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of <h1>Dettol Classified as Disinfectant Under Drugs & Cosmetics Act: License Not Required</h1> <h3>RECKIT BENCKISER (INDIA) LTD. Versus STATE OF KERALA</h3> The court held that Dettol is classified as a 'Disinfectant' under the Drugs and Cosmetics Act, 1940, falling under the exempted category specified in ... Whether ‘Dettol’ is a ‘Disinfectant’ and hence exempted from Sec. 18 of the Act as contended by the accused - Hence, going by the definition of the word ‘Disinfectant’ and the use for which Dettol is manufactured I hold that Dettol is a ‘Disinfectant’ used to treat inanimate objects and materials though it may also be applied to agents used to treat the skin and other body membranes and cavities (externally) - Dettol contains some chemicals which are antiseptic but does not loose its character as a Disinfectant for the said reason or that it can be used to treat skin and other body membranes and cavities - ‘Dettol’ thus comes under item 12 of Schedule K of the Rules and hence is exempted from Chapter IV of the Act by virtue of Rule 123 of the Rules. - Hence for stocking, exhibiting and sale of ‘Dettol’ a license under the Act is not required - Prosecution against petitioners/accused have to fail - Decided in favour of assessee. Issues Involved:1. Whether Dettol is classified as a 'Disinfectant' under the Drugs and Cosmetics Act, 1940.2. Whether stocking, exhibiting, selling, or distributing Dettol without a license is punishable under Sec. 27(b)(ii) of the Act.3. Applicability of item No. 12 of Schedule K of the Drugs and Cosmetics Rules, 1945.Issue-Wise Detailed Analysis:Issue 1: Classification of Dettol as a 'Disinfectant'The primary legal question is whether Dettol qualifies as a 'Disinfectant' under the Drugs and Cosmetics Act, 1940. The petitioners argued that Dettol is a 'Disinfectant' and thus falls under the exempted category specified in item No. 12 of Schedule K of the Drugs and Cosmetics Rules, 1945. The Public Prosecutor contended that Dettol is primarily an 'Antiseptic' and does not possess the characteristics of a 'Disinfectant,' thereby requiring a license for its sale.The court examined various definitions and references, including the Complete Drug Reference and medical dictionaries, to differentiate between 'Disinfectant' and 'Antiseptic.' It concluded that a 'Disinfectant' is a chemical agent used to destroy or inhibit the growth of pathogenic micro-organisms on inanimate objects, while an 'Antiseptic' is used on living tissues for the same purpose. The court noted that Dettol's label specified its use for both purposes, including sterilization of instruments and general disinfection of wards, theatres, hands, face, masks, and soiled hospital linen.The court held that Dettol is indeed a 'Disinfectant' as per the definition and its intended uses, which include treating inanimate objects and materials.Issue 2: Requirement of License for Stocking, Exhibiting, Selling, or Distributing DettolThe court examined whether stocking, exhibiting, selling, or distributing Dettol without a license is punishable under Sec. 27(b)(ii) of the Drugs and Cosmetics Act, 1940. The Drug Inspector had filed complaints against the accused for stocking and exhibiting Dettol without a license, alleging a violation of Sec. 18(c) of the Act.The court referred to Sec. 18 of the Act, which prohibits the manufacture, sale, or distribution of any drug or cosmetic without a license. However, it also noted that Rule 123 of the Drugs and Cosmetics Rules, 1945, exempts certain drugs specified in Schedule K from the provisions of Chapter IV of the Act, which includes Sec. 18.Issue 3: Applicability of Item No. 12 of Schedule KThe court analyzed item No. 12 of Schedule K, which exempts substances intended for the destruction of vermin or insects causing disease in humans or animals, specifically 'Antiseptics and Disinfectants,' from the licensing requirements under Chapter IV of the Act. The court noted that the term 'viz' used in Schedule K means 'namely' or 'that is to say,' indicating that 'Antiseptics and Disinfectants' are included in the exempted category.Given that Dettol is classified as a 'Disinfectant,' it falls under item No. 12 of Schedule K. Therefore, by virtue of Rule 123, Dettol is exempted from the provisions of Chapter IV of the Act, including the requirement to obtain a license for its stocking, exhibition, and sale.ConclusionThe court concluded that Dettol is a 'Disinfectant' and falls under the exempted category specified in item No. 12 of Schedule K of the Drugs and Cosmetics Rules, 1945. Consequently, the stocking, exhibiting, selling, or distributing of Dettol does not require a license under the Drugs and Cosmetics Act, 1940. The prosecution against the petitioners/accused was quashed, and the complaints, cognizance taken, and proceedings against them were dismissed.
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