Regulatory bodies in India have released national guidelines to ensure the safe and ethical use of CRISPR-based therapies. The government highlighted efforts to enhance the country’s capacity for cell and gene therapeutics through programs like BioE3. These initiatives aim to advance precision medicine, focusing on next-generation therapies involving gene editing and cell-based approaches.
The Ministry of Science and Technology emphasized the importance of adhering to the “National Guidelines for Gene Therapy Product Development and Clinical Trials, 2019,” issued by CDSCO, ICMR, and DBT. These guidelines help stakeholders understand and meet regulatory standards for gene therapeutic products in India. The government also mentioned the successful Phase-I clinical trial for gene therapy of Hemophilia A, showing promising results in stable Factor VIII production.
Furthermore, the BioE3 Policy, approved by the Union Cabinet, seeks to position India as a global biomanufacturing hub by reducing import dependency and fostering sustainable growth. This policy focuses on enhancing biomanufacturing capabilities across various sectors, including chemicals, enzymes, agriculture, and therapeutics. Collaborative efforts between CSIR-Institute of Genomics and Integrative Biology and Serum Institute, Pune, are underway to commercialize gene therapy through technology transfer agreements.
Projects supported by ICMR aim to bolster translational research, infrastructure development, and industry-academia partnerships to establish a sustainable pipeline for advanced gene-editing therapies in India. These endeavors are geared towards ensuring affordability and accessibility of cutting-edge gene therapies for the populace.
