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An Insight on the Emerging Regulations for Radiopharmaceuticals by Europe and India

Abstract

Shrutay Mehta*, Dilip Maheshwari

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.

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