Context
On 21 September 2026, the Union Minister of State for Health and Family Welfare launched the 7th Edition of the National Formulary of India (NFI 2026) and announced government approval of the Biovigilance Programme of India.
Both strengthen patient safety, but they perform different functions:
NFI → Rational use of medicines
Biovigilance → Monitoring adverse events linked to transplantation-related products
What Is the National Formulary of India?
The National Formulary of India is an authoritative guidance document that helps healthcare professionals prescribe, dispense and administer medicines safely and rationally.
- It is published by the Indian Pharmacopoeia Commission (IPC).
- The first NFI was published in 1960; IPC has published it periodically since 2009.
- It connects scientific drug standards with clinical practice.
- It supports evidence-based prescribing and implementation of national medicine policies.
What Is New in NFI 2026?
The 7th edition contains:
- 34 chapters;
- 20 appendices;
- 653 drugs;
- 42 fixed-dose combinations;
- 30 immunologicals.
Its drug monographs have been aligned with the National List of Essential Medicines (NLEM) and National Health Programmes.
NFI 2026 also provides digital access to:
- Immunisation schedules;
- Jan Aushadhi information;
- National Health Programmes;
- Guidance on safe disposal of unused or expired medicines.
This alignment is important because it converts national medicine policy into practical prescribing guidance for healthcare professionals.
What Is the Biovigilance Programme of India?
The Biovigilance Programme of India expands India’s patient-safety framework to organ and tissue transplantation.
Under the programme, IPC will support the:
Reporting → Assessment → Monitoring → Prevention
of adverse events associated with medicines and biological products used in transplantation, including those involving donors and recipients.
Why Is Biovigilance Important?
- Expands Patient-Safety Coverage
It extends monitoring beyond conventional medicines and medical devices to transplantation-related biological products and procedures.
- Enables Early Risk Detection
Systematic reporting can help identify recurring adverse events and improve clinical protocols.
- Creates an Integrated Safety Architecture
India now has complementary systems:
- Pharmacovigilance → medicines;
- Materiovigilance → medical devices;
- Biovigilance → transplantation-related biological products and adverse events.
Together, they shift patient safety from one-time product approval to continuous post-use monitoring.
Way Forward
- Improve reporting: Encourage systematic adverse-event reporting from hospitals and transplant centres.
- Integrate databases: Link pharmacovigilance, materiovigilance and biovigilance information.
- Strengthen digital access: Expand use of NFI Online and electronic reporting systems for timely clinical decision-making.
FAQs
Q1. What is the National Formulary of India?
An IPC guidance document promoting the rational and safe use of medicines.
Q2. How many drugs are covered in NFI 2026?
653 drugs, including 42 fixed-dose combinations and 30 immunologicals.
Q3. What is Biovigilance?
Monitoring adverse events linked to medicines and biological products used in organ and tissue transplantation.
Q4. How is pharmacovigilance different from materiovigilance?
Pharmacovigilance focuses on medicines, while materiovigilance focuses on medical devices.
Q5. Which institution is central to both initiatives?
The Indian Pharmacopoeia Commission (IPC).
