Buoyed over the successful completion of Genome India Project that has sequenced 10,000 genomes of Indians, the Indian scientists are now intensifying efforts to make Cell and Gene Therapy (CGT) more accessible and affordable, as 70 million people in the country suffer from rare diseases, with 80% of these being genetic in nature.
The genome data build under the project now enables scientists and medicine researchers to make precision drugs, targeting the diseases more accurately, saving on time, cost and quality of patient’s life. Prime Minister Narendra modi hailed project that completed on 9 January 2025 as “historic step” that establishes India’s biotechnological might and opens a door of hope of patients who were turned away from hospitals for want of cure, or if there was, then the cost of one shot of imported drug ran in crores of rupees.
During a high-level meeting of the Prime Minister’s Science, Technology & Innovation Advisory Council (PM-STIAC), experts emphasized the need for a national mission on CGT, regulatory reforms, and greater collaboration between the government, industry, and academia to develop indigenous treatments.
Principal Scientific Adviser Prof. Ajay Kumar Sood, in his opening remarks, highlighted that the rising number of cancer cases and genetic disorders in India makes CGT a critical area for investment. He noted that advancements like the Genome India Project place India in a strong position to lead in personalized medicine and gene-based treatments. Referring to the success of CAR-T cell therapy and gene therapy for Hemophilia, he stressed that India must scale up research and infrastructure to ensure affordable and accessible healthcare. However, this requires an ecosystem that addresses cost, regulatory hurdles, public awareness, and industry participation.
Dr. V.K. Paul, Member (Health) of NITI Aayog, underlined the urgent need to accelerate CGT development. He emphasized that government support, industry engagement, and regulatory streamlining are key to making these therapies more accessible. He pointed out that CGT has shown significant success rates compared to conventional treatments and urged greater investment in research and clinical trials. Dr. Paul also called for the indigenization of CGT technology to reduce dependence on costly international treatments. He stated that through strong collaboration between the government, industry, start-ups, regulators, and academia, CGT treatments can be made affordable for millions.
The meeting featured key presentations from top scientific bodies, including the Department of Biotechnology (DBT), Indian Council of Medical Research (ICMR), and Council of Scientific and Industrial Research (CSIR), which are leading CGT research in India. Notable developments included the presentation by Dr. Rahul Purwar from IIT Bombay, who showcased India’s first indigenous CAR-T therapy, a potential breakthrough in treating blood cancers. Dr. Alok Srivastava from St. John’s Hospital in Bengaluru shared progress on gene therapy for Hemophilia, which could significantly reduce dependency on expensive imported clotting factors.
Several leading biotech firms, including Immuneel Therapeutics, Micro CRISPR, Laurus Labs, and INTAS Pharma, showcased their contributions to CGT. Industry leaders emphasized the need for regulatory reforms to speed up approvals, indigenization of raw materials to lower costs, and stronger infrastructure for clinical trials while developing a skilled workforce.
Dr. Rajeev Raghuvanshi, the Drugs Controller General of India (DCGI), provided an update on India’s CGT regulatory framework, highlighting ongoing reforms to simplify the CGT approval process. He stressed digitization as a way to fast-track clearances and the strengthening of Scientific Expert Committees (SEC) to evaluate therapies more efficiently. PM-STIAC members supported the call for a National CGT Mission, emphasizing that India needs a centralized database to track disease prevalence, research, and resources. Experts proposed the establishment of CGT clinics within government hospitals to improve patient access, offering financial incentives to industry for faster commercialization, and developing Centers of Excellence to lead research and innovation.
Summing up the discussion, Dr. Paul outlined key actions to scale up CGT in India, including technology sharing and transfer from academia to industry, complementary partnerships among key stakeholders, cost-effective analysis to ensure affordability, and securing public and private funding to sustain research. Prof. Sood concluded the meeting by urging a “mission-mode” approach for CGT development. He stressed the need for indigenizing the entire CGT supply chain, streamlining regulations, and creating a centralized dashboard for coordination. The ICMR, in collaboration with DBT and other agencies, has been tasked with preparing a comprehensive roadmap for CGT in India. With the right policies, investment, and industry participation, experts believe India can transform the treatment landscape for cancer, genetic disorders, and rare diseases, making CGT a viable, affordable solution for millions.
