Comparative assessment of implementation of Cigarette and Other Tobacco Products Act in three States of India: A pre-post study

Tobacco use is one of the important risk factors for various non-communicable diseases. However, the tobacco industry still holds high market value contributing to the country’s economy1. During the 18^th and 19^th centuries, tobacco use was primarily in the form of cigars and cigarettes, followed by the latest form of Electronic Nicotine Delivery Systems2.

According to the statistics released by the World Health Organization (WHO), tobacco kills more than 8 million people every year, of which 1.2 million deaths are due to second-hand smoke3. Globally, 36.7 per cent of men and 7.8 per cent of women of the total population use tobacco in any form4. A study entitled ‘Smoking: Our World Data’ pointed out that around 100 million premature deaths happened due to tobacco use throughout the entire 20^th century, and there was a projection of one billion deaths globally by the 21^st century5. The age of initiation of regular tobacco use is less than 20 yr, which strongly suggests focused interventions for young people to save the future population from harmful effects of tobacco use6.

According to the Global Adult Tobacco Survey (GATS-II), 2016-2017, 28.6 per cent of the Indian population used tobacco either in smoking or smokeless form, of which 42.4 per cent were men and 14.2 per cent women. Among these, 28.4 per cent of people used smokeless tobacco products, and 10.4 per cent smoked tobacco. The prevalence of tobacco use among the Indian population released in the National Family Health Survey Round 5 (NFHS-5, 2019-21) was comparable to the results of the GATS78. Studies have also shown that smokeless forms of tobacco products are replacing smoking in countries such as India, Bangladesh and Nepal, and the all-cause mortality rate attributed to smokeless tobacco products is much higher than smoking forms mainly due to oral, pharyngeal and oesophageal cancer. The total economic cost attributable to tobacco-related illness was around 104,500 crores in 20119, which was nearly 1.16 per cent of the GDP and was 12 times more than the total tax revenue collected by both States and centre7.

Considering the importance of tobacco control (TC), India (being the eight country signing WHO-Framework Convention on Tobacco Control treaty) enacted the Cigarette and Other Tobacco Products Act (COTPA) (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution)8 in the year 2003 to catalyze the process of TC in India. This Act includes section 4, prohibition of smoking in public places; section 5, prohibition of advertisement of cigarettes and other tobacco products; section 6, prohibition of sale of cigarettes or other tobacco products to anyone below the age of 18 yr and in a particular area; section 7, prohibition on trade and commerce in production, supply and distribution of cigarettes and other tobacco products; section 8, manner in which specified warning shall be made and section 9, language in which specified warning shall be expressed9.

India is one of the countries among those of the global south responsible for many TC interventions, and the first study in this regard was published in 198610, followed by various kinds of interventions in tobacco cessation11, as well as institution- and population-based interventions12. However, more effective interventions are needed to reduce or eliminate the threats related to tobacco use that focus mainly on large populations. Against this background, this study was attempted to assess the change in compliance with various sections of COTPA in three study States (Puducherry, Meghalaya and Telangana) before and after implementing the project activities as interventions.

Material & Methods

This pre-post observational study was undertaken by the department of Community Medicine & School of Public Health, Post Graduate Institute of Medical Education & Research, Chandigarh after procuring clearance from the Institutional Ethics Committee. The study was conducted for one year in three States of India –Puducherry [Union Territory (UT)], Meghalaya and Telangana with baseline and endline assessments in November 2020 and October 2021, respectively, before and after the implementation of project activities. The project titled ‘Advancing tobacco control at the national and subnational level through capacity building, MPOWER (monitor tobacco use and prevention policies; protect people from tobacco smoke; offer help to quit tobacco use warn about the dangers of tobacco; enforce bans on tobacco advertising, promotion and sponsorship and raise taxes on tobacco) implementation and support to National Tobacco Control Programme (NTCP)’, was undertaken as a Bloomberg Initiative through International Union against TB and Lung Diseases (The Union).

The study was aimed at strengthening TC administrative and institutional framework, providing technical support to identify and monitor Tobacco Industry Interference (TII) along with the development and implementation of State-specific policy on Article 5.3, and monitoring and evaluation of MPOWER status in focused States for strengthening TC programme in India. The project activities were primarily intended to, (i) increase compliance with various sections of the COTPA, (ii) raise awareness about the various consequences of tobacco use and (iii) emphasize the importance of curtailing its use in public settings (Fig. 1). These activities were successfully implemented by engaging various stakeholders, including education department, police, law enforcement agencies, municipalities and health departments. However, the aim of the present study was to improve compliance with various sections of COTPA.

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Fig. 1

Conceptual framework for project activities as intervention.

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All the field investigators were trained prior to undertaking this study. Questions were designed and asked in such a way as to minimize biases. Ten per cent cross-check was conducted with the filled checklist by study supervisors.

Sample size: The sample size was calculated using OpenEpi 3.01 version (www.OpenEpi.com), where alpha error was assumed as 5 with a 99.99 per cent confidence interval and the point prevalence as 67 per cent. The minimum sample size required to conduct the study was found to be 1338. During baseline assessment, a total sample size of 3849 [Puducherry (909), Telegana (2220) and Meghalaya (720)] could be covered in three UT/States considered, whereas 2176 [Puducherry (472), Telangana (1105), Meghalaya (599)] was the attained sample size in endline assessment. The total sample size at baseline and endline of the UT/States of Puducherry, Meghalaya and Telangana was spread into three study UT/States as in Supplementary Table.

Sampling technique: From the three project UT/States, districts were selected by convenient sampling technique (Fig. 2). Each district was considered separate strata, and each stratum was divided into urban and rural areas. Considering the cost-time constraints, from each district, two blocks were selected from the rural category, and two towns were selected from the urban category. From each block of the rural area, two villages were selected, and from each town of the urban area, four wards were selected.

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Fig. 2

Process of selection of the observation locations for the study.

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Observation points, such as educational institutions, point of sales (PoS) and public places, were selected at random and observed in each village and town to monitor compliance with various sections of COTPA. The percentage contribution of these observation locations may vary as their distribution differed from State to State.

Study procedure: The data for baseline and endline assessments regarding compliance with various sections of COTPA were assessed using an observational checklist with a set of pre-determined questions used to conduct observations. Data were collected using the same study tool in all the project UT/States for two weeks each for baseline and endline assessments.

The compliance with section 4 of COTPA was assessed by observing public places such as restaurants, hospitals, public transport, transit sites and offices. The PoS were observed during the peak business hours and assessed the compliance with section 5 and 6a of COTPA. The educational institutions were observed to assess the adherence to section 6b of COTPA. The compliance with sections 7, 8 and 9 was assessed by observing different tobacco products. The observation locations were also assessed for ‘active smoking’ (refers to the act of directly inhaling and consuming tobacco smoke by an individual) and ‘passive smoking’ (involuntary inhalation of tobacco smoke by individuals who are present in the vicinity of someone actively smoking).

Statistical analysis: Analysis was done using STATA version 14 (Stata Corp., TX, USA). The change in compliance with different sections of COTPA was summarized as proportion, and the statistical significance of the change in compliance for each state during baseline and endline was tested by performing a Chi-square test.

Results

A total of 3849 and 2176 samples were covered in baseline and endline assessment phases, respectively. Among the observation locations, more than half of the samples were from public places in both phases (accommodation facilities, 2.43 vs. 4%, eateries, 14.14 vs. 14%, offices, 13.5 vs. 11.16%, healthcare facilities, 9.97 vs. 9.43%, transit sites, 8.93 vs. 7.34% and public transport, 4.83 vs. 5.55%) (Table I). Among the PoS, the percentage contribution of independent kiosks was higher in both phases (49.54 and 47.53%, respectively). Educational institutions contributed nearly 14 per cent to the total sample size in both phases; however, the percentage contribution of the private schools was more in endline assessment compared to government institutions (51.3 and 48.69%, respectively).

Compliance with section 4 of COTPA was analyzed using the indicators mentioned in Table II. There was an increase in average compliance with section 4 in all study States from baseline to endline assessment. Compliance with the absence of active smoking [Puducherry= 83.5 vs. 96.4, prevalence ratio (PR)=0.18, 95% CI:0.07-0.41, Meghalaya= 80.49 vs. 93, PR=0.31, 95% CI=0.15-0.59, Telangana= 86.9 vs. 98.5, PR=0.09, 95% CI=0.04-0.19], smoking aids [Puducherry=78.08 vs. 86.7, PR=0.54, 95% CI=0.32-0.87, Meghalaya=81.56 vs. 90.9, PR=0.44, 95% CI=0.23-0.81, Telangana=86.9 vs. 98.7, PR=0.08, 95% CI=0.03-0.18] and cigarettes buds [Puducherry=59.78 vs. 84.2, PR=0.27, 95% CI=0.17-0.42, Meghalaya=65.24 vs. 78, PR=0.53, 95% CI=0.33-0.82, Telangana=80.4 vs. 91.3, PR=0.39, 95% CI=0.28-0.54] got increased in all States. Display of no smoking signages was the lowest in Meghalaya in both baseline and endline assessment (9.57 vs. 42.9%: PR=0.14: 95% CI=0.12-0.23). However, compliance with the specification regarding details of the reporting person in the signage board was less than 10 per cent in all States, with the highest proportion observed in Puducherry (9.41 vs. 3.7%: PR=2.81, 95% CI: 1.24-7.4).

There was an increase with the level of compliance with section 5 of COTPA in all three States, and it was doubled in Telangana (40.08 vs. 93.1%, PR=0.04, 95% CI: 0.02-0.07) (Table III). Meghalaya was most compliant with section 5 compared to other two States (86.7 vs. 97.7%, PR=0.15, 95% CI: 0.03-0.43). All the indicators used to assess compliance showed an increase from baseline to the end line in all States except in the case of Meghalaya where the absence of advertisement inside the shop showed decreased compliance in the endline assessment (99 vs. 96%, PR=4.1, 95% CI: 0.91-24.81).

The average compliance with section 6a increased slightly for Meghalaya (from 64 to 66.46%, PR=0.32, 95% CI: 0.21-0.48) and Telangana (64.3 to 66.46%, PR=0.91, 95% CI; 0.67-1.22) (Table IV). A reduction with compliance from 81.34 to 71.83 per cent was noted in Puducherry (PR=1.84, 95% CI: 1.14-2.95). Among the indicators used to assess compliance with section 6a, display of signage was the least adherent indicator, and for Meghalaya, it was 0 vs. 0.6% and for Telangana 0-0.3%, respectively.

Compliance with section 6b was assessed using four indicators (Table V). The average compliance increased in Meghalaya (63.65 vs. 77.85%, PR=0.48, 95% CI: 0.22-1) and Telangana (63.81 vs. 69.98%, PR=0.75, 95% CI: 0.48-1.18); however, there was more than 5 per cent reduction in average compliance for Puducherry (75.75 vs. 68.05%, PR=2.55, 95% CI: 0.94-7.43).

Reduction in average compliance with sections 7, 8 and 9 was reflected in all three States (Table VI). Warning in the local language was the least adhered indicator in both phases, but Meghalaya showed an increase in compliance (0-1.83%). Average compliance with sections 7, 8 and 9 was highest in Telangana in both phases, considering the reduction in the endline assessment (70.73 vs. 51.91%, PR=2.28, 95% CI: 1.09-4.72).

The average compliance with different sections of COTPA at two-time points in the same localities showed variations (Table VII). If we summarize results of all States, there was no significant change in compliance to section 4 (P=0.19), sections 5 (P=0.11) and 6a (P=0.06) whereas, section 6b (P=0.01) and section 7-9 (P=0.02) showed a significant change in the compliance status from baseline to endline assessment.

Discussion

This study attempted to capture the change in compliance in selected UT/States within a particular time interval and recorded mixed responses to compliance with different sections of COTPA from baseline to endline assessment. An increase in compliance with sections 4 and 5 was noted in all surveyed UT/States; a mixed response was observed for sections 6a and 6b, whereas a decrease in compliance with sections 7, 8 and 9 of COTPA was observed in all three States.

To analyze the extent of execution of different sections of COTPA, the observational locations were divided into public places, PoS and educational institutions. Similarly, Ali et al13 also divided the observatory locations into categories as previously mentioned, which may substantiate the logic behind categorization of the observational locations. The method employed to evaluate compliance with different sections of COTPA in the present study is similar to this earlier reported study, indicating that the approach chosen is suitable for comparability.

The percentage of compliance was more than 50 per cent in both time points in all the study UT/States, except in Meghalaya, where it was 42.4 per cent in the baseline assessment. In our study, Telangana was the most compliant State with section 4 of COTPA, with 66.1 per cent at endline and only 53.9 per cent in the baseline. Kummar et al14 reported 36.9 per cent compliance with section 4 of COTPA in their study, and a similar study reported a compliance rate of 23 per cent15. The disagreement in the percentage of compliance might be due to the difference in locations and strength of enforcement in different parts of India with regard to COTPA. Active smoking was absent in more than 80 per cent of public places in all three project UT/States, and it was more than 93 per cent in all UT/States during the endline assessment. On the contrary, Rijhwani et al16 found out that 75.4 per cent of active smoking in public places, and another study15 pointed out that 52.4 per cent of public places were prone to active smoking. The comparatively lower rate of active smoking in our project UT/States could be explained by consistent and periodic awareness programmes undertaken and the strong enforcement mechanisms used. These factors also helped in increasing the compliance with section 4 of COTPA from baseline to endline assessment.

Regarding section 5 of COTPA, the highest compliance at the endline was in Meghalaya, with 97.7 per cent changed from nearly 87 per cent at the baseline. However, the overall change in average compliance was highest in Telangana, which increased from 40 to 90 per cent. Our findings were substantiated by the results from a study conducted in the northern hilly State of Uttarakhand, where 93.8 per cent of the study units complied with the section 517. A cross-sectional study conducted by Khargekar et al18 recorded 47 per cent compliance in the city of Bengaluru in 2020. These findings suggested how enforcement mechanisms could improve compliance with different sections of COTPA in different places. A cross-sectional study conducted in the city of Ahmedabad by Sharma et al19 reported that nearly 77 per cent of the PoS displayed tobacco products, and this result was similar to that of our study where nearly 75 per cent of the shops displayed tobacco products in Telangana during the baseline assessment.

A mixed response was noted regarding compliance with sections 6a and 6b of COTPA. The average compliance with section 6 remained somewhere between 60 and 80 per cent in both baseline and end line. The increase in adherence was visible in the States of Meghalaya and Telangana but not in Puducherry. However, the highest average compliance for section 6a was in Puducherry (nearly 80%) and nearly 78 per cent in Meghalaya for section 6b. A study conducted by Pradhan et al9 concluded that nearly 69 per cent of the schools surveyed had not complied with section 6b of COTPA. This difference in results may be due to the large sample size covered in our study. The display of signage boards was present nearly at 13 per cent of the observed points in Puducherry during baseline assessment, and it was nil in the case of Telangana. The results from the study conducted by Priyanka et al20 were also similar to our findings, where 10 per cent compliance was reported. In the endline assessment also, the display of signage was less than half in all the study UT/States, and similar findings were reflected in a study conducted by Goel21. Most of the schools were closed during the COVID-19 pandemic during which the endline assessment was conducted. This might be the reason behind low compliance with section 6 compared to sections 4 and 5 in the three surveyed UT/ States.

All the UT/States showed a decrease in percentage from baseline to endline regarding compliance with sections 7, 8 and 9 of COTPA. The presence of a health warning was noted in more than 70 per cent of all tobacco products in project UT/States, and similar results were obtained in a study conducted by Joseph et al22 where the absence of a health warning was noted on 15 per cent of the products. A similar study reported that nearly 81 per cent of tobacco products displayed a health warning23. Inserts of promotion messages were also absent in more than 70 per cent of the cases, and in Telangana, it was 100 per cent at both time points; findings similar to other studies22.

As a pre–post interventional study, the present study was attempted to observe the change in compliance from baseline to endline in selected UT/States before and after the implementation of certain project activities. By conducting this study, we could set an example of the importance of interventions such as periodic monitoring, generating awareness among the public and various stakeholders regarding tobacco legislation and involvement of multiple departments in TC. However, the limitation of the present study was that we could not cover similar sample size in the baseline and endline phases of assessment due to COVID-19 restrictions.

Periodic monitoring and documentation of compliance with various sections of COTPA are essential. Overall, this study concludes that strengthening of a monitoring mechanism including direct observation, and ensuring participation of the enforcement department along with other stakeholder departments across sectors has the potential to increase compliance to various sections of COTPA. Prioritizing TC activities in each State and UT and mainstreaming the components of NTCP at the central level are the needs of the hour.