Containing ephedrine or its salts

Mixed medicaments containing ephedrine or its salts

NDPS CLEARANCE

HSN 3003 41 00 (Containing ephedrine or its salts) is subject to import prohibition under the Narcotic Drugs and Psychotropic Substances (Regulation of Controlled Substances) Order, 2013 [G.S.R. 191(E) dated 26-03-2013], administered by the Narcotics Commissioner. Import is permitted only under a No Objection Certificate issued by the Narcotics Commissioner, with mandatory drug-registration and import-licence documentation uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3003 41 00

Chapter

30 · Pharmaceutical products

Primary regulator

NDPS · Narcotic Drugs and Psychotropic Substances (Regulation of Controlled Substances) Order, 2013

Customs documentation

NOC from Narcotics Commissioner
Import licence from NDPS
Registration certificate from CDSCO

Applicable Partner Government Agencies

NDPSNDPS·Narcotics Control Bureau

Compliance steps

1
Obtain a No Objection Certificate from the Narcotics Commissioner before shipment. Import of ephedrine, its salts and preparations thereof is prohibited except in strict accordance with the conditions of the NOC; consignments arriving without a valid NOC are liable to seizure and confiscation under the NDPS framework.
NDPS (Regulation of Controlled Substances) Order, 2013 · G.S.R. 191(E) dated 26-03-2013
2
Upload all five mandatory documents in e-Sanchit before filing the bill of entry: Certificate of Analysis — Drug (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 all five document codes are verified in e-Sanchit.
NDPS (Regulation of Controlled Substances) Order, 2013 · G.S.R. 191(E) dated 26-03-2013; e-Sanchit mandatory document requirement

A word of counsel

The most common error on this tariff line is treating the drug import licence (9111dc) and the Narcotics Commissioner's NOC as interchangeable — they are independent instruments issued under separate legal bases, and both must be current and co-uploaded in e-Sanchit. Where the NOC carries quantity or validity conditions, any consignment that exceeds the authorised quantity or arrives after NOC expiry constitutes a prohibited import regardless of whether the drug registration remains valid, exposing the importer to criminal liability under the NDPS Act.

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 3003 41 00 require BIS certification?

No, mixed medicaments containing ephedrine are not within the BIS Quality Control Order regime. Import is governed by the Narcotics Commissioner under the Narcotic Drugs and Psychotropic Substances (Regulation of Controlled Substances) Order, 2013, with import prohibited except under a valid NOC issued by the Narcotics Commissioner.

What are the five mandatory e-Sanchit document codes for this tariff line?

The five codes are: 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.

What happens if the Narcotics Commissioner's NOC has conditions that the consignment does not satisfy?

A consignment that breaches the quantity, validity, or purpose conditions of the NOC is treated as a prohibited import under the NDPS (Regulation of Controlled Substances) Order, 2013, and is liable to seizure, confiscation, and criminal prosecution under the NDPS Act.

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