Anupriya Patel Launches 7th National Formulary, Announces Biovigilance Programme

Union Minister of State for Health and Family Welfare and Chemicals and Fertilizers, Anupriya Patel, launched the 7th Edition of the National Formulary of India (NFI) 2026, along with a guidance document for hospitals on safety monitoring and reporting of medical device-related adverse events, and an updated ADR-PvPI 2.0 mobile application for iOS users. The launch took place at the 6th National Pharmacovigilance Week programme organised by the Indian Pharmacopoeia Commission (IPC) at Dr. Ambedkar International Centre, New Delhi. The NFI 2026 has also been made available digitally through NFI Online.

The 6th National Pharmacovigilance Week is being observed from 17 to 23 September 2026 under the theme "Promoting Rational Use of Medicines through Pharmacovigilance: A Step Towards Safer Healthcare." The event brought together senior government officials, regulators, healthcare professionals, academicians, researchers and other stakeholders.

Addressing the gathering, Patel said rational use of medicines and continuous safety monitoring are integral to public health, and that every patient must receive the right medicine of assured quality, in the right manner and with the highest possible degree of safety. She noted that India has built a strong indigenous ecosystem capable of generating, collecting, processing and analysing medicine-safety data from across the country, describing this as an important dimension of Atmanirbhar Bharat in healthcare.

Biovigilance Programme of India approved

In a significant expansion of the country's patient-safety framework, Patel announced that the Biovigilance Programme of India has been approved by the Government of India. Under the programme, the IPC will play a lead role in strengthening the reporting, assessment, monitoring and prevention of adverse events associated with medicines and biological products used in organ and tissue transplantation, including products administered to donors and recipients. Together, the pharmacovigilance, materiovigilance and biovigilance initiatives will strengthen safety monitoring across medicines, medical devices and transplant procedures.

Global standing and digital push

Highlighting India's progress, the Minister said the country has moved from the 123rd position during 2009-2014 to 8th globally in contributions to the WHO patient safety database. She said India's transition from relying primarily on safety information generated elsewhere to producing and contributing its own pharmacovigilance evidence reflects a significant strengthening of national capacity. She also acknowledged the role of the Pharmacovigilance Programme of India (PvPI), coordinated by the National Coordination Centre at IPC, and the Materiovigilance Programme of India (MvPI) in monitoring adverse events associated with medical devices.

Patel said the NFI serves as an important bridge between scientific standards and clinical practice, guiding healthcare professionals in the appropriate and rational use of medicines. She emphasised that medicine safety is a continuous responsibility, from the development and manufacture of a drug or medical device to its prescription, dispensing, use and post-market monitoring. She noted that around 25 countries recognise and accept the Indian Pharmacopoeia, while IPC became a member of the Pharmacopoeial Discussion Group in 2023, strengthening India's role in global regulatory convergence and harmonisation.

Highlighting the role of technology, the Minister said digital initiatives including NFI Online, IP Online, the ADR-PvPI 2.0 Mobile App and the Adverse Drug Reaction Monitoring System (ADRMS) are making medicine-related information and adverse-event reporting more accessible, transparent and responsive. She called for greater adoption of emerging technologies, including artificial intelligence and advanced data analytics, to strengthen medicine-safety systems.

She also stressed the need to increase patient participation in adverse-event reporting, noting that digital platforms, mobile applications and helplines have made reporting easier, and called for addressing the "missing link" of patient reporting. Around 1,150 ADR reporting centres are currently operational across public and private hospitals and medical colleges, along with medical-device vigilance facilities. The Government plans to expand these capabilities to the primary healthcare level.

Referring to the vision of Viksit Bharat 2047, Patel said patient safety must remain a key national priority and called for India to build on its position as the "pharmacy of the world" to become a global leader in pharmacovigilance sciences and patient safety. "Medicine safety must become everyone's responsibility. Every single reported event can save a life," she said.

Dr. V. Kalaiselvan, Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission, highlighted the role of the National Formulary of India in promoting rational use of medicines and safer prescribing practices, and outlined IPC's efforts to expand NFI adoption nationwide and strengthen digitally enabled pharmacovigilance covering medicines, medical devices, blood and blood products and other medical products. Dr. Yvan J.-F. Hutin, WHO Representative to India, underscored the importance of sustained collaboration among national and international stakeholders. Prof. Y. K. Gupta, President, AIIMS Kalyani; Dr. V. M. Katoch, former Director General, ICMR and Secretary, DHR; senior officers from the Ministry of Health and Family Welfare and the Indian Pharmacopoeia Commission; and other stakeholders were also present.