Daijiworld Media Network - New Delhi

New Delhi, Mar 19: India has introduced national guidelines to ensure the safe and ethical use of CRISPR-based therapies, while stepping up efforts to build domestic capabilities in gene editing and advanced therapeutics, the government informed Parliament.

Responding in the Rajya Sabha, Minister of State Jitendra Singh said the government is strengthening the precision medicine ecosystem with a focus on next-generation cell and gene therapies. These include techniques such as gene augmentation, gene editing, gene silencing, and other cell-based interventions.

The “National Guidelines for Gene Therapy Product Development and Clinical Trials, 2019,” issued by the Central Drugs Standard Control Organisation, Indian Council of Medical Research, and Department of Biotechnology, provide a regulatory framework for the development and clinical testing of gene therapy products in the country.

Highlighting progress, the minister noted that a first-in-human Phase-I clinical trial for gene therapy targeting Hemophilia A has shown promising results, including stable production of Factor VIII, which could significantly reduce bleeding episodes over the long term.

The government is also advancing the BioE3 Policy, approved in August 2024, aimed at positioning India as a global hub for biomanufacturing. The initiative focuses on sectors such as chemicals, enzymes, agriculture, and therapeutics, while reducing dependence on imports.

In a key collaboration, the CSIR-Institute of Genomics and Integrative Biology has partnered with the Serum Institute of India to commercialise gene therapy through a technology transfer agreement, enabling clinical translation and scale-up.

Additionally, multiple projects supported by the ICMR are working to strengthen research infrastructure, promote industry-academia collaboration, and develop affordable, locally produced cell and gene therapies to expand access to advanced treatments across the country.