Salbutamol, terbutaline, ephedrine, salmeterol and methyl xanthimes

Bronchodilator and xanthine medicaments for retail sale

MEFCC CLEARANCE · NDPS CLEARANCE

HSN 3004 90 91 (Salbutamol, terbutaline, ephedrine, salmeterol and methyl xanthines) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and Import Licence requirements under the Drugs and Cosmetics Act, 1940. Ephedrine, its salts and preparations are additionally controlled under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, requiring a No-Objection Certificate from the Narcotics Commissioner per the NDPS (Regulation, Control and Supply) Order, 2013. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy overlay applicable to this tariff line.

What this is

HSN code

3004 90 91

Chapter

30 · Pharmaceutical products

Primary regulator

NDPS · NDPS (Regulation, Control and Supply) Order, 2013 [GSR 191(E)] for controlled substances; CDSCO · Drugs and Cosmetics Act, 1940 for drug registration

Customs documentation

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

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 valid drug Registration Certificate (document code 101dc1) and Import Licence for drugs (document code 9111dc) from CDSCO before filing the bill of entry. Upload both documents — alongside the Certificate of Analysis for drugs (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) — in e-Sanchit prior to customs out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1, 9111dc, 0010dc, 0030dc, 0110dc
2
Where the consignment contains ephedrine, its salts, or preparations thereof, obtain a No-Objection Certificate from the Narcotics Commissioner before import. Import without this NOC is prohibited under the NDPS (Regulation, Control and Supply) Order, 2013, and any contravention attracts seizure and criminal liability under the NDPS Act.
NDPS (RCS) Order, 2013 · GSR 191(E) dated 26-03-2013
3
Note that import of oxytocin is prohibited under this tariff line; only oxytocin reference standards for test and analysis are permitted, exclusively upon submission of a test licence issued by DGCI/CDSCO. Confirm the consignment contains no prohibited formulations before dispatch.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most frequent compliance failure on this tariff line is treating the CDSCO drug registration as the only clearance and overlooking the NDPS NOC requirement for ephedrine-containing formulations. Ephedrine is a controlled substance under the NDPS (RCS) Order, 2013, and the prohibition on import is absolute without the Narcotics Commissioner's NOC — a missing NOC results in consignment seizure and potential criminal prosecution under the NDPS Act, not merely detention pending documentation.

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Frequently asked

Does HSN 3004 90 91 require BIS certification?

No. No BIS Quality Control Order covers this pharmaceutical tariff line. Import is governed by CDSCO drug registration and Import Licence requirements under the Drugs and Cosmetics Act, 1940, with an NDPS NOC from the Narcotics Commissioner mandatory for ephedrine-containing formulations under the NDPS (RCS) Order, 2013.

Which e-Sanchit documents must be uploaded before out-of-charge for this HSN?

Five documents must be uploaded: Certificate of Analysis for drugs (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for drugs (101dc1), and Import Licence for drugs (9111dc); NDPS NOC is additionally required where ephedrine or its preparations are present.

Is any import of oxytocin permitted under this tariff line?

Commercial import of oxytocin is prohibited; only oxytocin reference standards intended exclusively for test and analysis may be imported, and only upon submission of a test licence issued by DGCI/CDSCO, per S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

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