Isoniazid

Isoniazid medicaments in measured doses for retail sale

MEFCC CLEARANCE

HSN 3004 90 51 (Isoniazid) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. Mandatory e-Sanchit document upload — including registration certificate, import licence, Certificate of Analysis, and batch release certificate — is required before customs out-of-charge. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) policy overlay applicable to this tariff line.

What this is

HSN code

3004 90 51

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 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 and an import licence for drugs from CDSCO before filing the bill of entry. Upload the registration certificate (document code 101dc1) and the import licence (document code 9111dc) in e-Sanchit; out-of-charge will not be granted until both documents are verified.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc per CCR e-Sanchit requirements
2
Upload the Certificate of Analysis for drugs (document code 0010dc), the batch release certificate (document code 0030dc), and the label of the consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. These are mandatory documents verified by the proper officer on PGA-facilitated bills before out-of-charge.
Document codes 0010dc, 0030dc, and 0110dc per CCR e-Sanchit requirements

A word of counsel

The most common error on this tariff line is filing the bill of entry with the registration certificate and import licence in order while omitting the batch release certificate or Certificate of Analysis. Customs proper officers are instructed to verify all five mandatory document codes — 101dc1, 9111dc, 0010dc, 0030dc, and 0110dc — before granting out-of-charge; a single missing upload causes consignment detention, triggering demurrage and ground rent that cannot be recovered retroactively.

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Frequently asked

Does HSN 3004 90 51 require BIS certification?

No, pharmaceutical medicaments such as Isoniazid 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) policy overlay.

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

Five documents are mandatory: 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 Isoniazid consignments?

No. The prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies exclusively to oxytocin, not to Isoniazid; the two active pharmaceutical ingredients are distinct and classified under separate regulatory controls.

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