Indian Journal of Nuclear Medicine
Home | About IJNM | Search | Current Issue | Past Issues | Instructions | Ahead of Print | Online submissionLogin 
Indian Journal of Nuclear Medicine
  Editorial Board | Subscribe | Advertise | Contact
Users Online: 173 Print this page  Email this page Small font size Default font size Increase font size
Year : 2021  |  Volume : 36  |  Issue : 2  |  Page : 153-162

A comparative study of pharmacopoeial quality standards and regulations of radiopharmaceuticals

1 Microbiology Division Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad, Uttar Pradesh, India
2 Department of Global Pharmacovigilance, Sun Pharmaceuticals Pvt. Ltd., Gurugram, Haryana, India
3 Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
4 Saveetha Institute of Medical and Technical Sciences, Chennai, Tamil Nadu, India

Correspondence Address:
Dr. Prasad Thota
Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad, Uttar Pradesh
Login to access the Email id

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijnm.ijnm_222_20

Rights and Permissions

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.

Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)

 Article Access Statistics
    PDF Downloaded99    
    Comments [Add]    

Recommend this journal