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India��?s Clinical Trial Regulatory Changes, Indian Researchers��? Awareness of Recently Changed Regulations, and the Impact of the New Drugs and Clinical Trial Rules

 Vishal Vennu

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 (NDTC Rules) issued in 2019 and also its impacts. Understanding the knowledge of Indian researchers on NDTC 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 researchers’ 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.