India Launches Biovigilance Program to Monitor Transplant-Related Adverse Events

Key facts

• The Indian government launched the Biovigilance Program, led by the Indian Pharmacopoeia Commission (IPC), to monitor adverse events linked to medicines and biological products used in organ and tissue transplantation, including products given to donors and recipients.
• The program was launched by Union Minister of State for Health & Family Welfare and Chemicals & Fertilizers Anupriya Patel at the 6th National Pharmacovigilance Week held at Dr. Ambedkar International Centre in New Delhi.
• India has risen from 123rd position during 2009–2014 to 8th globally in contributions to the WHO patient safety database.
• Around 1,150 Adverse Drug Reaction (ADR) reporting centres are operational across public and private hospitals and medical colleges, with plans to expand to the primary healthcare level.
• The Pharmacovigilance Program of India (PvPI), coordinated by the National Coordination Centre at IPC, collects adverse drug reaction data, while the Materiovigilance Program of India (MvPI) monitors adverse events linked to medical devices.
• Digital initiatives including NFI Online, IP Online, the ADR-PvPI 2.0 Mobile App and the Adverse Drug Reaction Monitoring System (ADRMS) make medicine information and adverse-event reporting more accessible.