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

Abstract

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.

Cancer Trials Ecosystem in India—Ready for Prime Time?

“…12,18 In response, several stringent regulations and regulatory amendments related to the protection of trial subjects for clinical trials were introduced by the CDSCO and the Ministry of Health in 2013 and 2014. 19,20…”

Regulatory overview on New Drugs and Clinical Trials Rules, 2019

“…John Haygarth provided an example of the need for a control group to correctly identify the placebo effect. Frederick Akbar Mahomed made a distinction between chronic nephritis and secondary hypertension (10)…”

“…A drug inquiry panel was established by the Indian government in 1940. (10) The Drug Bill, which ultimately evolved into the 1940 Drugs and Cosmetic Acts, was presented to the parliamentary assembly with its proposals for consideration. (10,11)These foundational laws continue to govern the manufacture, distribution, and sale of medications and cosmetics in India.…”

“…India only allowed "process" patents under the 1970 Indian Patent Act. (10) However, the Indian government ratified the Trade-Related Aspects of Intellectual Property Rights (TRIPS) affidavit in 1994. (10,11)…”

“…(10) However, the Indian government ratified the Trade-Related Aspects of Intellectual Property Rights (TRIPS) affidavit in 1994. (10,11)…”