Authors : Dr. Ashish Kumar Jaiswal

Volume/Issue : Volume 11 - 2026, Issue 10 - October

Google Scholar : https://tinyurl.com/ms9y2mfv

DOI : https://doi.org/10.38124/ijisrt/26Oct941

Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.

Abstract : The Indian Pharmacopoeia (IP) is India’s principal official compendium of drug quality standards. It plays a central role in ensuring the identity, purity, strength, and quality of pharmaceutical substances and medicinal preparations. The IP is published by the Indian Pharmacopoeia Commission (IPC) under the Ministry of Health and Family Welfare, Government of India. It provides scientifically validated specifications, analytical methods, and quality-control requirements in line with the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945. The development of the IP reflects the progress of pharmaceutical sciences, analytical techniques, regulatory systems, and institutional mechanisms for quality assurance in India. Pharmacopoeial standards offer a common scientific basis for assessing drug quality, ensuring regulatory compliance, and monitoring the quality of medicines after they reach the market. Because the IP has statutory recognition, its standards are also important for regulatory enforcement and for resolving disputes related to drug quality. This paper examines the historical evolution of the Indian Pharmacopoeia. It focuses on the IP’s institutional development, scientific advancements, regulatory importance, and contribution to building a strong national framework for pharmaceutical standardisation and quality assurance.

References :

1. Indian Pharmacopoeia Commission. About IP. Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India. Available from: https://ipc.gov.in/mandates/indian-pharmacopoeia/about-ip.html
2. Indian Pharmacopoeia Commission. History of Pharmacopoeia in India. IP Online, Indian Pharmacopoeia Commission. Available from: https://iponline.ipc.gov.in/jspui/indian-pharmacopoeia/history.jsp[iponline.ipc.gov]
3. Indian Pharmacopoeia Commission. About Us. Ministry of Health and Family Welfare, Government of India. Available from: https://ipc.gov.in/about-us.html
4. Indian Pharmacopoeia Commission. Formation of IPC. Available from: https://www.ipc.gov.in/about-us/about-ipc/formation-of-ipc.html
5. Indian Pharmacopoeia Commission. FAQ: Legal status of the Indian Pharmacopoeia. Available from: https://ipc.gov.in/faq.html
6. Indian Pharmacopoeia Commission. Legal Status of Indian Pharmacopoeia. Guidance document GD-01. Available from: https://ipc.gov.in/images/GD-01-Legal_Status_of_IP.pdf
7. Government of India. The Drugs and Cosmetics Act, 1940. Central Drugs Standard Control Organisation, Ministry of Health and Family Welfare. Available from: https://cdsco.mohfw.gov.in/opencms/resources/UploadCDSCOWeb/2022/acts_and_rules/Drugs%20and%20Cosmetics%20Act,%201940.pdf[cdsco.mohfw.gov]
8. Government of India. The Drugs Rules, 1945. Central Drugs Standard Control Organisation, Ministry of Health and Family Welfare. Available from: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/drug_rules/Drugs%20Rules%201945_2024%2009.09.2024.pdf[cdsco.gov]
9. Indian Pharmacopoeia Commission. Indian Pharmacopoeia 2022: Salient features. Available from: https://www.ipc.gov.in/mandates/indian-pharmacopoeia/indian-pharmacopoeia-2022.html
10. Indian Pharmacopoeia Commission. Indian Pharmacopoeia 2018 and its Addenda. Available from: https://www.ipc.gov.in/mandates/indian-pharmacopoeia/indian-pharmacopoeia-2018-and-its-addenda.html
11. Indian Pharmacopoeia Commission. Introduction to the Indian Pharmacopoeia 2018. Available from: https://www.ipc.gov.in/images/Introduction_IP-2018.pdf
12. Press Information Bureau, Government of India. Union Health Minister releases 10th edition of Indian Pharmacopoeia. 20 November 2025. Available from: https://www.pib.gov.in/PressReleasePage.aspx?PRID=2210754&reg=3&lang=1
13. World Health Organization. Index of pharmacopoeias. Working document QAS/11.453/Rev.18. Geneva: World Health Organization; 2025. Available from: https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/current-projects/index-of-pharmacopoeias_may_2025.pdf
14. Kumar S, et al. Ensuring the quality of medicines in India. Journal of Pharmaceutical Policy and Practice. 2023. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC10641554/
15. The Indian Pharmacopoeia Commission. The Indian Pharmacopoeia Commission. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC11970485/