Nutraceutical regulations in India: A comprehensive review Ramdasi Vaishnavi, Lingala Deepthi, Macharam Kaveri, Saxena Trapti, Prasanthi D. G. Pulla Reddy college of Pharmacy, Hyderabad, Telangana, India-500028 Online Published on 29 March, 2024. Abstract The term “nutraceutical” was coined from “nutrition” and “pharmaceutical” in 1989. A nutraceutical is any substance considered as a food or its part which, in addition to its normal nutritional value provides health benefits including the prevention of disease or promotion of health. Due to the adverse effects of drugs, consumers are preferring food supplements to improve health. Nutraceutical demand will grow with increasing risk of diseases is expected to boost product demand over the forecast period. High cost associated with healthcare treatments has resulted in rising consumer interest in nutraceuticals. The Food Safety and Standards Authority of India (FSSAI) has been established, which consolidates various acts and orders that were in existence to handle food related issues in various Ministries and Departments. FSSAI has been created for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption. The regulatory framework of nutraceuticals in India needs attention from the relevant authorities. Globally, the regulatory authorities are aware of changing needs of consumers and proactively protect consumers by amending existing laws to accommodate changes but in India old laws such as Prevention of Food adulteration Act, 1954, which regulates packaged foods, still exist for manufacturers. Top Keywords Nutraceutical, FSSAI, Nutrition and Pharmaceutical, Regulations, Acts and Laws, FSSA (Food Safety and Standards Act). Top |