ENDS devices inlcuding e-Cigarettes, E-Sheesha classified as DRUGS, under DCA, Holds CDSCO DTAB

New Delhi: Clearly stating that E-Sheesha, E-Nicotine, Flavoured Hookah and the like devices are recognized as "Drugs" under Section 26A of the Drugs and Cosmetics Act 1940, the Drugs Technical Advisory Board (DTAB) has supported the call for prohibiting the manufacture, sale (including online sale), distribution and import (including personal purpose ) of these devices.

The recommendation came after a detailed deliberation of the concern in DTAB meeting wherein it was submitted that the availability of Electronic Nicotine Delivery System (ENDS) including e-Cigarettes, Heat-Not Burn devices, Vape, e-Sheesha, e-Nicotine Flavoured Hookah and the like devices is widespread in the country posing serious health risks to the users and non-users.

The move will apparently monitor and regulate the uncontrolled consumption of Nicotine (more concentrated Nicotine liquid, deep inhalation, prolonged inhalation which may extend beyond traditional one cigarette use, etc.) and its adverse effects on human health.

Also Read: End of ENDS: CDSCO moves to ban electronic smoking devices by classifying them as DRUGS

The Government of India had issued an advisory on Electronic Nicotine Delivery System (ENDS) including E-cigarettes, Heat-Not burn devices, Vape, e-Sheesha, e-Nicotine, Flavoured Hookah, and the like products. This advisory had advised that in the larger public interest and in order to prevent the initiation of ENDS by non-smokers and youth with special attention to vulnerable groups, to ensure that any ENDS including e-cigarette, 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 jurisdiction, except for the purpose and in the manner and to the extent, as may be approved under the Drugs and Cosmetics Act 1940 and Rules made thereunder.

Subsequent to this advisory, CDSCO had issued letters to all State and UT Drugs Controllers that, Electronic Nicotine Delivery Systems (ENDS) including e-cigarette, Heat-Not burn devices, Vape, e-Sheesha, e-Nicotine, Flavoured Hookah, and the like products has not yet been approved under the Drugs and Cosmetics Act 1940 and Rules made thereunder and requested them to ensure that any of aforementioned products are not sold (including online sale), manufactured, distributed, traded, imported and advertised in their jurisdictions.

Also, the State Governments of Karnataka, Kerala, Mizoram, Maharashtra, Jammu & Kashmir, Uttar Pradesh and Bihar have issued necessary orders banning the manufacture, distribution and sale of e-cigarettes as an unapproved drug, under the Drugs and Cosmetics Act, 1940.

Also Read: Interim Relief: Delhi High Court stays the ban on e-cigarettes, Vapes, E-Sheesha till May 17, 2019

DTAB deliberated the matter in detail and obtained the insights on various aspects of ENDS and associated health hazards, socioeconomic issues etc. from Dr Mohammad Shaukat, Advisor (NCD) and Dr L. Swasticharan, CMO (NCD) the subject experts of National Tobacco control programme. Dr L. Swasticharan made a detailed presentation on different categories of ENDS & like devices and its adverse effects on human health and suggested to ban the ENDS & like products in the larger public interest. Uncontrolled consumption of Nicotine (more concentrated Nicotine liquid, deep inhalation, prolonged inhalation which may extend beyond traditional one cigarette use, etc.) from such devices may result in more worsened health hazards due to increased total nicotine intake.

Further DTAB examined the minutes of the Sub-Group meeting under the Chairmanship of Sh. Vikas Sheel, JS, MoHFW on Legal implications on ENDS and report of the Sub-Group on Health Effects of Electronic Nicotine Delivery System (ENDS)/ Electronic Non-nicotine Delivery System (ENNDS) and Heated Tobacco Products (HTPs) and the-like devices forwarded by the Ministry.

The Sub-Group in its report has concluded that ENDS and the like products, including HTPs and HnBs, are harmful to the health of their users and that presence of these products in their current form has a net negative impact on Public Health and recommends that the ENDS and like devices should be banned in the larger public interest.

DTAB after deliberation recommended that the manufacture, sale (including online sale) and distribution of Electronic Nicotine Delivery System (ENDS) including E-cigarette, Heat-Not burn devices, Vape, e-Sheesha, e-Nicotine, Flavoured Hookah and the like products shall be prohibited under Section 26A of the Drugs and Cosmetics Act, 1940 as well as their import (including personal purpose) shall also be prohibited under Section 10A of the said Act.