A REVIEW ON REGULATORY FRAMEWORK OF RADIOPHARMACEUTICALS IN PHARMACEUTICAL INDUSTRY: CURRENT SCENARIO AND FUTURE ASPECTS

In recent times, the use of radiopharmaceuticals in Medical Imaging and Nuclear medicine has increased. They are a special group of pharmaceuticals with short-shelf life in their final state, and their preparation has been done with utmost care. Due to the inherently hazardous nature of radionuclides on the one hand and the associated concern about radiation safety for patients and staff handling them on the other, this necessitates extreme caution during their manufacture, dispensing, storage and disposal. Therefore there is a need for the implementation of the regulatory guidelines to improvise the quality, safety, and potency of radiopharmaceuticals. This review mainly highlighted the regulatory framework for handling, disposal, and clinical trials of radiopharmaceuticals according to India, Europe Union and USA guidelines. However, in India Cosmetic and Drug act 1940 and rules govern the pharmaceutical industries for the regulatory framework and in Europe and the USA, they follow the EANM and USFDA guidelines. This guideline helps to improvise and remove the barrier for submission to regulatory authorities. The review article is to provide insight into the current regulatory framework surrounding radiopharmaceuticals in major countries around the world, as well as recommendations for delivering high-quality radiopharmaceuticals most cost-effectively.