Main description:

Clinical trials are integral to drug discovery and bringing out newer and better medicines. With the evolution of India's disease burden as well as its pharmaceutical industry, the need for clinical trials has increased manifold. This report analyses prospects and challenges of clinical trials in India, focusing on New Chemical Entities and new drugs, and likewise proposes actionable policy recommendations for the Indian drug regulatory landscape so that the country can realise its untapped potential, while addressing concerns raised regarding the conduct and quality of clinical trials. The Government of India needs to develop a promotive ecosystem around clinical trials-now more than ever, sooner rather than later. A clear set of policy, rules and guidelines around clinical trials would be a central component in the larger strategy to address India's public health challenges and incentivise the country's pharmaceutical industry to mature to the next level.

Contents:

List of Tables, Figures and Appendices
List of Abbreviations
Glossary
Foreword
Acknowledgements
Executive Summary
1. Introduction
1.1 Regulating Clinical Research
1.2 The Global Clinical Research Landscape
1.3 The Indian Clinical Research Growth Story
2. Research Methodology
2.1 Country Selection Criteria
3. The Dilemmas Afflicting Clinical Research in India
3.1 Overview
3.2 Developing a Culture of Research and Innovation: The Clinical Research Perspective
3.3 Regulatory Landscape for Clinical Research of Countries in the Sample
4. Under Trial: The Challenge of Clinical Trials in India
4.1 Use of Formulae for Calculating Compensation for Trial Related Injury/Death
4.2 Use of a 'Standard of Care'
4.3 Use of Placebos in a Placebo Controlled Trial
4.4 Clinical Trial Waivers
4.5 Mandatory Local Filing of Marketing Authorisation After the Clinical Trial
4.6 Audio-visual Recording of Informed Consent
4.7 Message Fidelity in Translated Informed Consent Forms
4.8 Trends in Clinical Research in Other Countries
4.9 Policy Recommendations
5. Conclusions
References
Appendices