OBJECTIVES: A Periodic Safety Update Report (PSUR) is intended to provide an update of the worldwide safety experience of a medicinal product to competent regulatory authorities at defined time points post-authorization. Drug Controller General of India (DCGI) has taken initiatives for enforcing the submission of PSURs from hospitals throughout the country for drugs launched 2011 onwards. This data would be used to validate the accuracy/bias of the PSURs submitted by pharmaceutical companies. In this study the assessment and validation of the impact of PSUR system implementation and its functioning in the hospital was carried out.  METHODS: Retrospective and prospective observational study for ADR reporting of three commonly prescribed drugs in the hospital for the period of 9 months before and 9 months after the PSUR system implementation in the hospital. RESULTS: Amlodipine, Furosemide and Risperidone are three commonly prescribed drugs in different wards of hospital. A total of 65 ADRs were reported for the period of March-November 2013, in which 10(2%), 40(5.69%) and 15(6.12%) ADRs were reported for Amlodipine, Furosemide and Risperidone respectively. There was a 60% rise in ADR reporting rate observed after implementation of PSUR system in the hospital. 107 ADRs were reported for the period of December-August 2014, out of which 20(4.62%), 62(9%) and 25(10%) ADRs were reported for Amlodipine, Furosemide and Risperidone respectively.  CONCLUSIONS: This study showed that implementation of PSUR system for reporting of ADRs in the hospital works as a great tool for effective pharmacovigilance. PSUR reporting through hospital is a great initiative directed through DCGI, India. By following PSUR practice in a hospital, we can encourage more health care professionals to get involved in ADR reporting program for the safety and wellbeing of mankind.