Union Minister for Health and Family Welfare and Chemicals and Fertilizers, Shri Jagat Prakash Nadda, officially released the 10th edition of the Indian Pharmacopoeia (IP 2026) at an event held at the Dr. Ambedkar International Centre, New Delhi. The launch marks a significant update to India’s official compendium of drug quality standards.
The Indian Pharmacopoeia is the authoritative reference that defines the quality, purity, strength and identity of medicines manufactured and marketed in India.
It forms the backbone of the country’s pharmaceutical regulatory framework under the Drugs and Cosmetics Act, 1940, and its standards are legally enforceable for quality control, licensing, inspection, and distribution.
The 2026 edition of the Pharmacopoeia incorporates 121 new monographs, bringing the total number of officially recognised drug monographs to 3,340.
A monograph is a detailed written standard that specifies expectations for a medicine including for its identity, strength, purity, and performance. They also describe the tests to validate that a medicine and its ingredients meet these criteria.
The latest edition expands coverage across key therapeutic categories, including:
Anti-tubercular medicines
Anti-diabetic drugs
Anti-cancer medicines
Iron supplements used in various national health programmes
These additions aim to ensure more comprehensive standardisation for medicines widely used in public health settings.
A notable regulatory milestone in IP 2026 is the first-time inclusion of 20 monographs for blood components used in transfusion medicine, aligning with provisions under the Drugs and Cosmetics (Second Amendment) Rules, 2020. These monographs are expected to support uniform quality standards for blood products, benefiting services like transfusions in surgeries, trauma care, and maternal health.
Shri Nadda noted that the Indian Pharmacopoeia has gained international acceptance and is now recognised in 19 countries of the Global South, reflecting growing global confidence in India’s pharmaceutical standards.
Speaking at the launch, the Union Health Minister highlighted the progress of the Pharmacovigilance Programme of India (PvPI), overseen by the Indian Pharmacopoeia Commission (IPC). India’s contributions to the World Health Organization (WHO) pharmacovigilance database have risen significantly, from 123rd position during 2009–2014 to 8th globally in 2025 reflecting strengthened monitoring of medicine safety and adverse drug reactions.
The Indian Pharmacopoeia plays a central role in safeguarding medicine quality, safety and efficacy for patients across India. By prescribing standards for the identity, purity and strength of drugs, it ensures that medications used in clinical settings and national health programmes meet consistent scientific and regulatory benchmarks.
Published by the Indian Pharmacopoeia Commission (IPC), an autonomous body under the Ministry of Health and Family Welfare, the Pharmacopoeia is updated regularly to reflect scientific advancements and global best practices. The IPC also provides reference substances that laboratories use to verify compliance with pharmacopoeial standards.
(Rh)