Affordable Indigenous Microsphere Cold-Kit for Selective Internal Radiation Therapy: Overcoming Economic Barriers

Targeted radionuclide therapy and precision oncology are transforming modern healthcare.^[1] Particulate radiopharmaceuticals have become powerful tools that can deliver high radiation doses directly to pathological tissues while minimising systemic toxicity, from liver-directed SIRT to radiation synovectomy and localised tumour treatment.^[2,3] Selective internal radiation therapy ( SIRT) is a well-tolerated treatment for hepatocellular carcinoma (HCC). However, despite treatment efficacy and scientific advances in SIRT, access to commercial ⁹⁰Y microspheres remains restricted in many low and middle-income nations (LMIN). High production costs, dependence on sophisticated technology, and intricate supply chains are the main contributing factors.^[4] As a result, these treatments are often concentrated in specialised facilities, leaving many patients doomed. This disparity poses a fundamental question for the future of nuclear medicine: can theragnostic fulfil its clinical promise if access remains confined to a privileged group of society? The answer demands affordable and clinically adaptable scientific innovations. Necessity-driven translational research from academic labs, government organisations and clinician-scientist partnerships is uniquely positioned to bridge the gap between laboratory discovery and affordable patient care.

Cold kits have historically revolutionised nuclear medicine by simplifying radiopharmaceutical preparation, improving accessibility, and enabling decentralised clinical use.^[5,6] The concept of an indigenous-developed cold kit offers various benefits for science and healthcare that go beyond reduced treatment costs. These include compliance with radionuclides locally available or on-site eluted from radionuclide generator; in-house radiolabelling; reduced reliance on global supply chain, and faster clinical translation. In this context, the development of indigenous cold-kit systems for SIRT is particularly compelling. The ready-toradiolabel cold-kit enables quick and facile formulation of theragnostic microspheres labelled with ⁹⁹mTc or ¹⁸⁸Re. The procedure requires only a single catheterisation procedure for lung shunt evaluation, dose calculation and dose delivery. This reduces procedural costs by half, minimises patient discomfort and hospital visits. Single catheterisation also eliminates potential discrepancies in catheter placement between procedures.^[7]

The microsphere cold kits have the potential to serve as an enabling technology for expanding nuclear medical infrastructure in LMIN.^[8] However, patient safety and scientific rigour should never be compromised for cost reduction. Standardised quality control and regulatory compliance remain crucial for ensuring patient trust and broad clinical adoption. The successful clinical translation of indigenous developed formulations requires a thorough assessment of radiolabelling, stability, particle properties, sterility assurance, biodistribution, dosimetry and long-term therapeutic effects.^[7,9]

The regulatory pathway for indigenous drugs and devices in India provides a valuable opportunity for academic innovators. Protection of intellectual property rights (IPR) is an important prerequisite for a successful marketable product. Therefore, before initiating the commercialisation process, the inventor should secure the innovation through the filing of appropriate national and/or international patent applications. The pilot clinical studies may be initiated following Institutional Ethics Committee (IEC) approval, supported by sufficient in vitro and preclinical data.^[8,10] The regulatory approval requires good manufacturing practice (GMP)-compliant manufacturing, essential for obtaining a test license from Central Drugs Standard Control Organisation (CDSCO). A thorough dossier, including information on quality control, stability, shelf-life, repeatability, and safety, is required for the further approval of Phase I/II regulatory clinical trials. Moreover, a commercial license also requires third-party clinical validation. The regulatory process is tedious and demanding, but these strict procedures are necessary to guarantee the safety, repeatability, and effective clinical translation of theragnostic technologies globally. Imported formulations such as ⁹⁰Y-TheraSpheres and ⁹⁰Y-SirSpheres could only be procured through the India Authorised Importer (IAI), which, as a sole registration and license holder under the regulatory framework, possesses the exclusive right to import products registered in its name.

It is very encouraging and greatly appreciated that government initiatives through Department of Atomic Energy (DAE), Indian Council of Medical Research (ICMR), Department of Science and Technology (DST), etc., financially support translational research, clinical studies and indigenous innovations. Med Tech Mission and Patent Mitra provide handholding for translating research products into clinically impactful technologies, regulatory guidance, and logistical support. A collaborative ecosystem involving scientists, clinicians and institutions is essential for fostering self-reliance in healthcare technology and broader societal benefit. Indigenous cold-kit–based microspheres for SIRT align directly with the Government’s ‘Make in India’ and ‘Ayushman Bharat’ initiatives by demonstrating that world-class theragnostic radiopharmaceuticals can be designed, manufactured, and clinically validated within the country. These technologies will reduce dependence on imports and strengthen indigenous capabilities in advanced healthcare technologies. Enabling indigenous-developed cold-kit delivery at regional hospitals may bring quality cancer care within reach of every patient, irrespective of economic, geographic, or social circumstances. Affordable indigenous theragnostic is, therefore, not merely a scientific achievement but a direct contribution to India’s national health mission.