Other antiepileptic drugs

Antiepileptic medicaments in measured doses for retail sale

MEFCC CLEARANCE

HSN 3004 90 82 (Other antiepileptic drugs) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit document upload before out-of-charge at the bill of entry. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) policy overlay, and a specific prohibition on oxytocin import applies under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

What this is

HSN code

3004 90 82

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940 (import licence and registration, drugs)

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 import licence for drugs (document code 9111dc) and a registration certificate for drugs (document code 101dc1) from CDSCO before the consignment departs the country of export. Both documents must be uploaded in e-Sanchit before the bill of entry is filed; customs out-of-charge will not be granted without confirmed upload.
Drugs and Cosmetics Act, 1940 · CDSCO import licence requirement · document codes 9111dc and 101dc1
2
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit. The proper officer is directed to verify these uploads for all PGA-facilitated bills not routed through the PGA for NOC.
CDSCO document codes 0010dc, 0030dc, 0110dc · e-Sanchit verification instruction in CCR
3
Confirm the consignment does not contain oxytocin: import of oxytocin is prohibited, except for reference standards exclusively for test and analysis with a test licence issued by DGCI/CDSCO. Any oxytocin present outside this carve-out attracts confiscation and criminal liability.
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 failing to upload all five mandatory documents — import licence (9111dc), registration certificate (101dc1), Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc) — before filing the bill of entry. A single missing upload results in consignment detention and ground rent accumulation; the proper officer is explicitly directed to verify each document code in e-Sanchit before granting out-of-charge, so post-arrival remediation at the port is not available.

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Frequently asked

Does HSN 3004 90 82 require BIS certification?

No. No BIS Quality Control Order covers antiepileptic medicaments under this tariff line. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with an ITC (HS) policy overlay administered by DGFT.

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

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 uploaded before out-of-charge is granted.

Is oxytocin permitted under this HSN if the importer holds a CDSCO import licence?

No. Import of oxytocin is prohibited regardless of licence status; the sole exception is oxytocin reference standards imported exclusively for test and analysis under a test licence issued by DGCI/CDSCO, per S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

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