Tranquilizers

Tranquilizer medicaments in measured doses for retail sale

MEFCC CLEARANCE

HSN 3004 90 89 (Tranquilizers) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940, with mandatory document verification at the bill-of-entry stage. The Directorate General of Foreign Trade (DGFT) administers an ITC (HS) policy overlay, and import of oxytocin falling within this tariff line is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

What this is

HSN code

3004 90 89

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940 (import licence and registration 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 ensure the drug registration certificate (document code 101dc1) for the specific tranquilizer formulation is current. Both documents must be uploaded in e-Sanchit before the bill of entry is filed; consignments lacking either document will be held without out-of-charge.
Drugs and Cosmetics Act, 1940 · document codes 9111dc and 101dc1 per CCR
2
Upload the full set of mandatory drug-clearance documents in e-Sanchit: Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), Label of Consignment (document code 0110dc), Registration Certificate (document code 101dc1), and Import Licence for Drugs (document code 9111dc). The proper officer will verify these before granting out-of-charge.
CCR e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Confirm the tranquilizer formulation is not oxytocin or an oxytocin-based product; import of oxytocin is prohibited, and only oxytocin reference standards for test and analysis are permitted, exclusively on production of a test licence issued by DGCI/CDSCO.
S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is filing the bill of entry with the import licence and registration certificate uploaded but omitting the Batch Release Certificate (0030dc) or Certificate of Analysis (0010dc), which are treated as independent mandatory documents — not annexures to the licence. Customs officers conducting PGA-facilitated-bill verification will deny out-of-charge for any missing document code regardless of the validity of the licence, and the resulting detention accrues demurrage from the date of arrival.

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Frequently asked

Does HSN 3004 90 89 require BIS certification?

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

Which document codes must be uploaded in e-Sanchit for tranquilizer imports under this HSN?

Five documents are mandatory: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc); all must be present before the proper officer grants out-of-charge.

Is any tranquilizer formulation outright prohibited under this tariff line?

Yes. Import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; the sole carve-out permits import of oxytocin reference standards exclusively for test and analysis, subject to a test licence from DGCI/CDSCO.

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