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Rachel V Thomas

India Launches Biovigilance Program To Strengthen Organ Transplant Safety

Medicine safety must become everyone’s responsibility, the Indian government said today while launching the Biovigilance Program to monitor adverse events linked to organ and tissue transplantation.

Under the program, the Indian Pharmacopoeia Commission (IPC) will lead efforts to strengthen the reporting, assessment, monitoring and prevention of adverse events associated with medicines and biological products used in organ and tissue transplantation, including products administered to donors and recipients.

Together, pharmacovigilance, materiovigilance and biovigilance initiatives will strengthen safety monitoring across medicines, medical devices and transplant procedures.

The program was launched by Union Minister of State for Health &amp; Family Welfare and Chemicals &amp; Fertilizers Anupriya Patel at the 6th National Pharmacovigilance Week organized by the IPC at Dr. Ambedkar International Centre in New Delhi.

Patel also launched initiatives to help healthcare professionals make informed, evidence-based decisions when prescribing and using medicines. These include:

<ul><li>The 7th Edition of the National Formulary of India (NFI), </li><li>The Guidance Document for Hospitals in India for Safety Monitoring and Reporting of Medical Device-Related Adverse Events, </li><li>The ADR-PvPI 2.0 Mobile App for iOS users.</li></ul>

“Rational use of medicines and continuous safety monitoring are integral to public health,” said Patel. She added that “every patient must receive the right medicine, of assured quality, in the right manner and with the highest possible degree of safety”.

“The NFI serves as an important bridge between scientific standards and clinical practice, guiding healthcare professionals in the appropriate and rational use of medicines,” Patel said.

<h2>India’s Pharmacovigilance Network</h2>

Patel emphasized that medicine safety is a continuous responsibility—from the development and manufacture of a drug or medical device to its prescription, dispensing, use and post-market monitoring.

She also highlighted the country’s progress in pharmacovigilance, noting that “India has built a strong indigenous ecosystem capable of generating, collecting, processing and analyzing medicine-safety data from across the country”.

India has moved from the 123rd position during 2009–2014 to 8th globally in contributions to the WHO patient safety database, Patel said.

The Pharmacovigilance Program of India (PvPI), coordinated by the National Coordination Centre at IPC, systematically collects, assesses and analyzes adverse drug reaction information. The Materiovigilance Program of India (MvPI) monitors adverse events associated with medical devices.

Patel said digital initiatives, including NFI Online, IP Online, ADR-PvPI 2.0 Mobile App and the Adverse Drug Reaction Monitoring System (ADRMS), are making medicine-related information and adverse-event reporting more accessible, transparent and responsive.

She called for greater use of emerging technologies, including artificial intelligence and advanced data analytics, to strengthen medicine-safety systems and enable timely generation and use of safety evidence.

The Minister also stressed the need to increase patient participation in adverse-event reporting. She noted that digital platforms, mobile applications and helplines have made reporting easier, and called for addressing the “missing link” of patient reporting.

"Around 1,150 ADR reporting centers are currently operational across public and private hospitals and medical colleges in the country, along with medical-device vigilance facilities. The government plans to expand these capabilities to the primary healthcare level," Patel said.

Referring to the vision of Viksit Bharat 2047, Patel said patient safety must remain a key national priority. She called for India to build on its position as the “pharmacy of the world” and aspire to become a global leader in pharmacovigilance sciences and patient safety.

“Medicine safety must become everyone’s responsibility. Every single reported event can save a life.”

She said collective participation would be critical to building a strong culture of medicine safety and promoting the rational use of medicines.

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Biovigilance Program

Organ Transplant Safety

Anupriya Patel

National Formulary of India

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Medicine safety

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Medicine safety must become everyone’s responsibility, the Indian government said today while launching the Biovigilance Program to monitor adverse events linked to organ and tissue transplantation.Under the program, the Indian Pharmacopoeia Commission (IPC) will lead efforts to strengthen the reporting, assessment, monitoring and prevention of adverse events associated with medicines and biological products used in organ and tissue transplantation, including products administered to donors and recipients.Together, pharmacovigilance, materiovigilance and biovigilance initiatives will strengthen safety monitoring across medicines, medical devices and transplant procedures.The program was launched by Union Minister of State for Health & Family Welfare and Chemicals & Fertilizers Anupriya Patel at the 6th National Pharmacovigilance Week organized by the IPC at Dr. Ambedkar International Centre in New Delhi.New Medicine Safety InitiativesPatel also launched initiatives to help healthcare professionals make informed, evidence-based decisions when prescribing and using medicines. These include:The 7th Edition of the National Formulary of India (NFI), The Guidance Document for Hospitals in India for Safety Monitoring and Reporting of Medical Device-Related Adverse Events, The ADR-PvPI 2.0 Mobile App for iOS users.“Rational use of medicines and continuous safety monitoring are integral to public health,” said Patel. She added that “every patient must receive the right medicine, of assured quality, in the right manner and with the highest possible degree of safety”.“The NFI serves as an important bridge between scientific standards and clinical practice, guiding healthcare professionals in the appropriate and rational use of medicines,” Patel said.India’s Pharmacovigilance NetworkPatel emphasized that medicine safety is a continuous responsibility—from the development and manufacture of a drug or medical device to its prescription, dispensing, use and post-market monitoring.She also highlighted the country’s progress in pharmacovigilance, noting that “India has built a strong indigenous ecosystem capable of generating, collecting, processing and analyzing medicine-safety data from across the country”.India has moved from the 123rd position during 2009–2014 to 8th globally in contributions to the WHO patient safety database, Patel said.The Pharmacovigilance Program of India (PvPI), coordinated by the National Coordination Centre at IPC, systematically collects, assesses and analyzes adverse drug reaction information. The Materiovigilance Program of India (MvPI) monitors adverse events associated with medical devices.AI And Patient ReportingPatel said digital initiatives, including NFI Online, IP Online, ADR-PvPI 2.0 Mobile App and the Adverse Drug Reaction Monitoring System (ADRMS), are making medicine-related information and adverse-event reporting more accessible, transparent and responsive.She called for greater use of emerging technologies, including artificial intelligence and advanced data analytics, to strengthen medicine-safety systems and enable timely generation and use of safety evidence.The Minister also stressed the need to increase patient participation in adverse-event reporting. She noted that digital platforms, mobile applications and helplines have made reporting easier, and called for addressing the “missing link” of patient reporting."Around 1,150 ADR reporting centers are currently operational across public and private hospitals and medical colleges in the country, along with medical-device vigilance facilities. The government plans to expand these capabilities to the primary healthcare level," Patel said.India’s Patient Safety PushReferring to the vision of Viksit Bharat 2047, Patel said patient safety must remain a key national priority. She called for India to build on its position as the “pharmacy of the world” and aspire to become a global leader in pharmacovigilance sciences and patient safety.“Medicine safety must become everyone’s responsibility. Every single reported event can save a life.”She said collective participation would be critical to building a strong culture of medicine safety and promoting the rational use of medicines.

india launches biovigilance program to strengthen organ transplant safety

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