India Approves Biovigilance Programme to Track Safety of Transplant Medicines and Biologicals
核心洞察
India's Central government approved the Biovigilance Programme of India, led by the Indian Pharmacopoeia Commission (搜索), to monitor adverse events tied to transplant medicines and biological products.
The programme covers products given to both organ and tissue donors and recipients, complementing existing pharmacovigilance and materiovigilance monitoring efforts.
Officials also launched the 7th Edition of the National Formulary of India, the ADR-PvPI 2.0 mobile app for iOS, and hospital guidance on medical device adverse events.
India's Central government has approved the Biovigilance Programme of India, a national initiative to monitor and prevent adverse events associated with medicines and biological products used in organ and tissue transplantation. The programme will be led by the Indian Pharmacopoeia Commission (搜索) (IPC), an autonomous institution under the Ministry of Health and Family Welfare responsible for setting official quality standards for drugs manufactured, sold and consumed in India.
The approval was announced by Union Minister of State for Health and Family Welfare Anupriya Patel at the 6th National Pharmacovigilance Week programme organised by the IPC in New Delhi. The week is being observed from 17 to 23 September 2026 and brought together senior government officials, regulators, healthcare professionals, academicians and researchers.
Scope of the transplant safety programme
The biovigilance programme will cover products administered to both organ and tissue donors and recipients, extending safety surveillance to a population that sits outside conventional adverse drug reaction reporting. According to the Ministry of Health and Family Welfare, the IPC will strengthen the reporting, assessment, monitoring and prevention of adverse events linked to these products.
The initiative complements two existing national systems: 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 are intended to strengthen safety monitoring across medicines, medical devices and transplant procedures.
"Medicine safety must become everyone's responsibility. Every single reported event can save a life," Patel said at the launch.
Formulary, app and device guidance released
Alongside the biovigilance approval, the government launched the 7th Edition of the National Formulary of India (NFI), which has been made available digitally through NFI Online. The formulary sets out prescribing information intended to support rational use of medicines.
Patel also unveiled the ADR-PvPI 2.0 Mobile App for iOS users, an update to the existing adverse drug reaction reporting tool, and released a guidance document for hospitals in India on safety monitoring and reporting of medical device-related adverse events.
The minister pointed to a broader set of digital tools, including NFI Online, IP Online, the ADR-PvPI 2.0 app and the Adverse Drug Reaction Monitoring System (ADRMS), as mechanisms making medicine-related information and adverse-event reporting more accessible, transparent and responsive.
Reporting infrastructure and global contribution
Around 1,150 adverse drug reaction reporting centres are currently operational across public and private hospitals and medical colleges in the country, in addition to medical device vigilance facilities. Patel said the government plans to expand these capabilities to the primary healthcare level.
She also cited India's movement from 123rd position during 2009-2014 to 8th globally in contributions to the WHO patient safety database. According to the minister, the shift from relying primarily on safety information generated elsewhere to producing and contributing national pharmacovigilance evidence reflects a strengthening of domestic capacity, which she described as an important dimension of self-reliance in healthcare.
Patel emphasised that rational use of medicines and continuous safety monitoring are integral to public health, and that every patient should receive the right medicine, of assured quality, in the right manner and with the highest possible degree of safety.