India Launches Comprehensive Patient Safety Initiatives including Biovigilance Programme and National Formulary 2026
Union Minister of State for Health & Family Welfare and Chemicals & Fertilizers, Smt. Anupriya Patel, launched multiple patient safety initiatives during the 6th National Pharmacovigilance Week programme organized by the Indian Pharmacopoeia Commission (IPC) at Dr. Ambedkar International Centre, New Delhi on September 21, 2026. The event marked the observance of National Pharmacovigilance Week from 17-23 September 2026 with the theme "Promoting Rational Use of Medicines through Pharmacovigilance: A Step Towards Safer Healthcare."
The most significant announcement was the government approval of the Biovigilance Programme of India, which will be led by IPC to monitor adverse events associated with medicines and biological products used in organ and tissue transplantation, including products administered to donors and recipients. This programme expands India's patient-safety framework to complement the existing Pharmacovigilance Programme of India (PvPI) and Materiovigilance Programme of India (MvPI).
Smt. Patel launched the 7th Edition of the National Formulary of India (NFI) 2026, which comprises 34 chapters, 20 appendices and covers 653 drugs including 42 fixed-dose combinations and 30 immunologicals. The formulary has been revised to align with the National List of Essential Medicines (NLEM) and National Health Programmes, and is available both in print and digitally through NFI Online.
Other digital initiatives launched include the Guidance Document for Hospitals in India for Safety Monitoring and Reporting of Medical Device-Related Adverse Events and the ADR-PvPI 2.0 Mobile App for iOS users. The Minister emphasized the role of digital platforms including IP Online and the Adverse Drug Reaction Monitoring System (ADRMS) in making medicine-related information and adverse-event reporting more accessible.
India has demonstrated remarkable progress in pharmacovigilance, moving from 123rd position during 2009-2014 to 8th globally in contributions to the WHO patient safety database. Currently, approximately 1,150 Adverse Drug Reaction (ADR) Reporting Centres are operational across public and private hospitals and medical colleges nationwide, with plans to expand these capabilities to the primary healthcare level.
The Minister called for greater adoption of emerging technologies including artificial intelligence and advanced data analytics to strengthen medicine-safety systems and enable timely generation of safety evidence. She also stressed the need to increase patient participation in adverse-event reporting through digital platforms, mobile applications and helplines.
Dr. V. Kalaiselvan, Secretary-cum-Scientific Director of IPC, highlighted the role of NFI in promoting rational use of medicines and safer prescribing practices, while Dr. Yvan J.-F. Hutin, WHO Representative to India, emphasized the importance of sustained collaboration among national and international stakeholders for strengthening medicine-safety systems.