Centre approves biovigilance programme for organ transplants
New Delhi, Sep 21 (PTI) Union Minister of State for Health Anupriya Patel on Monday said the Centre has approved the Biovigilance Programme of India, under which the Indian Pharmacopoeia Commission (IPC) will lead efforts to monitor and prevent adverse events linked to medicines and biological products used in organ and tissue transplantation.
The programme will cover products administered to both organ and tissue donors and recipients.
Announcing the approval at the 6th National Pharmacovigilance Week programme organised by the IPC here, Patel said the initiative would strengthen India's capacity to systematically identify and respond to safety concerns associated with transplantation.
"Medicine safety must become everyone's responsibility. Every single reported event can save a life," she said.
The biovigilance programme will complement the Pharmacovigilance Programme of India (PvPI), which monitors adverse drug reactions, and the Materiovigilance Programme of India (MvPI), which tracks adverse events associated with medical devices.
Together, the three programmes will strengthen safety monitoring across medicines, medical devices and products used in transplant procedures, the minister said.
Patel underscored the importance of continuous safety monitoring and rational use of medicines, saying every patient should receive the right medicine, of assured quality, in the right manner and with the highest possible degree of safety.
She said India has developed an indigenous system for generating, collecting, processing and analysing medicine-safety data from across the country, describing it as an important component of self-reliance in healthcare.
The minister said India has moved from the 123rd position during 2009-2014 to eighth globally in contributions to the WHO patient safety database, reflecting the country's growing contribution to pharmacovigilance.
The 6th National Pharmacovigilance Week is being observed from September 17 to 23 with the theme "Promoting Rational Use of Medicines through Pharmacovigilance: A Step Towards Safer Healthcare".
Patel also launched the seventh edition of the National Formulary of India, a guidance document for hospitals on safety monitoring and reporting of medical device-related adverse events, and the ADR-PvPI 2.0 mobile application for iOS users. The seventh edition of NFI has also been made available digitally through NFI Online.
Around 1,150 adverse drug reaction reporting centres are currently operational across public and private hospitals and medical colleges in the country, besides medical-device vigilance facilities. The government plans to expand such capabilities to the primary healthcare level, she said.
The minister also called for greater use of artificial intelligence and advanced data analytics to strengthen medicine-safety systems and urged increased participation of patients in reporting adverse events.
She said digital platforms, mobile applications and helplines have made reporting easier and called for addressing the "missing link" of patient participation in the process.
Patel said India should build on its position as the "pharmacy of the world" and aspire to become a global leader in pharmacovigilance and patient safety, with collaboration among government institutions, regulators, healthcare professionals, academia, research institutions, industry and patients.
