The Electronic Nicotine Delivery Systems (ENDS) are electronic devices that heat a glycol and/or glycerin-based solution containing nicotine or other flavoured substances to create an aerosol, which is then inhaled by a user. ENDS use chemical solutions and emissions process. Variation in chemicals produce known and unknown toxicity which raises red flags about the safety and efficacy of this system. The most commonly known ENDS is electronic cigarettes or E-cigarettes which include heat-not-burn devices, vape, e-sheesha, e-nicotine flavoured hookah and similar other devices that enable nicotine delivery. At present more than 460 brands of e-cigarettes with varied configuration are available in the market.
ENDS are being promoted by some industry bodies and smokers as a smoking cessation aid, but lack of evidence to support its safety and efficacy as a quitting aid has left their statement vague. Moreover, a few ex-smokers who reported discontinuation of their cigarette usage with the help of ENDS have been found to be addicted to the ENDS itself to satisfy their nicotine addiction during periods of temporary or forced restraint.
The usability of ENDS was questioned by the state Government of Punjab, Haryana and Union Territory of Chandigarh, who have declared ENDS or e-cigarettes as an unapproved drug under the Drugs and Cosmetics Act, 1940 and Rules made thereunder. Further, the State Governments of Karnataka, Kerala, Mizoram, Maharashtra, Jammu & Kashmir, Uttar Pradesh and Bihar have banned the manufacture, distribution and sale of e-cigarettes in their jurisdictions.
In the year 2018, Government of India had issued an advisory on ENDS, which advised youth especially nonsmokers to not use ENDS and the like devices. Moreover, it also advised State/UT governments to restrict the manufacturing sale, distribution, trading, advertisement of ENDS in their jurisdiction, except for the purpose and in the manner, as may be approved under the Drugs and Cosmetics Act 1940 and Rules made thereunder.
Subsequently, the Central Drugs Standard Control Organization in February 2019, issued an order to all State/ UT Drug Controllers stating that no ENDS and like products had yet been approved under the Drugs and Cosmetics Act 1940 and Rules made thereunder and requested them to therefore, direct the Controller to ensure that ENDS and like devices shall be monitored and restricted for sale, manufacturing, import, distribution, trade and advertisement in their jurisdictions.
In May 2019, the Indian Council of Medical Research on the eve of 'World No Tobacco' Day released a white paper on regulation of ENDS and like devices.
Tobacco Control Law and Related Laws in India
1. Drugs and Cosmetics Act, 1940('Act') and Rules made thereunder regulate the nicotine and few of its formulations.
- The Act defines Nicotine as 'Drug' under section 3(b).
- Smoking cessation aids like chewing gums and lozenges up to 2 mg of 'Nicotine' are exempted from sale license under chapter IV of Act, but manufacturing of these formulation requires drugs manufacturing license issued by DCGI.
- Various "Nicotine" preparations indicated to reduce withdrawal symptoms associated with quitting the smoking such as Nicotine Transdermal Patches 36 mg/78 mg/ 114 mg; Nicotine Lozenges 2mg/4mg; Nicotine ploacrilex lozenges are approved by DCG(I) under Act.
Nicotine is defined as 'drugs' and any product intended to be used as aid for smoking cessation has to be approved under the provisions of the Act. Therefore the Drug Consultative Committee (DCC) in its 48th meeting, recommended that since Electronic Nicotinic Delivery Systems (ENDS) and the like products are used as a tobacco [especially smoking forms such as cigarettes] cessation product and functions for nicotine delivery for reasons including nicotine de-addiction, these devices and products fall under the definition of "drug" as defined under Section 3(b) of the Drugs and Cosmetics Act, 19401. Now the Health ministry proposes an amendment in Drugs and Cosmetics Rule, 1940 to define e-cigarettes as drug for its regulation.
2. Cigarettes and Other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003 (COTPA 2003), is a comprehensive legislation passed by Ministry of Health & Family Welfare to regulate the advertisement, trade and commerce, production, supply and distribution of cigarettes and other tobacco products in India. Overall it aims to protect the population from the health hazards associated with the use of tobacco products.
3. Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011 ('Regulation') issued under the Food Safety and Standards Act, 2006 by the Food Safety & Standards Authority of India (FSSAI). The Regulation 2.3.4 states that no tobacco and nicotine products shall be used as ingredients in any food products e.g Gutkha is banned accordingly.
4. The Insecticide Act, 1968 listed out 'Nicotine' as insecticide
5. Juvenile Justice (Care and Protection of Children) Act, 2015. Section 77 of the said act discourages the use of any intoxicating liquor or any narcotic drug or tobacco products or psychotropic substance to any child, except for the medical reason. Any person enforcing any child to use the said substances shall be punishable by rigorous imprisonment.
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