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Abstract

India's Clinical Trial Regulatory Changes, Indian Researcher?s Awareness of Recently Changed Regulations, and the Impact of the New Drugs and Clinical Trial Rules: A Review

Author(s): V. VENNU* AND P. P. SAINI
Department of Rehabilitation Sciences, College of Applied Medical Sciences, King Saud University, 10219 Riyadh, Saudi Arabia, 1School of Pharmacy, Lingaya’s Vidyapeeth, Faridabad-121002, India

Correspondence Address:
Department of Rehabilitation Sciences, College of Applied Medical Sciences, King Saud University, 10219 Riyadh, Saudi Arabia, E-mail: [email protected]


Medical companies consider India is above other countries worldwide as an alternative nation for clinical trials due to easily available sources and infrastructure. However, the developing Indian clinical trial industry has been negatively affected by noncompliance with regulations and by reports of unethical trials. Several studies on Indian clinical trial regulations have been conducted and various articles have been published, but only a few researchers evaluated awareness of investigators and members of the ethics committee about previously amended regulations. No study evaluated the knowledge of researchers on the new drugs and clinical trial rules issued in 2019 and also its impacts. Understanding the knowledge of Indian researchers on new drugs and clinical trial rules, including its effect is crucial to determine whether the trials are being conducted in compliance with the new rules and regulations. Thus, this review aimed to evaluate India’s clinical trial regulatory changes based on the existing literature, Indian researcher’s knowledge of the recent changes, and assessment of the impact of the new 2019 regulations, elaborating upon clinical trials in both the global and the Indian context.

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