Abstract :
Radiopharmaceuticals are the radioactive substances or radioactive drugs
for diagnostic or therapeutic interventions. The formulation of
radiopharmaceuticals is different from ordinary pharmaceuticals. Many
radiopharmaceuticals are released and administered to patients shortly
after their production because radiopharmaceuticals may decompose
during process and labeling steps due to variation in environmental
conditions, indicating serious stability concerns. So, administrative
prerequisites must be taken for the formulation of the
radiopharmaceuticals. Radiopharmaceuticals production, unlike
conventional pharmaceuticals production, is still raw and processing at a
full fledged speed. Hence, implementing the cGMP guidelines which are
applicable for the drugs industry is both difficult and expensive. The
present article introduces radiopharmaceuticals in an effective and useful
way. Herein, the radiopharmaceuticals are described as a trustworthy aid
for curing the life threatening diseases. It demonstrates a brief
investigation of the guidelines constituted by the regulatory bodies for the
radiopharmaceuticals. It emphasizes on understanding the mandatory
regulations to be taken for the radiopharmaceuticals in various countries.
It includes the regulations framed for radiopharmaceuticals by Europe
and India. The present work provides information on the guidelines used
by Europe and India for the regulation of radiopharmaceuticals by the
special committees. The regulations in Europe are stringent whereas, in
several countries, like India, the regulations are still to get illumination. It
withholds the names of the guidelines in the world to be alluded for the
radiopharmaceuticals and the regulatory bodies responsible for the
regulation.
Keyword :
Radiopharmaceuticals, regulations, Europe and India.