Actions taken in reporting interval for safety reasons: This section of PSUR shall include a description of significant actions related to safety that have been taken during the reporting interval, related to either investigational uses or marketing experience by the licence holder, sponsor of a clinical investigation, regulatory authorities, data monitoring committee, or Ethics Committee. (c) Changes to reference safety information: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. This section of PSUR shall capture any significant changes to the reference safety information within the reporting interval. Such changes will include information relating to contraindications, warnings, precautions, adverse events, and important findings from ongoing and completed clinical investigations and significant non-clinical findings.