Comparative Study of Pharmacovigilance System in India, UK and USA

The pharmacovigilance was coined by the World Health Organization. Pharmacovigilance is useful in human needs like Humanitarian concern, Medicines are supposed to save lives. The aim of this study is to comparative study of analysis of pharmacovigilance in between (India, UK and USA). This will enable integration of good pharmacovigilance practice in the processes and procedures to help ensure regulatory compliance and enhance clinical trial safety and post marketing surveillance that contribute to the assessment of benefit, harm, effectiveness, and risk of medicines, encouraging their safe, rational, and more effective use. Also, this will promote understanding, education and clinical training in pharmacovigilance and its effective communication to health professionals and the public. There are various regulating authorities present like Regulating Authorities Central Drug Standard Control Organization-CDSCO for India and US-Food and Drug Administration-USFDA for US, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use etc. that help for developing, enhancing and monitoring Pharmacovigilance system. India has started five phased Pharmacovigilance programme of India which is in collaboration with WHO-UMC in India Pharmacovigilance system is still in its infancy. It only provides facility for reporting adverse reaction caused by drugs. This will help to build up large ADRs database. Pharmacovigilance regulations of USA are well developed and stricter. They have two separate ADR reporting for applicant for reporting of Adverse Drug Reactions. Pharmacovigilance system will help country to maintain the ADRs data which will be stored in one database and help to prevent and monitor further ADRs incidence