Authority: High Court of Judicature at Bombay

Order Date: 22 September 2026

Case Overview

  • Petitioners: Mumbai Travel Retail Ltd (operating a Duty Free Shop at Chhatrapati Shivaji Maharaj International Airport, Mumbai) and Fleming Dutyfree Shop Private Limited (operating a Duty Free Shop at the same airport). Both sell imported “tobacco‑free nicotine pouches” under the brand names “ZYN” and “FOX”.
  • Respondents: Union of India (Ministry of Health & Family Welfare), Drug Controller General (I) – CDSCO, Assistant Drugs Controller (I) – International Air Cargo Complex, Mumbai, and the Principal Commissioner of Customs, Mumbai Airport.
  • Background: On 3 Oct 2025, “Mothers Against Vaping” (MAV) lodged a complaint alleging health hazards from nicotine pouches. Respondent 4 (Customs) issued Notice No. F.No.ARPT/WH/MISC/81/2025‑DFS on 10 Oct 2025 demanding details of legality and authorization.
  • Petitioners replied on 15 Oct 2025, asserting that the DFS is within the customs frontier and domestic drug regulations do not apply. Subsequent communications (10 Nov 2025, 13 Nov 2025, 15 Dec 2025, 26 Dec 2025, 2 Jan 2026) involved requests for Bill of Entry, exemption notifications, and clarification of product description. The Bill of Entry listed only the brand “ZYN” under HS 24049100 (DGFT “free classification”).
  • On 5 Mar 2026, Respondent 3 (Assistant Drug Controller) conducted an investigation and issued an order on 2 Apr 2026 banning sale of nicotine pouches in the DFS, holding the sale contravenes the Drugs and Cosmetics Act, 1940 and its Rules.
  • On 8 Apr 2026, the Assistant Commissioner, DFS Bond, CSMI Airport communicated that nicotine pouches are “drugs” under Section 3(b) of the Act, requiring a valid Registration Certificate and import licence; the petitioner was advised to approach CDSCO.
  • Petitioners filed two writ petitions (WP 3079/2026 and WPL/20740/2026) seeking a writ of mandamus, certiorari, and interim relief to prevent application of the Act to their DFS operations.
  • An ad‑interim order dated 24 Jun 2026 restrained respondents from coercive action against existing stock, but further imports remained suspended.
  • Legal arguments: Petitioners relied on Supreme Court decisions in Hotel Ashoka and Garden Silk Mills asserting that transactions within DFS are outside the customs barrier for fiscal purposes only. Respondents argued that consumption occurs on Indian soil, invoking public‑health jurisdiction, and that nicotine is an API falling within Section 3(b).
  • The Court examined relevant provisions of the Customs Act 1962 (definitions of “customs area”, “import”, “prohibited goods”), the Drugs and Cosmetics Act 1940 (definition of “drug” under Section 3(b)), Section 10 (prohibition of import without licence), Schedule K (exemption for nicotine gum/lozenges up to 2 mg), Schedule D (exemption for non‑medicinal substances), and DGFT Notification No. 54/2015‑2020 (free classification of nicotine‑containing tobacco‑free products).
  • The Court noted that the impugned order of 2 Apr 2026 did not specify under which clause of Section 3(b) the nicotine pouch was classified, nor did the petitioners provide product specifications.
  • The Court held that it lacks expertise to determine the product’s classification and that such factual inquiry cannot be undertaken in a writ petition under Article 226.

Final Outcome

  • The Court declined to answer whether nicotine pouches fall within the definition of “drug” under Section 3(b) and therefore did not grant the petitioners’ relief.
  • The petitioners were directed to make representations to the appropriate authority (CDSCO), supported by product specifications, within four weeks of the judgment’s upload.
  • Any such representation shall be considered on its merits and a reasoned order shall be passed within 30 days of receipt, with a personal hearing if necessary.
  • No order as to costs was made.
  • The writ petitions were disposed of accordingly.

Topics: Regulatory Law, Public Health