7th National Formulary of India launched; new Biovigilance Programme approved
On 21 September 2026 the Health Ministry launched the 7th edition of the National Formulary of India, with 653 drugs, and announced that the Government has approved a Biovigilance Programme of India. Under it, the Indian Pharmacopoeia Commission will monitor adverse events linked to medicines and biological products used in organ and tissue transplantation.
- Date
- 21 Sep 2026
- Launched
- 7th National Formulary of India (NFI 2026)
- NFI 2026
- 34 chapters, 20 appendices, 653 drugs
- New programme
- Biovigilance Programme of India
- Lead body
- Indian Pharmacopoeia Commission (IPC)
- ADR centres
- around 1,150
The National Formulary and Biovigilance Programme: what happened?
Medicines can harm as well as heal. A country needs a way to collect reports of side effects and act on them. India has built such a system for drugs and devices. It now adds transplants, and has updated the handbook that guides doctors on safe prescribing.
- The 7th NFI was launched in print and on NFI Online.
- Also launched: a guidance document for hospitals on medical device-related adverse events, and the ADR-PvPI 2.0 mobile app for iOS.
- India moved from 123rd position (2009 to 2014) to 8th globally in contributions to the WHO patient safety database.
- The event marked the 6th National Pharmacovigilance Week, 17 to 23 September 2026.
What is the National Formulary of India?
- A guidance book for doctors and other health workers on rational and safe use of medicines.
- Published by IPC from time to time since 2009.
- NFI 2026 has 653 drugs, including 42 fixed-dose combinations and 30 immunologicals.
- Its drug monographs follow the National List of Essential Medicines (NLEM) and National Health Programmes.
What are the three vigilance programmes?
| Programme | Watches over |
|---|---|
| Pharmacovigilance Programme of India (PvPI) | adverse drug reactions; National Coordination Centre at IPC |
| Materiovigilance Programme of India (MvPI) | adverse events from medical devices |
| Biovigilance Programme of India (new) | medicines and biological products used in organ and tissue transplantation, for donors and recipients |
What do the numbers show?
| Indicator | Figure |
|---|---|
| NFI 2026 drugs | 653 |
| Fixed-dose combinations | 42 |
| Immunologicals | 30 |
| Chapters and appendices | 34 and 20 |
| ADR reporting centres | around 1,150 |
| Rank in WHO patient safety database | 8th (was 123rd in 2009 to 2014) |
| Countries accepting the Indian Pharmacopoeia | around 25 |
How does an adverse event report travel?
- Patient or doctor notices a side effect
- Report through an ADR centre, the ADR-PvPI app or a helpline
- National Coordination Centre at IPC assesses it
- Data goes into India’s database and the WHO patient safety database
- Regulators act on safety signals
Why does the National Formulary and Biovigilance Programme matter?
| Angle | What to note |
|---|---|
| Public health | Safer use of medicines and fewer harmful reactions. |
| Self-reliance | India now produces its own safety evidence instead of relying on others. |
| Global role | Indian Pharmacopoeia accepted by around 25 countries; IPC joined the Pharmacopoeial Discussion Group in 2023. |
| Transplants | Biovigilance closes a gap in organ and tissue transplant safety. |
| Technology | NFI Online, IP Online, ADRMS and the mobile app make reporting easier. |
What are the challenges in the National Formulary and Biovigilance Programme?
- Patients rarely report side effects; the Minister called it the “missing link”.
- ADR centres are mostly in hospitals and medical colleges, not at primary level yet.
- A new transplant programme needs trained staff at every transplant centre.
What should be done next on the National Formulary and Biovigilance Programme?
- Expand ADR reporting to primary health care, as planned.
- Raise patient reporting through apps and helplines.
- Use AI and data analytics to spot safety signals early.
- Get doctors to use the NFI in daily prescribing.
What can Prelims ask on the National Formulary and Biovigilance Programme?
- NFI is published by the Indian Pharmacopoeia Commission (IPC), since 2009.
- NFI 2026: 653 drugs, 34 chapters, 20 appendices.
- PvPI = drugs; MvPI = medical devices; Biovigilance = transplant products.
- India: 8th in contributions to the WHO patient safety database.
- IPC joined the Pharmacopoeial Discussion Group in 2023.
How to write about the National Formulary and Biovigilance Programme in Mains
Practice question (10 marks, 150 words): Pharmacovigilance is central to patient safety. Discuss India’s pharmacovigilance framework and the significance of the new Biovigilance Programme.
- Intro: NFI 2026 and Biovigilance Programme.
- Framework: PvPI, MvPI, Biovigilance; IPC role.
- Progress: 123rd to 8th; 1,150 ADR centres.
- Gaps: patient reporting, primary level.
- Way forward: technology, outreach.
How to use this in Mains
- As per PIB (2026-09-21): the 7th National Formulary of India 2026 was launched; a Biovigilance Programme of India was approved, with the Indian Pharmacopoeia Commission (IPC) to monitor adverse events linked to organ and tissue transplantation.
- Drug safety and pharmacovigilance are GS2 health-governance topics.
Quotable data pointIndia rose from 123rd to 8th in contributions to the WHO patient-safety (ADR) database; about 1,150 ADR reporting centres operate.
PIB: Ministry of Health: 7th National Formulary of India 2026 and Biovigilance Programme, 21 Sep 2026
Exam angle
Prelims: IPC's role; what pharmacovigilance means.
Practice MCQs
Original practice questions (not PYQs).
The National Formulary of India is published by
Answer (c) & explanation
PIB, 21 Sep 2026.
The Biovigilance Programme of India approved in 2026 deals with adverse events linked to
Answer (c) & explanation
PIB, 21 Sep 2026.
Questions students ask about this
What is the National Formulary of India?
A guidance document from the Indian Pharmacopoeia Commission on rational and safe use of medicines; the 2026 edition has 653 drugs.
What is the Biovigilance Programme of India?
A new programme under which IPC will monitor adverse events from medicines and biological products used in organ and tissue transplantation.
What is PvPI?
The Pharmacovigilance Programme of India, which collects and analyses adverse drug reaction reports.
Where does India rank in the WHO patient safety database?
8th globally, up from 123rd in 2009 to 2014.
Keep studying
Go deeper
Official source: PIB: Ministry of Health: 7th National Formulary of India 2026 and Biovigilance Programme, 21 Sep 2026
facts from cited sources only; faculty review pending