RESEARCH ARTICLE ON REGULATORY REQUIREMENTS FOR THE APPROVAL OF DIETARY SUPPLEMENTS UNDER FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA [FSSAI] IN COMPARISON WITH SWEEDEN

Dr. P. Ashok Kumar*, Ullas M. R., Vikas H. N., Sumanth Shettar, Bhavana A. R., Manohari A. S.

ABSTRACT

This project aims to analyse and compare the regulatory requirements related to dietary supplements in pharmaceutical products in India and Sweden. In India, these regulations are governed by the food safety and standards authority of India (FSSAI), whereas in Sweden, they fall under the jurisdiction of the medical Products Agency (MPA), in line with both the national legislation and European Medicines Agency (EMA) directives. The study categorizes the type of pharmaceutical products intended to supplement the normal diet by providing nutrients or other substances that have a nutritional or physiological effect. They are commonly available in forms such as tablets, capsules, powders, liquids, and gummies. The findings may be useful for manufacturers, researchers, and policymakers involved in the dietary supplement industry and may contribute to improving regulatory compliance and international trade. The global dietary supplement market has expanded rapidly, increasing the need for robust regulatory frameworks to ensure product safety, quality, and consumer protection. This study evaluates the regulatory requirements governing dietary supplements in India under the Food Safety and Standards Authority of India (FSSAI) and compares them with the regulatory framework in Sweden. In India, dietary supplements are regulated as health supplements and nutraceuticals under the Food Safety and Standards Act, 2006, and related regulations that specify requirements for product composition, manufacturing practices, licensing, labelling, safety assessment, and health claims. 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.

Keywords: Dietary supplements, FSSAI, India, Sweden, nutraceuticals, food, supplements, regulatory requirements, EU, health claims.