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The Drug Technical Advisory Board (DTAB), India’s top drugs advisory board has approved a proposal to regulate ‘e-cigarettes’ and ‘vapes’ as drugs and prohibit their sale in the country.
- In August 2018, the Union Government had issued an advisory to states to prevent the sale, of ENDS “in the larger public interest” and in order to prevent non-smokers, young persons and other vulnerable groups from initiating usage of these products.
- Based on this advisory, CDSCO issued letters to States and Union territories drug controllers in requesting them to “ensure” that they were not sold, made, distributed, traded, imported and advertised in their jurisdictions.
- Several states, including Mizoram, Maharashtra, Karnataka, Kerala and Uttar Pradesh, have so far issued orders banning e-cigarettes as “unapproved” drugs.
WHAT THE BOARD HAS DECIDED?
- Indian drug regulator, the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health proposed that manufacture, sale and distribution of ENDS, including e-cigarettes and similar products, should be prohibited under Section 26A of the Drugs and Cosmetics Act, 1940, while their import should be outlawed under Section 10A of the legislation.
- The proposal has been approved by the Drug Technical Advisory Board (DTAB), the government’s top advisory body on technical matters related to medicines in the country.
- The Drugs Technical Advisory Board has agreed on a proposal to:
- to prohibit the manufacture, sale and distribution of Electronic Nicotine Delivery Systems (ENDS), including e-cigarettes.
- to prohibit the import under Sections 26A and 10A of the Drugs and Cosmetics Act, 1940.
WHAT ARE ‘ENDS’?
- Electronic Nicotine Delivery Systems (ENDS) includes e-cigarettes, heat-not burn devices, vapes, e-Sheeshas and e-nicotine flavoured hookahs.
- ENDS heat a solution (e-liquid) to create an aerosol which frequently contains flavourants, usually dissolved into Propylene Glycol or/and Glycerin.
- All ENDS contain nicotine. Nicotine is a highly toxic chemical and potentially carcinogenic
- Electronic cigarettes, the most common prototype, are devices that do not burn or use tobacco leaves but instead vaporise a solution the user then inhales.
- The main constituents of the solution, in addition to nicotine when nicotine is present, are propylene glycol, with or without glycerol and flavouring agents.
- E-cigarettes are the most common type of ENDS, and more than 460 different e-cigarette brands are available in the market with over 7,700 flavours currently, according to government data.
- ENDS solutions and emissions contain other chemicals, some of them considered to be toxicants.
IMPACT ON HUMAN HEALTH:
- ENDS poses serious health risks to the users as well as non-users. As much as 13 percent of the 7,20,000 annual premature deaths in India are tobacco-related.
- he availability of these products is widespread in the country because they are promoted by the industry body as a smoking cessation aid but their efficacy and safety as a quitting aid have not yet been firmly established.
- Uses of ENDS have documented adverse effects on humans which include:
- DNA damage
- carcinogenesis (initiation of cancer formation)
- cellular, molecular and immunological toxicity
- respiratory, cardiovascular and neurological disorders
- Also, nicotine can have adverse effects on the development of the foetus during pregnancy and may contribute to cardiovascular disease.
WHY ENDS BECAME AN ALTERNATIVE OPTION?
- ENDS were promoted as a smoking cessation aid. They were being used as a way to satisfy nicotine addiction during periods of temporary or forced abstinence
- Though some smokers claim to have cut down smoking while using ENDS, the total nicotine consumption seems to remain unchanged.
WHAT WAS THE NEED OF REGULATING THEM?
- Prior to the decision, ENDS were not declared as ‘drugs’ in the country’s drug regulations.
- These products have neither been assessed for safety and efficacy in the national population, nor have they been approved under the provisions of the country’s Drugs and Cosmetics Act, 1940.
- Simply put, ENDS have not been approved under India’s drug regulations. Due to this, there remained an opposition on legal grounds to banning the products.
- A complete ban: This is a positive development, and it would help the government move ahead with its decision to ban electronic nicotine products like e-cigarettes and vapes.
- Blow to market: This may deal a blow to India’s nascent vapour products market, reportedly valued at $15.6 million in 2017 but reportedly expected to grow nearly 60 percent a year up to 2022.
THE ROAD AHEAD:
ENDS currently lie in a legal grey area in India, they are banned only in eight of the countries but not nationally. The present move follows attempts by the Ministry of Health and CDSCO to ban the import and sale of the products in the country over public health concerns earlier. Once notified by the Health Ministry, the CDSCO will be able to prohibit the manufacture, sale and distribution of these Electronic Nicotine Delivery Systems (ENDS).