Current Regulatory Requirements For Conducting Clinical Trials In India For Investigational New Drugs/New Drug (Version 3.0)

About

This course is co-developed by the Clinical Development Services Agency (CDSA), BRIC-THSTI and the Central Drugs Standard Control Organisation (CDSCO), with NPTEL.

CDSA is a centre of BRIC-THSTI, and was created with a mandate to support and nurture clinical product development and clinical research capacity in India. It fills a unique niche in the publicly funded clinical research landscape in the country as being the only such public agency established by the Department of Biotechnology, Government of India. THSTI is an autonomous institution under the Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India.

CDSCO is the National Regulatory Authority (NRA) of India, under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. CDSCO along with the state regulators are jointly responsible for grant of licenses of certain specialized categories of critical drugs such as blood and blood products, intravenous fluids, vaccines, and sera.

A thorough knowledge and understanding of regulatory guidelines is a prerequisite for conducting regulatory clinical trials, including those related to new drug development. This is particularly important in light of the numerous changes and amendments to clinical trial and new drug approval regulations in India in recent years.

This course was initially launched as a four-week program in early 2019 (Version 1), comprising 12 lectures. Between January and March 2019, 1,047 participants enrolled in the course.

On March 19, 2019, the New Drugs and Clinical Trials (NDCT) Rules, 2019 were released. The subsequent version of the course (Version 2) was updated to reflect the changes and amendments introduced through the NDCT Rules, 2019. To incorporate the latest regulatory updates and feedback from Version 1 participants, CDSA conducted a series of brainstorming sessions in collaboration with CDSCO. The updated version draws on key issues identified during…