More than 60 specialists in nicotine, science and medicine have urged the ICMR to reconsider its recommendation of prohibiting e-cigarettes, citing a critical appraisal by experts which stated that the apex research body's white paper did not present a balanced overview on the issue and has failed to justify the ban.
Sixty-two experts from 20 countries, including India, have written to Director General of the Indian Council of Medical Research (ICMR) Dr Balram Bhargava in response to ICMR's "White Paper on Electronic Nicotine Delivery System", published on May 31, recommending a "complete" ban on such "alternative" smoking devices saying their use can initiate nicotine addiction among non-smokers.
In the white paper, the ICMR also said e-cigarettes adversely affect the cardiovascular system, impair respiratory immune cell function and airways in a way similar to cigarette smoking and is responsible for severe respiratory diseases.
In their letter, the specialists have cited a critical appraisal co-authored by Konstantinos Farsalinos of National School of Public Health, Greece, Riccardo Polosa of the Department of Clinical and Experimental Medicine, University of Catania, Italy, and Dr Atul Ambekar of AIIMS, also chairperson of the Addictive Disorder Specialty Section, Indian Psychiatric Society.
These experts in "White Paper on Electronic Nicotine Delivery Systems by the Indian Council of Medical Research: A Critical Appraisal of the Scientific Evidence" claimed that the white paper fails to present a balanced overview of the risk-benefit ratio of ENDS vis-a-vis other combustible tobacco products and therefore, their recommendations for e-cigarette ban are not justified.
It was published in the Indian Journal of Clinical Practice in August.
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ENDS are devices that heat a solution to create an aerosol, which also frequently contains flavours, usually dissolved into propylene glycol and glycerin.
There are various types of ENDS devices like e-cigarettes, heat-not-burn devices, vape, e-sheesha, e-nicotine flavoured hookah among others.
The critical appraisal systematically reviewed the four key arguments made by ICMR and presented evidence to counter them.
The experts stated that ICMR's paper presents a selective review of literature and fails to consider the substantial evidence that demonstrates the harm reduction potential of e-cigarettes.
In their critical appraisal, the experts highlighted that credible international institutes maintain that e-cigarettes are at least 95 per cent less harmful than tobacco cigarettes.
One of the major contentions of ICMR's white paper was the lack of long-term evidence.
However, it is accepted practice, even among pharmaceutical products, to rely on post-marketing surveillance to examine long-term health effects, as it is unviable for any product to be marketed only after decades of research, they said.
Additional evidence cited in the critical appraisal shows a positive association between e-cigarette use and smoking cessation or reduction. An analysis of a large US Population Survey indicated that the substantial increase in e-cigarette use between 2010 and 2015 was significantly associated with the first significant increase in smoking cessation in the past 25 years.
ICMR's paper claims that e-cigarettes are a gateway to "smoking and nicotine addiction", citing the 2016 US Surgeon General's report which reports a large increase in e-cigarette use among youth.
However, the critical appraisal shows that the US Surgeon General's report does not differentiate between ever-use (even once), experimental use (in the past month) and regular use.
The experts presented evidence from the US' Monitoring the Future and National Youth Tobacco Survey, which shows that frequent e-cigarette use is confined almost completely to smoking youth and rate of use among never-smokers is low.
The issue of addiction to nicotine from e-cigarettes, therefore, is irrelevant since its users are already addicted to nicotine from tobacco cigarettes.
According to the experts, ENDS offer an opportunity to improve public health and they fear that this opportunity will be lost if ENDS are banned in the country.
Farsalinos, Polosa, and Ambekar drew attention to the regulatory framework for e-cigarettes in the European Union and Canada and urge that India combat its huge tobacco challenge by including tobacco harm reduction in its tobacco control strategy and frame regulations on similar lines.
Banning such alternative smoking devices like e-cigarettes, heat-not-burn devices, vape and e-nicotine flavoured hookah among others, is one of the priorities of the Health ministry as part of the first 100 days agenda of the second term of the Narendra Modi government.
The Central Drugs Standards Control Organisation (CDSCO) had written to all state drug controllers, saying they should not allow the sale, online sale, manufacture, distribution, trade, import or advertisement of ENDS.
The Delhi High Court has stayed the Centre's circular banning sale and manufacture of ENDS like e-cigarettes and e-hookah with nicotine flavour, saying as the products were not a "drug", the authorities did not have the jurisdiction to issue such a direction.
Some states, including Punjab, Karnataka, Kerala, Bihar, Uttar Pradesh, Himachal Pradesh, Tamil Nadu, Maharashtra, Jharkhand, Rajasthan and Mizoram have already banned use and sale of e-cigarettes, vape and e-hookah.