The effect of the New Trial Guidelines on society

It is crucial to maintain the highest standards in clinical trials and drug tests, as any compromise may jeopardize public confidence and participation in the clinical trials and may ultimately affect the availability of safe and effective products. Rules and regulations are mechanisms to ensure that the quality and integrity of data collected in clinical trials is maintained and also to ensure that the rights, safety and welfare of research participants are protected. The Ministry of Health and Family Welfare on 9th March 2023, issued the Draft New Drugs and Clinical Trials Amendment Rules 2023 to amend further New Drug and Clinical Trial Rules 2019. An amendment to the New Drugs and Clinical Trial Rules (2023), recently passed by the Government of India, aims to replace the use of animals in research, especially in drug testing. The new amendments in India made in new trial guidelines authorise researchers to instead use non-animal and human-relevant methods, including technologies like 3D organoids, organs-on-chip, and advanced computational methods, to test the safety and efficacy of new drugs. There is a need for a law to ensure that the people who undergo clinical trials are not exploited and should be well informed about risk as well to provide clarity on regulations.

Continue ReadingThe effect of the New Trial Guidelines on society