Two books can sit on the same shelf in the same institution and answer entirely different questions. One tells you whether a tablet contains what the label claims, at the purity it claims. The other tells you whether that tablet is the right thing to give this patient.
On 21 September 2026, Minister of State for Health and Family Welfare Anupriya Patel launched the 7th edition of the National Formulary of India at the 6th National Pharmacovigilance Week, organised by the Indian Pharmacopoeia Commission at the Dr Ambedkar International Centre, New Delhi. In the same address she announced that the government has approved a Biovigilance Programme of India — a third watch over a part of medicine that the existing two did not reach.
Standards and guidance are different jobs
The Indian Pharmacopoeia is a book of standards. For each drug it specifies identity, purity, strength and the analytical methods by which those are to be tested. It is a legal reference: under the Drugs and Cosmetics framework, a drug that fails its pharmacopoeial standard is a substandard drug, and the consequence is regulatory, not advisory. The pharmacopoeia is addressed to manufacturers and to drug testing laboratories.
The National Formulary of India is a book of guidance. It is written for prescribers — doctors, medical students, nurses and pharmacists — and it exists to support rational use: the right medicine, for the right indication, at the right dose, for the right duration. It selects from the very large universe of marketed products a smaller set of therapeutic agents of proven effectiveness, and describes how they should be used.
Neither substitutes for the other. A perfectly manufactured drug prescribed for the wrong condition harms the patient; a correctly chosen drug that fails its purity standard does the same. India's answer is to put both functions in one institution — the IPC at Ghaziabad publishes the pharmacopoeia and the formulary alike — while keeping the two documents distinct in purpose.
Seven editions in 66 years
The NFI's publication record is itself informative. The first edition appeared in 1960, the second in 1966, the third in 1979. Then nothing for over three decades. The fourth edition came only in 2011, followed by 2016, 2021 and now 2026.
The thirty-two-year gap between 1979 and 2011 is the part worth noticing. Those were precisely the decades in which Indian pharmaceutical manufacturing scaled into a global industry. The standards function kept pace; the guidance function did not. What restored it was an administrative decision — a Ministry of Health and Family Welfare notification of 8 May 2008 assigning the NFI to the IPC with instructions to publish it on a regular basis. Since then the cycle has held at roughly five years.
NFI 2026 contains 34 chapters, 20 appendices and 653 drugs, including 42 fixed-dose combinations and 30 immunologicals. Monographs have been revised to align with the National List of Essential Medicines and with National Health Programmes, and the edition is available digitally through NFI Online alongside the print volume.
The forty-two fixed-dose combinations deserve a sentence of their own. An FDC is two or more active ingredients in a single dosage form. Some are genuinely valuable — they improve adherence, which matters enormously in tuberculosis and HIV treatment, where a patient taking four separate tablets is more likely to miss one. Others combine ingredients with no rational basis for being together, and India's regulators have spent years acting against such products. A formulary that names which combinations are appropriate is doing something a pharmacopoeia structurally cannot: a pharmacopoeia can certify that an irrational combination was manufactured to specification, but it cannot say the combination should not exist.
Three vigilance programmes, three different risks
India now runs three post-market safety systems, and the distinctions between them are clean enough to be worth memorising as a set.
Pharmacovigilance covers medicines. The Pharmacovigilance Programme of India was initiated in July 2010 by the Central Drugs Standard Control Organisation, initially with AIIMS New Delhi as the National Coordination Centre, a role that now sits with the IPC. It collects, assesses and analyses adverse drug reaction reports.
Materiovigilance covers medical devices. The Materiovigilance Programme of India was approved on 6 July 2015. A device fails differently from a drug — through mechanical failure, material degradation, software error or use error — so it needs its own reporting categories and its own analysis. Alongside the formulary, the Minister also launched a Guidance Document for Hospitals on safety monitoring and reporting of medical device-related adverse events.
Biovigilance is the new one. Under the programme approved this year, the IPC will lead the reporting, assessment, monitoring and prevention of adverse events associated with medicines and biological products used in organ and tissue transplantation, covering products administered to donors as well as recipients.
Why transplantation needs a separate watch is worth understanding rather than assuming. The risk set is genuinely different. A transplant patient faces the hazards of the graft itself — disease transmission from donor to recipient, graft failure, rejection — and, on top of that, a lifetime of immunosuppressant medication whose entire purpose is to weaken a defence system. The interactions between the biological product, the immunosuppressive regimen and the patient are not the interactions that an ordinary ADR form was designed to capture. Extending the vigilance net to donors is the other significant feature: a donor is not a patient being treated for a disease, and safety monitoring for a healthy person who has undergone a procedure for someone else's benefit is its own category of obligation.
Taken together the three cover medicines, devices and transplantation — and the naming convention is the memory aid: pharmaco- for drugs, materio- for materials, bio- for biological products.
What the numbers do and do not show
The government's stated figures are striking. India has moved from 123rd position during 2009–2014 to 8th globally in contributions to the WHO patient safety database — the global repository of individual case safety reports to which national programmes submit. Around 1,150 adverse drug reaction reporting centres now operate across public and private hospitals and medical colleges, with plans to extend the network to the primary healthcare level. Roughly 25 countries recognise or accept the Indian Pharmacopoeia, and the IPC became a member of the Pharmacopoeial Discussion Group in 2023, the forum in which the major pharmacopoeias work towards harmonised standards.
A rise in reports is not the same as a rise in adverse events, and this is the single most misread statistic in the field. Spontaneous reporting systems measure what gets reported. A country moving from 123rd to 8th has not become a more dangerous place to take medicine; it has built the capacity to notice and record what was previously happening unobserved. More reports from a maturing system is the intended outcome, not a warning sign.
The Minister named the remaining weakness directly, calling patient reporting the "missing link". Every spontaneous-reporting system in the world under-reports, because it depends on a busy clinician recognising a reaction, attributing it to a drug, and taking the time to file. Patients experience adverse effects that never reach a clinician at all. This is why the ADR-PvPI 2.0 mobile app, launched for iOS users at the same event alongside the existing Adverse Drug Reaction Monitoring System, matters more than an app launch usually would — the design objective is to move reporting from the institution to the person.
The Minister also framed the ambition in a phrase worth holding: India should build on its position as the "pharmacy of the world" to become a leader in patient safety science. The domestic standards capacity behind that claim is the subject of our explainer on how India sets its biosimilar reference standards, and the regulatory reasoning in our piece on the stem cell therapy advisory covers the same tension between promise and proof.
Present at the launch were Dr V. Kalaiselvan, Secretary-cum-Scientific Director of the IPC, and Dr Yvan J.-F. Hutin, WHO Representative to India.
The same architecture, built twice
Three days before the formulary launch, on 18 September 2026, a first meeting took place at Ghaziabad that is the exact structural counterpart of it.
The Sowa-Rigpa Working Group, constituted under the Pharmacopoeia Commission for Indian Medicine and Homoeopathy, met to begin developing pharmacopoeias and formularies for Sowa-Rigpa — the same two documents, for a different system of medicine. It was chaired by Dr Kousthubha Upadhyaya, Director of PCIM&H, with four experts including Dr Padma Gurmet, Director of the National Institute of Sowa-Rigpa, Leh. The work will proceed within the Drugs and Cosmetics Act, 1940 and the rules under it.
Sowa-Rigpa is the traditional medical system of the Himalayan belt, practised in Ladakh, Himachal Pradesh, Sikkim, Arunachal Pradesh and Darjeeling. It entered the statutory definition of Indian medicine through the Indian Medicine Central Council (Amendment) Act, 2010, and the National Institute at Leh was approved by the Union Cabinet in November 2019, beginning work in 2020.
PCIM&H is a subordinate office under the Ministry of AYUSH. Its remit mirrors the IPC's precisely: it develops pharmacopoeias and formularies, and it functions as the Central Drug Testing-cum-Appellate Laboratory for Indian systems of medicine and homoeopathy. Two commissions, both at Ghaziabad, doing the same two jobs for two bodies of medicine.
That symmetry is the most useful thing to carry away from the day. A system of medicine becomes regulable when its preparations have written standards and its practitioners have written guidance. Statutory recognition in 2010 made Sowa-Rigpa an Indian medical system in law. The pharmacopoeia and formulary now being drafted are what will make that recognition operational — the same instruments, sixty-six years after the first National Formulary of India, applied to a system that has been practised in the Himalaya for far longer than either book has existed.
🔑 Revision block
- Launched 21 September 2026: 7th edition of the National Formulary of India, by MoS Health Anupriya Patel
- Also launched: Guidance Document for Hospitals on medical device adverse events; ADR-PvPI 2.0 mobile app for iOS
- Occasion: 6th National Pharmacovigilance Week, 17–23 September 2026, organised by IPC
- NFI 2026 contents: 34 chapters, 20 appendices, 653 drugs, including 42 fixed-dose combinations and 30 immunologicals; aligned with NLEM
- NFI editions: 1960, 1966, 1979, 2011, 2016, 2021, 2026 — note the 32-year gap
- IPC given NFI responsibility: MoHFW notification of 8 May 2008
- Pharmacopoeia vs formulary: standards for quality and testing vs guidance on rational selection and use
- PvPI: pharmacovigilance for medicines, initiated July 2010 by CDSCO; NCC now at IPC
- MvPI: materiovigilance for medical devices, approved 6 July 2015
- Biovigilance Programme of India: approved 2026; IPC to lead; adverse events in organ and tissue transplantation, covering donors and recipients
- WHO patient safety database: India from 123rd (2009–2014) to 8th globally
- ADR reporting centres: about 1,150; to be extended to primary healthcare level
- Indian Pharmacopoeia: recognised or accepted by about 25 countries; IPC joined the Pharmacopoeial Discussion Group in 2023
- PCIM&H: under Ministry of AYUSH; publishes pharmacopoeias and formularies for Indian systems; Central Drug Testing-cum-Appellate Laboratory
- Sowa-Rigpa: Himalayan system — Ladakh, Himachal, Sikkim, Arunachal, Darjeeling; statutory recognition via IMCC (Amendment) Act, 2010; National Institute at Leh approved November 2019
- Sowa-Rigpa Working Group: first meeting 18 September 2026 at PCIM&H, Ghaziabad
🎯 Practice MCQs
Q1. The National Formulary of India is published by: (a) Indian Pharmacopoeia Commission (b) Central Drugs Standard Control Organisation (c) Indian Council of Medical Research (d) National Medical Commission
→ (a) — at Ghaziabad, which also publishes the Indian Pharmacopoeia.
Q2. The essential difference between a pharmacopoeia and a formulary is that: (a) A pharmacopoeia covers Indian drugs and a formulary covers imported ones (b) A pharmacopoeia sets quality standards while a formulary guides selection and use (c) A formulary is legally binding and a pharmacopoeia is advisory (d) There is no difference in practice
→ (b)
Q3. The 7th edition of the NFI contains how many drugs? (a) 342 (b) 500 (c) 653 (d) 1,024
→ (c) — including 42 fixed-dose combinations and 30 immunologicals.
Q4. The Materiovigilance Programme of India monitors adverse events associated with: (a) Medicines (b) Organ transplantation (c) Vaccines only (d) Medical devices
→ (d) — approved on 6 July 2015.
Q5. The Biovigilance Programme of India covers: (a) Biological pest control agents (b) Adverse events linked to medicines and biological products in organ and tissue transplantation (c) Biodiversity monitoring (d) Biosafety in laboratories
→ (b) — including products administered to donors as well as recipients.
Q6. A rise in adverse drug reaction reports from a country most likely indicates: (a) That its reporting and detection capacity has improved (b) That its medicines have become less safe (c) That prescribing has increased proportionally (d) That manufacturing standards have fallen
→ (a) — spontaneous reporting systems measure what is reported, not what occurs.
Q7. Sowa-Rigpa received statutory recognition as an Indian system of medicine through: (a) The Drugs and Cosmetics Act, 1940 (b) The AYUSH Ministry's formation in 2014 (c) The National Medical Commission Act, 2019 (d) The Indian Medicine Central Council (Amendment) Act, 2010
→ (d)
Q8. The National Institute of Sowa-Rigpa is located at: (a) Dharamshala (b) Gangtok (c) Leh (d) Ghaziabad
→ (c) — approved by the Union Cabinet in November 2019.
Q9. PCIM&H functions as the Central Drug Testing-cum-Appellate Laboratory for: (a) Indian systems of medicine and homoeopathy (b) All drugs marketed in India (c) Veterinary medicines (d) Imported medicines only
→ (a) — it is a subordinate office under the Ministry of AYUSH.
Q10. Consider the following statements about fixed-dose combinations: 1. They can improve patient adherence in conditions requiring multiple medicines. 2. A pharmacopoeial standard can certify a combination's quality without addressing whether the combination is therapeutically rational. Which is/are correct? (a) 1 only (b) 2 only (c) Both 1 and 2 (d) Neither 1 nor 2
→ (c) — which is precisely the gap a formulary fills.
📋 How this gets asked (PYQ pattern)
Health and pharmaceutical regulation is a growing area in the CDS and OTA general knowledge section, and it rewards institutional precision more than most topics.
The body question is the commonest form: which organisation does what. IPC publishes the Indian Pharmacopoeia and the National Formulary of India; CDSCO is the central drug regulator; NPPA fixes prices; PCIM&H does the pharmacopoeial work for Indian systems of medicine. Candidates lose marks by merging IPC and CDSCO, which sit at different points in the same system — one writes the standard, the other enforces the law.
The programme question asks which vigilance programme covers what. Three programmes, three domains, and the prefixes give the answer away once the set is learnt together.
The definitional question — what is a formulary, what is a pharmacopoeia, what is an essential medicines list — appears in both objective and descriptive papers. These are not synonyms, and a question testing the distinction cannot be bluffed.
The AYUSH question asks which systems come under the Ministry. Sowa-Rigpa is the one candidates most often miss, and its 2010 statutory route is the specific detail that distinguishes a prepared answer.
For the descriptive paper, a useful frame is that regulating medicine requires three separate capacities — setting standards, guiding use, and watching what happens afterwards — and that India has built institutions for each. An answer that names the three functions and attaches an institution and a date to each is stronger than one that lists schemes.
Preparing for CDS or OTA? Science and health questions reward learning institutions in sets rather than one at a time. Build the base with our CDS/OTA general studies notes, follow the daily CDS/OTA current affairs, and prepare with our faculty in the upcoming Cavalier courses in Delhi.
✍️ Written by The Cavalier — Science & technology desk at The Cavalier. Reviewed by the Cavalier Faculty Desk.