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Review Article

Banning smokeless tobacco in India: Policy analysis

Aroral M, Madhu R
Health Promotion and Tobacco Control, Public Health Foundation of India, NewDelhi, India
Correspondence to: Dr.Monika Arora, Email:monika.arora@phfi.org

Abstract
India is the second largest producer and third largest consumer of tobacco. According to GATS India Report(2009-10), the users of only smokeless tobacco(SLT) are more than double than that of smokers. SLT use is an imminent public health problem, which is contributing to high disease burden in India. It is a unique tobacco product due to its availability in myriad varieties, easy access, and affordability especially for adolescents. It has been studied to be a gateway product and facilitates initiation. Currently, the Food Safety and Standards Authority of India(FSSAI) have prohibited the use of tobacco and nicotine in any food products; yet, the implementation of a permanent ban on SLT across India is still pending. This paper examines how multiple legislations have failed to effectively control or regulate SLT in India and regionally; thus, there is need to strengthen SLT control efforts as no ordinary product. Key words: Ban, gutka, India, legislation, policy, smokeless tobacco

Introduction India is the second largest producer and third largest consumer of tobacco in the world.[1] The predominant forms of smokeless tobacco (SLT) use in India are (i)chewing tobaccoleaf, khaini, zarda, kiwam, gundi, and betel quid with tobacco. (ii) Areca nut mixtures for chewing pan masala, gutka, Mainpuri tobacco, mawa, and dohra. (iii) Products for application gudhaku, gul, creamy snuff, lal dantmanjan, and mishri. (iv) Products for gurgling/sipping tuibur, hidakphu . [2] According to GATS India Report(200910) those using SLT only(163.7 million) are more than double of those who are exclusive smokers(42.3 million). The focus on SLT control policies should be strengthened as its use has increased from 28% by men and 12% by women in NFHS2(1998-99) to 33% by males and 18% by females in 2009-10.[3] This is alarming, as the increase in use is despite implementation of populationlevel legislative measures. India has a comprehensive tobacco
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control(TC) law; the Cigarettes and other Tobacco Products(Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003(COTPA), [4] which aims to regulate both smoking and smokeless forms of tobacco. Increase in the prevalence of SLT use in India has resulted in increased disease and mortality burden in the country. SLT is carcinogenic and the incidence of oral cancers in India is very high, which is attributable to the widespread habit of chewing tobacco.[5] Other adverse health effects of SLT studied till date are dental caries, gingival recession, tooth attrition, oral sub mucous fibrosis(areca nuttobacco products), cardiovascular risk factors, hypertension, diabetes, reproductive health problems, low birth weight babies, and overall mortality.[6] Moreover, SLT use enhances the frequency of public spitting. Acase control study in this regard has been proposed as this would increase the probability of spreading communicable diseases like tuberculosis. Nonspitters have the right to protect themselves from the hazard of public spitting.[7] The grim public health picture painted due to proliferation of SLT product usage in India has been a cause of concern for the Ministry of Health and Family Welfare(MoHFW), FSSAI, Indian Judiciary, Ministry of Environment and Forests. Reviewing the existing SLT control policies was one of the important recommendations from the World Health Organization,
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SouthEast Asia Regional Office(WHOSEARO) expert group meeting on SLT control and cessation.[2]
Issues on smokeless tobacco use Economic costs and related arguments

Need for SLT focused policies

SLT is a multifaceted challenge and upholds an evident confluence of economic interests of a few over the indirect cost borne by the populations and the Government in the form of diseases and health care costs.[8] The effect of tobacco control policies in India is incessantly subdued by underscoring the other facet, tobaccos significant contribution to the economy, employment, and government income and revenue.[9] The gutka and pan masala business is estimated around Rs. 10,000 crore in the country and there are 375 to 400 gutka brands. [10] Yet, the social costs due to tobaccorelated diseases in India are significantly higher than the revenue earned from the tobacco industry. The most affected are the rural and low socioeconomic populations who prefer SLT use, leading to further impoverishment from tobaccoattributed diseases.[1113] Thus, the argument of the tobacco industry regarding the dilapidation of economy, if there are strong Tobacco Control(TC) policies is ambiguous. Scientific reports have put forth logical inferences against it. The numbers of people employed in the industry are overestimated by counting those for whom it is one of many sources of income and provides only seasonal employment. Earnings from homebased tobacco related employment is barely sustainable, thereby leading to inequitable distribution of income.[12] In addition, an estimated 90% of the chewing tobacco manufacturers in India allegedly escape excise duties even though they are registered as they declare only 10% of the production.[14] Such reports of illegal trade and excise evasion contradict the industries claims of economic advantage to the country. Drastic legislative and policy changes are crucial to contain this growing health, social, and economic burden rather than regulation of this no ordinary product.[15,16]
Gateway product

The local as well as global TC policies including WHOFramework Convention on Tobacco Control (WHOFCTC)[22] and funds are focused on cigarettes or smoking forms of tobacco with minimum attention to SLT. Unlike the prohibition on smoking in public places, under Article 8, considering the hazards of exposure to second hand smoke, there is no similar provision or mandate against SLT. The harmful effects of smoking on health of the nonsmokers resulted in such a prohibition under FCTC and other local legislations. There is lack of similar scientific evidence against dangers of spitting in public places and the dangers of using SLT on the environment. However, environmental hazards due to plastic packaging of these products were established and Supreme Court of India prohibited plastic packaging for pan masala, SLT products, and other similar chewing products.[23]
No ordinary product

Chewing tobacco has also been reported as starters for adolescents as it is cheap and easily accessible, who at a later age initiate dual(smoking and smokeless forms) use.[17] Awareness of the hazards from use of SLT is very low amongst the rural populations; they believe SLT has actually medicinal values for curing or palliating common discomforts such as toothache, stomachache, and headache, further leading to its use through advice.[1820] Age of initiation has reduced with SLT introduction and children as young as 14years old have been diagnosed with precancerous lesions resulting from SLT use.[17,21]
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Furthermore, the Supreme Court in the Ankur Gutka vs . Indian Asthma Care Society and Ors.(2007) [23] directed the Ministry of Health and Family Welfare to undertake a comprehensive analysis and study of the contents of gutka, tobacco, pan masala, and similar products manufactured in the country and harmful effects of consumption of such articles. The National Institute of Health and Family Welfare(NIHFW) was asked to compile available literature in this regard. The committee of technical experts constituted by the NIHFW highlighted that there are 3095 chemical components in SLT products(including gutka ), among them 28 are proven carcinogens. The major and most abundant group of carcinogens is the tobaccospecific Nnitrosamines(TSNA) and no safe level of this chemical has been ascribed so far. Other carcinogens reportedly present in SLT include volatile Nnitrosamines, certain volatile aldehydes, polynuclear aromatic hydrocarbons, certain lactones, urethane, metals, and radioactive polonium. It has also been mentioned that chemicals used in the perfume industries are being used in SLT products, but the government machinery do not have laboratories to ascertain it, whereas such food products are banned by the law.[24]
National policies and legislation

It is emphatically stated in the Article 47 of Constitution of India (1950) that State shall endeavor to bring about prohibition of the consumption, except for medicinal purposes, of intoxicating drinks and drugs which are injurious to health.[25] A serious legislative turmoil materialized in 1990, when under the Prevention of Food Adulteration Act, 1954 (PFA), concerned with the prevention of adulterated articles that fall below the prescribed standards of purity or quality was expanded
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to cover chewing tobacco and pan masala . Several states(e.g.Tamil Nadu, AndhraPradesh, Maharashtra, Goa, and Bihar) used Section 7(clause 4) of the PFA to impose a blanket ban on gutka during 2001 to 2003 in the interest of public health. However, in 2004 the Honorable Supreme Court struck down these orders of banning sale of Gutka as unconstitutional, stating only the Centre has the power to ban manufacturing and sale of such items. To resolve the dispute, which Godawat law suit[26] raised giving importance to two different statues for different reasons, the Government of India decided to amend the provisions of the PFA Rules 1955 and incorporated a rule, which read: Rule 44J: Product not to contain any substance which may be injurious to health: Tobacco and nicotine shall not be used as ingredients in any food products. However, with recent legal developments, the amended PFA Rules of 2006 and 2007 were pending before the Supreme Court till August, 2011. Not only did the tobacco industry bail out its primary interests of sale but also created ample scope for surrogate marketing by revising the Cable Television Amendment Rules 2009, which states that a product that uses a brand name or logo, which is also used for cigarettes, tobacco products, wine, alcohol, liquor, or other intoxicants may be advertised, keeping space for surrogate promotion to be continued. Surrogate advertising of SLT products through similar name pan masala brands is rampant on public transport, radio, sponsorship of sports, and cultural events. These surrogate advertising and sponsorships have received strong reactions from health advocates in India and globally, as these advertisements confuse the consumers. Though COTPA is the comprehensive legislation that covers all tobacco products under the Central Government, the provisions of the Act do not indicate a ban on tobacco or tobacco products. The provisions impose a conditional prohibition of these products against sale to person/s less than 18years of age (Sec 6); pictorial health warnings to be inscribed on all forms of tobacco products indicative of harmful effects of SLT(Sec 7); and prohibition of all direct and indirect advertisements of all smokeless forms of tobacco products(Sec 5). Apart from COTPA, other SLT legislations have also been enacted since the past two decades in India as enlisted in Table1. To curb the nuisance habituating out of SLT use, a host of other allied legislations were initiated. Such legislations[Table2] aimed to reduce SLT prevalence and burden and included municipal laws prohibiting spitting in any public place, building, public road, public street, or wall causing insanitation or annoyance to others, and prohibiting littering.
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Though multiple laws aimed to regulate SLT use since 1990s; yet, there has been considerable increase in its use. Goa is the only State that has successfully sustained the ban on SLT products through the Goa Public Health (Amendment) Act, 2005,[27] which states no person himself or by any other person on his behalf shall manufacture for sale, or store, exhibit, sell or distribute or in any way deal with any injurious food article used for human consumption. The ban had been challenged Table 1: Smokeless tobacco specific enacted legislations[2]
Year 1990 Legislations Statutory warnings on chewing tobacco products were made mandatory under the prevention of food Adulteration Act(1955) The central government banned the manufacture and sale of toothpastes and toothpowders containing tobacco under the drugs and Cosmetics Act(1940) The central government prohibited, on cable television, advertisements(direct or indirect) of cigarettes and other tobacco products. This was done by amending the advertisement codes as provided in the cable television Networks(regulation) Act(1994) The railway authorities banned the sale of gutka on railway station premises, concourses and reservation centers, and on trains Under COTPA rules, depiction of tobacco usage and its promotion was banned in films and on television.(amended in 2006, 2009, 2011) The packaging and labeling rules were introduced that prescribed pictorial health warnings on all tobacco product packages

1992

2000

2001

2005

2009

Table2: Enlistment of allied laws that referred to smokeless tobacco control

The Bombay Police Act of 1951, Section 116, prohibiting smoking and spitting in government premises in Maharashtra The consumer Protection Act, 1986(CPA), is available to consumers to redress their complaints and seek compensation for health cost incurred on account of tobacco. The CPA facilitates fair commercial trade and marketing and, secondly, protects consumers from the undue risk of harm caused by products The Indian Railways Act, 1989, banning spitting in railway premises or buildings The Himachal Pradesh Municipal Act, 1994 Chandigarh Municipal Corporation(Sanitation and Public Health) Bye Laws, 1999 The Goa Public Health(Amendment) Act, 2005 Mumbai Municipal Solid Waste(Prohibition of Littering and Regulation of Segregation, Storage, Delivery and Collection), Rules 2006 Environmental laws: Invoking the principle of Polluter pays for environmental pollution, the High Court of Rajasthan(2007) gave a verdict banning the use of plastic packaging for gutka sachets
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in a litigation filed as Sai Traders vs . State of Goa and Ors.(2005) before the Bombay High Court and was upheld. The same has been challenged before the Supreme Court without any reverse orders. The turning point for India was Environment Ministrys Plastic Waste(Management and Handling) Rules, 2011, that prohibited the use of plastic materials in sachets for storing, packing, or selling gutka, tobacco, and pan masala. The rules came into effect from February 4, 2011. The Ankur Gutka vs. Indian Asthma Care Society and Ors.(2007)[23] case brought out a ruling to ensure plastic material shall not be used for storing, packing, or selling gutka , tobacco, and pan masala . From March 1, 2011, all the manufacturers of gutka, tobacco, and pan masala were restrained from using the plastic material in their sachets. This increased the price of gutka and pan masala for consumers. Yet, not all SLT manufacturers heeded to this ban and reportedly many of them are still selling in plastic packaging. [28] Such violations also go unnoticed as there is an absence of a tobacco use and product surveillance system, which should be an integral part of the national tobacco control programs. [2,29] The NIFHW s report compiled the existing scientific evidence of harmful ingredients in SLT products like TSNA. This spurred the organization of the National Consultation on SLT organized by MoHFW, WHO in collaboration with Public Health Foundation of India that highlighted a ban in phased manner in April, 2011.[30] A comprehensive approach to tobacco prevention and control requires coordination and collaboration across the central government, across the nation and within each state.[31]
Recent developments

product(2004). In the event of two laws in conflict, public health benefit would prevail over commercial interest. This requires not only prohibiting SLT but also banning its trade and commerce, production, supply, and distribution. Currently, the implementation of this ban at the ground level is carried out by food inspectors of Food Safety department as well as implementers identified under the COTPA. Madhya Pradesh was the first state to implement ban on gutka and products containing tobacco on March 31, 2012 by the Food Safety department. Licenses of gutka manufacturing companies have been cancelled from April 1, 2012. Gutka and other tobacco chewing products that is being supplied from neighboring states are been seized by the State Government. Kerala was the next to implement the ban on May 22, 2012. Bihar implemented the ban on May30, 2012, currently for a year. More recently, the States of Haryana, Himachal Pradesh, and Maharashtra have banned gutka and other chewing tobacco products. The experts at the National Consultation on SLT [30] reviewed the countrys preparedness on scaling up cessation efforts in the country and activities around providing alternate livelihood options for people employed in the manufacturing sector of SLT. Implementation of a progressive ban through multilateral approach is now being reflected in the action by States taking lead in implementation of FSSAI notification, raising taxes on SLT products(as in Uttar Pradesh), and promoting cessation services at State and district level. This can be seen as Indias step towards endgame that focuses on supply side actions.
Summary and recommendations

As per Food Safety and Standards(Prohibition and restriction on sales), regulation 2011, dated August 1, issued by the FSSAa nodal unit under the Ministry of Health and Family Welfare, explicitly published that Product not to contain any substance which may be injurious to health: Tobacco and nicotine shall not be used as ingredients in any food products.[32] This is a central legislation in effect from August 5, 2011, which needs to be implemented through State governments. State governments are coordinating the implementation of this regulation by imposing a complete ban on the trade and commerce, production, supply, and distribution of products containing tobacco. Aletter was issued by Special Secretary, MoHFW, Government of India, on May 8, 2012 to emphasize and direct the States towards implementing the ban under the regulation of FSSA. The SLT products are governed by the FSSA as the Supreme Court of India in The Godawat law suit [26] declared that Gutka is a food
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In summary, all previous policy and legislative attempts to regulate SLT are yet to produce the desired results. On the contrary, there has been relentless increase in SLT usage in the past few decades, according to National Survey Reports. In this paper, we suggest a strong case for banning SLT in India and recommend some effective approach for implementing this ban, as follows: Asserting the prohibition of tobacco and nicotine  use in any food, as conferred in FSSAI, a complete ban on the trade and commerce, production, supply, and distribution of SLT needs to be facilitated by stern public health advocacy and good governance. A national ban to ensure no smuggling of  products between the States and no circumvention of the Law by selling pan masala and tobacco powder separately. All provisions related to supply side action will now need to be strengthened to sustain this ban on SLT products in India by providing alternative crops and organized
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livelihood for people employed in tobacco and allied sectors A progressive increase of taxes on all smoking  tobacco products in order to compensate the loss of revenue to the States from SLT ban. C urrently, the gutka and pan masala are being  seized in the States that have implemented the ban. Measures should be taken to ensure that the seized SLT products are destroyed in order to leave no scope for illicit trade. I t is vital to plan and implement a needbased  comprehensive and sustained TC programmes ensuring targeting the public awareness without losing focus on smoking products.

13. 14.

15.

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[Downloadedfreefromhttp://www.indianjcancer.comonFriday,June07,2013,IP:117.192.158.252]||ClickheretodownloadfreeAndroidapplicationforthisjourn Arora and Madhu: Banning smokeless tobacco in India: Policy analysis 31. B e s t P r a c t i c e s f o r C o m p r e h e n s i v e To b a c c o C o n t r o l Programs. Available from: http://www.cdc.gov/tobacco/ stateandcommunity/best_practices/pdfs/2007/BestPractices_ Complete.pdf. [Last accessed on 2012Jun22]. 32. Food Safety and Standards(Prohibition and Restrictions on sales) Regulations, 2011. Available from: http://www.fssai.gov. in/Portals/0/Pdf/Food%20safety%20and%20standards%20 (Prohibition%20and%20Restrction%20on%20sales)%20 regulation,%202011.pdf[Last accessed on 2012Jul25].
How to cite this article: Aroral M, Madhu R. Banning smokeless tobacco in India: Policy analysis. Indian J Cancer 2012;49:336-41. Source of Support: Nil, Conflict of Interest: None declared.

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