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        Case ID :

        2011 (3) TMI 760 - HC - Customs

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        Dettol Classified as Disinfectant Under Drugs & Cosmetics Act: License Not Required The court held that Dettol is classified as a 'Disinfectant' under the Drugs and Cosmetics Act, 1940, falling under the exempted category specified in ...
                      Cases where this provision is explicitly mentioned in the judgment/order text; may not be exhaustive. To view the complete list of cases mentioning this section, Click here.
                        Provisions expressly mentioned in the judgment/order text.

                            Dettol Classified as Disinfectant Under Drugs & Cosmetics Act: License Not Required

                            The court held that Dettol is classified as a 'Disinfectant' under the Drugs and Cosmetics Act, 1940, falling under the exempted category specified in item No. 12 of Schedule K of the Drugs and Cosmetics Rules, 1945. Therefore, stocking, exhibiting, selling, or distributing Dettol does not require a license. The prosecution against the accused was quashed, and all complaints and proceedings were dismissed.




                            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 Dettol
                            The 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 K
                            The 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.

                            Conclusion
                            The 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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