India

Pharmacovigilance activities in India are overseen by the Central Drugs Standard Control Organization (CDSCO) in collaboration with the Pharmacovigilance Programme of India (PvPI), coordinated by the Indian Pharmacopoeia Commission (IPC). Under the final Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products, Version 2.0, MAHs should establish a pharmacovigilance system and create and maintain a Pharmacovigilance System Master File (PSMF) at the MAH site. A qualified and trained Pharmacovigilance Officer In-charge (PVOIC) should be appointed; the PVOIC should be a medical or pharmacy professional trained in the collection and analysis of adverse-event reports and should reside in India. MAHs are required to report serious adverse events within 15 calendar days and non-serious adverse events within 90 calendar days to CDSCO and NCC-PvPI/IPC. For new drugs, PSURs are submitted every six months for the first two years after approval and annually for the subsequent two years, with reports due within 30 calendar days after the end of the reporting period; the Central Licensing Authority may extend the reporting period when necessary. Risk Management Plans are addressed where applicable, and MAH pharmacovigilance systems may be subject to routine or targeted regulatory inspections. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.