Indian Pharmacopoeia 2026 Launches with 121 New Drug Standards, Boosts Key Therapies

According to the Ministry of Health and Family Welfare, releasing the new edition, Nadda highlighted that the Indian Pharmacopoeia serves as the official book of standards for drugs in the country and is a cornerstone of India's regulatory framework for pharmaceuticals. He stated that the 10th edition reflects scientific advancements, global best practices, and India's growing leadership in pharmaceutical manufacturing and regulation.

He also highlighted that Indian Pharmacopoeia 2026 incorporated 121 new monographs, increasing the total number of monographs to 3,340. He further noted that coverage has been significantly strengthened across key therapeutic categories, including anti-tubercular, anti-diabetic and anti-cancer medicines, as well as iron supplements, thereby ensuring more comprehensive standardisation of medicines used under various National Health Programmes.

Referring to pharmacovigilance, the Union Health Minister stated that, 'In recent years, the Indian Pharmacopoeia standards have also gained international acceptance as it has become a focused agenda under the health diplomacy of the Government of India. He also noted that the Indian Pharmacopoeia is now recognised in 19 countries of the global south.

As per the release, Nadda also highlighted the remarkable progress of the Pharmacovigilance Programme of India (PvPI) under the Indian Pharmacopoeia Commission (IPC). He noted that India, which was ranked 123rd globally in terms of contributions to the World Health Organization's pharmacovigilance database during 2009-2014, has now risen to 8th position worldwide in 2025. Commending the IPC and the PvPI team for this significant achievement, Nadda stated that the strengthened pharmacovigilance ecosystem reflects India's sustained commitment to patient safety, quality assurance, and robust regulatory vigilance.

Highlighting significant regulatory advancements, the Minister underscored the first-time inclusion of 20 blood component monographs pertaining to transfusion medicine in the Indian Pharmacopoeia 2026, in accordance with the provisions of the Drugs and Cosmetics (Second Amendment) Rules, 2020.

In his concluding remarks, Nadda stated that under the visionary leadership of Prime Minister Narendra Modi, the Government of India has consistently worked towards strengthening healthcare systems and regulatory institutions. He said that Indian Pharmacopoeia 2026 is a reflection of this sustained effort and the Government's unwavering focus on quality, transparency, and public welfare.

The Union Minister once again congratulated the Indian Pharmacopoeia Commission and all stakeholders involved in bringing out the tenth edition, expressing confidence that Indian Pharmacopoeia 2026 would further strengthen pharmaceutical quality standards, reinforce India's regulatory framework, and enhance the country's standing in the global pharmaceutical sector.

Speaking at the occasion, Punya Salila Srivastava, Union Health Secretary, stated that the release of the Indian Pharmacopoeia 2026 marks an important step in further strengthening India's pharmaceutical regulatory ecosystem.

Srivastava emphasised that a robust, science-based pharmacopoeia is essential for ensuring the availability of safe, effective, and quality-assured medicines across the country. The Health Secretary noted that the continuous updating and harmonisation of pharmacopoeia standards reflect India's commitment to global best practices, patient safety, and regulatory excellence, while also supporting the country's growing role in the global pharmaceutical supply chain.

The Indian Pharmacopoeia (IP) is published by the Indian Pharmacopoeia Commission (IPC) on behalf of Ministry of Health & Family Welfare, Government of India to fulfil the requirements of the Drugs and Cosmetics Act 1940. IP prescribes the official standards for drugs produced and/or marketed in India and thus contributes in the control and assurance of the quality of the medicines. The standards of the IP are authoritative and legally enforceable. It intends to help in the licensing of manufacturing, inspection and distribution of medicines in our country.

Indian Pharmacopoeia, as a member of the Pharmacopoeial Discussion Group (PDG), is actively collaborating with the European, Japanese, and United States Pharmacopoeias for the harmonisation of monographs and general chapters. The general requirements of the Indian Pharmacopoeia have been aligned with the International Council for Harmonisation (ICH) standards, reinforcing India's commitment to internationally benchmarked pharmaceutical quality norms.

Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India); Harsh Mangla, Joint Secretary, Ministry of Health and Family Welfare and Dr. V. Kalaiselvan, Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission and other top industry experts were also present at the event.

- ANI