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Review
. 2021 Apr-Jun;36(2):153-162.
doi: 10.4103/ijnm.ijnm_222_20. Epub 2021 Jun 21.

A Comparative Study of Pharmacopoeial Quality Standards and Regulations of Radiopharmaceuticals

Prasad Thota  1 , Anusha Thota  2 , Manoj Kumar Pandey  1 , Phulen Sarma  3 , Bikash Medhi  3 , Rakesh Kumar Sharma  4 , Jai Prakash  1 , Anil Kumar Teotia  1
Affiliations
Review

A Comparative Study of Pharmacopoeial Quality Standards and Regulations of Radiopharmaceuticals

Prasad Thota et al. Indian J Nucl Med. 2021 Apr-Jun.

Abstract

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.

Keywords: Indian Pharmacopoeia; quality control; radiopharmaceutical standards.

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Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Trends of development of drug standards in Indian Pharmacopoeia
Figure 2
Figure 2
Trends of development of radiopharmaceutical standards in Indian Pharmacopoeia
See this image and copyright information in PMC

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