Catering the Need of Drug Manufacturing Standard in India: An Update to Indian Pharmacopoeia.

Abstract

India is currently among the top 10 pharmaceutical markets by value and is the third largest by volume in 2024; it manufactures more than 65,000 generic drugs across 60 therapeutic segments. Holding a 20% market share of generics, the industry is a key supplier to Africa and the USA and other markets. Following the Drugs and Cosmetics Act of 1940, for the manufacture of drugs in India, there is always legal supervision on the quality of the products being manufactured in the country. The IP, published every ten years by the IPC, which is an autonomous body of the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India, is the official reference for drug standards in India for the purpose of guaranteeing drug quality and effectiveness. The IPC, set up in 1948 under the Ministry of Health and Family Welfare, monitors the publication and changes of the IP in consultation with other agencies. The IPC consists of four major divisions: Governing, Scientific, General, and Executive, which deal with the policy, scientific and academic standards, performance, organizational, and administrative work, respectively. The Indian Pharmacopoeia Laboratory has also proactively adapted or added to its roles in areas of research, writing monographs, and providing the public with drug standards. The monograph development in the IP undergoes an evaluation by the specialist, public comment, and the need to update and align with the current scientific research and internationally recognized guidelines. There are significant changes on average every 4 to 5 years, with supplements and addenda between revisions. This review article focuses on India's position as the world's largest supplier of generic medicines, the mechanisms of drug safety and quality control and the IPC's current and further endeavours to harmonize Indian standards with those of the global world. It also provides information about the position of India in the global market of pharmaceuticals, the large production and export of the Indian generics and vaccines.