Isoniazid

Isoniazid medicaments containing antibiotics, retail pack

MEFCC CLEARANCE

HSN 3004 20 91 (Isoniazid) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit documentation verified at the bill-of-entry stage. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy overlay applicable to this tariff line, and the Ministry of Environment, Forest and Climate Change is listed as a notified PGA for this heading.

What this is

HSN code

3004 20 91

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Drugs and Cosmetics Act, 1940 (CDSCO import licensing regime)

Customs documentation

Import licence for drugs from CDSCO
Registration certificate 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 import licence for drugs (document code 9111dc) and a registration certificate for drugs (document code 101dc1) from the Central Drugs Standard Control Organisation before shipment. Both documents must be uploaded in e-Sanchit prior to filing the bill of entry; customs out-of-charge will not be granted until the proper officer verifies their presence in the system.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 9111dc and 101dc1
2
Upload the Certificate of Analysis for drugs (document code 0010dc), the Batch Release Certificate (document code 0030dc), and the Label of Consignment (document code 0110dc) in e-Sanchit at the bill of entry. PGA-facilitated bills not routed through the PGA for NOC are subject to direct verification of all five mandatory documents by the proper officer before out-of-charge.
e-Sanchit document codes 0010dc, 0030dc, 0110dc · CDSCO import documentation requirements

A word of counsel

The most common error on this tariff line is treating the import licence alone as sufficient clearance, while overlooking that the proper officer will independently verify all five e-Sanchit documents — 9111dc, 101dc1, 0010dc, 0030dc, and 0110dc — before granting out-of-charge, even on PGA-facilitated bills. A missing or expired batch release certificate or label upload at the time of bill-of-entry filing results in consignment detention and accumulating demurrage; pre-lodgement of all documents in e-Sanchit before vessel arrival is the operative safeguard.

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Frequently asked

Does HSN 3004 20 91 require BIS certification?

No. No BIS Quality Control Order covers isoniazid medicaments under this tariff line. Import is governed by Central Drugs Standard Control Organisation licensing and registration under the Drugs and Cosmetics Act, 1940, with the ITC (HS) import policy administered by the Directorate General of Foreign Trade as an overlay.

Which five documents must be uploaded in e-Sanchit before out-of-charge for this HSN?

The mandatory uploads are: 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 in e-Sanchit before the proper officer grants out-of-charge.

Does the oxytocin import prohibition affect isoniazid consignments under this tariff line?

No. The prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies specifically to oxytocin (permitted only as a reference standard for test and analysis under a DGCI/CDSCO test licence) and does not restrict isoniazid, which falls under a separate drug-import licence regime.

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