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.