Research Journal of Biotechnology

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Review Paper:

Gene Therapy in India: Current Landscape and Future Prospects

Devani Harsh and Khristi Avani

Res. J. Biotech.; Vol. 20(4); 210-214; doi: https://doi.org/10.25303/204rjbt2100214; (2025)

Abstract
Gene therapy has emerged as a revolutionary approach in the field of medicine, offering potential cures for genetic disorders and other diseases. This review provides an overview of the current status of gene therapy in India, highlighting recent advancements and future prospects. The study encompasses key developments, regulatory frameworks and promising clinical trials, shedding light on India's role in the global gene therapy landscape. The regulatory oversight, primarily administered by the Central Drugs Standard Control Organization (CDSCO), plays a crucial role in ensuring the safety and efficacy of gene therapy products. The document explores the challenges and opportunities associated with the import of gene therapy products into India.

Gene therapy is not approved in India yet and only around ten gene therapies are in clinical trials. As research progresses in this exciting field, it is likely that these therapies will become first-line treatments and will have tremendous positive impacts on the lives of patients with genetic disorders.