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Launch of BIRSA 101 Gene Therapy
India has launched its first indigenous CRISPR-based gene therapy, named BIRSA 101, developed to treat Sickle Cell Disease, a condition that largely affects tribal communities in central and eastern India. The scientific development strengthens efforts toward a Sickle Cell-free India by 2047.
Developed at CSIR-Institute of Genomics & Integrative Biology (IGIB), this breakthrough showcases India’s ability to develop advanced gene-editing treatments at a fraction of the global cost. In contrast, similar therapies abroad can cost INR 20-25 crore.
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BIRSA 101 Gene Therapy: Scientific Significance and Technology Platform
The BIRSA 101 gene therapy uses a precise CRISPR-based gene-editing approach, often described as “precise genetic surgery.” This platform can potentially treat not only Sickle Cell Disease but also several other hereditary and genetic disorders.
A technology transfer agreement between CSIR-IGIB and the Serum Institute of India will enable the engineered enFnCas9 CRISPR platform developed at IGIB to be scaled into affordable gene therapies for Sickle Cell Disease and other major genetic disorders.
This partnership mirrors India’s successful public-private model used in developing several vaccines and is designed to ensure:
- High-quality manufacturing,
- Rapid and affordable deployment,
- Accessibility for underserved populations, mainly tribal communities, and
- Clear communication about scientific breakthroughs in an easy-to-understand format,
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Research Infrastructure and National Science Collaboration
A new advanced research and translational facility has been inaugurated at CSIR-IGIB, strengthening India’s genomic medicine capabilities.
The focus is on integrated national research models involving CSIR, DBT and partner institutions, including thematic collaboration frameworks such as “One Week-One Theme.”
India’s progress from vaccines to gene therapies shows its growing strength in developing indigenous biomedical technologies. The launch of BIRSA 101 further reinforces this shift toward advanced, locally developed genomic and therapeutic capabilities.
DhruvStar Industry Insights: What it Means for the Biotech Industry
- Strengthening Public-Private Innovation Models: The BIRSA 101 framework shows how research institutions and industry can jointly accelerate translation of gene-editing platforms into real-world therapies. Similar collaboration models can be expanded for rare diseases and emerging genetic disorders.
- Building Affordable Gene Therapy Manufacturing: With technology-transfer mechanisms now in place, biotech firms have an opportunity to invest in scalable, cost-efficient gene therapy production systems. This can help position India as a global hub for low-cost genomic therapeutics.
- Expanding Skilled Workforce for Genomic Medicine: Industry and academic institutions can develop specialised training programmes in CRISPR, cell therapy and molecular diagnostics to build a workforce capable of supporting next-generation therapeutic pipelines.
- Developing Regulatory and Quality Frameworks: As advanced therapies expand, there is scope for industry associations to work with regulators to shape quality, safety and ethical standards that enable faster approvals while maintaining patient safety.
Sources
[1] PIB
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