REGULATORY REQUIREMENTS FOR THE APPROVAL OF NANOPARTICLES IN INDIA AS PER CDSCO COMPARISON WITH AUSTRALIA

Dr. Ashok Kumar P.*, B. Abhishek, Bhoomika S., Nandini M. S., Sneha Shahapure, Brunda N.

ABSTRACT

Any material having at least one dimension between 1 and 100 nanometers is considered a nanoparticle. Numerous applications in the fields of medicine, energy, and the environment are made possible by their special physicochemical characteristics, which include their nanoscale size, high surface area-to-volume ratio, and variable surface chemistry, and materials science. Various synthesis methods, including physical, chemical, and biological approaches, have been developed to produce nanoparticles with controlled size, shape, and functionality. Characterization techniques such as electron microscopy, spectroscopy, and dynamic light scattering provide crucial insights into their structure and stability. In biomedical fields, nanoparticles are employed in drug delivery, imaging, and diagnostics, where their ability to cross biological barriers and provide targeted action enhances therapeutic efficacy while minimizing side effects. Through increased conductivity and catalytic activity, materials based on nanoparticles boost the performance of batteries, fuel cells, and solar cells in energy conversion and storage. Environmental applications include water purification, pollutant degradation, and sensing of hazardous substances. Despite their potential, challenges remain regarding large-scale synthesis, reproducibility, and long-term safety. Environmental persistence, bioaccumulation, and nanoparticle toxicity are issues that underscore the necessity of comprehensive risk assessment and regulatory regimes. Future research aims to design multifunctional, biocompatible, and sustainable nanoparticles that balance performance with safety. Overall, nanoparticles represent a transformative technology with immense potential to address critical global challenges in health, and environment. The continued advancement in nanoparticle research promises to drive innovation and address some of the most pressing challenges in science and technology.[1]

Keywords: Nanomaterial, Nano mission, CDSCO, BIS, Therapeutic Goods Administration (TGA), WHS.