
Drug labeling and packaging in India are governed by a comprehensive regulatory framework primarily rooted in the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. These instruments establish mandatory labeling particulars, cautionary statements, and packaging standards designed to ensure product safety, prevent misbranding, and empower healthcare professionals and patients with essential information. The framework is further supplemented by the Legal Metrology (Packaged Commodities) Rules, 2011, which mandate declarations such as net quantity, MRP, and manufacturer details on the principal display panel; the Consumer Protection Act, 2019, which imposes product liability for defective or misleading labels; and the Drugs (Price Control) Order, 1995, which requires clear display of the maximum retail price. A critical component of regulatory architecture is the system of Schedules under the Rules—including Schedules G, H, H1, H2, J, M, P(I), R, X, and C/C(I)—each imposing specific labeling obligations based on the drug’s risk profile, therapeutic category, and potential for abuse. Recent developments include the mandatory QR code for the top 300 drug brands (Schedule H2), alignment of Good Manufacturing Practices (Schedule M) with WHO standards, and the upcoming excipient disclosure requirement. This regulatory framework aims to combat counterfeiting, ensure traceability, prevent medication errors, and protect public health. Compliance requires meticulous attention to schedule specific requirements, regular audits, and continuous monitoring of amendments
