This chapter seeks to discuss the manner in which enforcement of regulatory laws laying down standards for the safety and efficacy of vaccines can create tensions between different stakeholders during the roll out of vaccines. In particular, this chapter discusses five controversies in India since 2008 involving different vaccines to illustrate the tensions between different stakeholders who often have different goals.. These five controversies demonstrate the tensions between the Indian drug regulator, the Indian pharmaceutical industry, and different stakeholders in India, ranging from groups advocating for improved access to medicines, to doctors demanding greater transparency of clinical trial data, to ordinary citizens demanding compensation due to adverse events caused by vaccines, and finally a relatively new anti-vaxxer movement. These five controversies are a reminder of how a robust regulatory framework for vaccines is key to building long-term public trust in vaccines.

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A Regulatory Vacuum and its Consequences for Public Trust in Vaccines: A Cautionary Tale from India

  • Prashant Reddy Thikkavarapu

摘要

This chapter seeks to discuss the manner in which enforcement of regulatory laws laying down standards for the safety and efficacy of vaccines can create tensions between different stakeholders during the roll out of vaccines. In particular, this chapter discusses five controversies in India since 2008 involving different vaccines to illustrate the tensions between different stakeholders who often have different goals.. These five controversies demonstrate the tensions between the Indian drug regulator, the Indian pharmaceutical industry, and different stakeholders in India, ranging from groups advocating for improved access to medicines, to doctors demanding greater transparency of clinical trial data, to ordinary citizens demanding compensation due to adverse events caused by vaccines, and finally a relatively new anti-vaxxer movement. These five controversies are a reminder of how a robust regulatory framework for vaccines is key to building long-term public trust in vaccines.