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.
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.
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.
Various drugs have been approved as aid for smoking cessation under the provisions of the Act and its rules, a source said while elaborating on the proposal.
According to the proposal, "After revisiting its earlier deliberations, the Drugs Consultative Committee has recommended that since ENDS and the like products are used as a tobacco cessation product and function for nicotine delivery for reasons including nicotine de-addiction, hence these devices and product fall under the definition of 'drug' as defined under section 3(b) of the Drugs and Cosmetics Act, 1940." Asserting that availability of ENDS devices is widespread in the country and is posing serious health risks, the proposal mentioned that the safety aspect of these products has not been established and their efficacy on Indian population too has not have been approved under the provisions of the drug law.
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 dilemma 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.
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.
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