A comparative evaluation of Regulatory requirements for Registration of Dietary Supplements in Brazil, Russia, India, China and South Africa
Abstract
Nutraceuticals are products that are rich in nutrients and provide health benefits, because of many factors like lifestyle changes and change in the dietary habits of people now a day, these products are widely used. Among all the other categories of Nutraceuticals Dietary supplement comprises huge part of Nutraceuticals. They are distinguishable from conventional food or drugs. They are intended to use to supplement the normal diet. The terms, nomenclature and definitions of the dietary supplements vary throughout the world. Different countries have their own regulation and legislative requirements. In regulated countries streamlined regulations are there, while well-structured and streamlined regulations for Nutraceuticals are lacking in other countries. In developing and emerging nations the regulation of dietary supplements are constantly evolving. It is necessary that the product complies all the regulatory requirements before they are placed on the market. The proposed study is based on the regulation and legislative requirements of dietary supplements in Brazil, Russia, India and South Africa.
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References
https://www.researchgate.net/publication/343846825_Nutraceuticals_History_Classification_and_Market_Demand
2. Nori L, Mani Kiran SS. Nutraceuticals: Regulatory process across the world. Curr Trends Pharm Pharm Chem. 2022;4:137-143.
3. Hassan S, et al. Dietary Supplements: Types, Health Benefits, Industry and Regulation. In: Egbuna C, Dable Tupas G, editors. Functional Foods and Nutraceuticals. Cham [Internet]. Springer; 2020 [cited 2023 Jun 10]. Available from:
https://www.researchgate.net/publication/343843720_Dietary_Supplements_Types_Health_Benefits_Industry_and_Regulation
4. Guidelines for Brazil [Internet]. Brazil: Brazilian Health Regulatory Agency (Anvisa); 1999 Jan 26 [cited 2023 Jun 10]. Available on:
http://antigo.anvisa.gov.br/en/english
5. Abe-Matsumoto L, Iglesia V, Minazzi-Rodrigues R. Vitamin Dietary Supplement: Changes and Challenges with the New ANVISA Regulations. Int J Nutrol. 2021;14. DOI: 10.1055/s-0041-1730416.
6. Tutelyan VA, Sukhanov BP, Kochetkova AA, Sheveleva SA, Smirnova EA. Russian Regulations on Nutraceuticals and Functional Foods. In: Food Science and Technology: Nutraceutical and Functional Food Regulations in the United States and Around the World. 2nd ed.;2014.p.309-326.
7. Food safety and standards authority of India [Internet]. India: Ministry of Health and Family Welfare, Govt of India; 2008 Sept 05 [cited 2023 Jan 08] Available from:
https://www.fssai.gov.in/upload/uploadfiles/files/Licensing_Regulations.pdf
8. 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]. 2018Jun.15 [cited 2023 Jun.17];6(2):22-9. Available from:
https://ijdra.com/index.php/journal/article/view/232
9. Patel D, Dufour Y, Domigan N. Functional Food and Nutraceutical Registration Processes in Japan and China: A Diffusion of Innovation Perspective. J Pharm Pharm Sci. 2008;11:1-11. DOI: 10.18433/J32S3N.
10. Guidelines for Registration of Medicinal Products in South Africa [Internet]. South Africa: SAHPRA; 2023 [cited 2023 Jan 24]. Available from:
https://www.sahpra.org.za/complementary-medicines/
11. 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. 17];10(4):18-3. Available from:
https://ijdra.com/index.php/journal/article/view/546
12. Chegu S, Nagabhushanam MV. A Comprehensive Study on Regulation of Herbal Drugs in India, US and European Union. Int J Drug Reg Affairs [Internet]. 2021 Mar. 19 [cited 2023 Jun. 17];9(1):78-6. Available from:
https://ijdra.com/index.php/journal/article/view/458
13. Budhwar V, Yadav S, Choudhary M, Nitesh ,. A COMPREHENSION STUDY ON REGULATION OF HERBAL DRUGS IN USA, EUROPEAN UNION AND INDIA. Int J Drug Reg Affairs [Internet]. 2017 Dec. 7 [cited 2023 Jun. 17];5(4):8-17. Available from:
https://ijdra.com/index.php/journal/article/view/205
14. 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
15. 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. 17];10(4):18-3. Available from:
https://ijdra.com/index.php/journal/article/view/546
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