 90 27 require BIS certification?

No, pharmaceutical medicaments such as Pentamidine are not within the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with MEFCC and DGFT policy overlays applying at the bill-of-entry stage.

Which five documents must be uploaded in e-Sanchit for Pentamidine imports?

The mandatory set is: Certificate of Analysis for drugs (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 under S.O. 2357(E) and DGFT Notification 09/2015-2020 affect Pentamidine imports?

No. The prohibition on oxytocin imports under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 is specific to oxytocin and does not apply to Pentamidine; however, importers should confirm the consignment description precisely matches the licensed product to avoid misclassification enforcement.

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