Losartan

Losartan medicaments in measured doses for retail sale

MEFCC CLEARANCE

HSN 3004 90 73 (Losartan) 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. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy overlay applicable to this pharmaceutical tariff line. Customs out-of-charge requires prior upload of five prescribed documents in e-Sanchit, including a registration certificate and import licence for drugs.

What this is

HSN code

3004 90 73

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 (document code 101dc1) and an import licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before the consignment is dispatched. Both documents must be current and cover the specific Losartan formulation and pack size being imported.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
2
Upload all five mandatory documents in e-Sanchit prior to filing the bill of entry: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). The proper officer will verify each upload before granting out-of-charge.
CBIC PGA-facilitated bill verification procedure · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc

A word of counsel

The single most common failure on this tariff line is presenting a registration certificate that covers a different strength or formulation of Losartan than the consignment actually shipped — CDSCO registration is formulation-specific, and a strength mismatch between the 101dc1 and the batch release certificate (0030dc) triggers consignment detention pending regularisation. Verify that the registered product description, pack size, and manufacturer details on the registration certificate align exactly with the invoice and Certificate of Analysis before out-of-charge is requested.

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Frequently asked

Does HSN 3004 90 73 require BIS certification?

No. No BIS Quality Control Order covers Losartan medicaments under HSN 3004 90 73. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with the ITC (HS) policy overlay administered by the Directorate General of Foreign Trade.

Which document codes must be uploaded in e-Sanchit for Losartan imports?

Five documents are mandatory: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). Out-of-charge will not be granted until all five are verified in e-Sanchit.

Does the oxytocin import prohibition affect Losartan consignments under this HSN?

No. The prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies exclusively to oxytocin, not to Losartan; however, an importer whose consignment contains any oxytocin admixture — even incidentally — would require a DGCI/CDSCO test licence for any oxytocin reference standard component.

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