NEW DELHI: The centre on Monday approved the Biovigilance Programme of India, which will monitor and prevent adverse events linked to medicines and biological products used in organ and tissue transplantation.
The programme, which will be led by the Indian Pharmacopoeia Commission (IPC), will also cover products administered to both organ and tissue donors and recipients.
Launching the programme, Union Minister of State for Health Anupriya Patel, said, “Medicine safety must become everyone’s responsibility. Every single reported event can save a life.”
Announcing the approval at the 6th National Pharmacovigilance Week programme organised by the IPC, an autonomous institution under the ministry, responsible for setting official quality standards for all drugs manufactured, sold, and consumed in India, Patel said the initiative would strengthen India’s capacity to systematically identify and respond to safety concerns associated with transplantation.
Together, the pharmacovigilance, materiovigilance and biovigilance initiatives will strengthen safety monitoring across medicines, medical devices and transplant procedures.
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.
She highlighted the importance of continuous safety monitoring and rational use of medicines.
Noting that 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.
Patel 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 minister 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.
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.
She said the launch of its 7th Edition marks another step towards enabling healthcare professionals to make informed, evidence-based decisions while prescribing and using medicines.
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.
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.”
