Gene Therapy — Tech Evolutions

Entry	Year	Description	Impact
N/A (No direct constitutional amendments)	2017 (updated 2024)	ICMR National Guidelines for Stem Cell Research and Therapy	These comprehensive guidelines, periodically updated, govern all advanced cellular and genetic therapies, including gene therapy, in India. They provide the ethical and regulatory framework for research, clinical trials, and oversight by Institutional Ethics Committees, ensuring patient safety and responsible scientific conduct. The 2024 updates reflect advancements in the field and global best practices.
N/A (No direct constitutional amendments)	2019	New Drugs and Clinical Trials Rules, 2019	These rules by the CDSCO formally include 'gene therapeutic products' under the definition of 'new drug,' subjecting them to stringent regulatory approval processes similar to other novel pharmaceuticals. This provides a clear legal pathway for the development, testing, and eventual marketing of gene therapies in India, ensuring quality, safety, and efficacy.