Abstract

The inclusion of monographs of several radiopharmaceuticals in the Indian Pharmacopoeia has drawn the attention of drug control authorities in the country and other stakeholders. Therefore, in a move towards better regulation of radiopharmaceuticals, the Office of the Drug Controller General of India has issued some important notices concerning their import. However, these notices have resulted in several misgivings among the nuclear medicine community as appointment of patients for nuclear medicine scans had to be cancelled/rescheduled and clinical decisions delayed. An analysis of the sequence of events is presented in this study, highlighting the effects of decisions taken regarding import of radiopharmaceuticals, and suggestions to implement regulations with minimal repercussions.

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