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Kiran Kulkarni, Snehal Shetti and Shrikant Magdum


Pharmacovigilance systems are needed to safeguard the public health. The pharmacovigilance study of vaccines means science and activities related to detection, assessment, understanding, prevention and communication of adverse events of vaccines. It is an important part of clinical trials. The vaccines are the immunized preparations containing antigens which are useful against the infectious diseases which act by providing active immunity. There are severe and rare adverse events associated with vaccines. The main aim of vaccine pharmacovigilance is to detect the rare and unexpected side effects of vaccines. The vaccine vigilance is important and needed because the vaccines are administered to the healthy person and children who are sensitive to adverse events occurring after vaccination are less acceptable. The vaccine pharmacovigilance includes different methods of study like ADR reporting, drug event monitoring, cohort studies, case controlled studies and randomized controlled studies. The pharmacovigilance program in India was started with the main aim of improvement of patient safety and welfare in Indian population by effective monitoring of vaccine safety. It also provides training and consultancy support to the pharmacovigilance program. The future aspect of pharmacovigilance in India includes building and maintaining a robust system in India. Also includes education and training to health workers like doctors, nurses, pharmacists regarding the vaccine pharmacovigilance. Key words: pharmacovigilance, India, adverse events, ADR reporting, clinical trials.


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