2 hrs ago
India Approves Biovigilance Programme for Safer Organ Transplant Products
The Indian government approved a new programme to make organ and tissue transplants safer.
It will watch for harmful problems caused by medicines and biological products used during transplants.
The programme will cover both donors and people receiving organs or tissues.
The Indian Pharmacopoeia Commission will lead this work.
It will work alongside programmes that monitor medicines and medical devices.
The government wants doctors, patients and others to report safety problems.
It also plans to use mobile apps, artificial intelligence and data analysis to improve reporting.
Officials said better reporting can help prevent harm and save lives.
The Centre approved the Biovigilance Programme of India to monitor adverse events linked to transplant medicines and biological products.
The Indian Pharmacopoeia Commission will lead monitoring covering products used by organ and tissue donors and recipients.
The programme will complement existing pharmacovigilance and medical-device vigilance initiatives.
India has about 1,150 adverse drug reaction reporting centres across public and private healthcare facilities.
The government also launched the seventh National Formulary of India edition and the ADR-PvPI 2.0 iOS application.
- Who
- The Union Health Ministry, Union Minister of State for Health Anupriya Patel and the Indian Pharmacopoeia Commission are involved.
- What
- The Centre approved the Biovigilance Programme of India to monitor adverse events associated with products used in organ and tissue transplantation.
- Where
- The announcement was made in New Delhi.
- When
- The approval was announced on Monday during the 6th National Pharmacovigilance Week, observed from September 17 to 23.
- Why
- The programme aims to systematically identify, report and respond to safety concerns related to transplant products.
Key facts
- Lead agency
- Indian Pharmacopoeia Commission
- Coverage
- Medicines and biological products used for organ and tissue donors and recipients
- Existing programmes
- Pharmacovigilance Programme of India and Materiovigilance Programme of India
- Reporting centres
- About 1,150 adverse drug reaction reporting centres are operational
- New mobile tool
- ADR-PvPI 2.0 was launched for iOS users
- New reference guide
- The seventh edition of the National Formulary of India was launched
- National theme
- Promoting Rational Use of Medicines through Pharmacovigilance: A Step Towards Safer Healthcare
Quotes
Anupriya Patel
Union Minister of State for Health who announced the programme’s approval
“Medicine safety must become everyone's responsibility. Every single reported event can save a life.”
thehansindia.com






