Drafting of comprehensive harmonized regulatory guideline for storage and disposal of radiopharmaceuticals

Recent era has witnessed an inordinate rise in the demand for radiopharmaceuticals due to their multifarious biomedical and clinical application. Scientific fraternity worldwide is continuously working in developing different innovative radiopharmaceuticals of immense clinical importance both from specialized theranostics and personalized medicine point of view. However, this increased production and use of radiopharmaceuticals in various nuclear medicine procedures have been accompanied by an inevitable problem concerning their storage after use and final disposal. Keeping in view the inherently hazardous nature of radiopharmaceuticals due to the presence of radionuclide in them, it is imperative to have an adequate regulatory backup which if followed meticulously can assure their safe storage and disposal so that threat to men and environment is prevented. The present work has been aimed to draft comprehensive regulatory guidelines for the storage and disposal of radiopharmaceuticals which is in resonance with the global standards. For this, the methodology consisting of a thorough research of existing guidelines from Atomic Energy Regulatory Board (AERB) exclusively on storage and disposal of radiopharmaceuticals in India has been done with the objective to identify and select various parameters not yet explicitly covered as is their scope. The guideline has been made to suitably address all sorts of necessary documentation, allocation of responsibility, ways of waste prevention, various mechanisms to deal with radiopharmaceuticals waste in all forms of matter and suggestive recommendations. Keywords: Radiopharmaceuticals, Atomic Energy Regulatory Board, Regulatory guidelines of radiopharmaceutical