New Delhi, Dec 9,2022: The Indian government must try to reduce tobacco use and second-hand smoke by adopting a robust consumer awareness movement regarding the harms caused by tobacco use, a top international consumer policy expert said on Friday.

According to Professor Bejon Kumar Misra, Founder at Patient Safety and Access Initiative of India Foundation, in the area of public health, harm reduction is about developing policies to try and minimise the negative health impact of a risky activity without stopping it entirely.

Most importantly, there should be an effort to move towards less harmful alternatives as compared to conventional tobacco which has been successfully implemented by several countries, professor Misra told IANS.

Here are the excerpts from an interview:

Q. How can the government’s concerns around excessive tobacco usage and nicotine addiction be addressed?

A: We need a strong political will to make it happen. It is crucial that the Government of India aggressively looks at all the three-pronged strategies for controlling tobacco use or addiction, which are (1) supply control (2) demand reduction and (3) harm reduction. The WHO Framework Convention on Tobacco Control (WHO FCTC) defines “tobacco control” to mean a range of supply, demand and harm reduction strategies that aim to improve the health of a population by eliminating or reducing their consumption of tobacco products and exposure to tobacco smoke.

The UN Focal Point on Tobacco or Health (1997) has stated that to attain a substantial reduction in tobacco-caused death and disease in existing smokers and in future generations it is important to adopt a triadic approach of coordinated (1) tobacco-use prevention; (2) smoking cessation; and (3) reduction of exposure to toxins in people who are unable or unwilling to completely abstain from tobacco.

Government must try to reduce tobacco use and second-hand smoke by adopting a robust consumer awareness movement regarding the harms caused by tobacco use, strict tobacco-free designated areas and policies on advertising / tracing, providing expert counselling and appropriate Nicotine Replacement Therapies (NRT) to tobacco users who want to quit and innovative harm reduction products to empower consumers to make an informed choice as tobacco users who are unable to quit but want to shift to a less harmful product.

As per the 2017 Global Adult Tobacco Survey (GATS) (a global study for systematically monitoring adult tobacco use, funded by the Governments of India, Brazil, Greece, Malaysia, Panama, Qatar, Thailand, and Turkey with support from the Bloomberg Foundation, ACS Foundation and others) 99.5 million adults smoke tobacco in India.

Of those, 38.5 per cent reportedly attempted to quit smoking, yet only a small fraction of them succeeded. Although NRTs (nicotine chewing gums, patches etc.) are approved cessation therapies, more than 80 percent of smokers who use them to stop smoking fail. So, clearly just the cessation measures adopted by the Government have not proved to be enough.

Q. The Indian government imposed a ban on e-cigarettes and related products in 2019. How has the ban impacted the consumers/smokers?

A: Via the 2019 ban, a wide range of products, including e-cigarettes, all forms of electronic nicotine delivery systems, tobacco heating devices, also known as “Heat Not Burn (HnB products), e-hookah and like devices etc. were banned.

These products are sold globally as viable alternatives to conventional tobacco products to consumers who have unsuccessfully tried to quit smoking cigarettes. Due to the ban in India, Indian consumers/smokers are being deprived of the benefits of such products without any credible justification, whereas consumers around the world continue to derive benefits as they are legally sold with appropriate controls in place.

Research and development are indispensable for resolving public health challenges and if regulated appropriately in India, such innovative products will also provide consumers a better choice and will also help control the sale and use of illegally sourced e-cigarettes, especially by youth and non-smokers in our country. Such irrational bans only help to promote unsafe and spurious products in the supply chain, enriching the smugglers and depriving the consumers to access harm reduction products in a legal manner.

It is the basic right of consumers to have access to information on new and low-risk alternatives driven by innovation and science which are available across the world to arrive at an informed decision. Government ought to follow global best practices, appropriately regulate such alternatives, and give consumers (who struggle to quit smoking) the option to choose this significant reduced harm category rather than deny them the very accessibility.

Banning the entire range of innovative products would block innovations that could prove to be less harmful sources of nicotine and which could help users reduce or end their dependence on combustible tobacco Blanket bans, instead, as an unintended consequence, expose consumers and, often youth to unregulated counterfeit products which exposes them to an additional health risk.

India’s experiences with alcohol prohibition demonstrate how bans on products typically lead to a number of unintended consequences such as thriving black markets, loss of revenue to the exchequer and unintended public health risks from life-threatening spurious products.

In the area of public health, harm reduction is about developing policies to try and minimise the negative health impact of a risky activity without stopping it entirely. For tobacco, this means offering less risky alternatives to regular cigarettes for those smokers who cannot, or choose not to, give up. Combustible cigarettes have been considered the most harmful products because more than 7,000 chemicals are present in cigarette smoke, of which more than 70 are linked to cancer.

Smoking combustible cigarettes have proved to be fatal for half of those who do not quit. Saving smokers with the help of effective cessation methods has been a challenge globally. The WHO FCTC as well as the United Nations Focal Point on Tobacco or Health both accentuate the importance of harms reduction strategies to reduce consumption of and exposure to tobacco, such as by promoting safer alternatives.

Q. India is said to be the second highest consumer of tobacco products in the world. How can the current tobacco control measures be strengthened in India?

A: India is the second largest consumer and producer of tobacco. A variety of tobacco products are available at very low prices in the country. The most prevalent form of tobacco use in India is smokeless tobacco and commonly used products are khaini, gutkha, betel quid with tobacco and ZARDA. Common smoking forms of tobacco used are bidi, cigarette and hookah. Tobacco use is a major risk factor for many chronic diseases, including cancer, lung disease, cardiovascular disease and stroke. It is one of the major causes of death and disease in India and accounts for nearly 1.35 million deaths every year.A

Nearly 267 million adults (15 years and above) in India (29 PER CENT of all adults) are users of tobacco, according to the Global Adult Tobacco Survey India, 2016-17. Therefore, tobacco use is a big health threat for India.A

Historically, India began ratifying to Global Tobacco Control treaties and initiated regulation of tobacco by providing statutory warnings of the potential harm of tobacco consumption on health. With evidence of greater harm of tobacco consumption coming to light, governments took stringent measures such as regulating smoking and non-smoking spaces and banning the advertisement of tobacco products.

Further, with awareness regarding the impact of second-hand smoke, the approach to regulating tobacco products became more forceful (e.g., mandating graphic images of health impacts on cigarette packs and imposing smoking bans in public spaces). The current tobacco control measures can be strengthened in India by strictly implementing the provisions of the sectoral law – The Cigarettes and Other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply And Distribution) Act, 2003 (COTPA) which is applicable to all products containing tobacco in any form as detailed in the Schedule to COTPA.

The COTPA, had been enacted with the objective to prohibit the advertisement of, and to provide for the regulation of trade and commerce in, and production, supply and distribution of, cigarettes and other tobacco products and for matters connected therewith or incidental thereto.

India must continue using economic incentives such as high taxes, aggressively promoting awareness about the harms of smoking and set up more counselling facilities/ helplines/Quitlines for those users wanting to stop smoking or in certain cases shift to a lesser harmful product.

Most importantly, there should be an effort to move towards less harmful alternatives as compared to conventional tobacco which has been successfully implemented by several countries and as suggested by WHO FCTC and United Nations. It is unfortunate, most tobacco users and adult smokers even after best treatment attempts go back to limited or previous patterns of tobacco use. With limited success of abstinence-oriented tobacco cessation methods or NRTs, it is imperative that Government of India embrace harm reduction alternatives that could significantly help in reducing smoking-related diseases and prevent over one million annual deaths that are caused by smoking.

Q. What role does research and innovation play in policy making?

A: Policy making works in a stable policy environment, where multiple stakeholders are consulted, and collective policy is made. Research and Innovation indeed play an important role in policy making. This is because times change and a policy which was relevant say 20 years ago cannot be said to be relevant now. Therefore, research and innovation help a lot in framing of a policy which is relevant in the current times. Innovation in policy making is not a new concept and has been widely used in our country since a long time.

India is among the fastest-growing economies globally and innovation has played a critical role in achieving this status. India has rightly identified innovation as a key priority and is committed to further influencing its innovative footprint across the globe. Time and again we have witnessed Government of India’s focus on promoting innovation. For example, GoIs flagship Make in India initiative focuses on the creation of additional employment opportunities by encouraging innovation and investments in the country’s manufacturing sector.

In recent times, Covid-19 accelerated the adoption of new technologies/innovation in India too. The pandemic led to the emergence of several path breaking ideas. Never before has the need to adapt and adopt new technologies and innovations felt more urgently. Ministry of Science and Technology is working on a Science, Technology, Innovation Policy that aims to bring about profound changes through short-term, medium-term, and long-term mission mode projects by building a nurtured ecosystem that promotes research and innovation.

Other such examples include, the extant National Pharmaceutical Pricing Policy (NPPP), notified on December 7, 2012, which was formulated with an objective to put in place a regulatory framework for pricing of drugs to ensure availability of essential medicines at reasonable prices while providing sufficient opportunity for innovation and competition to support the growth of pharma industry. The policy made a shift from earlier acost based’ pricing under the Drug Policy, 1994 to amarket based’ pricing.A In pursuance of NPPP, 2012, the Government notified the Drugs (Prices Control) Order, 2013 (DPCO-2013).

As per the provisions of DPCO, 2013, the National Pharmaceutical Pricing Authority (NPPA) fixes the ceiling price of all scheduled formulations appearing in National List of Essential Medicines (NLEM). All the manufacturers of these drugs are required to sell their product equal to or lower than the ceiling price. Further, NPPA monitors the prices of non-scheduled drugs so as to ensure that the increase in their Maximum Retail Price (MRP) is not more than 10% of what was prevalent during the preceding twelve months.

Q. As an international consumer policy expert, your take on where India is today in the implementation of WHO-FCTC?

A: India was one of the leading countries to ratify the WHO FCTC in 2004, the first ever international public health treaty focusing on the global public health issue of tobacco control. I fondly recall how we played a leading role in FCTC negotiations since 2000 to finalize its provisions and was the regional coordinator for the South-East Asian countries.

FCTC recommends evidence-based measures and parallel to the treaty India adopted its comprehensive tobacco control law i.e. the COTPA which came into force on May 1, 2004. Further, the Ministry of Health and Family Welfare, Government of India, as an express commitment to implement the treaty obligations, took a step towards translating the law into practice and adopted the National Tobacco Control Programme (NTCP).

WHO-FCTC provides various measures for “tobacco control” including supply, demand and harm reduction strategies. various measures to reduce the demand as well as supply of tobacco.

India has adopted and implemented to some success the demand reduction strategies as contained in Articles 6 to 14 which includes price and tax measures to reduce the demand for tobacco, non-price measures to reduce the demand for tobacco, protection from exposure to second hand tobacco smoke, tobacco content and product regulation, packaging and labelling of tobacco products, education, communication, training and public awareness, tobacco advertising, promotion and sponsorship and demand reduction measures concerning tobacco dependence and cessation.

Also, reduction strategies as contained in Articles 15 to 17 such as illicit trade in tobacco products, sales to and by minors and provision of support for economically viable alternative activities. However, the third set of measures that is “harm reduction” as included in Article 1 is yet to be adopted by India. In contrast to the initial Cigarette Act of 1975, a marked improvement in tobacco control efforts was evident under COTPA as it not only included cigarettes but also brought all other forms of tobacco products (both smoking and smokeless) under the realm of legislative control.

However, innovative harm reduction products like Heat not Burn products (which are tobacco products but less harmful than combustible cigarettes) are yet to be regulated under COTPA. Scientific studies, appropriate regulation, and post-market monitoring can ensure that the potential benefits of innovative harm reduction or smoke-free products are realized, and the risk of use by non-smokers and minors is minimized.

It is high time we revisit THE PROHIBITION OF ELECTRONIC CIGARETTES (PRODUCTION, MANUFACTURE, IMPORT, EXPORT, TRANSPORT, SALE, DISTRIBUTION, STORAGEAND ADVERTISEMENT) ACT, 2019 and make it part of COTPA to reinstate the right to informed choice based on Science to empower the consumers to access harm reduction products as part of the existing SCHEDULE.