Nutraceutical Regulations in India: A comprehensive Review
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.
Downloads
References
2. Praneetha KPS, Sritaja PS, Durga KSC, Priyanka MB. A Regulatory Overview on Nutraceuticals and Regulatory Compliances in India and USA. World J Pharm Res. 2022;11(8):496-512.
3. Vishvakarma P, Mandal S, Verma A. A Review on Current Aspects of Nutraceuticals and Dietary Supplements. Int J Pharma Prof Res. 2023;14(1):78-91.
4. Verma B, Popli H. Regulations of Nutraceuticals in India and US. The Pharma Innovation Journal. 2018;7(7):811-816.
5. Nutraceutical and Functional Food Regulation in the United States and Around the World (Second Edition).
6. Keservani RK, Sharma AK, Ahmad F, Baig ME. Nutraceutical and functional food regulations in India. InNutraceutical and functional food regulations in the United States and around the world. Academic Press; 2014 Jan 1.p.327-342.
7. Praneetha KPS, Sritaja PS, Durga KSC, Priyanka MB. A Regulatory Overview on Nutraceuticals and Regulatory Compliances in India and USA. World J Pharm Res. 2022;11(8):496-512.
8. Praneetha KPS, Sritaja PS, Durga KSC, Priyanka MB. A Regulatory Overview on Nutraceuticals and Regulatory Compliances in India and USA. World J Pharm Res. 2022;11(8):496-512.
9. Putta S. FSSAI guidance and notification on Nutraceuticals – An insight. FnB news; 2020 Jun 8.
10. Verma B, Popli H. Regulations of Nutraceuticals in India and US. The Pharma Innovation Journal. 2018;7(7):811-816.
11. Rani A, Shukla VK. Study of Nutraceutical regulations around the Globe. Int J Drug Reg Affairs [Internet]. 2020 Mar. 16 [cited 2023 Jun. 17];8(1):15-4. Available from:
https://ijdra.com/index.php/journal/article/view/378
12. Jain PN, Rathod MH, Jain VC, S. M. V. Current Regulatory requirements for Registration of Nutraceuticals in India and USA. Int J Drug Reg Affairs [Internet]. 2018 Jun. 15 [cited 2023 Jun. 13];6(2):22-9. Available from:
https://ijdra.com/index.php/journal/article/view/232
13. Patel K, Patel U, Vaghela K, Kanki N, Zaveri M, Movaliya V. Comparisons of registration requirements of Nutraceuticals in Philippines, Tanzania, Cambodia and India. Int J Drug Reg Affairs [Internet]. 2022 Dec. 15 [cited 2023 Jun. 12];10(4):18-3. Available from:
https://ijdra.com/index.php/journal/article/view/546
14. Prabhu SL, SuriyaPrakash TNK, Kumar CD, Kumar SS, Raghavendran T. Nutraceuticals: A Review. Elixir Pharmacy Journal. 2012 May 16;76:8372-8377.
15. Swathi JB, Venkatesh DN. Introduction to Nutraceuticals and its Regulatory Requirements in India. Pharma Times. 2022 Nov;54(11):14-17.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM