How to Cite: Brahmbhatt, S., & Rajput, M. (2022). Pharmacovigilance: Significance and challenges. International Journal of Health Sciences, 6(S5), 5860–5863. https://doi.org/10.53730/ijhs.v6nS5.11201 International Journal of Health Sciences ISSN 2550-6978 E-ISSN 2550-696X © 2022. Manuscript submitted: 27 Feb 2022, Manuscript revised: 9 April 2022, Accepted for publication: 18 June 2022 5860 Pharmacovigilance: Significance and challenges Dr. Shruti Brahmbhatt Department of Pharmacology, Smt. B K Shah Medical Institute & Research Centre, Sumandeep Vidyapeeth deemed to be University, Piparia, Vadodara Gujarat, India Corresponding author email: dr.shruti1988@gmail.com Dr. Mahavirsingh Rajput Department of Physiology, Smt. B K Shah Medical Institute & Research Centre, Sumandeep Vidyapeeth, Piparia, Vadodara. Abstract---The World Health Organization (WHO) defines Pharmacovigilance as the science & activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug related problem. The National Pharmacovigilance Programme (NPVP) was launched in 2004 with World Bank funding till 2009, which was renamed as Pharmacovigilance Programme of India (PvPI). With advancement in the field of science and technology, India is emerging as a hub for clinical trials and new drug development, which challenges the monitoring of safety concerns in the use of new drugs. It has been difficult to identify or track the adverse drug reactions (ADRs) that occur in the patients due to polypharmacy, use of over the counter (OTC) preparations, change in physician etc. Hence the national programme has gained importance in our country off late. Yet it is observed that the importance of this programme is not realized by all health care professionals. Therefore, to support & strengthen the national programme which aims to identify, report & analyze the identified ADRs, it would be essential to sensitize the health care professionals through various means & faculty development programmes. Keywords---Adverse Drug Reaction, CDSCO, National Pharmacovigilance Programme, OTC, Pharmacovigilance programme of India, WHO. 1. Introduction As defined by WHO, Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.[1] Pharmacovigilance is an important discipline, which deals with adverse drug reactions. Role of pharmacovigilance in