India has achieved a significant milestone in genomic medicine with the launch of its first indigenous CRISPR-based gene therapy for sickle cell disease. The therapy, named "BIRSA 101" in honor of tribal freedom fighter Bhagwan Birsa Munda, was developed by the Council for Scientific and Industrial Research Institute of Genomic and Integrative Biology (CSIR-IGIB) and transferred to Serum Institute of India Private Limited (SII) for clinical development.
Union Minister Dr. Jitendra Singh announced the breakthrough, emphasizing that India has formally begun its journey toward becoming a sickle cell disease-free nation by 2047. The development represents a major step in advancing Prime Minister Narendra Modi's vision while supporting the goal of Atmanirbhar Bharat in frontline medical technologies.
Addressing India's Sickle Cell Disease Burden
India faces a substantial sickle cell disease burden, with the second-highest number of children born with the condition globally. An estimated 15,000 to 25,000 new cases occur each year, particularly among tribal communities in Central India. The disease disproportionately affects tribal populations in central and eastern India, where the disease burden is highest.
Dr. Souvik Maiti, Senior Principal Scientist at CSIR-IGIB and lead investigator for the project, explained the clinical trial preparations: "We have created a pool of around 150 potential participants from cities such as Jabalpur in Madhya Pradesh, Raipur in Chhattisgarh, and Ranchi in Jharkhand to begin the clinical trial. We will finalise three participants from this pool for our first trial after obtaining the necessary approvals."
Revolutionary Cost Reduction
The indigenous CRISPR technology promises to dramatically reduce treatment costs. Current CRISPR-based gene-editing therapy for sickle cell disease costs around USD 3 million (approximately Rs 26 crore), mainly due to high licensing fees. The newly developed indigenous technology is expected to bring the cost down to around Rs 50 lakh, making it significantly more accessible to Indian patients.
Dr. Umesh Shaligram, Executive Director of Serum Institute of India, highlighted the affordability mission: "Globally, gene therapies cost over three million dollars and are beyond the reach of even the wealthy. Our mission is to take Indian innovation and make it accessible for the poorest of the poor. Serum has saved over 30 million lives through affordable vaccines, and we are fully committed to supporting the Prime Minister's vision of a Sickle Cell-Free India by 2047."
Clinical Trial Implementation
IGIB has already begun the first phase of clinical trials in collaboration with multiple agencies, including the Drug Controller General of India (DCGI), the Department of Biotechnology (DBT), the Department of Science and Technology (DST), the Ministry of Tribal Affairs, and CSIR.
The treatment process involves extracting the affected gene from bone marrow at AIIMS Delhi, while gene editing will take place at IGIB's dedicated center. The extraction process is expected to take 120 days. Following the technology transfer, SII will collaborate with IGIB to conduct the second and third phases of clinical trials, involving a larger pool of participants.
Scientific Foundation and Global Context
The development builds on successful international precedents. IGIB noted that a similar treatment was successfully administered to three African individuals in the United States. Encouraged by this progress, Indian scientists decided to replicate the process domestically using indigenous technology. The development process took nearly six years for India to develop its own CRISPR platform.
Dr. Jitendra Singh described the technology as working like "precise genetic surgery," capable not only of curing sickle cell disease but also transforming treatment pathways for several hereditary disorders. The indigenous CRISPR platform positions India among global leaders in advanced therapeutics.
Public-Private Partnership Model
The formal technology transfer and collaboration agreement between CSIR-IGIB and Serum Institute of India represents a successful public-private partnership model. Dr. Singh emphasized that government alone cannot shoulder the entire burden of biotechnology expansion, and industry participation is essential for scale, affordability, and global competitiveness.
The partnership ensures that breakthroughs achieved in laboratories reach real-world clinical deployment at scale. The collaboration guarantees affordability, scalability, and global-standard manufacturing pathways, ensuring that advanced gene-editing cures become accessible for Indian patients, especially among underserved tribal populations.
Broader Implications
The breakthrough demonstrates India's capability to produce pathbreaking therapies at a fraction of global costs, potentially replacing treatments priced at Rs 20-25 crore overseas. Experts believe that similar indigenization of CRISPR technology can also be achieved in the agriculture sector, where ICAR has been negotiating licensing fees with foreign agencies rather than developing indigenous CRISPR systems.
Dr. Singh concluded that the development reaffirms India's scientific capabilities and represents the country's journey from being dependent on imported biomedical technologies to becoming a global leader in drug development, vaccines, and now CRISPR therapeutics. "We are no longer just adopting global technologies; we are creating them. The world will now look to India for the future of affordable, cutting-edge healthcare," the Minister stated.
