New Delhi, March 19 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. Jitendra Singh said in a written reply in the Rajya Sabha.
"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.
The BioE3 (Biotechnology for Economy, Environment, and Employment) Policy, approved by the Union Cabinet in August 2024, aims to transform India into a global biomanufacturing hub, promoting sustainable growth and reducing import reliance.
The program focuses on high-performance biomanufacturing for chemicals, enzymes, agriculture, and therapeutics, the statement said.
CSIR-Institute of Genomics and Integrative Biology (CSIR-IGIB) is working with Serum Institute, Pune, towards commercialisation of the gene therapy, having executed a technology transfer agreement for clinical translation and upscaling its novel gene therapy.
Several research projects supported by ICMR strengthen translational research, infrastructure development, and industry-academia collaboration to create a sustainable pipeline of indigenous CGTs and to ensure that advanced gene-editing therapies are affordable and have widespread access, the minister noted.
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