Published Paper Details:

India's role as a major producer and global supplier of generic medicines makes the assurance of drug quality a central public health and regulatory priority. The Indian Pharmacopoeia (IP), published by the Indian Pharmacopoeia Commission (IPC), is the official compendium of standards for the identity, strength, purity and performance of drugs and related substances marketed in the country and serves as a legally enforceable benchmark under the Drugs and Cosmetics Act and Rules. Through monographs, general chapters and Indian Pharmacopoeia Reference Substances (IPRS), the IP provides validated analytical methods and acceptance criteria that guide manufacturers, quality control laboratories and regulators in ensuring that medicines are of standard quality and suitable for patient use. Over successive editions, the IP has expanded and modernized to include chemical drugs, traditional medicines, biologicals, vaccines and complex formulations, while aligning with World Health Organization (WHO) good pharmacopoeial practices and participating in international harmonization initiatives such as the Pharmacopoeial Discussion Group. This review outlines the historical evolution, legal status, scientific content and implementation of the IP and critically examines its contribution to detecting substandard and falsified medicines, supporting Good Manufacturing Practices (GMP) and enabling generic interchangeability in India, as well as its growing relevance for international trade and regulatory convergence.