Insights and compliance challenges for nutraceutical regulations in Indian market
DOI:
https://doi.org/10.25004/IJPSDR.2024.160218Keywords:
Nutraceuticals, Dietary Supplements, Food Safety and Standards Authority of India, Food safety Compliance System, Compound annual growth rate, Covid – 19Abstract
Nutraceuticals, comprising supplements, herbal medicines, vitamins, and minerals, claim therapeutic benefits in addressing disease causes. Coined in 1989, the term denotes compounds promoting health. Projections suggest India's nutraceutical business will reach USD 18 billion by 2025, necessitating robust oversight. Food Safety and Standards Authority of India, established under Food Safety and Standards Act of 2006, governs approvals. This study aimed to collate data on approved, refused, and withdrawn nutraceutical products and ingredients in India from 2020 to 2023. During this period, 58 out of 110 applications, constituting 52.7%, gained approval. Notably, 20-40% of applications related to nutraceuticals faced refusal or withdrawal within the preceding four years. Factors contributing to rejections and withdrawals include the sorting of S-adenosyl-L-methionine (SAMe) as a pharmaceutical compound, non-compliance with recommended dietary intake, potential drug-like properties, misleading labeling, and insufficient evidence of product efficacy. Withdrawals often result from issues like adulteration, substandard ingredients, and noncompliance with Good Manufacturing Practices (GMP) regulations. To surmount these challenges, FSSAI must establish rigorous regulations and guidelines for nutraceutical promotion, including public notifications for any modifications, with a concurrent expectation for industries to adhere to these guidelines in promoting public health. The collaboration of applicants/nutraceutical industry, and FSSAI would foster stable expansion, as evident in the CAGR for nutraceutical products and ingredients in India.
Downloads
References
Dudeja P, Gupta RK. Nutraceuticals. In Food safety in the 21st century 2017 Jan 1; pp. 491-496. Academic Press. Available from: doi.org/10.1016/B978-0-12-801773-9.00040-6.
Puri V, Nagpal M, Singh I, Singh M, Dhingra GA, Huanbutta K, Dheer D, Sharma A, Sangnim T. A comprehensive review on nutraceuticals: therapy support and formulation challenges. Nutrients. 2022;14(21):4637. Available from: doi.org/10.3390/nu14214637
Krasina IB, Filippova EV, Kurakina AN, Krasina EV. The influence of mechanochemical activation on organoleptic and physicochemical parameters of dietary supplements obtained from dry stevia leaves. Research Journal of Pharmacy and Technology. 2021;14(12):6693-8. Available from: doi.org/10.52711/0974-360X.2021.01156
Trottier G, Boström PJ, Lawrentschuk N, Fleshner NE. Nutraceuticals and prostate cancer prevention: a current review. Nature Reviews Urology. 2010;7(1):21-30. Available from: doi.org/10.1038/nrurol.2009.234.
Resu NR, Manju MS, Kondaveti S, Kumar SB. Neutraceuticals and nutrivigilance–Present scenario in India. Int J Food Biosci. 2019;2(1):35-40. DOI not available.
Rajasekaran A, Sivagnanam G, Xavier R. Nutraceuticals as therapeutic agents: A Review. Research Journal of Pharmacy and Technology. 2008;1(4):171-174. DOI not available.
Maharini FS, Amridjati M, Poddar S. Standardization of Growol processing and the effect of different processing processes on the potential of Growol as functional food. Research Journal of Pharmacy and Technology. 2023;16(2):615-20. Available from: doi.org/10.52711/0974-360X.2023.00105
Zorin SN, Sidorova YS, Petrov NA, Perova IB, Malinkin AD, Bokov DO, Bessonov VV, Mazo VK. A new functional food ingredient enriched by Phytoecdisteroids and Polyphenols from quinoa grains (Chenopodium quinoa Willd.). Research Journal of Pharmacy and Technology. 2021;14(8):4321-8. Available from: doi.org/10.52711/0974-360X.2021.00750
Nawale K, Namdeo AG, Gaware D. Current regulatory requirements for registration of nutraceuticals in India and Japan. World Journal of Pharmacy and Pharmaceutical Sciences. 2020;9(4):183-205. Available from: doi.org/10.20959/wjpps20204-15477
Sura NK, Hiremath L. Hydroxycitric Acid (Hca)-A Potent Nutraceuticals. Research Journal of Pharmacy and Technology. 2019;12(7):3163-8. Available from: doi.org/10.5958/0974-360X.2019.00533.X
Mohanty S, Pal A, Si SC. Flavonoid as Nutraceuticals: A Therapeutic approach to Rheumatoid Arthritis. Research Journal of Pharmacy and Technology. 2020;13(2):991-8. Available from: doi.org/10.5958/0974-360X.2020.00184.5
Praneetha KP, Sritaja PS, Durga KS, Bhavya M. A. A regulatory overview on nutraceuticals and regulatory compliances in INDIA and USA. World Journal of Pharmacy and Pharmaceutical Sciences. 2022;11(8):496-512. Available from: doi.org/10.20959/wjpr20228-24560
Park JH, Moon JH, Kim HJ, Kong MH, Oh YH. Sedentary lifestyle: overview of updated evidence of potential health risks. Korean journal of family medicine. 2020;41(6):365-73. Available from: doi.org/10.4082/kjfm.20.0165
Jadhav HB, Sablani S, Gogate P, Annapure U, Casanova F, Nayik GA, Alaskar K, Sarwar N, Raina IA, Ramniwas S, Mousavi Khaneghah A. Factors governing consumers buying behavior concerning nutraceutical product. Food Science & Nutrition. 2023;11(9):4988-5003. Available from: doi.org/10.1002/fsn3.3518
Kannan S, Naha A, Singh RR, Bansal P, Nayak VC, Goud S, Rani U. Role of dietary supplements in sports performance. Research Journal of Pharmacy and Technology. 2020;13(12):6259-65. Available from: doi.org/10.5958/0974-360X.2020.01090.2
Lordan R. Dietary supplements and nutraceuticals market growth during the coronavirus pandemic–Implications for consumers and regulatory oversight. PharmaNutrition. 2021; 18:100282. Available from: doi.org/10.1016/j.phanu.2021.100282
Ray A, Joshi J, Gulati K. Regulatory aspects of nutraceuticals: An Indian perspective. In Nutraceuticals 2016 Jan 1; pp. 941-946. Academic Press. Available from: doi.org/10.1016/B978-0-12-802147-7.00066-8
Naresh K. Impact Of Nutraceutical Sector in Post COVID Era. Food Safety Standard Authority of India (FSSAI). 2021. Available from: https://www.fssai.gov.in/in-the-media-all.php?pages=7
Sanjaya M. Accelerating the growth of the Indian Nutraceutical Sector – speed in execution is must. 2022. Available from: https://health.economictimes.indiatimes.com/news/industry/accelerating-the-growth-of-the-indian-nutraceutical-sector-speed-in-execution-is-a-must/96186084
Shinde N, Bangar B, Deshmukh S, Kumbhar P. Nutraceuticals: A Review on current status. Research journal of pharmacy and technology. 2014;7(1):110-3. DOI not available.
Razzouk MT, Ali FA. Comparative study of several Analytical methods for determination of Manganese content in some dietary supplements in Syrian market. Research Journal of Pharmacy and Technology. 2021;14(1):162-6. Available from: doi.org/10.5958/0974-360X.2021.00028.7
Food Safety Standard Authority of India. Available from: https://fssai.gov.in/cms/act-2006.php
Bhupathiraju K, Krishnaraju AV, Sengupta K, Golakoti T, Akolkar SK, Datla P. Regulations on nutraceuticals, functional foods, and dietary supplements in India. In Nutraceutical and functional food regulations in the United States and around the world 2019 Jan 1; pp. 445-464. Academic Press. Available from: doi.org/10.1016/B978-0-12-816467-9.00029-0
Sravya A, Lalitha PT, Juturia RK. Nutraceutical Regulations and Market in India: Current Opportunities and Challenges. International journal of Pharmacy and Pharmaceutical Research, 2020;18(4): 765-88. DOI not available.
Food Safety Standard Authority of India (FSSAI). Available from: https://fssai.gov.in/cms/non-specified-food.php
Food Safety Compliance System (FoSCoS). Standardized food Products. Available from: https://foscos.fssai.gov.in/
Food Safety Standard Authority of India (FSSAI). Food business registration process. Available from: https://fssai.gov.in/cms/registration.php
Rao AR, Naha A, Kannan S, Asagoankar S. A review on dietary supplements: Delivery systems, applications and regulations. Research Journal of Pharmacy and Technology. 2019;12(8):4002-6. Available from: doi.org/10.5958/0974-360X.2019.00689.9
Downloads
Published
Issue
Section
License
Copyright (c) 2024 NIKHITHANJANI THAMMISETTY
This work is licensed under a Creative Commons Attribution 4.0 International License.
