Ergot preparations, ergotamine and salts thereof

Ergot preparations, ergotamine and salts thereof (medicaments)

MEFCC CLEARANCE · NDPS CLEARANCE

HSN 3004 49 40 (Ergot preparations, ergotamine and salts thereof) is subject to Narcotic Drugs and Psychotropic Substances (NDPS) controls: import of ergotamine and its salts is prohibited except under a No Objection Certificate issued by the Narcotics Commissioner, per the NDPS (Regulated Controlled Substances) Order, 2013 [G.S.R. 191(E) dated 26-03-2013]. The Directorate General of Foreign Trade (DGFT) classifies this tariff line as Restricted under the ITC (HS) import policy, and mandatory drug-registration documents must be uploaded in e-Sanchit before out-of-charge.

What this is

HSN code

3004 49 40

Chapter

30 · Pharmaceutical products

Primary regulator

NDPS · Narcotic Drugs and Psychotropic Substances (Regulated Controlled Substances) Order, 2013 [G.S.R. 191(E)]

Customs documentation

NOC from Narcotics Commissioner
Registration certificate from CDSCO
Import licence for drugs from CDSCO

Applicable Partner Government Agencies

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

NDPSNDPS·Narcotics Control Bureau

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.

Compliance steps

1
Obtain a No Objection Certificate from the Narcotics Commissioner before shipment. Import of ergotamine and its salts without a current NOC constitutes a prohibited import under the NDPS (Regulated Controlled Substances) Order, 2013, and is liable to seizure and criminal prosecution under the NDPS Act.
NDPS (Regulated Controlled Substances) Order, 2013 · G.S.R. 191(E) dated 26-03-2013
2
Upload all mandatory drug documents in e-Sanchit before filing the bill of entry: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), Label of Consignment (document code 0110dc), Registration Certificate — Drugs (document code 101dc1), and Import Licence for Drugs (document code 9111dc). The customs officer must verify these uploads before granting out-of-charge.
CBIC e-Sanchit mandatory document codes: 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Note that import of oxytocin under this heading is prohibited; import of oxytocin reference standards is permitted exclusively for test and analysis, subject to submission of a test licence issued by DGCI/CDSCO. Confirm the product scope does not encompass oxytocin formulations before shipment.
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 treating the CDSCO drug registration and import licence as sufficient clearance, without separately securing the Narcotics Commissioner's NOC for ergotamine and its salts. The NDPS (Regulated Controlled Substances) Order, 2013 operates independently of the drugs-registration regime: a consignment bearing a valid CDSCO registration certificate but lacking a current NOC from the Narcotics Commissioner is liable to seizure and prosecution under the NDPS Act, regardless of the drug-import licence status.

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Frequently asked

Does HSN 3004 49 40 require BIS certification?

No, ergot preparations and ergotamine medicaments are not within the BIS Quality Control Order regime; no BIS QCO covers this product family. Import is governed by the NDPS (Regulated Controlled Substances) Order, 2013 requiring a Narcotics Commissioner NOC, with CDSCO drug-registration and import-licence requirements applying concurrently.

Which e-Sanchit document codes are mandatory at the bill of entry for this tariff line?

Five document codes must be uploaded: 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 officer verifies all five before granting out-of-charge.

Is the import prohibition on oxytocin relevant to ergotamine importers under this HSN?

Yes, as both oxytocin formulations and ergotamine salts fall under HSN 3004 49 40; importers must confirm their product does not constitute oxytocin, which is unconditionally prohibited, while oxytocin reference standards remain permissible solely for test and analysis under a DGCI/CDSCO test licence per S.O. 2357(E) and DGFT Notification 09/2015-2020.

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