About the Book:

The third edition of the textbook retains the similar style but with expanded contents. It is thoroughly revised and updated. It deals with all aspects ranging from concept to practice of pharmacovigilance. It covers the historical background of evolving pharmacovigilance globally and in India. The outstanding features are:

·         Written in easily understandable style.

·         Updated all chapters including regulation and practice.

·         Case studies on drug withdrawal and causality analysis.

·         Key messages giving the gist of each chapter.

Contents:

1.      Introduction

2.     Pharmacovigilance in India

3.     Methods in Pharmacovigilance

4.     Adverse Drug Reactions: Classification, Mechanisms and Susceptibility

5.     Assessment of Adverse Events’ Reports

6.     Signal: Identification and Strengthening

7.     Quality Assurance in Pharmacovigilance

8.     Periodic Safety Update Reports

9.     Pharmacogenetics in Pharmacovigilance

10.  Ethical Consideration in Pharmacovigilance

11.  Global Scenario in Pharmacovigilance

12.  Pharmacovigilance of Ayurveda, Siddha, Unani and Homeopathic Drugs

13.  Materiovigilance in India

14.  Haemovigilance in India

15.  Pharmacovigilance of Vaccines

16.  Management of ADR [Anaphylaxis]

17.  Communication in Pharmacovigilance (Risk Communication)

18.  Case Studies on Drugs Withdrawal

19.  Case Studies on Causality Assessment

About the Authors:

Guru Prasad Mohanta is Professor and Director at OM Sai Institute of Pharamedical Sciences, Ambadali, Odisha. He is Former Professor and Head of the Department of Pharmacy of Annamalai University.  He has the experience of serving World Health Organization as National Technical Officer in Essential Drugs and Medicines. He has more than 37 years of teaching, research and administrative experience at various levels and is currently associated with FIP as an expert. He was the Coordinator of Peripheral Centre under National Pharmacovigilance Programme supported by World Bank. He has more than 550 articles to his credit. He is a regular columnist for Newspapers and Pharma Magazines. He has authored several popular texts and reference books. He has completed several funded projects. He is associated with several Indian Universities and Institutions either as member of academic bodies or examiners. He is a member of various National and International Professional Bodies. He is recipient of the best researcher award of Annamalai University in 2012; IAPST Pharmaceutical Scientist of the Year 2015 Award; Recipient of Pharmacy Teacher of Eminence Award 2023, Association of Pharmaceutical Teachers of India, Tamil Nadu Branch; and Best Academician Award 2023, Research Journal of Pharmacy and Allied Sciences and Acharya P. C. Ray Gold Medal 2023, IPA Bengal Branch.

Prabal Kumar Manna is Former Professor and Head of Department of Pharmacy at Annamalai University. He has been trained on Pharmaceutical Technology at the University of Ghent, Belgium, with support of BADC Scholarship. He was recipient of the best Teacher Award 2011 of Annamalai University. He has more than 36 years of teaching, research and administrative experience at various levels with over 100 scientific publications to his credit. He has completed several funded projects. He is associated with several Indian Universities and Institutions either as member of academic bodies or examiners. He is a member of various National Professional Bodies. He has coordinated many continuing professional development programmes for pharmacy teachers and professional pharmacists.