For transdermal application

Nicotine products for transdermal application (patches)

MOHFW CLEARANCE

HSN 2404 92 00 (For transdermal application) is subject to the Ministry of Health and Family Welfare (MOHFW) packaging and labelling requirements under the Cigarettes and Other Tobacco Products (Packaging and Labelling) Amendment Rules, 2022, notified with effect from 1 December 2022. The Directorate General of Foreign Trade (DGFT) classifies import under General Note 13 of the ITC (HS) Schedule, and the Central Board of Indirect Taxes and Customs (CBIC) enforces compliance at the bill-of-entry stage.

What this is

HSN code

2404 92 00

Chapter

24 · Tobacco and manufactured tobacco substitutes

Primary regulator

MOHFW · Cigarettes and Other Tobacco Products (Packaging and Labelling) Amendment Rules, 2022

Customs documentation

Labelling compliance declaration from MOHFW
Health warning conformance from importer
ITC (HS) General Note 13 declaration from DGFT

Applicable Partner Government Agencies

MOHFWMOHFW·Ministry of Health and Family Welfare

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.

Compliance steps

1
Ensure all units in the consignment carry the new set of health warnings prescribed under the Cigarettes and Other Tobacco Products (Packaging and Labelling) Amendment Rules, 2022. Packaging that does not conform to the warnings notified via GSR 592(E) dated 21-07-2022 is not permitted entry and will be detained at the port of import.
GSR 592(E) dated 21-07-2022 · MOHFW letter D.O.P.16011/02/2017-TC (PART-1) dated 09-12-2022
2
At the bill-of-entry stage, confirm compliance with General Note 13 of the ITC (HS) Schedule and upload the requisite labelling-compliance documentation in e-Sanchit before out-of-charge. CBIC Instruction 02/2023 dated 07-01-2023 directs customs officers to verify this documentary compliance before granting out-of-charge.
CBIC Instruction 02/2023 dated 07-01-2023 · General Note 13 of ITC (HS) Schedule

A word of counsel

The most common error on this tariff line is shipping stock packaged to an earlier health-warning design — the Amendment Rules, 2022 introduced a revised set of warnings effective 1 December 2022, and consignments bearing pre-amendment health warnings are treated as non-compliant regardless of when they were manufactured. Importers should obtain written confirmation from the foreign manufacturer that packaging was produced against the GSR 592(E) specifications before the purchase order is finalised; non-conforming consignments face detention and potential confiscation, not merely re-labelling.

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 2404 92 00 require BIS certification?

No, no BIS Quality Control Order covers nicotine products for transdermal application. Import is governed by the Ministry of Health and Family Welfare under the Cigarettes and Other Tobacco Products (Packaging and Labelling) Amendment Rules, 2022, with compliance enforced at the bill of entry under CBIC Instruction 02/2023.

Which health warnings are required on transdermal nicotine products under the 2022 Amendment Rules?

The specific health-warning specifications are set out in GSR 592(E) dated 21-07-2022, notified by MOHFW; the current artwork and text requirements are accessible at www.mohfw.nic.in and must appear on all import packaging before the consignment is shipped.

What happens if the consignment arrives with pre-amendment health-warning packaging?

Consignments bearing health warnings that do not conform to the Cigarettes and Other Tobacco Products (Packaging and Labelling) Amendment Rules, 2022 (effective 01-12-2022) are liable to detention and confiscation at the port of import; re-labelling after arrival is not an available remedy under the current CBIC instructions.

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