Vaccines and Immunotherapy — Tech Evolutions

Entry	Year	Description	Impact
New Drugs and Clinical Trials Rules	2019	These rules, notified under the Drugs and Cosmetics Act, 1940, significantly updated the regulatory framework for clinical trials and approval of new drugs and biologicals, including vaccines and immunotherapies, in India. They aim to streamline the approval process, enhance patient safety, and promote ethical conduct of research.	Provided a clearer, more efficient, and globally aligned pathway for the approval of novel vaccines and immunotherapies, including provisions for accelerated approval in public health emergencies. Strengthened ethical oversight and compensation mechanisms for trial participants.
National Vaccine Policy	2011	While not a legislative amendment, this policy document represents a significant update in India's strategic approach to vaccines. It outlined objectives for universal immunization, indigenous research and development, strengthening regulatory mechanisms, and ensuring equitable access.	Guided the launch of major public health initiatives like Mission Indradhanush and fostered a robust domestic vaccine manufacturing ecosystem. Emphasized self-reliance and India's role in global vaccine supply, influencing subsequent policy decisions and resource allocation for vaccine programs.