Union Minister for Health and Family Welfare and Chemicals and Fertilizers, Shri J. P. Nadda, on January 2, 2026, released the Indian Pharmacopoeia 2026 (IP 2026)—the 10th edition of India’s official book of drug standards—at the Dr. Ambedkar International Centre, New Delhi. The release marks a major milestone in India’s efforts to enhance the quality, safety, and efficacy of medicines, while reinforcing the country’s growing leadership in pharmaceutical regulation and manufacturing.
Indian Pharmacopoeia: A Cornerstone of Drug Regulation
Releasing the new edition, Shri Nadda underscored that the Indian Pharmacopoeia serves as the authoritative legal standard for drugs in India and forms the backbone of the country’s pharmaceutical regulatory framework. He noted that IP 2026 reflects scientific advancements, global best practices, and India’s expanding role as a trusted pharmaceutical producer.
Expanded Coverage with 121 New Monographs
A key highlight of Indian Pharmacopoeia 2026 is the inclusion of 121 new monographs, taking the total number of monographs to 3,340. Shri Nadda stated that the expanded coverage significantly strengthens standardisation across critical therapeutic areas, including:
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Anti-tubercular medicines
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Anti-diabetic medicines
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Anti-cancer medicines
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Iron supplements
This expansion ensures greater quality assurance for medicines used under various National Health Programmes.
First-Time Inclusion of Blood Component Monographs
Marking an important regulatory advancement, the Minister highlighted the first-time inclusion of 20 blood component monographs related to transfusion medicine in IP 2026. This step, aligned with the Drugs and Cosmetics (Second Amendment) Rules, 2020, strengthens standards for blood safety and transfusion practices across the country.
Global Recognition and Health Diplomacy
Shri Nadda noted that the Indian Pharmacopoeia has gained international acceptance, becoming a key pillar of India’s health diplomacy. He highlighted that IP standards are now recognised in 19 countries of the Global South, reflecting India’s growing influence in shaping global pharmaceutical quality norms.
India’s Rise in Global Pharmacovigilance
Highlighting India’s progress in patient safety, the Union Health Minister praised the achievements of the Pharmacovigilance Programme of India (PvPI) under the Indian Pharmacopoeia Commission (IPC). He noted that India has risen from 123rd position globally (2009–2014) to 8th position worldwide in 2025 in contributions to the WHO pharmacovigilance database. This milestone underscores India’s strengthened regulatory vigilance and commitment to medicine safety.
Government’s Vision for Quality and Transparency
In his concluding remarks, Shri Nadda stated that under the leadership of Prime Minister Shri Narendra Modi, the Government has consistently focused on strengthening healthcare systems and regulatory institutions. He said Indian Pharmacopoeia 2026 reflects this commitment to quality, transparency, and public welfare, and will further elevate India’s standing in the global pharmaceutical sector.
He congratulated the Indian Pharmacopoeia Commission and all stakeholders involved, expressing confidence that the new edition would enhance pharmaceutical quality standards and regulatory excellence.
Strengthening the Regulatory Ecosystem
Speaking on the occasion, Union Health Secretary Smt. Punya Salila Srivastava said that the release of IP 2026 is a significant step towards strengthening India’s pharmaceutical regulatory ecosystem. She emphasised that a robust, science-based pharmacopoeia is essential for ensuring safe, effective, and quality-assured medicines, while supporting India’s expanding role in the global pharmaceutical supply chain.
About the Indian Pharmacopoeia
The Indian Pharmacopoeia (IP) is published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Ministry of Health & Family Welfare, under the Drugs and Cosmetics Act, 1940. Its standards are legally enforceable and guide drug manufacturing, licensing, inspection, and distribution in India.
As a member of the Pharmacopoeial Discussion Group (PDG), India collaborates with the European, Japanese, and United States Pharmacopoeias to harmonise standards. The IP’s general requirements are aligned with International Council for Harmonisation (ICH) norms, reinforcing India’s commitment to globally benchmarked pharmaceutical quality.
Conclusion
The release of Indian Pharmacopoeia 2026 marks a transformative step in India’s pharmaceutical journey. With expanded drug coverage, strengthened pharmacovigilance, global recognition, and enhanced regulatory standards, the 10th edition reinforces India’s position as a global leader in pharmaceutical quality, safety, and regulatory excellence.
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Source: PIB
