India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers
Background/Purpose: Few studies have examined investigators’ and ethics members’ understanding of previous guidelines, as well as their perspectives on them. No study, however, has looked into the perceptions and viewpoints of Indian researchers on the most recent medications and clinical trial regulations for 2019. (NDCTR-19). The current study’s goal is to find a solution to this problem.
Methods: The Checklist for Reporting Results of Internet E-Surveys was used to create a web-based online survey using a widely approved Google form with an already verified questionnaire. Participants were given a web URL to use in order to respond to the survey. Between July and September 2019, the data was gathered by emailing the link to several researchers across India. The perceptions and viewpoints of Indian scholars were expressed as a percentage (%) and a mean (%). (standard deviations).
The NDCTR-19 was perceived by 75 (70.8 percent) of the 106 researchers, including those from all zones (100 percent, p.0001). Changes to the timeframe, open post-trial drug passage, and embracing equality were all approved by 36 (63.2%), 32 (53.1%), and 31 (54.5%) of respondents, respectively. 37 people agreed that recent developments in severe adverse effects and compensation were beneficial (64.9 percent ). Furthermore, the majority of respondents felt that sharing the NDCTR-19 with other researchers, particularly those from the central zone, would impact the working atmosphere (100 percent, p.0001, respectively).
Conclusion: The findings suggest that the NDCTR-19 can help speed up clinical trials and expand India’s pharmaceutical sector. The findings will be of interest to investigators as well as stakeholders from pharmaceutical corporations on a national and worldwide level.
School of Pharmacy, Lingaya’s Vidyapeeth, Faridabad, India and Department of Rehabilitation Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.