A comparative study of pharmacopoeial quality standards and regulations of radiopharmaceuticals

Radiopharmaceutical preparations are the important pharmaceutical dosage forms used for the diagnosis and therapeutic purposes. Various pharmacopoeias are having methods for the quality control of these preparations in the form of monographs. Indian Pharmacopoeia (IP) also included these monographs in IP 2014 first time with the help of an experts' group on radiopharmaceutical, drawing expertise from elite stakeholder institutions and the core team of Indian Pharmacopoeia Commission. Since then, these standards are regularly updated through the IP addendum and bringing out new edition of IP. IP is a book of official methods as per Drugs and Cosmetic Act, 1940. These standards can be used in government laboratories, private laboratories, or academia in India and abroad. This review provides an overview of the journey of radiopharmaceuticals' standard setting in IP. A comprehensive comparative information of regulatory perspectives of radiopharmaceuticals in different jurisdictions such as the US, EU, and India is also presented.

Automated summary

The Indian Pharmacopoeia (IP) has included monographs for radiopharmaceutical preparations for the first time in 2014, with standards regularly updated and applicable in various laboratories in India and abroad. This review provides an overview of the journey of setting standards for radiopharmaceuticals in IP, along with a comparative analysis of regulatory perspectives in different jurisdictions.