Nutraceuticals: Regulatory Landscape, Clinical Evidence, Challenges, Nutrivigilance in India

Abstract

Nutraceuticals are the nutrient-dense, physiologically active ingredients that combine the best aspects of diet and medicine to support optimal health and benefits. Nutraceutical product safety, efficacy, and quality requirements are set by regulatory authorities the Central Drugs Standard Control Organization (CDSCO), and the Food Safety and Standards Authority of India (FSSAI). The rapidly expanding nutraceutical market in India is expected to increase, but producing strong clinical data and managing the regulatory environment will be difficult tasks. Clinical evidence supporting health claims for nutraceuticals is still lacking, despite regulatory control, hence thorough clinical trials are required. To guarantee the validity of trial results, issues such as participant compliance, safety concerns, complex study designs, and standardization of dosage must be resolved. Furthermore, the implementation of strong nutrivigilance systems is essential for post-market monitoring and the detection of unfavorable incidents. This review article focuses on the rules, situation, difficulties, safety, and effectiveness aspects of nutraceuticals.