Nutraceuticals
Submitted by
Ishika P Patel
Master of pharmacy (Regulatory Affairs) 1 St year
, Sr.no Contents
1 Introduction
2 Regulatory Requirement
3 Documentation
4 Approval Procedure
5 Reference
Nutraceuticals are natural products from food or non-food sources, providing health benefits and aiding in disease prevention and treatment. Originating in 1989, the term combines "nutrition" and "pharmaceutical". In India, they are classified as "Foods for Special Dietary Uses" and regulated by the Food Safety and Standards Authority of India (FSSAI). The regulatory process involves product evaluation, obtaining various licenses (import, manufacturing, marketing), and adhering to specific health and label claims. Approval requires submitting comprehensive documentation, including forms and detailed product and manufacturing information.
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