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HomeHSNChapter 30HSN 3004 42 00

Containing pseudoephedrine (INN) or its salts

Medicaments containing pseudoephedrine or its salts

MEFCC CLEARANCE · NDPS CLEARANCE

HSN 3004 42 00 (Medicaments containing pseudoephedrine or its salts) is subject to the Narcotic Drugs and Psychotropic Substances (NDPS) regime: import of pseudoephedrine, its salts, and preparations thereof is prohibited except in accordance with conditions of a No Objection Certificate issued by the Narcotics Commissioner under the NDPS (Regulation of Controlled Substances) Order, 2013. The Directorate General of Foreign Trade (DGFT) classifies this tariff line as Restricted under the ITC (HS) import policy, and mandatory drug-registration documentation must be uploaded in e-Sanchit before out-of-charge.

What this is
HSN code
3004 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 for drugs from DGFT
  • 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. 1
    Obtain a No Objection Certificate from the Narcotics Commissioner before shipment. Import of pseudoephedrine, its salts, and preparations thereof is prohibited except in strict accordance with the conditions of that 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. 2
    Upload all mandatory drug-import 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 — Drugs (101dc1), and Import Licence for Drugs (9111dc). The proper officer will verify each document code before granting out-of-charge.
    CBIC e-Sanchit document codes: 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
A word of counsel

The most frequent error on this tariff line is shipping the consignment before the Narcotics Commissioner's NOC is in hand, on the assumption that the drug registration certificate and import licence are sufficient. They are not: pseudoephedrine preparations are a controlled substance under the NDPS (Regulation of Controlled Substances) Order, 2013, and arrival at port without a current, consignment-specific NOC exposes the importer to seizure, confiscation, and criminal liability under the Narcotic Drugs and Psychotropic Substances Act, 1985 — irrespective of the commercial validity of the drug registration.

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Frequently asked
Does HSN 3004 42 00 require BIS certification?
No, medicaments containing pseudoephedrine are not within the BIS Quality Control Order regime. Import is governed by the Narcotic Drugs and Psychotropic Substances (Regulation of Controlled Substances) Order, 2013, requiring a Narcotics Commissioner NOC, alongside the standard drug-registration and import-licence requirements administered by CDSCO and DGFT.
Which e-Sanchit document codes are mandatory at the bill of entry for this tariff line?
Five documents 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 proper officer will not grant out-of-charge until all five codes are verified.
Is import of oxytocin-containing medicaments under this heading also prohibited?
Import of oxytocin is separately prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, though import of oxytocin reference standards is permitted exclusively for testing and analysis on submission of a test licence issued by DCGI/CDSCO.
Last verified against gazette notifications: 2026-05-16. Source: MEFCC / NDPS / DGFT / Indian Customs CUSDATA.
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