Indomethacin

Indomethacin medicaments in measured doses for retail sale

MEFCC CLEARANCE

HSN 3004 90 65 (Indomethacin) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit documentation verified at the bill of entry. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy overlay, and an oxytocin-prohibition carve-out under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies to the broader tariff chapter.

What this is

HSN code

3004 90 65

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Certificate of Analysis from exporter

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 the drug (document code 101dc1) and an import licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before the consignment departs. Both documents must be uploaded in e-Sanchit prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc · e-Sanchit mandatory-document requirement
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 before customs out-of-charge. The proper officer is required to verify all five mandatory documents before granting out-of-charge on PGA-facilitated bills.
CCR mandatory-document list · document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is submitting an incomplete e-Sanchit set — typically the Batch Release Certificate (0030dc) or the Label of Consignment (0110dc) is omitted under the assumption that the registration certificate and import licence alone suffice. All five document codes (0010dc, 0030dc, 0110dc, 101dc1, 9111dc) must be uploaded and verifiable before the proper officer can grant out-of-charge; a missing document at the bill-of-entry stage results in consignment detention and accruing demurrage until the deficiency is remedied.

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Frequently asked

Does HSN 3004 90 65 require BIS certification?

No, Indomethacin medicaments 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 DGFT administering the ITC (HS) import policy overlay.

Which five documents must be uploaded in e-Sanchit for this tariff line?

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 uploaded before out-of-charge is granted.

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

No, the oxytocin prohibition applies to oxytocin and its formulations, not to Indomethacin; however, importers should ensure the consignment description and documentation clearly identify the active pharmaceutical ingredient to avoid misclassification scrutiny at the bill-of-entry stage.

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