Containing ephedrine or its salts

Medicaments containing ephedrine or its salts

MEFCC CLEARANCE · NDPS CLEARANCE

HSN 3004 41 00 (Medicaments containing ephedrine or its salts) is subject to Narcotic Drugs and Psychotropic Substances (NDPS) controls under the NDPS (Regulation of Controlled Substances) Order, 2013 — import of ephedrine, its salts, and preparations thereof is prohibited except under a No Objection Certificate issued by the Narcotics Commissioner. Directorate General of Foreign Trade (DGFT) policy classifies this tariff line as Restricted, and mandatory customs documentation including a registration certificate and import licence for drugs must be uploaded in e-Sanchit before out-of-charge.

What this is

HSN code

3004 41 00

Chapter

30 · Pharmaceutical products

Primary regulator

NDPS · NDPS (Regulation of Controlled Substances) Order, 2013 [G.S.R. 191(E) dated 26-03-2013]

Customs documentation

NOC from Narcotics Commissioner
Import licence for drugs from CDSCO
Registration certificate 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
Secure a No Objection Certificate from the Narcotics Commissioner before shipment. Import of ephedrine, its salts, and preparations thereof is prohibited absent this NOC, and any consignment arriving without it is liable to seizure and confiscation under the NDPS (Regulation of Controlled Substances) Order, 2013.
NDPS (Regulation of Controlled Substances) Order, 2013 · G.S.R. 191(E) dated 26-03-2013
2
Upload all mandatory documents in e-Sanchit at the bill of entry stage: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc). Customs out-of-charge will not be granted until each document code is verified.
CBIC e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc

A word of counsel

The most frequent error on this tariff line is conflating the drug-import registration and licence (CDSCO document codes 101dc1 and 9111dc) with the NDPS NOC from the Narcotics Commissioner — these are two independent clearances, and customs officers verify each separately at the bill of entry. A current CDSCO registration does not substitute for, or accelerate, the Narcotics Commissioner's NOC; a consignment presented with all drug-licence documents but without the NOC will be detained, and prolonged detention of a controlled substance attracts demurrage, ground rent, and potential confiscation under the NDPS framework.

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Frequently asked

Does HSN 3004 41 00 require BIS certification?

No, medicaments containing ephedrine are not within any BIS Quality Control Order regime. Import is governed by the Narcotic Drugs and Psychotropic Substances framework — specifically the NDPS (Regulation of Controlled Substances) Order, 2013 — with DGFT Restricted-import policy and CDSCO drug-registration requirements as concurrent overlays.

Are all five e-Sanchit document codes mandatory for every consignment?

Yes. The customs proper officer is directed to verify that document codes 0010dc (Certificate of Analysis), 0030dc (Batch Release Certificate), 0110dc (Label of Consignment), 101dc1 (Registration Certificate), and 9111dc (Import Licence) are all uploaded in e-Sanchit before granting out-of-charge.

Is the import of oxytocin-containing products under this heading permitted?

No — import of oxytocin is prohibited outright; the sole exception is import of oxytocin reference standards exclusively for test and analysis, subject to a test licence issued by DGCI/CDSCO, per S.O. 2357(E) and DGFT Notification 09/2015-2020 both dated 23-05-2022.

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