Author(s): Vishal Vennu, Prem Saini

Email(s): vishal_vennu@outlook.com , prem_hsaini@yahoo.co.in

DOI: 10.5958/0974-360X.2020.00738.6   

Address: Vishal Vennu1, Prem Saini2
1Ph.D. Scholar, SOP, Lingaya’s Vidyapeeth, Faridabad, Haryana, India & Department of Rehabilitation Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.
2 Head, School of Pharmacy, Lingaya’s Vidyapeeth, Faridabad, Haryana, India. *Corresponding Author

Published In:   Volume - 13,      Issue - 9,     Year - 2020


ABSTRACT:
Studies have examined possible problems regarding previous clinical trial regulations. However, no study studied the knowledge and views of Indian researchers about the current new rules. Therefore, the 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 over India between July 2019 and September 2019. Google form was used to develop the survey questionnaires, which had already been validated. A web link was created for participants to perceive the survey. The demographic characteristics, knowledge, and views of Indian researchers were described in numbers (percentages) and means (standard deviations). Of 106 researchers, 75 (70.8%) knew the new regulations. The modification in the timeline, open post-trial drug passage, and welcoming equality was accepted by 36 (63.2%), 32 (53.1%), and 31 (54.5%), respectively. The new advances in severe adverse effects and compensation were accepted by 37 (64.9%). Overall, 34 (59.6%) agreed on the new rules, and 71 (67%) answered that the new regulations would often influence on profit clinical trial investigations. Generally, 91 (87.5%) researchers believed that the new rules are incredibly beneficial to the development of clinical research in India. The study results suggest that most researchers know and agree with the modifications. The current new rules force to extend clinical research and the pharmaceutical industry in India. Overall, this study strengthens the aim of the new regulations that promote clinical trials, accept new drugs, and enhance the country's moral norms.


Cite this article:
Vishal Vennu, Prem Saini. The knowledge and views of Indian researchers concerning India’s current drugs and clinical trial regulations. Research J. Pharm. and Tech. 2020; 13(9):4179-4184. doi: 10.5958/0974-360X.2020.00738.6


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