Containing norephedrine or its salts

Medicaments containing norephedrine or its salts

MEFCC CLEARANCE · NDPS CLEARANCE

HSN 3004 43 00 (Containing norephedrine or its salts) is subject to Narcotic Drugs and Psychotropic Substances (NDPS) regime controls: import of norephedrine (phenylpropanolamine), its salts and preparations is prohibited except under a No Objection Certificate issued by the Narcotics Commissioner per the NDPS (Regulation of Controlled Substances) Order, 2013. Directorate General of Foreign Trade (DGFT) Restricted-import policy and CDSCO drug-registration requirements apply as additional clearance obligations at the bill of entry.

What this is

HSN code

3004 43 00

Chapter

30 · Pharmaceutical products

Primary regulator

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

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
Obtain a No Objection Certificate from the Narcotics Commissioner before any import of norephedrine, its salts, or preparations thereof. The NOC is the operative authorisation under the NDPS (Regulation of Controlled Substances) Order, 2013, and import without it is categorically prohibited — not merely restricted.
NDPS (Regulation of Controlled Substances) Order, 2013 · G.S.R. 191(E) dated 26-03-2013
2
Upload all 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 (Drugs) (101dc1), and Import Licence for Drugs (9111dc). The proper officer will verify these documents before granting out-of-charge.
CBIC e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc · DGFT ITC (HS) Restricted import policy

A word of counsel

The most common error on this tariff line is conflating the CDSCO drug registration and import licence with the NDPS Narcotics Commissioner NOC — they are separate instruments issued by separate authorities, and the absence of either is an independent ground for consignment detention and potential confiscation. The NDPS prohibition is absolute absent the NOC; a current CDSCO import licence does not substitute for it, and no rectification window exists at the port after the consignment has arrived without the NOC in place.

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Frequently asked

Does HSN 3004 43 00 require BIS certification?

No, medicaments containing norephedrine are not within the BIS Quality Control Order regime. Import is governed by the NDPS (Regulation of Controlled Substances) Order, 2013 under the Narcotics Commissioner's NOC framework, with concurrent CDSCO drug-registration requirements under the Drugs and Cosmetics Act, 1940.

What happens if the Narcotics Commissioner NOC is not obtained before shipment?

Import without the NOC is prohibited under G.S.R. 191(E) dated 26-03-2013; the consignment is liable to seizure, and the importer faces criminal liability under the Narcotic Drugs and Psychotropic Substances Act, 1985 — there is no provision to regularise the import retrospectively at the port.

Does the prohibition on oxytocin import affect this tariff line?

The oxytocin prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 is a separate product-specific control; it does not affect norephedrine imports, which are governed exclusively by the NDPS (Regulation of Controlled Substances) Order, 2013 and the Narcotics Commissioner NOC condition.

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