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With the evolution of India's disease burden as well as its pharmaceutical industry, the need for clinical trials has increased. This report analyses the prospects and challenges of clinical trials in India, focusing on new chemical entities and new drugs, and proposes actionable policy recommendations for the Indian drug regulatory landscape.
This report, the first-of-its-kind, based on extensive desk and field research in four Indian states - Maharashtra, Karnataka, Gujarat and Telangana - and seven countries - USA, UK, Switzerland, Germany, South Africa, Singapore and Indonesia - incorporates the views of more than 150 stakeholders to identify lessons as well as opportunities address challenges of drug regulation in India.
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