Atropin and salts thereof

Atropine and its salts, medicaments for retail sale

MEFCC CLEARANCE

HSN 3004 49 10 (Atropine and salts thereof) is subject to drug import controls under the Drugs and Cosmetics Act, 1940, with mandatory registration and import licensing administered through the Central Drugs Standard Control Organisation. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under ITC (HS) policy controls, and the Ministry of Environment, Forest and Climate Change (MoEFCC) conditions apply where used or refurbished medical equipment is co-classified under adjacent provisions.

What this is

HSN code

3004 49 10

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Drugs and Cosmetics Act, 1940; ITC (HS) import policy, Chapter 30

Customs documentation

Registration certificate from CDSCO
Import licence for drugs 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 registration certificate and import licence for atropine or its salts from the Central Drugs Standard Control Organisation before the consignment is shipped. Both documents — registration certificate (document code 101dc1) and import licence for drugs (document code 9111dc) — must be uploaded in e-Sanchit prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis for the drug batch (document code 0010dc), the Batch Release Certificate (document code 0030dc), and the Label of Consignment (document code 0110dc) in e-Sanchit before customs out-of-charge. The proper officer will verify all five mandatory documents before granting out-of-charge.
CBIC e-Sanchit mandatory document verification · document codes 0010dc, 0030dc, 0110dc
3
Note the absolute prohibition on import of oxytocin; confirm the consignment is correctly classified as atropine or its salts and not a prohibited formulation. Import of oxytocin reference standards is the only carved-out exception, and that is permitted solely for test and analysis on production of a test licence issued by DGCI/CDSCO.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is treating the drug import licence as the sole clearance and overlooking that all five e-Sanchit document codes — 101dc1, 9111dc, 0010dc, 0030dc, and 0110dc — must be individually uploaded before the proper officer can grant out-of-charge. A single missing document causes consignment detention at port, accruing demurrage and ground rent; the licence itself does not substitute for the batch-level Certificate of Analysis or the Batch Release Certificate, which must correspond to the specific shipment lot.

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Frequently asked

Does HSN 3004 49 10 require BIS certification?

No, atropine and its salts are pharmaceutical medicaments outside the BIS Quality Control Order regime. Import is governed by drug registration and import licensing requirements under the Drugs and Cosmetics Act, 1940, administered by the Central Drugs Standard Control Organisation, with DGFT ITC (HS) policy controls as an overlay.

Which document codes must be uploaded in e-Sanchit for this tariff line?

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). Out-of-charge is refused until all five are verified in e-Sanchit.

Does the prohibition on oxytocin import affect atropine consignments?

The oxytocin prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies to oxytocin formulations, not to atropine; however, a misclassified or mixed-formulation consignment could attract the prohibition, so the Certificate of Analysis must clearly confirm the active substance as atropine or its specified salt.

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