Nanomedicine
Its significance in the Pharmaceutical Sector
Vinoth-Kumar Lakshmanan, 1. Prostate Cancer Biomarker Laboratory, Faculty of Clinical Research, Sri Ramachandra Institute of Higher Education & Research 2. Department of Mechanical, Industrial and Mechatronics Engineering, Faculty of Engineering and Architectural Science, Toronto Metropolitan University
Recent developments in cancer nanomedicine have garnered significant interest from the medical field. Research into nanomedicines, especially in the area of targeted cancer therapies, has significantly increased over the past decade. The possible applications of a specific nanomedicine, Abraxane (paclitaxel), could be expanded to include therapeutic strategies for solid tumors, with the goal of enhancing patient quality of life and increasing survival rates.
The Indian pharmaceutical sector is witnessing remarkable expansion, influenced by several elements including patent expirations, governmental support, and the increasing prevalence of chronic illnesses. It is projected that the industry will attain a valuation of US$ 130 billion by the year 2030 and is acknowledged as the 'Pharmacy of the World'. India accounts for one in five generic medications distributed worldwide and has advanced from seventh position in 2019 to third in terms of global export volume. The total revenue of the industry for FY25 was recorded at Rs. 2,25,000 crore (US$ 26.26 billion), primarily driven by the cardiac, gastrointestinal, and anti-diabetic sectors. The CRDMO (Contract Research, Development, and Manufacturing Organisation) sector is swiftly advancing, offering comprehensive services that merge research, development, and manufacturing for companies in the pharmaceutical and biotechnology fields. The CRDMO sector is projected to grow to Rs. 1,21,282 crore (US$ 14 billion) by 2028, further solidifying India's position in international supply chains.
The recent budget presentation for 2026 by Finance Minister Nirmala Sitharaman, representing the Ministry of Finance, India, has pinpointed key sectors for enhancing manufacturing, including biopharma. For example, the Biopharma SHAKTI initiative is designed to position India as a global hub for biopharma manufacturing, with a budget allocation of Rs 10,000 crores over the next five years. This initiative will prioritise the development of domestic biologics and biosimilars manufacturing, the expansion of pharmaceutical education capacity, and the establishment of a network comprising over 1,000 accredited clinical trial sites. The government's approach is centered on fostering growth through targeted industrial interventions, particularly in sectors such as biopharmaceuticals.
The majority of high-priority cancer medications recognised by Indian oncologists are generic chemotherapy drugs that significantly enhance survival rates and are already part of the WHO Essential Medicines List (EML). However, access to these therapies is hindered by the considerable financial challenges faced by patients. This issue is especially pronounced within the private healthcare sector. There is an urgent need for strategies to guarantee that high-quality cancer treatment is both affordable and accessible to all patients in India [1].
Recent developments in cancer nanomedicine have garnered significant interest within the medical community. Research into nanomedicines, particularly in the realm of targeted cancer therapies, has surged notably over the last ten years. Success stories in the clinical application of nanomedicines include the creation of formulations that achieve optimal loading efficiency in carriers, enhanced release kinetics, and reduced toxicity to healthy cells. Medicines utilising nanoparticles have been engineered to specifically target cancer tissues through the use of aptamers, antibody targeting, and controlled release of nanomedicines in a manner that is dependent on both dosage and time. Nanomedicines have also been designed for therapeutic use in conjunction with real-time image-guided therapy. The potential applications of one such nanomedicine, Abraxane (paclitaxel), may be expanded to include therapeutic interventions for solid cancers, aiming to improve patient quality of life and extend survival rates [2].
The French National Metrology Institute (LNE) has launched a series of events aimed at identifying priorities for test methods and their harmonisation that specifically cater to regulatory requirements in Nanomedicine. One notable workshop, titled "The International Standardisation Roadmap for Nanomedicine," took place in October 2023 in Paris, France. This event gathered leading experts in the characterisation of nanomedicines and medical products that incorporate nanomaterials. The discussions yielded two key takeaways. Firstly, the development of standard test methods and Reference Materials (RMs) for nanomedicines is a crucial priority for the European Commission and its stakeholders. Secondly, there was a collective agreement on the necessity for a cohesive strategy among standardisation committees, regulators, and the nanomedicine sector [3].
Nanotechnology has revolutionised modern medicine, leading to remarkable advancements in diagnostics, therapies, and personalized treatment strategies. Its uses extend from targeted drug delivery to enhanced imaging and regenerative medicine. However, these innovations come with potential risks, necessitating a careful evaluation of their benefits and challenges. The integration of nanotechnology into medicine has significantly improved diagnostic precision, drug bioavailability, and treatment options tailored to specific diseases, particularly in oncology and regenerative medicine. Nanoparticles enable targeted delivery while minimising systemic toxicity and enhancing therapeutic effectiveness. Nevertheless, the very nanoscale properties that facilitate these benefits also raise concerns about biocompatibility, long-term toxicity, and activation of the immune system. Research indicates that nanoparticles may accumulate in vital organs, induce oxidative stress, and pose environmental hazards due to their persistence in biological systems. Moreover, inconsistencies in regulations, high production costs, and public skepticism hinder the broader clinical application of nanomedicine. While nanotechnology presents groundbreaking medical possibilities, its ethical and safe implementation must be carefully managed. Establishing regulated standards, conducting thorough risk assessments, and designing sustainable nanoparticles are essential to mitigate potential harms. By fostering interdisciplinary collaboration and developing global safety protocols, nanotechnology can be harnessed to maximise health benefits while minimising unintended consequences [4].
Current clinical applications of nanomedicine encompass:
- Targeted Drug Delivery: Nanoparticles are employed to deliver drugs directly to cancer cells, reducing systemic toxicity and improving treatment efficacy.
- Imaging Techniques: Nanoparticles are utilised in imaging approaches to visualise biological processes and diagnose diseases.
- Regenerative Medicine: The possibilities of nanomedicine are being explored for regenerative medicine, aiming to repair and regenerate damaged tissues.
- Personalized Therapeutics: Nanoparticles can be engineered to target specific diseases and respond to biological signals, offering customised treatment options.
- Innovative Theranostics: Theranostics combine diagnostics and treatment, using nanoparticles to administer medications and monitor the therapeutic response.
These applications underscore the potential of nanomedicine to revolutionise healthcare, providing more precise and effective treatments for patients. As research advances, nanomedicine is poised to play a vital role in the future of medicine. [4]
Few lists of approved nanomedicine products such as A) Abraxane® (albumin-bound paclitaxel): A notable example of a protein-based nanomedicine that enhances solubility and tumor absorption in cases of metastatic breast cancer. B) Doxil® (liposomal doxorubicin): The first nanodrug to receive FDA approval, utilised for the treatment of ovarian cancer and Kaposi’s sarcoma. Its PEGylated liposome formulation improves circulation duration and minimises cardiotoxic effects. C) Onpattro® (patisiran): A siRNA drug based on lipid nanoparticles, employed in the treatment of hereditary transthyretin-mediated amyloidosis. This drug marks a significant advancement in RNA interference therapy. D) Comirnaty® (Pfizer–BioNTech COVID-19 vaccine): The worldwide success of this mRNA-LNP vaccine has confirmed the effectiveness of nanotechnology in the swift and scalable development of vaccines [5].
To foster growth, India must establish clear regulatory frameworks for nano-pharmaceuticals akin to those of the EMA, FDA, and the French National Metrology Institute (LNE). Developing standard testing methods and Reference Materials (RMs) for nanomedicines is a vital priority for the Indian Commission and its stakeholders. Additionally, there was a shared consensus on the need for a unified approach among standardisation committees, regulators, and the nanomedicine industry. By expanding these initiatives and promoting collaborations between academia and industry, we can expedite innovation. The integration of nanomedicine with existing generic drugs can provide a cost-effective solution.
References:
- Sengar M, Fundytus A, Hopman W, Pramesh CS, Radhakrishnan V, Ganesan P, Mathew A, Lombe D, Jalink M, Gyawali B, Trapani D, Roitberg F, De Vries EGE, Moja L, Ilbawi A, Sullivan R, Booth CM. Cancer Medicines: What Is Essential and Affordable in India? JCO Glob Oncol. 2022 Jul;8:e2200060. Doi: 10.1200/GO.22.00060.
- Lakshmanan VK. Therapeutic efficacy of nanomedicines for prostate cancer: An update. Investig Clin Urol. 2016 Jan;57(1):21-9. Doi: 10.4111/icu.2016.57.1.21.
- Caputo F, Favre G, Borchard G, Calzolai L, Fisicaro P, Frejafon E, Günday-Türeli N, Koltsov D, Minelli C, Nelson BC, Parot J, Prina-Mello A, Zou S, Ouf FX. Toward an international standardisation roadmap for nanomedicine. Drug Deliv Transl Res. 2024 Sep;14(9):2578-2588. Doi: 10.1007/s13346-024-01646-2.
- Fortune, A., Aime, A., Raymond, D. et al. Nanotechnology in medicine: a double-edged sword for health outcomes. Health Nanotechnol 1, 9 (2025). https://doi.org/10.1186/s44301-025-00008-2
- Anup Basnet C. Nanomedicine In 2025: Current Trends and Future Prospects. J Recent Adv Nanomed & Nanotech. 2025; 1(3): 555570.
Vinoth-Kumar Lakshmanan is a Senior Investigator and Professor for Prostate Cancer Biomarker Laboratory, Faculty of Clinical Research at Sri Ramachandra Institute of Higher Education and Research (DU), India and Adjunct Professor of Faculty of Engineering and Architectural Science, Toronto Metropolitan University, Canada. Vinoth has 20+ years’ experience in cancer biology. Scientific H Index 33 achieved with 4500 plus citations. He obtained Ph.D from University of Strasbourg, France, Post Doctoral from University of Regensburg and Karlsruhe Institute of Technology (KIT), Germany.
