Acetyl salicylic acid (aspirin) and formulations thereof

Acetyl salicylic acid (aspirin) medicaments, formulations thereof

MEFCC CLEARANCE

HSN 3004 90 62 (Acetyl salicylic acid (aspirin) and formulations thereof) is subject to Central Drugs Standard Control Organisation (CDSCO) drug-import licensing and registration under the Drugs and Cosmetics Act, 1940, with mandatory document verification at the bill of entry. The Directorate General of Foreign Trade (DGFT) administers the applicable ITC (HS) import policy, and an oxytocin-prohibition carve-out under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies as an additional policy overlay.

What this is

HSN code

3004 90 62

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate (drugs) from CDSCO
Import licence for drugs from CDSCO
Certificate of Analysis (drug) 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 import licence and registration certificate from the Central Drugs Standard Control Organisation before the consignment is shipped. Both documents must be uploaded in e-Sanchit under document codes 9111dc (import licence for drugs) and 101dc1 (registration certificate for drugs) prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · document codes 9111dc and 101dc1
2
Upload all five mandatory documents in e-Sanchit before customs out-of-charge: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). Consignments presented without any of these documents are detained at the port pending regularisation.
e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Confirm the consignment does not contain oxytocin in any form, as import of oxytocin is prohibited. The sole permitted exception is oxytocin reference standards imported exclusively for test and analysis, subject to a test licence issued by DGCI/CDSCO.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is presenting an otherwise complete CDSCO file while overlooking the Batch Release Certificate (0030dc) as a standalone mandatory document separate from the Certificate of Analysis. Customs officers verify all five e-Sanchit codes individually; a missing Batch Release Certificate triggers detention and ground rent liability regardless of whether the Certificate of Analysis is current and valid. Importers carrying aspirin formulations that contain oxytocin as an ancillary ingredient must additionally produce the DGCI/CDSCO test licence or face outright prohibition enforcement.

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Frequently asked

Does HSN 3004 90 62 require BIS certification?

No, aspirin and its formulations are not within the BIS Quality Control Order regime; no BIS QCO covers pharmaceutical medicaments under Chapter 30. 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.

Are all five e-Sanchit document codes mandatory at the bill of entry, or do some apply only conditionally?

All five — Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate (101dc1), and Import Licence for Drugs (9111dc) — are mandatory and must be uploaded in e-Sanchit before customs out-of-charge; none is conditional on the consignment value or quantity.

Is the import of oxytocin reference standards permissible under this tariff line?

Yes, but only for test and analysis purposes and only on production of a test licence issued by DGCI/CDSCO; commercial import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 both dated 23-05-2022.

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