CRISPR-Oriented Theranostics: A Blueprint for Affordable Integration into the Indian Market

Lt Col (Dr) Harshad J Aparajit (Retd)

Abstract: Recent regulatory approvals of the first CRISPR-based therapy (exa-cel/Casgevy) have validated genome editing as a clinical reality. Yet, multi?million?dollar pricing exposes a major access gap for low? and middle?income settings. India carries a high burden of hemoglobinopathies, infectious diseases, and cancers-precisely the domains where CRISPR diagnostics (e.g., SHERLOCK / DETECTR) and therapeutic platforms (ex vivo gene editing, cell therapies) can deliver outsized public?health gains. This manuscript presents a policy?to?practice blueprint for affordable and equitable integration of CRISPR-oriented theranostics in India. Using a structured literature and policy review, the article deconstructs the main cost drivers (autologous ?one patient-one batch? manufacturing, vector/reagent supply, clinical trial and long?term follow?up costs, and complex IP landscapes). It then proposes a four?pillar strategy: (1) agile but rigorous regulation with regulatory sandboxes and fast?track pathways for national?priority indications; (2) indigenous, frugal innovation focused on scalable processes (non?viral delivery, platform manufacturing) and public?private partnerships; (3) innovative financing through Ayushman Bharat, outcome?linked payments, and CSR?supported access programs; and (4) ecosystem building via accredited hubs, cold?chain logistics, ABDM?linked registries, and workforce development. A phased 10?year roadmap is provided to operationalize this strategy and to position India as a global hub for affordable gene therapy and CRISPR diagnostics.

Keywords: CRISPR, theranostics, gene therapy, point?of?care diagnostics, affordability, India, public?private partnership, Ayushman Bharat

How to Cite?: Lt Col (Dr) Harshad J Aparajit (Retd), "CRISPR-Oriented Theranostics: A Blueprint for Affordable Integration into the Indian Market", Volume 15 Issue 3, March 2026, International Journal of Science and Research (IJSR), Pages: 381-385, https://www.ijsr.net/getabstract.php?paperid=SR26305140315, DOI: https://dx.doi.org/10.21275/SR26305140315

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