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The landscape of modern medicine in India is undergoing a paradigm shift with cell and gene therapy (CGT) becoming the game-changer in offering potential cures for life-threatening conditions including genetic disorders, cancers, and rare diseases. The advancements in CGTs have registered standout clinical success as compared to conventional treatment methods. The global market is poised for exceptional growth at a compound annual growth rate of 44%, with sales projected to rise from $ 8.70 billion in 2024 to $ 76.03 billion in 2030. With rapidly advancing biotechnology sector and robust government policies, India is also joining the CGT bandwagon of developed countries like the US, China, Japan, Singapore, Malaysia among others.
Indian CAR-T therapies are available at a fraction of cost compared to similar treatments in developed countries, making advanced gene therapies more affordable and accessible to Indian patients. This cost advantage is a direct result of local research and development, manufacturing, and streamlined commercialisation.
The government is currently on a mission-mode approach to promote CGT in the country. Early this year, the Central Board of Indirect Taxes and Customs has exempted Goods and Service Tax (GST) on gene therapy, making life-saving CAR-T cell therapy, an advanced gene-based treatment, more affordable and accessible for patients with blood cancer. Even in the Union Budget 2025 demonstrated, the government has announced to add 36 life-saving drugs to the list of those fully exempt from basic customs duty and introduce concessional duties for six others for cancer and rare disease. The Central Drugs Standard Control Organization (CDSCO) and the Indian Council of Medical Research (ICMR) have jointly outlined the national guidelines for Gene Therapy Product Development and Clinical Trials in 2019. BIRAC and the department of science & technology support biotech startups through initiatives like the Biotechnology Ignition Grant (BIG), ATGC, and EDGE Centres, providing early-stage funding, mentorship, and industry linkages to strengthen India’s innovation ecosystem.
India faces challenges in scaling up manufacturing infrastructure and technical expertise, especially in advanced vector biology and GMP compliance. Addressing these gaps is critical for expanding access and ensuring quality.
Despite being in the nascent stage, India is making great strides in CGT research and clinical trials. However, accessibility still remains limited due to high treatment costs. To increase patient access and affordability, a multi-pronged financial strategy involving insurance coverage, government subsidies, and risk-sharing models is essential. Most traditional health insurance plans do not cover one-time, high-cost therapies like CGT, as they fall outside standard reimbursement models. Governments can also mandate CGT coverage under public and private health insurance schemes, ensuring that patients suffering from rare diseases and life-threatening conditions receive necessary treatment.
Given the high R&D and production costs associated with CGT, government subsidies can play a crucial role in making these therapies more affordable. Public funding for CGT research and local manufacturing can reduce dependence on costly imports, making treatments more accessible. There is an urgent need for expanding high-quality CGT manufacturing, strengthening local supply chains, and ensuring GMP compliance will improve accessibility and reduce costs. Additionally, subsidised treatment programmes like those in the US and Europe can be introduced in India to support financially disadvantaged patients. The government is already supporting the cell and gene therapy ecosystem through funding and regulatory facilitation, but there is still scope to expand incentives such as tax breaks and targeted R&D grants, to further boost innovation and reduce treatment costs.
India’s journey towards becoming a global leader in CGT requires a national strategy that integrates R&D advancements, infrastructure expansion, regulatory support, and affordability measures. Increased investments from biotech firms, venture capital, and government incentives will accelerate research and innovation. Public-private partnerships (PPPs) and global collaborations will play a crucial role in bringing advanced technologies and expertise to strengthen India’s CGT ecosystem.
To ensure wider accessibility, faster regulatory approvals, dedicated CGT treatment centres, and specialised workforce training programmes are essential. Recent government measures, including GST exemptions and duty cuts on critical medicines, must be complemented with insurance coverage, subsidies, and risk-sharing models to make treatments more affordable. By leveraging technology transfers, domestic manufacturing, and the Make in India initiative, India can position itself as a global CGT hub.
India’s ability to deliver advanced therapies at lower costs and in a resource-constrained setting positions it as a potential global leader of CGT solutions, especially for other low- and middle-income countries.
This article is authored by Amit Mookim, CEO, Immuneel Therapeutics.
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