The Union government is looking to ban e-cigarettes in India on the grounds that they fall under the category of drugs. Fourteen states, including Karnataka, Uttar Pradesh, Haryana, Kerala, Punjab, Jammu and Kashmir, Mizoram, Bihar and Maharashtra have banned the product. The health ministry decided to ban nicotine inhalers, also known as electronic nicotine delivery systems (ENDS), after identifying their harmful effects.
"ENDS, including e-cigarettes, heat-not-burn devices, vape, e-sheesha, e-nicotine, flavoured hookah, and similar products, are used as a tobacco cessation product, and functions for nicotine delivery for reasons, including nicotine de-addiction. Hence, these devices and products fall under the definition of "drug" in the Drugs and Cosmetics Act," read the minutes of a recent health ministry meeting. The possible ban now hovers over the national capital. The Delhi High Court has directed the Delhi government to examine the issue of sale and consumption of e-cigarettes.
A voluntary body of Trade Representatives of ENDS in India (TRENDS), an association of importers, distributors, and marketers, is spreading awareness to dispel myths around the practice of alternative smoking. Manufactured outside India, e-cigarettes are handheld battery powered electronic devices which heat a liquid formulation — often containing nicotine — to create a vapour which can be inhaled.
By heating and not burning the liquid, no tar is generated.
Carcinogenic risk compared to a cigarette is less than a percent and completely switching greatly reduces exposure to toxins. No doubt a healthier alternative to cigarettes, but critics oppose the risk of promoting it as a healthy fad among non-smokers, especially the youth. In fact, the Indian Council of Medical Research (ICMR), in a white paper released in May 2019, noted that such devices ‘could encourage non-smokers to get addicted to tobacco’.
Dr Nimmi Rastogi, a gynaecologist and advisor to the Delhi government, revealed that the submissions are being prepared in consultation with pulmonologists in Delhi. “E-cigarettes are a good transition from cigarettes to vaping but to bring in a new product into the market which youngsters can pick up and justify as an healthier alternative is risky,” Rastogi said. She further explained that nicotine still enters the bloodstream and youngsters can get hooked. She revealed that the Delhi government isn’t completely opposed to the idea since the product has a high safety margin as compared to bidi and cigarettes.
Another issue she raised was the flooding of markets with Chinese products that don’t filter the tar. On 31 May, a New Delhi-based not-for-profit organisation Consumer Voice released findings of a survey on e-cigarettes which revealed that 36 brands have been selling the devices illegally for the past three years. Salaam Bombay Foundation, a Mumbai-based NGO, released findings of a survey on World Tobacco Day (31 May) that revealed that nearly 80 percent of e-cigarette users in India had not used any tobacco product previously, making e-cigarettes a potential gateway to tobacco consumption.
The other side of the argument is that the ban of a product that’s arguably less damaging to personal and public health will harm smokers. And data backs up their claims. According to a study published in the New England Journal of Medicine, the one year abstinence rate was 18 percent in the e-cigarette group versus about 10 percent in the traditional nicotine-replacement group. Users of e-cigarettes were more likely to have not smoked traditional cigarettes, had less cough and phlegm production at the end of a year and had a less severe urge to smoke than those on replacement patches and other forms of nicotine replacement.
E-cigarettes offer smokers, who would not otherwise give up their habit, an alternative source of nicotine with a lower health risk.
“Combustible cigarettes have not materially evolved in over 65 years and two-thirds of long-term smokers are expected to die prematurely due to smoking-attributable diseases. What we are essentially doing is curbing an effective de-addiction opportunity,” said Praveen Rikhy, convener of TRENDS. “The solution to tobacco consumption is often confined to one word: Quit. While there is no denying that quitting may be the most desirable outcome to safeguard the health of smokers, how do we treat those who cannot quit? The answer is evidence-based solutions,” added Dr Sameer Kaul, senior consultant Oncology & Robotics, Apollo Cancer Institute in New Delhi.
The problem stems from the lack of a regulatory framework. Even though TRENDS has been proposing a robust self-regulatory mechanism, 14 state governments have banned the product. It all started with Punjab declaring ENDS an unapproved drug and asking its officers to remain vigilant. In fact, on 21 May, 2015, the Chandigarh administration imposed a complete ban on nicotine under the provisions of the Poison Act, 1919 and the Poison (Possession and Sale) Rules 2015.
The inconsistency on the government’s end is that in August 2018, the Ministry of Health and Family Welfare issued an advisory that encouraged states to take measures to prohibit sale ‘except for the purpose and in the manner, to the extent, it is allowed under the Drug and Cosmetic Act 1940'. However, in 2015, the ministry admitted that e-cigarettes are not covered under the definition of drug and do not come under the purview of the said Act.
The discrepancy caught the attention of the largely unorganised industry that caters to less than one percent of India. “We are being targeted because we are a low-hanging fruit, but cigarettes which are unhealthy and cause irreversible damage to health are sold and consumed widely,” said Rikhy.
As per rule 122 E of the Drugs and Cosmetics Act 1940 and Rule 1945, every new drug should be sold in the country with the prior approval of Drugs Controller General of India. Permission to sell lozenges or gums containing less than 2mg nicotine are already given by Drugs Controller General of India. However, nicotine products above 2 mg are supposed to be sold only when prescribed by a registered medical practitioner.
“There are various kinds of e-cigarettes. Some without nicotine, some with 2 mg, some with more a little more. We are asking for standardisation and regulation,” explained Rikhy. The demand of the TRENDS body is that licensed sellers of e-cigarettes should be allowed to sell at authorised shops instead of a blanket ban. A ban could give a fillip to the grey market and push the product into a category of banned substances such as heroin and cocaine.
A ban without adequate enforcement makes little sense. For instance, liquor prohibition was enforced in Bihar in 2016 and the neighbouring states of West Bengal, Jharkhand and Uttar Pradesh saw a sharp rise in excise revenue which indicated that liquor from these states was being smuggled into Bihar.
Updated Date: Sep 09, 2019 12:11:29 IST