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Implementation research for taking tobacco control policies to scale in India: a realist evaluation study protocol
  1. Pragati Bhaskar Hebbar1,
  2. Vivek Dsouza1,
  3. Upendra Bhojani1,
  4. Onno CP van Schayck2,
  5. Giridhara R Babu3,
  6. Gera Nagelhout4,5
  1. 1Institute of Public Health Bengaluru, Bangalore, Karnataka, India
  2. 2Department of Family Medicine, Maastricht University (CAPHRI), Maastricht, Netherlands
  3. 3Epidemiology, IIPH-H, Bangalore campus, Associate Professor, Public Health Foundation of India, IIPH-H, Bangalore, Karnataka, India
  4. 4Department of Health Promotion, Maastricht University (CAPHRI), Maastricht, The Netherlands
  5. 5IVO Research Institute, Koningin Julianaplein, The Hague, Netherlands
  1. Correspondence to Dr Pragati Bhaskar Hebbar; pragati{at}


Introduction There are ongoing policies and programs to reduce tobacco use and minimise the associated health burden in India. However, there are several challenges in practice leading to different outcomes across Indian states. Inadequate understanding of how national tobacco control policies achieve their results under varied circumstances obstruct the implementation and scaling up of effective strategies. This study is a realist evaluation using largely qualitative methods to understand the implementation process of India’s tobacco control policies. It will do so by evaluating India’s Cigarettes and Other Tobacco Products Act (COTPA) and the National Tobacco Control Program (NTCP). The study aims to examine how, why, for whom and under which circumstances COTPA and NTCP are implemented in India.

Methods and analysis A realist synthesis on implementation of tobacco control policies in low-income and middle-income countries is conducted. This is followed by qualitative data collection and analysis in three Indian states selected based on data from two rounds of the Global Adult Tobacco Survey. The study comprises of three steps (1): development of initial programme theories, (2) testing and refinement of initial programme theories and (3) testing and validation of refined programme theories. We will interview policy-makers, programme managers and implementers to identify facilitators and barriers of implementation. The purpose is to identify context-specific evidence-based strategies to gain insights into the implementation process of COTPA and NTCP. Further we aim to contribute to tobacco control research by establishing communities of practice to engage with cross-cutting issues.

Ethics and dissemination The Institutional Ethics Committee, at the Institute of Public Health (Bengaluru), has approved the protocol. Written informed consent forms will be obtained from all the participants. Dissemination has been planned for researchers, policy-makers and implementers as well as the public through peer-reviewed publications, conference presentation, webinars and social media updates.

PROSPERO registration number CRD42020191541.

  • health policy
  • public health
  • protocols & guidelines

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  • Contributors PH was responsible for the funding acquisition and project administration. UB and PH were involved in conceptualisation and GN helped in strengthening the methodology. VD and PH were involved in data collection, analysis and writing original drafts. Whereas UB, OCPvS, GRB and GN were involved in supervision, reviewing and editing drafts. All authors read and approved the final manuscript.

  • Funding The study is supported by the Department of Biotechnology/Wellcome Trust India Alliance Early Career Fellowship awarded to Pragati Hebbar [IA/ CPHE/17/1/503338].

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods and analysis section for further details.

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.