Current regulatory requirements for conducting clinical trials in India

Overview

Demonstration of safety and efficacy of the drug product for use in human being is essential before the drug can be approved for import or manufacturing and marketing in the country. The Rules 122A, 122B and 122D, 122 DA, 122DB, 122DAA, 122 DAB, 122 DD, and 122E of Drugs and Cosmetics Rules and Appendix I, IA and VI of Schedule Y, describe the information/data required for approval of clinical trial and/or to import or manufacture of new drug for marketing in the country. Recently, there are few amendments made related to the new drug rules. and “ New Drugs and Clinical Trial Rules, 2018. (Draft) published by the CDSCO. This course will make the participant aware about all the current regulatory and ethical requirements for conducting clinical trials in India.Enjoy the course

Syllabus

Week 1  : Introduction, Definitions, Drug Regulatory Authorities
Week 2  : Drugs & Cosmetic Act & Rules (Relevant Act and Rules), Drugs & Cosmetics Rules (Relevant Guidelines issued by CDSCO), Drug development Overview
Week 3  : Good Clinical Practice (Indian), Schedule Y: Overview, Schedule Y: Appendices
Week 4  : Ethical considerations, Recent amendments , Special concerns (Approval procedure for Medical device, Biologicals, Phytopharmaceuticals, r-DNA derived products)