Abstract
Background: Over the past decade, there has been great development arising in the field of Molecular imaging and Nuclear medicine using innovative Radiopharmaceuticals. The Radiotherapy practices are also expanding due to increasing number of Cancer cases and technological advances. Indian market is also emerging as a foremost country to carry out research for a new drug. There is a need for the implementation of strict guidelines to assess the quality, safety, and efficacy of Radiopharmaceuticals.
Discussion: Radiopharmaceuticals have proven its therapeutic potential but it still comes in Schedule K of Drugs & Cosmetic Act 1940 and the rules frames there under. There is a need to provide it a status of the drug. This review aims to highlight the current regulatory challenges faced by Radiopharmaceuticals regarding various issues.
Conclusion: These unique issues intensify the concern for stipulated guidelines for conducting preclinical studies, clinical trials, bioavailability and bioequivalence studies of radiopharmaceuticals. It helps in drafting the uniform regulatory framework with respect to the radiopharmaceuticals which are accepted globally by the investigator.
Keywords: Regulatory affairs, radiopharmaceuticals, clinical trials, bioavailability & bioequivalence study, pre-clinical trials.
Graphical Abstract
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