Radiopharmaceuticals - regulatory framework and market authorization process in us and india

Radiopharmaceuticals are radioactive sterile and non-sterile drugs that are used to diagnose, monitor, and treat diseases.The exponential rise in use of Radiopharmaceutical in healthcare can be attributed to their twin application as diagnostics and therapeutic agents. They are special group of pharmaceuticals containing a short-lived radionuclide in their final form and are generally administered intravenously. This mandate utmost care coupled with stringent quality and essential safety requirements throughout their production, dispensing, storage and disposal. Further these safety measures are important due to inherent hazardous nature of radionuclide on one side and the associated concern regarding radiation safety for patient as well as staff handling them on the other side. These pertinent safety requirements and unique features associated with the hazardous nature of Radiopharmaceuticals have attributed to increased regulatory controls worldwide and having a complex regulatory market authorization process. Most of the regulatory regimes in the world regulate these drug compounds both under the drug / pharmaceutical regulatory authority as well as atomic nuclear radiation energy regulating authorities. The present article aims at providing insight into current regulatory framework for radiopharmaceuticals in US & India. An attempt has been made to compare the two regulatory models and analyze the impact on regulatory approval pathway with the implementation of India Medical Device Rules 2017.