BioE3 advances India's gene‑editing and cell therapy drive: Minister
New Delhi, March 19 (IANS) Regulatory bodies have issued national guidelines to ensure safe, ethical deployment of CRISPR-based therapies in India, while the BioE3 is accelerating indigenous capacity for cell and gene therapeutics, the government said on Thursday responding to a question on self-reliance in CRISPR and gene editing.
The government through various programs has been steadily advancing the precision medicine ecosystem with a strong emphasis on next-generation cell and gene therapies that includes approaches to modify cells or genetic material through gene augmentation, gene editing, gene silencing, and other cell-based approaches, MoS Ministry of Science and Technology & Earth Sciences Dr.
"National Guidelines for Gene Therapy Product Development and Clinical Trials, 2019”, issued by CDSCO, ICMR and DBT, guide stakeholders to comprehend and comply with regulatory requirements for research and development of gene therapeutic products (GTPs) in India.
The first-in-human Phase-I clinical trial for gene therapy of Hemophilia A has shown clinically significant outcomes, whereby stable production of Factor VIII has been observed, offering potential treatment for long-term reduction of bleeding episodes, the minister cited progress of government supported initiatives.