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The Knowledge and Views of Indian Researchers

88 Citations2021
V. Vennu
India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers

The study results suggest that most researchers know and agree with the modifications of the NDCTR-19 that promotes clinical trials, accepts new drugs, and enhances the country's standards ethical norms.

Abstract

No study studied the knowledge and views of Indian researchers about changes in the new drugs and clinical trial rules (NDCTR-19). The present study aimed to address this gap. In this cross-sectional web-based online survey, a total of 106 male and female researchers were chosen randomly from various sources across India over three months, starting from July 2019. The study results suggest that most researchers know and agree with the modifications. NDCTR-19 forces to extend clinical research and the pharmaceutical industry in India. Overall, this study strengthens the aim of the NDCTR-19 that promotes clinical trials, accepts new drugs, and enhances the country's standards ethical norms.