Introduction Despite India having the highest burden of cervical cancer globally, the HPV vaccine is not part of the routine immunisation programme. The decision process on HPV vaccine was put-off in 2010 shortly after a high profile vaccine demonstration trial was suspended when five girls died. Although the evidence that the deaths were linked to the vaccine is highly contested, nonetheless a political decision on HPV vaccine introduction differed. The purpose of the current study is to explore the political, socio-economic and cultural factors influencing the HPV policy decision in India. Evidence from the study may have implications for future vaccines targeting STIs in contested policy environments.

Methods We used qualitative methods for policy analysis based on primary data collection supplemented with in-depth documentary review. Semi-structured interviews were conducted with 46 participants including policy makers, health system actors and community based organisations at State and National level. We used the Gilson and Walt Health policy triangle framework to analyse the data.

Results Interim results have highlighted a number of features of the policy process in India, which may have influenced vaccine policy decision-making. These include: lack of adequate policy space for transparent discussion of concerns; strong suspicion of conflict of interest among researchers and international donors; mistrust of Government officials by civil society members; Government concerns around sustainable funding options; and a dearth of Government initiatives to promote culturally sensitive sexual health issues.

Conclusion The [non]-introduction of the HPV vaccine into the Indian policy landscape was influenced by a variety of factors including contested empirical evidence of safety and perceptions of institutional (particularly commercial) interests outweighing public health evidence. This study provides important lessons not only for the future introduction of HPV vaccine in India, but also for any other vaccines targeting STIs.

Disclosure of interest statement The study is funded by Wellcome Trust and the Public Health Foundation of India. No pharmaceutical grants were received for this research study.