Containing norephedrine or its salts

Bulk medicaments containing norephedrine or its salts

NDPS CLEARANCE

HSN 3003 43 00 (medicaments containing norephedrine or its salts, not in retail packs) is subject to Narcotic Drugs and Psychotropic Substances (NDPS) controls: import is prohibited except under a No Objection Certificate issued by the Narcotics Commissioner under the NDPS (Regulation of Controlled Substances) Order, 2013 [G.S.R. 191(E) dated 26-03-2013]. Five mandatory documents must be uploaded in e-Sanchit before customs out-of-charge is granted.

What this is

HSN code

3003 43 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 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 norephedrine (phenylpropanolamine), its salts, and preparations thereof is prohibited except in strict conformance with the conditions of this NOC 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 five mandatory documents in e-Sanchit prior to filing the bill of entry: Registration Certificate for drugs (101dc1), Import Licence for drugs (9111dc), Certificate of Analysis — drug (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc). Customs out-of-charge will not be granted until all five are verified in e-Sanchit.
CBIC e-Sanchit document codes 101dc1, 9111dc, 0010dc, 0030dc, 0110dc · NDPS (RCS) Order, 2013

A word of counsel

The most common error on this tariff line is arriving at the port of entry with drug-registration and analysis documents in order but without a current Narcotics Commissioner NOC — an omission that triggers outright prohibition enforcement, not a rectifiable labelling defect. Because the NOC is issued per shipment and tied to the specific controlled substance and quantity, importers must confirm scope coverage for norephedrine salts and preparations explicitly; a NOC issued for the base substance alone does not cover preparations thereof.

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Frequently asked

Does HSN 3003 43 00 require BIS certification?

No. No BIS Quality Control Order covers bulk medicaments in this product family. Import is instead governed by the Narcotic Drugs and Psychotropic Substances regime — specifically the NDPS (Regulation of Controlled Substances) Order, 2013 — which prohibits import of norephedrine and its preparations except under a Narcotics Commissioner NOC.

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

Five codes are mandatory: Registration Certificate for drugs (101dc1), Import Licence for drugs (9111dc), Certificate of Analysis — drug (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc); all must be uploaded before customs out-of-charge.

Does the NDPS prohibition cover both the base substance and preparations?

Yes. The NDPS (Regulation of Controlled Substances) Order, 2013 expressly covers norephedrine (phenylpropanolamine), its salts, and preparations thereof; a NOC limited to the base compound does not authorise import of multi-constituent preparations containing it.

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