In a development that would help the government move ahead with its decision to ban electronic nicotine products like e-cigarettes and vapes, India’s top drugs advisory board Tuesday approved a proposal to regulate them as “drugs” and prohibit their sale in the country, The Indian Express has learnt.
Once notified by the Health Ministry, the CDSCO will be able to prohibit the manufacture, sale and distribution of these Electronic Nicotinic Delivery Systems (ENDS). 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 per cent a year up to 2022.
The move follows attempts by the Ministry and CDSCO to ban the import and sale of the products in the country over public health concerns earlier.
The Drugs Technical Advisory Board (DTAB) on Tuesday agreed on a proposal to prohibit the manufacture, sale and distribution of ENDS, including e-cigarettes, as well as their import under Sections 26A and 10A of the Drugs and Cosmetics Act, 1940, people close to the development told The Indian Express.
Before, ENDS were not declared in India’s drug regulations as ‘drugs’, so there was an opposition on legal grounds to banning the products, said a senior government official. “Once they declare it, (the Health Ministry) can take necessary action to ban it,” the official said. According to sources close to the development, these products have neither been assessed for safety and efficacy in the national population, nor have they been approved under provisions of the country’s Drugs and Cosmetics Act, 1940.
“But availability of these products is widespread in the country, posing serious health risks to the users and non-users,” said a source. 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 including e-cigarettes are promoted by the industry body as a smoking cessation aid but their efficacy and safety as a quitting aid has not yet been firmly established. Though some smokers claim to have cut down smoking while using ENDS, the total nicotine consumption seems to remain unchanged,” said the source, adding that there were “various” studies to suggest that ENDS was being used as a way to satisfy nicotine addiction during periods of temporary or forced abstinence.
Till now, ENDS like e-cigarettes, heat-not burn devices, vapes, e-Sheeshas and e-nicotine flavoured hookahs have not been approved under India’s drug regulations. The Indian Council of Medical Research in May 2019 released a white paper stating ENDS contain nicotine solution.
“Uses of ENDS, or e-cigarettes 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 and adverse impact on foetal development and pregnancy,” stated ICMR, adding that it recommended a “complete prohibition” of these products.
In August 2018, the government had issued an advisory to states to prevent the sale, including online, of ENDS “in the larger public interest” and in order to prevent non-smokers, young persons and other vulnerable groups in the country from initiating usage of these products.
Based on this advisory, CDSCO had issued letters to state and Union territory drug controllers in February 2019 requesting them to “ensure” that they were not sold, made, distributed, traded, imported and advertised in their jurisdictions, The Indian Express has learnt.
Several states, including Karnataka, Kerala, Mizoram, Maharashtra and Uttar Pradesh, have so far issued orders banning e-cigarettes as “unapproved” drugs. Governments of Punjab, Haryana and Chandigarh have also commenced prosecution of sellers of ENDS.