Anthelmintics and preparations thereof

Anthelmintic medicaments and preparations for retail sale

MEFCC CLEARANCE

HSN 3004 90 21 (Anthelmintics and preparations thereof) is subject to drug import licensing and registration under the Drugs and Cosmetics Act, 1940, administered by the Central Drugs Standard Control Organisation (CDSCO). The Directorate General of Foreign Trade (DGFT) classifies this tariff line as subject to policy conditions, including a prohibition on the import of oxytocin under DGFT Notification 09/2015-2020 dated 23-05-2022.

What this is

HSN code

3004 90 21

Chapter

30 · Pharmaceutical products

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
Import licence for drugs from CDSCO
Batch release certificate 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
Ensure the anthelmintic product holds a valid CDSCO registration certificate and import licence for drugs before filing the bill of entry. Upload the registration certificate (document code 101dc1) and the import licence for drugs (document code 9111dc) in e-Sanchit; customs out-of-charge will not be granted without these documents.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc · CDSCO import licensing regime
2
Upload the Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. The proper officer must verify all five mandatory documents are present before granting out-of-charge on PGA-facilitated bills.
CDSCO mandatory document set · document codes 0010dc, 0030dc, 0110dc
3
Confirm the consignment does not contain oxytocin, the import of which is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. Import of oxytocin reference standards is the sole permitted exception, and only subject to a test licence issued by DGCI/CDSCO for test and analysis purposes exclusively.
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 distinguish between the oxytocin general-import prohibition and the narrow research-use carve-out: a test licence issued by DGCI/CDSCO authorises oxytocin reference standards solely for test and analysis, and any consignment presented as a therapeutic or prophylactic preparation containing oxytocin is liable to outright confiscation with no rectification window. Separately, anthelmintic importers sometimes upload only the registration certificate and omit the batch release certificate (0030dc) or the label (0110dc), which triggers hold pending re-upload and accrues demurrage.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 3004 90 21 require BIS certification?

No. No BIS Quality Control Order covers anthelmintic medicaments. Import is governed by the drug registration and licensing regime under the Drugs and Cosmetics Act, 1940 administered by the Central Drugs Standard Control Organisation, with policy conditions including the oxytocin prohibition administered by DGFT under DGFT Notification 09/2015-2020.

Which documents must be uploaded in e-Sanchit for anthelmintic drug imports?

Five documents are mandatory: Certificate of Analysis — Drug (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 customs out-of-charge is granted.

Can oxytocin reference standards be imported under this HSN?

Yes, but only on a test licence issued by DGCI/CDSCO and exclusively for test and analysis purposes; commercial therapeutic imports of oxytocin are prohibited under 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.