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@article{210628,
        author = {Vasudha Ambadas Pargave and Sarika Gunderao Zingade and Nasheer Shaikh and Dr. Padmaja Sidram Giram and Pallavi Rajendra Borphale and Shruti Suresh Pandge and Ankita Pavan Suryawanshi and Pranita Pandurang Nade},
        title = {Regulatory Perspective and Challenges in the Approval of Nanopharmaceuticals: A Comparative Study of India and the US},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {6},
        pages = {1680-1690},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=210628},
        abstract = {Nano pharmaceuticals, which utilise nanoscale carriers, challenge regulatory frameworks intended for conventional drugs. This review contrasts the US FDA's and India's CDSCO's evaluation processes. It references FDA guidance on nanomaterials (April 2022), liposome guidance, and India's 2019 nanopharmaceutical guidelines within its NDCT Rules. The US employs non-binding, product-focused guidance via NDA, 505(b)(2), and ANDA pathways, while India incorporates a specific nano guideline within its existing regulations. Both authorities assess applications on a case-by-case basis, with no formal regulatory definition of nanopharmaceuticals in the US. nanomaterial, whereas the Indian guideline supplies a working definition of a nano pharmaceutical. Shared difficulties are physicochemical characterisation, scale-up, equivalence of follow-on products, immunogenicity and long-term safety. India additionally faces limited implementation capacity, few reference laboratories and a lack of nano-specific pharmacovigilance. Recent updates are reviewed: the FDA final liposome (2018) and nanomaterial (2022) guidance, the FDA platform-technology draft (2024), India's 2019 guideline, and the 2025 EU Innovation Network report. The paper closes with recommendations for harmonisation and capacity building.},
        keywords = {nano pharmaceuticals; nanomedicine; regulatory affairs; US FDA; CDSCO; NDCT Rules 2019; nano similar},
        month = {November},
        }