Omeprazole and lansoprazole

Omeprazole and lansoprazole medicaments, retail-packed

MEFCC CLEARANCE

HSN 3004 90 34 (Omeprazole and lansoprazole) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit document uploads before customs out-of-charge. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) policy overlay, including a prohibition on oxytocin imports under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 that is operative at the chapter level.

What this is

HSN code

3004 90 34

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence for drugs from CDSCO
Certificate of Analysis 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 valid drug registration certificate and import licence for the omeprazole or lansoprazole formulation from CDSCO before shipment. Upload both documents in e-Sanchit under document codes 101dc1 (registration certificate, drugs) and 9111dc (import licence for drugs) prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc per CCR e-Sanchit requirement
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 before customs out-of-charge. Proper officers verify these on all PGA-facilitated bills that have not been routed through the PGA for NOC.
CCR e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is shipping without a batch-specific Certificate of Analysis and Batch Release Certificate matched to the consignment lot number — registration and import licence are necessary but not sufficient. Customs officers verify all five mandatory document codes (0010dc, 0030dc, 0110dc, 101dc1, 9111dc) in e-Sanchit at out-of-charge, and a missing or mismatched batch document detains the consignment regardless of whether the drug registration is current.

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Frequently asked

Does HSN 3004 90 34 require BIS certification?

No. No BIS Quality Control Order covers omeprazole or lansoprazole medicaments. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT administering the ITC (HS) policy overlay at the bill of entry.

Are all five e-Sanchit document codes mandatory for every shipment of omeprazole or lansoprazole?

Yes. The CCR requires that document codes 0010dc (Certificate of Analysis), 0030dc (Batch Release Certificate), 0110dc (Label of Consignment), 101dc1 (Registration Certificate), and 9111dc (Import Licence for Drugs) all be uploaded in e-Sanchit before the proper officer grants out-of-charge.

Does the oxytocin import prohibition under S.O. 2357(E) affect omeprazole or lansoprazole consignments?

No, the prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies specifically to oxytocin; omeprazole and lansoprazole are distinct proton-pump inhibitors and are not restricted under that notification, though the full CDSCO registration and import-licence regime remains applicable.

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