India has expanded its medicine-safety framework with the launch of the 7th edition of the National Formulary of India (NFI) 2026 and the approval of the Biovigilance Programme of India.
Union Minister of State for Health and Family Welfare Anupriya Patel unveiled the initiatives during the 6th National Pharmacovigilance Week programme organised by the Indian Pharmacopoeia Commission (IPC).
The new biovigilance programme will focus on identifying, assessing and preventing adverse events associated with medicines and biological products used in organ and tissue transplantation. The IPC will lead the monitoring programme, covering products administered to both donors and recipients.
The government has also released a new guidance document for hospitals on reporting adverse events linked to medical devices, along with the ADR-PvPI 2.0 mobile app for iOS users. The NFI 2026 is available in both print and digital formats.
The latest NFI contains 34 chapters, 20 appendices and 653 drugs, including 42 fixed-dose combinations and 30 immunologicals. Its drug monographs have been updated in line with the National List of Essential Medicines and various National Health Programmes.
The formulary is intended to support healthcare professionals in making evidence-based prescribing decisions and promoting the rational and safe use of medicines.
Digital access through NFI Online also provides links to resources covering immunisation schedules, Jan Aushadhi, national health programmes and safe disposal of unused or expired medicines.
India currently has around 1,150 adverse drug reaction reporting centres operating across hospitals and medical colleges. The government plans to extend the reporting network further into primary healthcare.
India’s contribution to the WHO patient safety database has also increased significantly, with the country moving from 123rd position during 2009–2014 to 8th globally, according to the government.
The government is also encouraging greater participation from patients in reporting suspected adverse events through digital platforms, mobile applications and helplines.
“Medicine safety must become everyone’s responsibility. Every single reported event can save a life.”
The government plans to make greater use of artificial intelligence and advanced data analytics to improve the collection and analysis of safety information.
Along with NFI Online and the ADR-PvPI 2.0 app, digital systems such as the Adverse Drug Reaction Monitoring System are being used to make reporting and access to medicine-safety information more efficient.
The new biovigilance initiative adds another layer to India’s existing pharmacovigilance and materiovigilance programmes, creating a broader safety-monitoring framework covering medicines, biological products, medical devices and transplant-related therapies.
The expanded monitoring network and updated prescribing guidance are aimed at strengthening India’s approach to patient safety while supporting safer and more rational use of medicines across the healthcare system.
(Photo courtesy: x.com/AnupriyaSPatel)