INITIATIVES AND CHALLENGES IN SCHEDULE Y REGULATION IN INDIA: STILL LONG WAY TO GO

Schedule Y has been established under Drugs and Cosmetic Act 1940 and rule 1945 for the conduction of clinical trials. It is referred to fundamentals and guidelines for import and manufacture of original drugs for trade or for clinical trials. Schedule Y provides guidance for conducting various clinical trials in different fields of clinical research, controlling and regulating any new drug prior to their entry into the market. It includes the responsibilities of key authorities such as sponsors, investigators, and ethics committee) and year wise evolutions, as well as the evolution of these guidelines over the years as the review present (sponsor, investigator and ethics committee) and year wise evolution suggested by various authorities. In addition, different phase of clinical trials with their respective roles. This updated study demonstrates the Indian government’s strong commitment to the conduct of trials in India and safeguarding the interests of human subjects. The Suggestive consolidations for improving clinical trials may contribute significantly to strike balance between the interest of the subjects and the growth of clinical trials in India. The conclusion of this study encouraging selective participation of clinical research organizations. Reduce the number of unethical clinical trials being run by private hospitals and research laboratories for profit business. The present compilation provides comprehensive and up to it also offers a dated information about Schedule Y and review the status of clinical trials in India. A detailed discussion about evolution of Schedule Y in India Omitted from the manuscript.