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FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN INDIA, RECOMMENDED DIETARY ALLOWANCE (RDA)
- 1. N G S M Institute of Pharmaceutical Sciences DEPT OFPHARMACEUTICAL REGULATORY AFFAIRS REGULATORY ASPECTS OF FOODAND NUTRACEUTICALS N.G.S.M.INSTITUTE OF PHARMACEUTICAL SCIENCES, NITTE (DEEMED to be UNIVERSITY) MANGALORE - SWAPNIL D. FERNANDES FSSAI REGULATIONSFORTHE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN INDIA,RECOMMENDEDDIETARY ALLOWANCE (RDA)
- 2. N G S M Institute of Pharmaceutical Sciences WHAT ARE NUTRACEUTICALS? • The term “nutraceutical” combines two words – “nutrient” (a nourishing food component) and “pharmaceutical” (a medical drug). • Broad umbrella term to describe products derived from food sources that possess extra health benefits in addition to the basic nutritional value found in foods. • Philosophy – Focus on prevention, “Let food be your medicine.”
- 3. N G S M Institute of Pharmaceutical Sciences HOW DO NUTRACEUTICALS ENTERINTO THE MARKET
- 4. N G S M Institute of Pharmaceutical Sciences ENTRY OF NUTRACUETICALS INTO THE MARKET IMPORTANT ASPECTS include: Product evaluation. Product analysis. Developing India-specific health and label claims. Procuring Licenses. • Import licensing • Manufacturing licensing • Marketing licensing
- 5. N G S M Institute of Pharmaceutical Sciences IMPORT OFNUTRACEUTICALS • No person shall import any unsafe or misbranded or substandard food. • Foreign Trade (Development and Regulation) Act 1992 • All imports will come under Central Licensing and an existing importer also needs to be registered under the Central Authority.
- 6. N G S M Institute of Pharmaceutical Sciences • The Central Licensing Authority has engaged the National Institute of Smart Government (NISG) under the Ministry of Communications and Information Technology. • NISG is assisting the central authority operationalize food import clearance, at 14 ports of entry.
- 7. N G S M Institute of Pharmaceutical Sciences IMPORT PROCESS OF NUTRACEUTICALS
- 8. N G S M Institute of Pharmaceutical Sciences
- 9. N G S M Institute of Pharmaceutical Sciences
- 10. N G S M Institute of Pharmaceutical Sciences MANUFACTURE • FSSA, 2016 – Regulation that standardised manufacture of nutraceuticals. • An FBO may manufacture nutraceuticals from food or non-food sources. • Nutraceuticals manufactured should contain ingredients specified in Schedules.
- 11. N G S M Institute of Pharmaceutical Sciences Schedule I contains a list of Vitamins and minerals Schedule II contains the list of essential amino acids and other nutrients Schedule IV List of plant or botanical ingredients Schedule VI List of ingredients as nutraceuticals Schedule VII List of strains as probiotics (live micro- organisms) Schedule VIII List of prebiotic compounds
- 12. N G S M Institute of Pharmaceutical Sciences • Quantity of Nutrients in Nutraceuticals - as per RDA. • When daily minimum and maximum usage levels aren’t specified, relevant data and evidence should be considered and submitted by FBO. • Additives – Specified under Schedule VA, VE, VF. • Already Approved Nutraceuticals.
- 13. N G S M Institute of Pharmaceutical Sciences SALE OF NUTRACEUTICALS Licenses issued by the FSSAI – 3 types. Central License State License Basic Registration
- 14. N G S M Institute of Pharmaceutical Sciences 1. FSSAI Registration Central License – Major Manufacturers or FBO’s. 2. FSSAI Registration State License. – Small to Medium sized manufacturers or FBO’s. 3. Basic Registration. – Petty or very small sized manufacturers.
- 15. N G S M Institute of Pharmaceutical Sciences
- 16. N G S M Institute of Pharmaceutical Sciences RECOMMENDED DIETARY ALLOWANCE
- 17. N G S M Institute of Pharmaceutical Sciences WHAT IS RDA? • “Recommended Dietary Allowances (RDAs) are the levels of intake of essential nutrients that, on the basis of scientific knowledge, are judged by the Food and Nutrition Board to be adequate to meet the known nutrient needs of practically all healthy persons.” • RDA doesn’t apply to sick people.
- 18. N G S M Institute of Pharmaceutical Sciences THE NEED FOR RDA IN INDIA • UNICEF reports – – 46% of preschool children, 30% of adults in India suffer from protein-calorie malnutrition. – Over 50% women (particularly pregnant women) and children suffer from iron deficiency anaemia. • Iodine Deficiency Disease (IDD) has been considerably reduced after the introduction of universal iodised salt.
- 19. N G S M Institute of Pharmaceutical Sciences REFERENCE SUBJECTS Age:20-39 yrs. Wt.:60 kg for men, 50kg for women. Healthy, fit for active work He/she spends 8 hrs daily on occupational work While not at work he/she spends 8 hrs in bed, 6 hr sitting & moving around, 2 hr walking & household work
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- 21. N G S M Institute of Pharmaceutical Sciences FACTORS INFLUENCING RDA • Age • Sex • Working Condition • Body Composition • Physical Activity • Vulnerable / At Risk Groups –Pregnant & Lactating mothers –Infants & Children –Elderly
- 22. N G S M Institute of Pharmaceutical Sciences USES OF RDA Basis for all feeding program ( school lunch program) To interpret food consumption record To understand nutritional needs Guidelines for public food program To develop and evaluate the new food product To develops the nutritional education program
- 23. N G S M Institute of Pharmaceutical Sciences CONCLUSION • Nutraceutical market has shown steady increase in the last decade. • The import, manufacture and marketing regulations for nutraceuticals in India have been streamlined with the updation of the FSSAI regulations 2016. • RDA’s are a collection of values to express a persons nutrient need based on their life stage & gender. • The RDA recommendations for the Indian population has been provided by the ICMR on the basis of scientific studies and subsequent data generated.
- 24. N G S M Institute of Pharmaceutical Sciences REFERENCES • Bagchi D.Nutraceutical and Functional Food Regulations in the United States and Around the World. London: Academic Press; 2014. • Dr Tomislav Meštrović P.What are Nutraceuticals? [Internet]. News-Medical.net. 2018 [cited 4 April 2018]. Availablefrom: https://www.news-medical.net/health/What-are-Nutraceuticals.aspx • FSSAI. Gazette Notification on Food Safety and Standards (Import) First Amendment Regulations, 2018. NewDelhi;2018. • Licenses Required for the Manufacture of Nutrition and Healthcare Product [Internet]. FSSAI Food license. 2018 [cited 10 April 2018]. Availablefrom: https://www.fssaifoodlicense.com/fssai-license-nutrition-healthcare-products/
- 25. N G S M Institute of Pharmaceutical Sciences • Revised RDA for Indians 2010 [Internet]. New Delhi: National Institute of Nutrition, ICMR; 2018 [cited 7 April 2018]. Available from: http://nutritionfoundationofindia.res.in/PPT- 2011/Seven17-18teen/Dr-B-Sesikeran.pdf • Nutrient requirements and recommended dietary allowances for Indians. New Delhi: Indian Council of Medical Research; 2010. • Kotecha P. Micronutrient malnutrition in India: Let us say "no" to it now. Indian Journal of Community Medicine. 2008;33(1):9. • GUPTA S. NUTRACEUTICAL – A BRIGHT SCOPE AND OPPORTUNITY OF INDIAN HEALTHCARE MARKET. International Journal of Research and Development in Pharmacy and Life Sciences. 2013;2(04):478-481.
Editor's Notes
- - The name was coined in 1989 by Stephen DeFelice.
- PRODUCT EVALUATION/ASSESSMENT = it is of utmost importance to examine each active ingredient and additive in the context of permissibility, standards and dosage of vitamins/minerals allowed as per the therapeutic, prophylactic, or RDA for Indians. PRODUCT ANALYSIS = Developing extracts of documents and authenticating them, Sample collection, Sample dispatch to concerned authority, Food analysis, Adjudication proceedings in case of incomplete analysis within stipulated period of time. DEVELOPING INDIA SPEC LABEL = Based on the results of a regulatory assessment of the product, India-specific label content and claims are developed. New entrants should also consider some of the health claims used in India and the requirements to be met to make specific product claims.
- As per the FSSA Act or any act thereunder. The Central Government shall, while prohibiting, restricting, or otherwise regulating import of articles of nutraceuticals shall follow the standards laid down by the Food Authority under the provisions of this Act and the rules and regulations made there under. Also, all imported products will be screened for safety parameters by an IT-enabled Food Safety System as a new initiative under the Food Safety and Standards Act.
- The Central Licensing Authority has engaged the National Institute of Smart Government (NISG) under the Ministry of Communications and Information Technology for the design and conceptualization of the IT-enabled Imported Food Safety System. This is done through the appointment of Authorised officers, who will head their respective teams in inspecting and providing clearance to the import products.
- IEC – Importer exporter code DGFT – Directorate general of foreigh trade
- An FBO may extract, isolate, manufacture or purify nutraceuticals from food or non-food sources. This can include preparing amino acids and their derivatives by bacterial fermentation under controlled conditions.
- Prebiotics – promote the growth or activity of beneficial microorganisms. EG: as seen in the GIT. Probiotics – are good microorganisms that help keep the digestive system healthy by controlling the growth of harmful bacteria. Eg: Yoghurt
- as specified by the Indian Council of Medical Research (ICMR) and when the standards aren’t clearly defined, then as per international food standards body, namely Codex Alimentarius Commission shall apply. Since the general public is unaware about RDA in nutraceuticals, it is important for the manufacturer to ensure that nutraceuticals contain nutrients as prescribed by ICMR. For the ingredient for which the daily minimum and maximum usage levels have not been specified, the food business operator shall adopt the usage level based on relevant scientific data and retain the documentary evidence of such data and submit the documented scientific data to the Food Authority as and when called for. If additives are used in nutraceutical formulations then they must only be those additives as specified in Schedule VA or Schedule VE or Schedule VF in the nutraceutical regulation. A nutraceutical whose safety has been established in India or in any other country, shall be manufactured or sold in India only on prior approval of the Food Authority. For this purpose the FBO will need to apply to the FSSAI which will be accompanied by documented history of usage of at least fifteen years in India thirty years in the country of origin
- The three licenses are granted on the basis of the scale of operation of the food business which is being carried out.
- Food business operators are required to obtain a Central Food License, granted by the Central Govt. FBOs have to obtain the Central License for their head office, and if they have operations in more than 1 state Therefore, it is mostly applicable to the units who are having an annual turnover which is greater than 20 crores. The State License is issued by the State Government and it is important that you have operations in only 1 state. Therefore it is mostly applicable to the units having an annual turnover of more than 12 lakh. The Food business operators like petty food manufacturers and also the small-sized manufacturers are required to obtain the FSSAI Registration. The FSSAI Registration is however issued by the State Government. It is thus mostly for the units having an annual turnover which is up to 12 lakh.