Going tough on Electronic Nicotine Delivery Systems (ENDS), including e-cigarettes, the health ministry has proposed to classify such alternative smoking devices as "drugs" under the Drugs and Cosmetics Act, in a bid to ban their manufacture, sale, distribution and import.
According to official sources, 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 move comes amid a raging debate over the harm-reduction aspects of ENDS.
Some organisations claim that these devices help in smoking cessation and are less harmful alternatives to traditional cigarettes, while the government is seeking to ban them contending they pose health risks to users, similar to those of conventional cigarettes.
Indian drug regulator, the Central Drugs Standard Control Organisation (CDSCO), under the health ministry has 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 stated that under the provisions of 'drugs' in the Act, any item intended to be used as an aid to help quit smoking is covered under the definition of drugs.
Some states, including Punjab, Haryana, Kerala, Mizoram, Karnataka, and Jammu and Kashmir, have already banned e-cigarettes as an unapproved drug. While all of them have banned it under the Drugs and Cosmetics Act, some have added the Poisons Act, 1919.
Apex research body – the Indian Council of Medical Research (ICMR) has recommended a "complete ban" on ENDS, saying their use can initiate nicotine addiction among non-smokers also.
In a white paper released last month, the ICMR said e-cigarettes adversely affects the cardiovascular system, impairs respiratory immune cell function and airways in a way similar to cigarette smoking and is responsible for severe respiratory diseases.
It also poses risk to foetal, infant and child brain development, the white paper claimed.
A consumer body, the Association of Vapers India (AVI), has questioned the veracity of ICMR white paper on ENDS, saying empirical evidence from countries that have allowed e-cigarettes show "smoking rates have declined at a historic pace".
In August last year, the Union Health Ministry issued an advisory to all states and Union Territories to stop manufacture, sale and import of ENDS. The advisory was subsequently challenged in the Delhi High Court which ruled it to be non-binding on states and government bodies.
However, 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.
The health ministry was earlier in a didilemma on whether to ban ENDS under the Cigarettes and Other Tobacco Products Act (COTPA) or the Drugs and Cosmetics Act.
In March, the CDSCO directed all drug controllers in states and UTs not to allow the manufacture, sale, import and advertisement of ENDS, including e-cigarettes and flavoured hookah, in their jurisdictions.
Over 1,000 doctors from 24 states and three UTs in April this year urged Prime Minister Narendra Modi to enforce a ban on ENDS before it becomes an "epidemic in India", especially among the youth.
However, over 3,000 users of such devices have written to the prime minister, requesting him to legalise them claiming their health has improved significantly after switching to vaping from smoking conventional cigarettes.
E-cigarettes banned in 25 countries
The sale of e-cigarettes is completely banned in 25 countries, including Brazil, Norway and Singapore, while market authorization is required in 17 other countries.
In the United States, ENDS, that are marketed for therapeutic purposes are currently regulated by the US-FDA and Center for Drug Evaluation and Research, the ICMR white paper stated.
Association promoting ENDS urges govt to consult industry before banning e-cigarettes
An umbrella body of trade representatives promoting Electronic Nicotine Delivery Systems (ENDS) including e-cigarettes has urged the government to refrain from rushing into any proposals to ban such devices without consulting stakeholders or examining the facts.
The voluntary association of Trade Representatives of ENDS in India (TRENDS) comprising importers, distributors, and marketers of such "alternative" smoking devices has suggested that the government should initiate a consultative process so that opinion of all stakeholders can be heard and facts placed in the correct perspective.
In a representation submitted to the Union Health Secretary, the association raised their concerns in the wake of health ministry's proposal to classify such devices as "drugs" under the Drugs and Cosmetics Act, in a bid to ban their manufacture, sale, distribution and import in the country.
The representation highlighted that ENDS are not "drugs" as they are not promoted or intended to be of any therapeutic value.
They do not mitigate or prevent smoking but are an option for a habitual smoker who would like to switch to a non-combustible version, the representation said.
Some organisations claim that these devices help in smoking cessation and are less harmful alternatives to traditional cigarettes, while the government is seeking to ban them, contending that they pose health risks to users, similar to those of conventional cigarettes.
"We believe that strong reasons exist for the government to re-examine its stand vis–vis ENDS. We would request it to objectively consider the benefits and harms related to the product and initiate open consultation.
"We are also ethically committed not to market our products to minors and pregnant women and are ready to work with the Indian government to ensure enforcement of legal purchase age and valid label warnings, training and awareness against harmful use," Convener of TRENDS, Praveen Rikhy, said.
The TRENDS association argued that such a consultation should consider all voices on the issue including industry players, civil society organizations, NGOs, medical experts (both who are in opposition and support), and other relevant organizations with a view to develop an appropriate regulatory framework that must be adhered to by the industry.
Asking for a ban on e-cigarettes and not cigarettes or 'beedis' would mean asking for a ban on a less harmful nicotine delivery system while allowing a more harmful one free market availability, Rikhy said.
"This is fundamentally unsustainable as policy or a public health imperative or even in law and consumer rights. This is also in stark contrast and regressive when compared with the fact that developed economies are regulating ENDS and many see the category as complementary to their tobacco control goals," she said.
A ban will end up opening up the black market and create room for substandard unregulated products. It would be of utmost importance to the Health Ministry to not be seen as creating such a market scenario, she added.
Asserting that availability of ENDS devices is widespread in the country and is posing serious health risks, the health ministry's proposal mentions that the safety aspect of these products has not been established and their efficacy on Indian population too has not been approved under the provisions of the drug law.
What are END devices
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.