Sowmyashree MS

This project aims to analyze and compare the regulatory requirements related to packaging and labeling of pharmaceutical products in India and Sweden. In India, these regulations are governed by the Central Drugs Standard Control Organization (CDSCO), whereas in Sweden, they fall under the jurisdiction of the Medical Products Agency (MPA), in line with the European Medicines Agency (EMA) directives. The study categorizes the types of pharmaceutical products-such as prescription drugs, over-the-counter (OTC) medicines, biological and medical devices-and examines the specific packaging and labeling requirements for each category. It investigates critical elements such as Language requirements, font size, barcoding, serialization, tamper-evidence features, and safety warnings, highlighting the underlying rationale rooted in patient safety and traceability. Through comparative analysis, the project identifies key differences and similarities between Indian and Swedish regulations. While CDSCO emphasizes local language labeling and rigid compliance with the Drugs and Cosmetics Rules, Sweden follows harmonized European Union (EU) standards with multilingual packaging requirements and Centralized Pharmacovigilance practices. This comparative study provides insights for pharmaceutical companies looking to market their products in both regions, guiding them to navigate regulatory expectations efficiently. The project also highlights potential challenges and opportunities in harmonizing global regulatory practices.