9911796707
TMI Blog2019 (5) TMI 793X X X X Extracts X X X X X X X X Extracts X X X X ..... bstances intended to be used for or in the diagnosis, treatment mitigation or prevention of disease or disorder. It does not appear that the devices in question are sold as therapeutic devices, or as having any medicines for internal or external use of human beings, or animals intended to be used for in the diagnosis treatment of any disease. The said products do not have any medicinal value - this Court is, prima facie, of the view that the products do not fall within the definition of a drug , as defined under section 3(b) of the Drugs and Cosmetics Act 1940. If the product in question is not a drug, respondent no.1 would not have the jurisdiction to issue the impugned circular. In this view, the impugned communication and the impugne ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... licensing authorities to ensure that Electronic Nicotine Delivery systems (ENDS) including e-Cigarettes, Heat-Not Burn devices, Vape, e-Sheesha, e-Nicotine Flavoured Hookah, and the like devices that enable nicotine delivery are not sold (including online sale), manufactured distributed, traded, imported and advertised in their jurisdictions, except for the purpose and in the manner and to the extent, as may be approved under the Drugs and Cosmetics Act, 1940. 2. Similarly, by the impugned circular dated 27.11.2018, all Customs Authorities have been requested to ensure that the advisory issued by the respondent is implemented, and all authorities are directed to ensure import consignments of ENDS including e-Cigarettes, Heat-Not- ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... in to nicotine gum . She submits that in view of the aforesaid assertion the ENDS and other devices would fall within the definition of a drug, as defined under Section 3(b) of the Drugs and Cosmetics Act, 1940. She also referred to Schedule K Rule 23 read with Schedule K of the said Act, and drew the attention of this Court to Entry 33 of the said schedule which includes Nicotine gum and Lozenges containing upto 2 mg of nicotine . She submitted that since the products in question are stated to be a kin to nicotine gum, the same would be covered under the Cosmetics and Drugs Act, 1940. She further states that the petitions have been filed in various courts against the notifications but no interim orders have been passed. 6. Clau ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 8. A plain reading of Clause (b) of Section 3 of the said Act indicates that it covers all medicines for internal or external use, and all substances intended to be used for or in the diagnosis, treatment mitigation or prevention of disease or disorder. It does not appear that the devices in question are sold as therapeutic devices, or as having any medicines for internal or external use of human beings, or animals intended to be used for in the diagnosis treatment of any disease. The said products do not have any medicinal value. 9. In view of the above, this Court is, prima facie, of the view that the products do not fall within the definition of a drug , as defined under section 3(b) of the Drugs and Cosmetics Act 1940. ..... X X X X Extracts X X X X X X X X Extracts X X X X
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