Comparative Study about Requirements of Drug Labeling in the USA and India

The pharmaceutical sector is one of the most highly regulated industries worldwide, and the labelling of medicines is a crucial aspect that ensures patient safety and proper use. Drug labeling falls under the purview of pharmaceutical regulation and ensures that both patients and professionals are adequately informed about the safety, efficacy, and use of a medication. The FDA in the USA and the CDSCO in India are the major regulatory bodies entrusted with ensuring the safety and efficacy of drugs through proper labeling. In the process of enhancing international governance of pharmaceuticals, this review aimed to highlight commonalities, discrepancies, and any potential opportunities for harmonization. The main features of drug labeling laws of the USA and India are summarized in a comprehensive comparative table. The study aimed to determine the need for and importance of pharmaceutical labeling regulations to help protect the customers by including appropriate directions for the use of the drug product in an appropriate location and format