Smokeless Tobacco and Public Health in India

Full text

Smokeless Tobacco and
Public Health in India
Executive Summary
Ministry of Health and Family Welfare
Government of India

e ndings and conclusions in this report are those of the authors and do not necessarily
represent the ocial position of the Centers for Disease Control and Prevention.
Smokeless Tobacco and
Public Health in India
Scientific Editors
Prakash C. Gupta
Monika Arora
Dhirendra Sinha
Samira Asma
Mark Parascondola
Editorial Assistants: Cecily S. Ray, Manu Raj Mathur, Lauren Bartell

Message
India has always rearmed its position as the global leader in the area of tobacco control.
I commend my Ministry for taking concrete steps in advancing tobacco control initiatives
at National, State and Sub-National levels through National Tobacco Control Programme.
2. Tobacco use is the foremost preventable cause of death and disease globally as
well as in India. As per the Global Adult Tobacco Survey (GATS) – India, 2010, smokeless
tobacco/chewing forms are the most prevalent forms with 206 million Indians using it. As
such, the consequent burden of mortality and morbidity due to consumption of smokeless
tobacco (SLT) is very high in India. Available evidence suggest that India shares the maximum
burden of oral cancer in the world. The use of SLT is associated with high prevalence of oral
cancer in India and almost 90% of these oral cancers are linked to tobacco use.
3. The challenges before the nation are formidable, both in their number and in their complexity, especially,
in view of the growing Non-Communicable Diseases (NCDs), and that too amongst disadvantaged people who live
in rural areas. Therefore, it becomes imperative to take all social determinants of NCD into account, and to curb the
use of tobacco at large.
4. I believe that the monograph on Smokeless Tobacco and Public Health in India will bridge a very important
gap in the area of public health, as it provides a comprehensive review on impact of smokeless tobacco consumption.
The compilation of scientic studies on smokeless tobacco provides abundant information on consumption patterns
and associated usage risks. Since the problem of SLT usage is unique to South Asia, the monograph would be
extremely useful for public health managers both in India and neighbouring countries especially South-East Asian
countries, to promote eective initiatives for curbing SLT usage.
5. I applaud the eorts made by the Healis Sekhsaria Institute for Public Health; Public Health Foundation of
India; World Health Organization (WHO); the Centers for Disease Control and Prevention, U.S.A; National Cancer
Institute, U.S.A., and other eminent organisations/experts in bringing out a comprehensive report with empirical
evidences on smokeless tobacco, which would be able to generate interest amongst stakeholders to address the
problem adequately.
(Jagat Prakash Nadda)

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Smokeless Tobacco and Public Health in India
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Smokeless tobacco products use is increasingly becoming a serious public health issue in
WHO South-East Asia Region. Nearly 80% of global smokeless tobacco users live in the
Region, which has myriad varieties of smokeless tobacco products.
Traditionally betel quid was the most commonly used product. However, in recent
years, there has been a shift towards manufactured smokeless tobacco products, such
as khaini. In many countries, while the prevalence of smoking is decreasing, the use of
smokeless tobacco is on the rise. In India, in 2010, an estimated 368 127 deaths (217 076
women and 151 051 men) were attributable to smokeless tobacco use.
Smokeless tobacco causes oral and gastrointestinal cancers, and a number of other cardiovascular diseases.
The incidence of mouth cancer is increasing in SEAR countries especially among the younger generation. The
situation is grim and calls for urgent and focused action to stop this epidemic.
WHO welcomes this joint initiative of the Ministry of Health and Family Welfare, Government of India, and
global experts for detailing issues relating to smokeless tobacco use in this document.
WHO is pleased to note that individual states in India invoked food safety laws in 2011 to ban gutka and
pan masala containing tobacco, and banned the production and sale of avored and packaged smokeless tobacco
products. India and other countries in the Region have rolled out intensive mass media campaigns to inform people
about the harmful health impact of smokeless tobacco use. India has also introduced presumptive taxes, resulting in
a fourfold increase in revenue collection from taxation on smokeless tobacco in the last ve years.
Health education and counseling, changing cultural norms associated with smokeless tobacco, strict
implementation of anti-tobacco laws in the community and work places, and providing cessation support are
important measures for preventing initiation and continuation of tobacco use.
We need to make more eorts for strengthening smokeless tobacco control policies and their implementation,
increasing awareness on the harmful eects of smokeless tobacco use and eective cessation programmes.
This document is a welcome move by the Ministry of Health and Family Welfare, Government of India,
and international partners for identifying gaps and providing comprehensive strategies and recommendations for
smokeless tobacco control.
WHO hopes that all countries in the Region and beyond are able to make the best use of the evidence,
guidance and recommendations in this document to curb smokeless tobacco use.
Dr Poonam Khetrapal Singh
Regional Director
WHO South-East Asia Region
Message from the Regional Director
WHO South-East Asia Region

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Smokeless Tobacco and Public Health in India
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Message from WHO Representative
to India
This monograph is a timely and a welcome initiative as it puts the spotlight on the serious
public health challenge posed by the consumption of smokeless tobacco. Unlike cigarettes,
smokeless tobacco often doesn’t get enough attention despite being a serious health hazard;
this monograph addresses the gap not only by providing evidence on how smokeless tobacco
impacts health and the economy but also recommending a comprehensive strategy to deal
with the unique challenge it poses.
The widespread use of Smokeless Tobacco (SLT) is unique to India and South-East
Asia, with a range of SLT products being produced and consumed. Each state in India has
its own variants of SLT products, which may be produced industrially or assembled locally
using tobacco and other condiments. SLT use is associated with cancer of the oral cavity, oesophagus, pancreas
heart disease and stroke, as well as adverse reproductive outcomes and developmental eects including still-birth,
preterm birth and low birth weight. One in four adults and one in ten school students (13-15 years) in India use
SLT and are at grave risk due to their addiction. India bears the highest burden of oral cancer globally, due to high
prevalence of smokeless tobacco use.
SLT products in India are attractively packaged in colorful sachets that are widely retailed at very low cost
making them easily aordable, even for children. Although advertising of tobacco products is prohibited in India,
SLT manufacturers are using surrogate means by advertising non-tobacco variants of these products through
deceptive brand sharing strategies. The worrisome issue is that these brands are being endorsed by lm stars and
celebrities, thereby increasing the appeal of these deadly products to the masses and especially to vulnerable youth
and poor.
Government of India has been progressively regulating SLT products through various strategies by using
the environmental, food safety and other regulations. States have prohibited manufacture, sale, transportation
and storage of packaged SLT products under the Food Safety Act. A number of hard hitting national level public
awareness messages with specic focus on SLT usage have been released using real stories of victims who lost their
lives to this deadly addiction in the prime of their youth.
The Global Knowledge Hub on Smokeless Tobacco has been set up in India in collaboration with the WHO
FCTC Secretariat. Tobacco testing laboratories are in the process of being established to test the constituents and
emissions of all tobacco products. Tobacco cessation services have also been strengthened through the launch of the
National Tobacco Cessation Quitline and mCessation initiatives.
WHO India has been working closely with the Ministry of Health & Family Welfare (MoHFW) in this crucial
public health endeavor. In partnership with MoHFW, a number of consultations have been organized to bring
greater attention to the issue and build partnerships to strengthen policy interventions for curbing consumption of
smokeless tobacco. In addition, a number of research studies have been undertaken to build the evidence-base.
With strong political commitment at the highest level, India is well positioned to take on the challenge of
SLT usage, which is putting a huge burden on the health care system as well as on the economy. There are multiple
litigations opposing the prohibition on SLT products and, against this background, the release of this report is

Executive Summary
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strategic. The prohibitions imposed on the packaged SLT products need to be strictly enforced, and the use of SLT
to be de-normalized in the society by raising awareness about the negative health impacts and drain on economy.
There is an urgent need to uncover the indirect advertising strategies of the SLT manufacturers and advocate for
policies to reduce youth exposure and initiation.
I urge all stakeholders to come together to use the evidence and recommendations contained in this report to address
this epidemic in a comprehensive manner and save precious lives.
Henk Bekedam
WHO Representative to India

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PREFACE
Tobacco use is now universally considered the most important preventable cause of adult death and
disease in the world. In most countries, cigarette smoking is the predominant form of tobacco use, and
most research and prevention eorts are directed toward it. In some countries, however, other forms of
tobacco are more prevalent. In India, smokeless tobacco is the dominant form of tobacco used, although
little comprehensive documentation is available on this subject. Regardless of the type of product used, it
is a well-established scientic fact that tobacco use in any form aects health adversely.
The idea for this monograph emanated during the National Consultation on Smokeless Tobacco organised
by Ministry of Health & Family Welfare, Government of India (MOHFW) in collaboration with World
Health Organization Country Oce (WCO) India and Public Health Foundation of India (PHFI) during
4-5 April, 2011. The idea got further crystalized during a stakeholders’ meeting in New Delhi (17 October
2011) organized by the Healis-Sekhsaria Institute for Public Health. Joining Healis-Sekhsaria Institute
in moving this project forward were PHFI, the World Health Organization (WHO), and the U.S. Centers
for Disease Control and Prevention (CDC), under the auspices of India’s Ministry of Health and Family
Welfare (MoHFW). This group undertook the task of developing an evidence-based, peer-reviewed report
in the form of a scientic monograph to be issued by the MoHFW. The U.S. National Cancer Institute
(NCI) provided the technical support to develop this report.
A concept proposal was developed, along with a list of chapters to be included in the monograph. Possible
editors, reviewers, and authors were then identied. Scholars with specic expertise in smokeless tobacco
control were invited to contribute to dened chapters. In several authors’ meetings, drafted chapters were
thoroughly reviewed and modied based on the editors’ suggestions. These modied drafts were then
reviewed by independent experts. A meeting of authors and reviewers that included Indian and international
subject experts extensively reviewed each chapter, cross-checking and suggesting modications. After a
lengthy process consisting of multiple rounds of reviews and editing as well as consultation between
Healis, PHFI, WHO and NCI, the report underwent technical editing at BLH Technologies, Inc.
This monograph provides a comprehensive overview of the public health burden of smokeless tobacco use
in India for anyone interested in this topic: public health practitioners, researchers, policy-makers, policy
advocates, activists, and many others. This report attempts to oer specic directions on addressing the
public health impact of smokeless tobacco use in India, and it identies a number of relevant research,
capacity building, and policy needs. Special care has been taken to keep the language of this report free
from technical jargon for wider understanding. The chapters incorporate data available until 2014 and
later data are included in an Appendix.
The editors are thankful to all who contributed to this report for their enthusiasm and support for this
project. We deeply appreciate the eorts of all the authors and co-authors for their hard work. We are
grateful to the MoHFW for assigning us a task of such great importance for advancing public health in
India. We hope the information in this report increases awareness of smokeless tobacco use and the death
and disease it causes, and leads to widespread recognition of smokeless tobacco use as a high-priority
public health issue. We hope that this increased awareness will lead to timely action, which is critical to
saving lives now endangered by the epidemic of smokeless tobacco use.
Prakash C. Gupta Monika Arora Dhirendra N. Sinha Samira Asma Mark Parascandola

Executive Summary
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Smokeless Tobacco and Public Health in India
1
INTRODUCTION
Smokeless tobacco (SLT) is available in many forms in India and is widely used by all social groups. It
is more prevalent among the disadvantaged and people who live in rural areas, and is common among
women of all ages, including reproductive age. There is a wide spectrum of morbidity and mortality related
to SLT use, but SLT has not yet received the attention it deserves as a public health problem. Tobacco
control policies have not been sucient to curb its use. SLT use is high not only in India, but also in South
East Asia and many other countries globally. The Ministry of Health and Family Welfare, Government of
India, proposed the development of a comprehensive peer-reviewed report and invited the collaboration
of Healis-Sekhsaria Institute of Public Health, PHFI, WHO, CDC, and NCI, U.S.A. This monograph is
a response to a recommendation from the National Consultation on Smokeless Tobacco, held on 4th–5th
April 2011 in New Delhi.
This monograph is a comprehensive document intended to raise the prole of the challenge posed by
SLT so that tobacco control eorts can eectively respond to this epidemic. The monograph describes the
background, economics, and science of SLT use; the characteristics of SLT products; and policy eorts
to combat this public health threat. This report also documents sources of information, discusses gaps in
knowledge, describes research and policy needs, and provides recommendations. One goal of this report
is to help the various stakeholders understand how they can work together to ght the menace of SLT.
HISTORICAL AND SOCIOCULTURAL OVERVIEW OF SMOKELESS
TOBACCO IN INDIA
Originating in the Americas, tobacco came to India through Portuguese traders in the early 1600s. Tobacco
was introduced rst among the nobility and soon became popular among the common people. For millennia,
betel quid (pan) chewing was a socially accepted practice and a part of culture and religious customs. Soon
after tobacco arrived in India, it was added as an ingredient in betel quid, and this combination is still
widely used. The use of SLT has been justied for its purported medicinal properties, although no system
of medicine in India has ever encouraged its medicinal use. Tobacco has been an important cash crop since
the early 1600s and an important item of trade both domestically and internationally.
New SLT products containing areca nut were introduced in the early 1970s (pan masala with tobacco,
gutka, mawa, etc.); some of these products are vendor made and others industrially made. With vigorous
marketing these products soon became very popular.
ECONOMICS OF SMOKELESS TOBACCO IN INDIA
The SLT market in India is the world’s largest. Over the last two decades, the SLT industry in India has
grown exponentially, mostly in the unorganised sector. About 14% of land under tobacco cultivation is
used for growing SLT varieties, and one-fth of total tobacco production is used for SLT.
The cumulative tax rate, 76%, is similar across all SLT products. Excise revenue from chewing tobacco
has increased 15-fold in 10 years, from Rs 722 million in 1990-1991 to Rs 10,532 million in 2010-2011.
However, the share of chewing tobacco in overall gross tax revenue has been less than 1%. Although the
tax rate has gone up over time, it has never been high enough to reduce consumption, due to very low unit
prices.

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From 1991 to 2010 the value of SLT exports from India increased ninefold, from Rs 181 million to Rs
1,648 million. Over 70% of SLT exports from India go to the Eastern Mediterranean Region, followed by
the Western Pacic and American Regions.
SMOKELESS TOBACCO USE AMONG YOUTH
SLT use usually begins in youth and continues through adulthood. SLT is easy to hide from elders who
might disapprove. Youth typically start using SLT as a dentifrice (mishri, gul, lal dant manjan, tobacco
toothpastes) or gutka and other avoured SLT products as mouth freshener. The Global Youth Tobacco
Survey (GYTS) in India in 2003 revealed that prevalence varied widely among the states, ranging from 1%
in Himachal Pradesh to 56% in Bihar. Between 2006 and 2009 there was no change in prevalence of SLT
use by school-going youth. In 2009, GYTS found that nearly one in ten students in India ages 13–15 years
used some form of SLT (9.4% overall; 10.7% boys; 7.5% girls). The most important factors aecting SLT
use by youth in India are advertisements, promotions, and price, all of which can be inuenced by policy.
Surveys conducted in India in 2006 and 2009 showed that seven in ten students ages 13–15 years were
exposed to SLT advertisements. Psychosocial variables aecting SLT use include sociodemographics,
school characteristics, social norms, SLT use by parents and peers and knowledge of health eects.
SMOKELESS TOBACCO USE AMONG ADULTS IN INDIA
The Global Adult Tobacco Survey (GATS) conducted in India in 2009–2010 among those ages 15 years or
over revealed that smokeless tobacco was the most common form of tobacco used. Prevalence of current
SLT use was 26% (33% men; 18% women) and of daily use, 21%. The average age of initiation to SLT
was 17.9 years, similar to that for smoking.
Product preferences varied by gender and by region. Men generally preferred khaini, followed by gutka
and betel quid (the last two contain areca nut). The pattern of product preferences for women is more
complicated. In the South and North-East, women preferred betel quid; in the Western, Central, and
Eastern regions, women used SLT products mainly for dental application; and they preferred khaini in the
Eastern, North-Eastern, and Central regions and gutka in the Central and North-Eastern regions. In the
North, very few women used SLT.
The low rate at which SLT users quit use is indicated by the fact that former daily use of SLT was 1.2%.
DUAL TOBACCO USE IN INDIA
A dual tobacco user uses both smoking and smokeless forms of tobacco. According to GATS India 2009-
2010, the prevalence of dual tobacco use was 5.3% (men 9.3%; women 1.1%), amounting to 42.3 million
adults. The North-East region had the highest prevalence (9.8%). The interval between starting the use of
the two forms of tobacco was two years or less for over half of all dual users. Somewhat more than half of
dual users used both forms daily. Over one-third of daily dual users were interested in quitting all tobacco,
but only 5% were former users. In an intervention study, dual tobacco users were only half as successful
in quitting tobacco compared to exclusive smokers and one-third as successful as exclusive SLT users.

Smokeless Tobacco and Public Health in India
3
Dual users show higher risk of diseases than single users; for example, among dual users the risk of oral
cancer is 2–12 times higher, and risk of heart attack is twice as high compared to single users.
DETERMINANTS OF SMOKELESS TOBACCO USE IN INDIA
Determinants of SLT use are gender (men), wealth index (inverse association), and belonging to a scheduled
tribe. Parental use, peer use, exposure to advertising and promotions of SLT, and lack of knowledge of health
risks conferred higher risk of SLT use. Awareness of SLT harms was somewhat higher in men, younger
adults, students, individuals with higher levels of education, and urban residents. This knowledge of SLT
harms was higher in the North and lowest in the West, and declined with increasing age. A widespread
misconception is that SLT is good for dental health.
ADVERTISING AND MARKETING OF SMOKELESS PRODUCTS
Tobacco marketing in India can be divided into three time periods: pre-1985, 1985 through 2003, and
2004 through 2013.
Phase I: SLT marketing in India evolved with the introduction of new products and the diusion of mass
media. Most mass media advertising for SLT products containing areca nut began with pan masala in
1973. Celebrity endorsement was an important marketing strategy.
Phase II: In the 1980s, with the introduction of the low-priced, single-portion pouch, sales of gutka and of
pan masala with tobacco increased greatly, and many more manufacturers entered this market. Television
ads promoted these products. In 2000, the Cable Television Networks Ordinance Rules (1994) were
amended to prohibit advertisements of tobacco and alcohol on television, but there was no restriction on
advertising pan masala that did not contain tobacco, even under the same brand names as tobacco products.
Phase III: In 2004, although the Cigarettes and Other Tobacco Products Act (COTPA) 2003 prohibited
tobacco advertising in all media, advertising for identical brands of pan masala without tobacco continued
in all media. Corporate social responsibility campaigns, cultural events, and sponsorship activities also
made use of brand stretching. GATS India 2009-2010 showed that 55% of adults had noticed promotion
of SLT products within the previous month. In 2012, when states started banning gutka under Food Safety
and Standards Act (FSSA) Rule 2.3.4, manufacturers intensied their marketing by special oers to small-
scale distributors and retailers. Several television news channels began featuring news breaks sponsored
by a pan masala manufacturer. Packets of chewing tobacco were given away free along with areca nut
mixtures without tobacco. Brand names and imagery on areca nut products were often aimed at children
and women.
WOMEN AND SMOKELESS TOBACCO: SPECIAL
CONSIDERATIONS
Smoking by women in India is still socially unacceptable but SLT use is common. Currently, 70 million
women age 15 and older use SLT. Easy availability and low cost of SLT are key factors promoting SLT use
by women. One factor inuencing SLT use among disadvantaged women is the desire to suppress hunger
while performing dicult and labourious tasks.

Executive Summary
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In addition to a number of other disease risks, SLT use raises women’s risk of adverse reproductive
outcomes. The prevalence of SLT use while pregnant or breastfeeding is similar to prevalence of use
among all women of reproductive age in India. Using SLT during pregnancy results in:
70% higher risk of anaemia in pregnant women
2–3 times higher rate of low birthweight
2–3 times higher rate of stillbirth.
Areca nut use also has adverse reproductive eects of its own.
The relative risk of oral cancer among women SLT users is 8 times higher than that for men, and the
relative risk of cardiovascular disease among women SLT users is 2–4 times higher than in men. Relative
risk of all-cause mortality due to SLT use is higher among women than among men.
SMOKELESS TOBACCO AND ALL-CAUSE MORTALITY
Three large cohort studies from India have shown a higher age-adjusted relative risk of death among SLT
users. Corroborating this, four large studies in Western countries (two from Sweden and two from the
United States) have also shown signicantly higher mortality in SLT users. Except for one study in India,
where after adjustment, there was a slight reversal of risk for SLT users (men and women), relative risks of
death among SLT users in all other studies were signicantly elevated, from 10% to 96%. In other studies
where women participated, the relative risk of death in women SLT users was higher than that for men.
All-cause mortality was higher in dual tobacco users in one study. Additional risk factors contributing
to higher mortality from SLT use were alcohol use, hypertension, and being grossly underweight or
grossly overweight. Causes of death associated with SLT use were circulatory system diseases, malignant
neoplasms, and pulmonary diseases.
SMOKELESS TOBACCO USE AND CANCER
Cancers of the oral cavity and pharynx are an important public health problem in India, with nearly 85,000
new cases among men and 34,000 among women in India each year. At least 90% of these cancers are
caused by tobacco use in some form, and more than half are caused by SLT use. The association between
SLT and cancers of the oral cavity and pharynx in India has been studied and documented for several
decades. All cohort and case control studies from India conrm a strong association between SLT use
(which includes betel quid with tobacco) and cancers of the oral cavity (Odds Ratios of 3 to 22) and
pharynx (Odds Ratios of 2 to 4). At least two studies in India have shown an association between use of
SLT containing areca nut and oesophageal cancer (Odds Ratios of 2 to 7), and one of these showed an
association of plain tobacco use with oesophageal cancer (Odds Ratio=4.9).
CARDIOVASCULAR DISEASES AND OTHER HEALTH
CONSEQUENCES OF SMOKELESS TOBACCO USE
SLT use causes more prolonged and sustained levels of nicotine in the body than cigarette smoking.
Acute cardiovascular (CVD) eects of SLT use seem to be similar to those caused by cigarette smoking,
including increased heart rate and blood pressure.

Smokeless Tobacco and Public Health in India
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Epidemiologic studies suggest an association between SLT use and CVD morbidity and mortality,
including myocardial infarction (heart attack), stroke, and coronary artery disease. Risks of myocardial
infarction among SLT users increased from 30% to 220%, as reported in the INTERHEART case control
study, which included India; the Cancer Prevention Study cohorts (CPS-I and CPS-II) in the United States;
and a case control study in Bangladesh. SLT is a risk factor for stroke (40%–70% higher risk), and in
association with hypertension, SLT use markedly increases the risk of stroke. In a few studies from India,
chewing tobacco, like smoking, was also found to be associated with higher risks of high blood pressure
and dyslipidemia.
A few studies provide evidence for an association with other diseases including diabetes, tuberculosis,
asthma, cataract, and infertility.
ORAL HEALTH CONSEQUENCES OF SMOKELESS TOBACCO
USE
Like studies from other parts of the world, studies from India, although limited, show association between
SLT use and gingival inammation, loss of attachment, and tooth wear.
SLT use is strongly associated with various oral lesions, including precancerous lesions. Some 70% of oral
cancers in India are estimated to be preceded by oral precancer.
Oral submucous brosis (OSF) is a high-risk precancerous condition caused by using areca nut in such
products as pan, gutka, and mawa, or by itself. Incidence of OSF has increased over the last three decades
in India. The increase in OSF among youth is of great concern as it puts young people at risk of early
cancers.
Leukoplakia is a major precancerous lesion that develops in users of all kinds of SLT. Behavioural
interventions directed toward tobacco use have been shown to reduce tobacco use and consequently lower
the incidence of leukoplakia, which could lower the risk of cancer.
CHEMISTRY AND TOXICOLOGY OF SMOKELESS TOBACCO
Even the simplest SLT products are chemically complex, containing nearly 4,000 dierent chemicals,
many of them toxic, mutagenic, and carcinogenic. The alkaloid nicotine, the primary addictive substance
in tobacco, causes elevated heart rate and blood pressure. Use of slaked lime with SLT increases the
bioavailability of nicotine.
Of the 36 known carcinogens in SLT, the most abundant strong carcinogens in Indian products are tobacco-
specic nitrosamines (TSNAs), which arise from nitrosation in the process of drying tobacco leaves.
Areca nut, which is combined with tobacco in several SLT products, is also a conrmed carcinogen. Areca
nut contains alkaloids, the most abundant among them being arecoline, from which areca nut–specic
nitrosamines, known carcinogens, are formed. Adverse health eects of consuming SLT products that
contain areca nut, as assessed through some human data and many animal experiments, include liver and
intestinal abnormalities, diabetes, damage to testes and sperm, and low birthweight ospring.

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Polycyclic aromatic hydrocarbons including the carcinogen benzo[a]pyrene occur mainly in products such
as gul and mishri that are made from pyrolysed tobacco. Toxic and carcinogenic elements such as arsenic,
cadmium and polonium-210 have also been found in Indian SLT products.
Detection of TSNA in saliva samples from SLT users as well as the presence of nicotine and cotinine
in saliva, urine, or gastric uid samples indicates that internal tissues are exposed to tobacco toxicants.
Biological uids as well as extracts of SLT products have all elicited a mutagenic response in various in
vitro assays and have caused chromosomal (DNA) damage to oral cells or lymphocytes both in vivo and
in vitro. SLT exposure contributes to cancer initiation, promotion, and progression as well as adverse
reproductive outcomes in animal experiments. Despite popular misconceptions about SLT having health
benets, chemical analysis and toxicology experiments clearly show that SLT is very harmful to health.
SMOKELESS TOBACCO: ADDICTION, WITHDRAWAL, AND
CESSATION
A major reason for the high prevalence of SLT use is the addictive property of nicotine, the main active
chemical in tobacco. Nicotine absorption is slower among smokeless tobacco users than among smokers,
but peak venous levels are similar. Blood nicotine falls rapidly after smoking, but levels o much more
slowly among SLT users.
Criteria for nicotine dependence include continuing use despite knowledge of potential physical or
psychological harm. Questionnaires for assessing nicotine dependence have not yet been validated for
SLT use in India.
Pharmacological and behavioural processes that determine tobacco addiction are similar to those that
determine addiction to drugs such as heroin and cocaine. Nicotine acts by binding to receptors on neurons
in a reward pathway. Nicotine produces the same kind of psychoactive eects whether tobacco is smoked
or used in smokeless forms. Because of its addictive nature, cessation of tobacco use may temporarily lead
to specic withdrawal symptoms.
To help people quit using tobacco, several Tobacco Cessation Clinics (TCCs) were set up in 2002, and
these clinics became part of the National Tobacco Control Programme (NTCP) in 2007-2008. Between
2002 and 2007, SLT users represented 65.5% of enrolled cases at the TCCs. Behavioural counselling is
the primary strategy for cessation intervention at these clinics, although pharmacotherapy was also given
in about 30% of cases. The quit rate among all men attending cessation clinics was 31.1%.
Other tobacco cessation eorts in India include mass media campaigns, targeted campaigns at work places,
and community-based programmes.
ADVOCACY AND POLICY MEASURES
Policy developments to reduce the SLT use include COTPA 2003, other laws, and specic court orders.
Committed government leadership in policy development, sustained and eective advocacy by NGOs
were instrumental in facilitating the passage of COTPA, a comprehensive tobacco control law which
dealt with SLT as well as smoked products. Continued commitment of government to strengthen tobacco
control, led to stringent laws that banned gutka. Right-to-information initiatives have revealed tobacco

Smokeless Tobacco and Public Health in India
7
industry interference in implementation of pictorial warnings, which have been used by NGOs to advocate
for stronger pictorial warnings. Media advocacy by NGOs has highlighted SLT in general as a menace
and gutka in particular as a especially harmful product. Public interest litigation (PIL) by NGOs helped
in implementing labelling and pictorial warnings laws. Coupled with government’s eorts of presenting
courts with evidence on adverse health eects of SLT, a PIL has led to prohibition of plastic packaging and
development of laws regulating or banning dentifrices and food items containing tobacco.
MoHFW has sent advisories to all states to raise taxes on tobacco products. State governments have been
consulting multi-stakeholder groups to strengthen enforcement of tobacco control laws and other tobacco
control measures. GATS India 2009-2010 revealed that SLT use was very high, leading MoHFW and
WHO to organise the rst National Consultation on Smokeless Tobacco in India.
Although gutka has been banned in almost all states of India, eective implementation leaves a lot to
be desired. Related challenges in implementation include procedures for disposing of seized products,
preventing interstate smuggling, preventing sale of gutka in separate packets of tobacco and pan masala,
restricting surrogate advertising, preventing tax evasion, not exempting export-oriented units, and
increasing cessation services.
LITIGATION AND JUDICIAL MEASURES
The tobacco industry challenges almost every tobacco control measure in the court of law. The government,
aided by civil society interventions, has responded successfully to many of these challenges.
Court decisions have helped in prohibiting the use of tobacco as an ingredient in toothpastes and tooth
powders (1992); banning storage, packing, or selling of gutka, as well as tobacco and pan masala in plastic
sachets (2011); and stopping advertisements and sponsorships by the tobacco industry (2012-13).
In 2011, Rule 2.3.4 under the Food Safety and Standards Act, 2006 (FSSA, 2006) prohibited the use
of tobacco and nicotine as ingredients in any food product. Earlier, in connection with a court case, the
Supreme Court had ruled that gutka was a food product. This led to a ban in 2012 on the manufacture,
storage, and sale of gutka and pan masala containing tobacco in the vast majority of states and Union
Territories of India.
The Indian judiciary has not only delivered strong judgements in favour of SLT control but has also
followed through with monitoring of enforcement. In April 2013, the Hon’ble Supreme Court sought
reports from the states that had not banned gutka and compliance reports from states governments that
have banned gutka.
HEALTH COMMUNICATION FOR SMOKELESS TOBACCO
CONTROL IN INDIA
MoHFW, Government of India has invested substantial budget in raising public awareness on health impact
of SLT use and has aired several mass media campaigns. Intervention through personal and community
channels of communication have been evaluated as eective in promoting cessation and reducing the use
or uptake of SLT. These interventions have targeted the general population, school-children, teachers, and
blue collar workers. Several interventions were designed as part of cancer prevention programs.

Executive Summary
8
Since 2002, health communications eorts such as the school-based health education programmes of
HRIDAY-CATCH (Health Related Information Dissemination Among Youth – Child & Adolescent Trial
for Cardiovascular Health) and MYTRI (Mobilising Youth for Tobacco Related Initiatives in India) have
used a theory based multicomponent intervention model to provide behaviour change for preventing
tobacco use among adolescents.
Pack warnings oer governments an easily enforceable means of reaching large segments of the population;
the messages they deliver are brief and pictorial warnings are especially eective.
Using the yardstick of reach and cost-eectiveness, community media such as audio-visuals have greater
potential than interpersonal communication. Mass media campaigns that employ health-focused messages
have impacted diverse groups.
Anti-SLT mass media campaigns have also inuenced social norms and beliefs, and have been helpful in
advocating for eective public policy. A holistic approach using various means to reach the public will
involve dierent media supplementing and reinforcing common messages.
STRATEGIC PARTNERSHIPS AND INTEGRATION
Reaching out to other stakeholders as partners is an essential component of the holistic approach to
comprehensive tobacco control.
Tobacco goes through a ‘life cycle’ of four stages. Each stage represents an opportunity for specic
interventions in partnership with various stakeholders:
1. Tobacco cultivation – Tobacco is a cash crop which is promoted by government, the tobacco industry,
nancial institutions, and middle men. Reduction in cultivation of tobacco would require the
engagement of the political establishment, bureaucracy, and farmers by encouraging alternative crops
and withdrawing incentives to produce tobacco.
2. Tobacco manufacture – A large number of unregistered manufacturers escape the reach of regulatory
bodies. Local law enforcers, workers unions, and vigilant society groups can be engaged to monitor
these manufacturers.
3. Tobacco marketing – Aggressive promotion and novel supply chains are used to increase the sales of
SLT products. Intervention is necessary through a comprehensive ban on advertising and implementing
larger pictorial health warnings. Education of youth and the community about the deceptive nature of
tobacco marketing is also needed.
4. Tobacco use – Informing potential consumers of the risks posed by SLT products and oering help to
quit tobacco addiction are essential interventions in this phase.
Control measures at dierent stages of the life cycle of tobacco can be seen as falling into three major
categories, each of which requires strategic partnerships:
Law and policy interventions: Initiating judicial interventions, advocacy by civil society organisations,
and active partnerships between health and developmental groups have helped states adopt and enforce
appropriate laws.

Smokeless Tobacco and Public Health in India
9
Educational interventions: The success of educational interventions in schools has been primarily due to
partnerships among non-governmental organisations in health and development, funding organisations,
government, and the community. Evidence on eectiveness of such interventions led MoHFW to issue
guidelines on Tobacco Free Schools, which were released by Central Board of Secondary Education to all
schools in India.
Health system interventions: Tobacco Cessation Clinics set up by the Government of India and WHO
have been training health professionals in cessation support. The Ministry of Health and Family Welfare is
integrating tobacco control into health programmes and providing health education to motivate and assist
users to quit.

Executive Summary
10
High prevalence of smokeless tobacco (SLT) use in India and its signicant adverse health consequences
make SLT control an important area of focus for policy, programmes, and research. To meet the multiple
challenges of the epidemic, ve dimensions of SLT problems—health, economic, social, environmental, and
demographic—must be addressed. The following recommendations for policy, programme, and research
aim to contain the SLT epidemic in India and are derived from the evidence and conclusions presented in
each chapter of this report. These recommendations are in alignment with the World Health Organization
Framework Convention on Tobacco Control (WHO FCTC) Articles and MPOWER measures.
POLICY RECOMMENDATIONS
The policy recommendations on SLT products in this report are based taking into account the specic
situation in India. The key recommendation is to enforce a countrywide ban on production, supply and
distribution of all packaged SLT products.
Tobacco Manufacture, Storage & Sale Bans
India has made signicant policy strides in prohibiting gutka under FSSA, 2006 Regulation 2.3.4 and
in initiating supply-side tobacco control measures. Bans on manufacturing, storage and sales of gutka
products are currently being implemented in India; similar bans on SLT products are being phased in.
Many states in India have banned all SLT products. For the SLT products that are currently not banned,
the subsequent recommendations apply.
• The scope of all supply-side tobacco control measures should be expanded to include all types of
packaged smokeless tobacco products, so that all products are regulated in a uniform manner, and to
prevent users from replacing banned SLT products with unbanned products.
• The sale of pan masala and areca nut, which are strongly associated with smokeless tobacco use,
should be banned because of their carcinogenicity and the increasing prevalence of oral pre-cancerous
and cancerous conditions attributable to these substances, especially among youth.
• Pan Masala and avoured chewing tobacco are currently being sold separately to circumvent law and
this should be strictly prohibited. Strict orders from FSSAI and court should restrict sale in this form.
• Policies should be implemented to prevent the sale of tobacco products in places that also sell basic
food items or medicines.
Tobacco Marketing Bans
Measures to reduce pro-tobacco advertising, promotion, and sponsorship include the following:
• Tobacco control laws prohibiting direct and indirect advertising, product displays, promotion and
sponsorship should be strengthened. This can be achieved through partnerships between the Food
Safety and Standards Authority of India (FSSAI), the Ministry of Health and Family Welfare, and the
Ministry of Information and Broadcasting.
RECOMMENDATIONS

Smokeless Tobacco and Public Health in India
11
• Mechanisms should be developed for monitoring and reporting tobacco marketing infractions (e.g.,
registering brand names of tobacco products under non-tobacco categories under the Trademark Act)
at state and national levels.
Implementation and Enforcement
• The eectiveness of existing measures—such as prohibiting the sale of tobacco to and by minors,
prohibiting sale within 100 yards of educational institutions, and requiring health warnings at the point
of sale—should be evaluated, and possible means of improving these measures should be examined.
• The ban on indirect and surrogate advertising of SLT products should be strictly enforced.
• Partnerships should be established with civil society groups to actively monitor, report, and penalise
activities that violate tobacco control laws.
• Criminal and civil suits should be allowed for claims involving injuries to person, community,
consumer, or the environment caused by tobacco manufacture and use, as is done in other parts of the
world (e.g., the United States, Canada, and Australia).
• Mechanisms for monitoring and prohibiting tobacco advertising on the internet, including promotional
emails, websites, blogs, and social media sites, should be imposed.
Taxation
Raising taxes on tobacco products is one of the most eective ways to discourage young people and
other segments of the population from initiating tobacco use and to encourage tobacco users to quit.
Considerations for eectively using the tobacco tax strategy include:
• Taxes on SLT should be increased to uniformly high level in each state in India. Taxes should also be
increased regularly to keep up with ination and income level.
• Reduce the price dierential between smoked and smokeless tobacco products, and address the
minimum price for SLT products in price policies (with the goal of making SLT less aordable for
more consumers).
Packaging
Prescribe a minimum pack size, by weight, for all SLT products so that they are not sold in small packs
and are not easily accessible and aordable for youth.
PROGRAMME RECOMMENDATIONS
Targeted Interventions
• Targeting interventions toward SLT use among women, youth, and rural populations could reach SLT
users more eectively.
• Counselling against SLT use should be incorporated in women’s routine prenatal and antenatal health
care.
Public Awareness Campaigns
• Campaigns should work to raise public awareness of the economic, social, and environmental impacts
of SLT use, in addition to its health consequences.

Executive Summary
12
• Campaigns should educate the public about specic tobacco control policies—such as those that ban
gutka and other SLT products, prohibit sale of tobacco to and by minors, and ban sale of tobacco
within 100 yards of an educational institution—in order to increase compliance.
Cessation Programmes
• High priority should be given to including SLT cessation programmes in health care systems and
implementing national SLT cessation guidelines.
• SLT cessation training packages should be tailored for professionals in the health system, frontline
health workers, other community outreach programmes, counsellors, teachers, and other stakeholders.
• Tobacco treatment programmes should be targeted for high-risk and vulnerable groups such as youth,
women, rural populations, and the economically underprivileged, and should include an SLT focus.
More intensive programmes could be benecial with dual users.
Tobacco Testing Laboratories
• Laboratories should be established that are mandated to test harmful ingredients in all SLT products
registered under the Trademarks Act as tobacco products.
Multisectoral Integration
Successful control of SLT use will depend on the involvement and cooperation of stakeholders in multiple
sectors:
• In the health sector, interventions should be integrated into programmes associated with tobacco
control—for example, the Revised National TB Control Programme (RNTCP); the Reproductive
and Child Health Project (RCH); the National Programme for Prevention and Control of Cancer,
Diabetes and Cardiovascular Disease and Stroke (NPCDCS), National Oral Health Care Programme
and National Mental Health Programme. Oral health professionals are particularly strong potential
partners in combatting SLT use.
• Programmes not directly focused on health, such as poverty alleviation, rural development, woman
and child welfare, and tribal welfare, have extensive reach and should engage vulnerable populations
around preventing and quitting SLT use.
• To incorporate tobacco control training into the legal profession, tobacco control policies should be
introduced into the current curriculum of legal education as elective courses.
RESEARCH RECOMMENDATIONS
This report has revealed the following research gaps:
Economics
• Data on revenue generated by dierent SLT products should be disaggregated in order to understand
the patterns of tobacco revenue and to inform tobacco control policies.
• Protability and diversication plans of the SLT industry should be studied in greater depth to better
understand illicit trade of smokeless tobacco between states.

Smokeless Tobacco and Public Health in India
13
• Analysis should be undertaken to understand the spending pattern of SLT industry on indirect
advertising.
SLT Use by Youth
• The determinants inuencing SLT use among youth, such as individual, psychosocial, and
environmental factors, are subjects for further investigation.
• To produce state-specic results, the Global Youth Tobacco Survey should be conducted on a
representative sample in each state in India.
• An industry monitoring study should be conducted to provide information on SLT industry marketing
tactics that target youth and adolescents in India and the South-East Asia Region.
Adult Use
• Trends in attitudes, behaviours, knowledge of policies, awareness of SLT’s adverse impacts, and
social norms related to SLT use by adults should be tracked over time.
• Standardised tobacco use questions should be included in all relevant national surveys with a tobacco
use component in order to produce comparable data across surveys.
Dual Use
• Determinants of initiation of dual use, dependence and withdrawal symptoms, variations in exposure
levels from using dierent products, and lack of success in cessation eorts are all subjects in need
of further study.
SLT Use by Women
Given that the rate of SLT use among women is high, it is important to better understand women’s usage
and cessation patterns. Suggested initial steps include the following:
• All studies and national data should report data disaggregated by gender.
• Factors that may inuence SLT use among women before, during, and after pregnancy should be
examined in order to design evidence-based intervention models and guidelines for cessation across
the life course.
• Research on tobacco industry tactics targeting women could help to better inform programme and
policy interventions to protect girls and women from initiating use and help those who already use
SLT to quit.
• Further investigation is needed of the health eects of SLT use on women throughout the life course,
including pregnancy complications, placental function, menstrual function, infertility, and menopause.
Health Eects
• Further research is needed in order to better quantify:
§The eects of smokeless tobacco on all-cause and cause-specic mortality
§Risk of cardiovascular diseases, cancers of cervix and pancreas, and other diseases that may
be caused by SLT use
§Excess risks associated with specic products of regional preference.

Executive Summary
14
Addiction, Withdrawal, and Cessation
• A behavioural scale that tests levels of addiction to SLT should be developed for India.
• The eectiveness of nicotine replacement therapy (NRT) and pharmacotherapy for SLT cessation is
in need of further study in India.
• Biochemical methods for validating use and non-use of SLT, such as urine cotinine testing, should be
studied at the clinic and population levels.
Advocacy and Policy
• The impact of current tobacco policies, especially the SLT ban, should be researched to strengthen the
evidence base used by states when broadening the ban to all SLT products.
• Successes and challenges related to enforcement of the SLT ban should be documented and analysed
in terms of implementation and impact.
Legal
• Legal systems that are implementing eective public health laws and providing the judicial basis for
the right to health should be researched to assist litigation and strengthen the legal basis for tobacco
control policies.
Strategic Partnerships
• The feasibility and cost-eectiveness of integrating brief interventions for tobacco control and tobacco
cessation into dierent health and development programmes should be studied in order to propose
models for scaling up integrated programmes at the national and state levels.

Ministry of Health and Family Welfare
Government of India