Comparisons of registration requirements of Nutraceuticals in Philippines, Tanzania, Cambodia and India
Abstract
"Nutraceuticals" are the combination of Nutrition and pharmaceutical. The term Nutraceutical was given by Dr. Stephen in 1989. A dietary supplement is a product taken by mouth that contains a dietary ingredient (Vitamins, Minerals, Herbs, Amino acids etc.) Numerous definitions and nomenclature for dietary supplements exist worldwide. In India Food Safety and Standards authority (FSSA), defines Nutraceuticals as "foods for special dietary uses or functional foods or health supplements". In Philippines Nutraceuticals are known as food supplement & dilatory supplement. In Sudan, Nutraceuticals are known as dietary supplement & health product .In Cambodia Nutraceuticals are known as health supplement product. Every country has their own guidelines, regulatory requirements which deal with regulatory registration procedures of Nutraceuticals. In order to enter the Indian Nutraceutical market, some of the very important areas of focus include product evaluation, actual product analysis, procuring licenses and developing India specific health and label claims.
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References
https://ijdra.com/index.php/journal/article/view/232.
2. Jinish Dhar M, Puranik S. Review Article February. Regulatory Requirements for Registration, Import, and Manufacture of Dietary Supplements, Nutraceuticals in India. jppr.Human, 2018; Vol. 11 (3): 238-249
3. GNK G, A. R, V. S, V. S, Baviya PR. Nutraceuticals - A Regulatory Review. Int J Drug Reg Affairs [Internet]. 2018Feb.13 [cited 2022 Jul. 20];3(2):22-9. Available from:
https://ijdra.com/index.php/journal/article/view/165.
4. Hoti G, Matencio A, Rubin Pedrazzo A, Cecone C, Appleton SL, Khazaei Monfared Y, Caldera F, Trotta F. Nutraceutical Concepts and Dextrin-Based Delivery Systems. International Journal of Molecular Sciences. 2022; 23(8):4102. doi.org/10.3390/ijms23084102
5. Sauer S, Plauth A. Health-beneficial nutraceuticals-myth or reality? Appl Microbiol Biotechnol. 2017 Feb;101(3):951-961. doi: 10.1007/s00253-016-8068-5.
6. Blaze J. A Comparison of Current Regulatory Frameworks for Nutraceuticals in Australia, Canada, Japan, and the United States. Innov Pharm. 2021 Apr 21;12(2):10.24926/iip.v12i2.3694.
doi: 10.24926/iip.v12i2.3694.
7. Mansi Athalye1, Sneha Vaghela and Nehal Bhavsar. The Study of the Registration Guideline of Nutraceutical Products in ASEAN Countries. Applied Clinical Research, Clinical Trials and Regulatory Affairs. 2020; 7(2):104-116
8. Philippine Food and Drug Administration. Bureau Circular 2007-002: Guidelines in the Use of Nutrition and Health Claims in Food Philippines: FDA 2007 [Internet]. FDA; 2007 Jan 23 [cited 2022 Jul. 20]. Available from:
https://www.fda.gov.ph/wp-content/uploads/2021/05/Bureau-Circular-No.-2007-002.pdf
9. Philippine Food and Drug Administration. Memorandum Circular No. 25 Series 1992: Additional Labelling Requirement for Food Supplements. [Internet]. Philippines: FDA; 1992 [cited 2022 Jul. 22]. Available from:
https://www.fda.gov.ph/wp-content/uploads/2021/05/Bureau-Circular-No.-02-s.-1999.pdf
10. 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 2022 Jul. 12];6(2):22-9. Available from:
https://ijdra.com/index.php/journal/article/view/232.

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