Bromohexin and solbutamol

Bromhexine and salbutamol medicaments, measured-dose forms

MEFCC CLEARANCE

HSN 3004 49 60 (Bromhexin and salbutamol) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940, with mandatory document verification covering Certificate of Analysis, batch release, and drug registration certificate at the bill of entry. The Directorate General of Foreign Trade (DGFT) maintains a Restricted-import policy overlay for the broader Chapter 30 regime, and the Ministry of Environment, Forest and Climate Change applies conditions on used or refurbished medical equipment consignments under its O.M. dated 15 December 2023.

What this is

HSN code

3004 49 60

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Drugs and Cosmetics Act, 1940; Ministry of Environment, Forest and Climate Change O.M. dated 15-12-2023

Customs documentation

Import licence for drugs from CDSCO
Registration certificate from CDSCO
Certificate of Analysis from supplier

Applicable Partner Government Agencies

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.

Compliance steps

1
Obtain a valid drug import licence from CDSCO and ensure the product registration certificate (drugs) is current before shipment. Upload the import licence (document code 9111dc) and registration certificate (document code 101dc1) in e-Sanchit prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · document codes 9111dc and 101dc1
2
Upload the Certificate of Analysis (document code 0010dc), batch release certificate (document code 0030dc), and label of consignment (document code 0110dc) in e-Sanchit before the bill of entry is assessed. The proper officer must verify all five mandatory documents before granting out-of-charge.
CBIC PGA-facilitated bill instructions · document codes 0010dc, 0030dc, 0110dc
3
Note that import of oxytocin is prohibited for this chapter; only oxytocin reference standards for test and analysis are permitted, exclusively upon submission of a test licence issued by DGCI/CDSCO. Confirm the product does not fall within the prohibited category before filing.
S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is arriving at the port of entry with the drug import licence and registration certificate uploaded but without the batch release certificate or the Certificate of Analysis — all five document codes (9111dc, 101dc1, 0010dc, 0030dc, 0110dc) are independently mandatory in e-Sanchit, and a missing single document triggers detention and demurrage regardless of the others being current. Brokers routinely treat the registration certificate as sufficient at the pre-shipment stage; CDSCO-facilitated bills that bypass the PGA NOC route face the same five-document verification by the proper officer before out-of-charge is granted.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 3004 49 60 require BIS certification?

No, medicaments in measured-dose forms are not covered by any BIS Quality Control Order. Import is governed by CDSCO drug licensing and registration under the Drugs and Cosmetics Act, 1940, with DGFT Restricted-import policy conditions and the Ministry of Environment, Forest and Climate Change overlay for used or refurbished equipment.

Which document codes must be uploaded in e-Sanchit for this tariff line?

Five documents are mandatory: Certificate of Analysis (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc) — all must be present in e-Sanchit before out-of-charge is granted.

Is oxytocin importable under HSN 3004 49 60?

Import of oxytocin is prohibited; however, oxytocin reference standards are permitted exclusively for test and analysis purposes upon submission of a test licence issued by DGCI/CDSCO, per S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23 May 2022.

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