Phenobarbitone, mephobarbitone, primidone, phenytoin, carbamazepine, ethosuccimide, valporic acid (sodium valporate), diazepam, lamotrigine, gabapentin, bigabatrin, phenacemide, trimethadione and acetazolamide

Anti-epileptic medicaments in measured doses for retail sale

MEFCC CLEARANCE

HSN 3004 90 81 covers anti-epileptic medicaments — including phenobarbitone, carbamazepine, sodium valproate, diazepam, lamotrigine, and gabapentin — and is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies the tariff line as policy-controlled, and five mandatory documents must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3004 90 81

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940 (drug registration and import licensing)

Customs documentation

Import licence for drugs from CDSCO
Registration certificate from CDSCO
Certificate of Analysis 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 (document code 9111dc) and a registration certificate for the specific drug product (document code 101dc1) from the Central Drugs Standard Control Organisation before filing the bill of entry. Both instruments must be current and cover the product formulation being imported.
Drugs and Cosmetics Act, 1940 · CDSCO drug registration and import licensing framework
2
Upload all five mandatory documents in e-Sanchit prior to 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). The customs proper officer will verify each document code before granting OOC on PGA-facilitated bills.
CCR e-Sanchit document requirements: 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Note that import of oxytocin is prohibited under this chapter; import of oxytocin reference standards is permitted exclusively for test and analysis purposes, subject to submission of a test licence issued by DGCI/CDSCO. Ensure no prohibited substance is included in the consignment.
S.O. 2357(E) · DGFT Notification 09/2015-2020, both dated 23-05-2022

A word of counsel

The most common error on this tariff line is uploading an import licence that covers the active pharmaceutical ingredient generically, without confirming the registration certificate (101dc1) names the specific finished-dose formulation and pack size being imported. A mismatch between the registered product description and the consignment label triggers detention and potential re-export, as the batch release certificate and certificate of analysis are validated against the registered product — not the licence alone.

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Frequently asked

Does HSN 3004 90 81 require BIS certification?

No, anti-epileptic medicaments in measured doses 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 policy controls and mandatory e-Sanchit documentation requirements applying at the bill-of-entry stage.

Which document codes are mandatory in e-Sanchit for this tariff line?

Five document codes are required: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc); all must be uploaded before the customs proper officer grants out-of-charge.

Is the prohibition on oxytocin import relevant to anti-epileptic drug consignments under this HSN?

The oxytocin prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies to the broader chapter and can trigger scrutiny; importers must ensure no oxytocin is present in the consignment, as its inclusion renders that portion liable to confiscation regardless of a valid drug import licence for the anti-epileptic products.

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