India Initiates Clinical Trials for Sickle Cell Disease Treatment

On 19 November 2025, coinciding with Janjatiya Gaurav Divas, the Council for Scientific and Industrial Research Institute of Genomic and Integrative Biology (CSIR-IGIB) announced the transfer of homegrown technology for a CRISPR-based gene-editing treatment for Sickle Cell Disease (SCD) to the Serum Institute of India Private Limited (SII).

India has the second-highest prevalence of Sickle Cell Disease globally, with an estimated 15,000 to 25,000 new cases emerging annually, especially within tribal populations in Central India. The Serum Institute of India is now set to conduct clinical trials aimed at developing a more affordable solution for this genetic disorder.

Currently, the cost of CRISPR-based gene-editing therapy for SCD is around USD 3 million (approximately ₹26 crore), largely due to hefty licensing fees associated with foreign technologies. However, the newly developed indigenous method is anticipated to reduce the expense to approximately ₹50 lakh.

In the meantime, CSIR-IGIB has commenced the first phase of clinical trials, collaborating with various entities 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 itself.

Dr Souvik Maiti, Senior Principal Scientist at CSIR-IGIB, stated, "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." Dr Maiti serves as the lead investigator for this significant project.

The procedure will involve extracting the affected gene from the bone marrow at the All India Institute of Medical Sciences (AIIMS) in Delhi, with gene editing taking place at a dedicated facility at IGIB. This extraction process is expected to take around 120 days.

Following the technology transfer, the Serum Institute will partner with IGIB to carry out the second and third phases of clinical trials, which will encompass a larger group of participants.

IGIB has reported that a similar treatment was successfully administered to three individuals in Africa while in the United States. Encouraged by these results, Indian scientists opted to replicate the procedure using indigenous technology. It has taken approximately six years for India to establish its own CRISPR platform.

Experts assert that a similar approach to the indigenisation of CRISPR technology could also be realised in the agricultural sector. Presently, the Indian Council of Agricultural Research (ICAR) has been negotiating licensing agreements with foreign companies rather than creating its own indigenous CRISPR systems.