Containing pseudoephedrine (INN) or its salts

Mixed medicaments containing pseudoephedrine or its salts

NDPS CLEARANCE

HSN 3003 42 00 (medicaments containing pseudoephedrine or its salts) is subject to Narcotic Drugs and Psychotropic Substances (NDPS) controls: import of pseudoephedrine, its salts, and preparations thereof 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]. Central Drugs Standard Control Organisation registration and DGFT import-licence conditions apply as concurrent documentary requirements at the bill of entry.

What this is

HSN code

3003 42 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 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 dispatch. Import of pseudoephedrine and its preparations is prohibited in the absence of this NOC; upload the import licence for drugs (document code 9111dc) and the registration certificate for drugs (document code 101dc1) in e-Sanchit before filing the bill of entry.
NDPS (Regulation of Controlled Substances) Order, 2013 · G.S.R. 191(E) dated 26-03-2013
2
Upload the full documentary set in e-Sanchit prior to out-of-charge: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc). The proper officer must verify all five mandatory document codes — 0010dc, 0030dc, 0110dc, 101dc1, and 9111dc — are present before granting out-of-charge.
CBIC e-Sanchit mandatory document verification · NDPS (RCS) Order, 2013

A word of counsel

The most common error on this tariff line is treating the drug registration certificate and import licence as sufficient and arriving at the bill of entry without a current Narcotics Commissioner NOC. The NOC is a condition precedent — not a parallel clearance — and a consignment presented without it is liable to detention and confiscation regardless of the status of the CDSCO registration. The NOC must cover the specific salt form and quantity declared on the bill of entry; a NOC issued for a different salt or an earlier shipment does not extend to a new consignment.

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Frequently asked

Does HSN 3003 42 00 require BIS certification?

No. No BIS Quality Control Order covers mixed medicaments containing pseudoephedrine. Import of this tariff line is governed by the Narcotic Drugs and Psychotropic Substances regime — specifically the NDPS (Regulation of Controlled Substances) Order, 2013 — and is prohibited except under a Narcotics Commissioner NOC.

Which document codes must be uploaded in e-Sanchit for a pseudoephedrine-containing medicament consignment?

Five document codes 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); all must be uploaded before out-of-charge is granted.

What happens if a consignment is imported without the Narcotics Commissioner NOC?

Import without the NOC is a prohibited import under the NDPS (Regulation of Controlled Substances) Order, 2013, exposing the consignment to seizure and confiscation and the importer to criminal liability under the NDPS Act, 1985.

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