Volume : 13, Issue : 05, May – 2026

Title:

SAFETY AND EFFICACY REQUIREMENTS FOR AYURVEDIC BASED NUTRACEUTICALS IN INDIA

Authors :

Neha D. Sawade*, Dr. Shilpa Gawande, Dr. A. Chandewar

Abstract :

Nutraceuticals are products derived from food sources that provide additional health benefits beyond basic nutritional value. These benefits may include improving physiological functions, enhancing immunity, delaying the onset of chronic diseases, and promoting overall wellness. These products are formulated using herbal ingredients that have been traditionally used for health promotion and are now supported by scientific research. Ayurvedic-based nutraceuticals represent a rapidly expanding segment of the global health and wellness industry. These products, derived from traditional Ayurvedic herbs and formulated to provide health benefits beyond basic nutrition, are increasingly preferred due to their natural origin, perceived safety, and role in preventive healthcare. The combination of traditional Ayurvedic wisdom with contemporary scientific methods signifies a distinct advantage of the Indian system. Nonetheless, inconsistencies in herbal raw materials and the scarcity of high-quality clinical studies present obstacles to reliable efficacy assessment.
Keywords: Nutraceuticals, Polyherbal Formulations, Marketed Nutraceuticals, safety, GLP, GMP, Ayurveda etc.

Cite This Article:

Please cite this article in press Neha D. Sawade et al., Safety And Efficacy Requirements For Ayurvedic Based Nutraceuticals In India.., Indo Am. J. P. Sci, 2026; 13(05).

REFERENCES:

1. Food safety and standards authority of india(FSSAI) .Food safety and standards ( health supplements, nutraceuticals, food for special dietary use, food for special medical puepose, functional foods and novel foods) regulation, 2016. New delhi: FSSAI; 2016.
2. Food safety and standards authority of india. Food safety and standard (health supplements, nutraceuticals, food for special dietary use, food for special medical puepose, and prebiotic and probiotic food) regulations, 2022. [ FSSAI (nutra) Regulations, 2022.
3. Ramdasi V, Lingala V, Macharam J, Saxena T, Prasanthi D: Nutraceutical regulations in india: A comprehensive Review. Int J Drug Reg Affairs. 2023;11(3): 80-86.
4. Patwardhan K, Pathak J, Acharya R. Ayurveda Formulations: A roadmap to address the safety concerns. J of ayurveda and integrative medicine 8(2017) 279-282.
5. Sharma Y, Sharma A, Tripathy S, Ojha A, Pali V: Ayurvedic Food And Nutraceuticals- A Review On Understanding roles, food as medicine. J Of ayurveda and integrated medical sciences. 2025;10(2):237- 242.
6. Shibna MV, Harti SS, Kulkarni M, Kumar A. A protocol for systematic review and meta –analysis on the efficacy and safety of nutraceuticals with special reference to ahara dreavya (food articles) in type 2 diabetes mellitus. J Drug Res Aurvedic SCI 2024;9:S0133-7.
7. Patel K, Jani D, Patel N, Jani D: Nutraceutical; contemporary and ancient view. International Education And Research Journal. E-ISSN No: 2454-9916, vol: 9, Issue: 6, 2023.
8. Plumptre A. A Comprehensive Review Of Reserching The Safety And Efficacy Of Ayurvedic Medicine. J Adv Res Pharm Sci Pharmacol Interv 2023; 6(1): 1-7.
9. kaur M, Chakraborty T. R. The Journey of ayurvedic medicines to nutraceuticals. Functional foods in health and disease 2025 15(7): 444-478.
10. Rajam R,Murugesan G, Vadivelkumar K, Manachisundram V: Nutraceuticals- World Journal Of Pharmaceutical Research. Vol 8, Issue 11, 1354-1374.
11. Kaushik R, Upadhyaya K, Sharma P, A comprehensive review of Ayurveda Aahar. Regulation, challenges, and future prospects. J Drug Res Ayurvedic Sci 2025; 10: 181-8.
12. Totawar V. Critical Review Of The Utilization Of Panchagavya In The From Of Ntraceuticals. J Ayurveda Integr Med SCI 2023;07:75-81.
13. Pandey M, Rastogi S, Rawat A. Indian Traditional Ayurvedic System of Medicine and Nutritional supplementation. Vol 2013.
14. Singh A. Herbal-based Nutraceuticals in Management of Lifestyle Diseases: Experience from Indian Population. Future Integrative Medicine 2024 vol.3(2), 106-115.
15. Messier H, Patel J, Bhomia V, Kataria D and Patel G (2026 ) Effectiveness and safety of an ayurvedic nutraceutical for improving clinical parameters of liver function in participant with metabolic dysfunction-associated steatotic liver disease: a randomized, placebo-controlled, preliminary phase 2 exploratory clinical trial. Front nutr. 13:1761666.
16. Bhoyar P, Solanki T, Hatwar P, Bakal R, Brewar S, Tajne P. Nutraceutical in disease prevention and management . GSC biological and pharmaceutical sciences,2025,30(02), 163-178.
17. Dr. Gurusiddamma, Dr. Sunita M. P, B Ravikiran . concept of Nutraceuticals in ayurveda- A Review publiahed in Intrernational journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456- 6470, Volume-8. Issue-5, 2024, pp.1134-1143.
18. Mutnuri V. Ayurveda Implication of Nutraceuticals: understating roles in preventive medicine. Journal of Aurvediiic and Herbal medicine. 2022; 8(3): 192-196.
19. Menon A, Sawant M,Mishra S, Bhatia P, Rathod S. Awareness, Prception and Usage of Nutraceutical in Indian Society, International Journal of Science and Technology ( IJSRST), ISSN: 2395-6011, Volume 8,
20. pp. 399-414, 2021.
21. Silpi C. Nutraceutical Traditional Practices, Regulatory guidelines, Opportunities and challenges. 2025.
22. Puri V, Nagpal M, Singh I, Singh M, Arora G, Huanbutta K, Dheer D, Sharma A, Sangnim T. Acomprehensive Review on Nutaceuticals: Therapy Support and Formulation Challenges. Nutrients 2022,14, 4637.
23. Khan MN, et al. (2023). Nutrivigilance: Boon for the Safety and Efficacy of Nutraceuticals Formulations. Mathews J Case Rep. 8(12): 141.
24. Gandhi K, Lal D. Potential of Herbal Nutraceuticals in Ghee: A Review. Research and Review: Journal of Dairy Science and Technology. 2015; 4(2): 1-5p.
25. Tayum Y. Assessing Indias Nutraceutical and their Impact on Disease Prevention. Bhartiya Knowledge Systems Volume 1, Issue 2, 2023.
26. Shinde A, Rathi B, Wanjari A, Rathi R. Pharmaceutical (Nutraceutical) Development, Quality Control Asswsment and Comparative Evaluation of Efficacy of a Polyherbal Compaund for Muscle Gain In Gym Going Healthy Volunteers: A Study Protocol. J of Pharmaceutical Research International. 33(61): 265- 272, 2021.
27. Gupta R, Lalla R, Shrivastava A. Nutraceuticals: efficacy, safety and toxicity. Academic Press, 2021.
28. Chopra A, Lordan R, Horbanczuk O, Atanasov A, Chopra Ishveen, Horbanczuk J, Jozwik A, Huang L, Pirgozliev V, Banach M, Battino M, Arkells N. The current use and evolving landscope of nutraceuticals. Pharmacological research 175, 106001, 2022.
29. Bansal P, Maithani M, Gupta V, kaur G, Bansal R. Future prospective of nutracetical and functional food with herbs and spices. Herbs, spices and their roles in nutraceuticals and functional foods, 361-381, 2023.
30. Bishnoi S, Mudgil D. Handbook of Nutracticals and Natural Products: Biological, Medicinal, and Nutritional Properties and Applications. Chapeter 10, Current Concept and Prospects of Herbal Nutraceutical.2022.