Current regulatory landscape for nutraceuticals (Record no. 16893)
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| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20220624161742.0 |
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| fixed length control field | 220624b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 16797 |
| Author | Chakraborty, Pradip |
| 245 ## - TITLE STATEMENT | |
| Title | Current regulatory landscape for nutraceuticals |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol.53(3), March |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Mumbai |
| Name of publisher, distributor, etc. | Indian Journal of Pharmaceutical Science |
| Year | 2021 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Pagination | 21-26p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Food Safety and Standards Authority of India regulates domestic and imported food products in India since 5 th August, 2011. In the absence of any regulations on health supplements and nutraceuticals in India, FSSAI considered these products as Proprietary and Novel food. FSSAI issued several guidelines inviting applications from the food business operators for approval / No Objection Certificate for Proprietary and Novel Food. However, the FSSAI also received several queries and concerns from food business operators regarding the complexity and timelines for product approval. Finally, FSSAI notified Regulations for Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Foods for Special Medical Purpose, Functional Foods and Novel Foods which is effective from 1 st January, 2018. The regulations specify the essential composition of the product, additives, compliance of specific labelling requirements, in addition to the provision of the Packaging and Labelling Regulations (2011), Compliance of the Contaminants, Toxins and Residue Regulations (2011) and Health Claims, if any. Eight categories of products have been defined. The regulations contain eight schedules consisting of a permitted list of vitamins, minerals, amino acids, botanicals, nutraceuticals, prebiotics and probiotics along with the permitted list of additives. For novel foods and health claims, pre-approval is required from the FSSAI. The quantity of nutrients added shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research. However, the regulations are under review and likely to be amended by the FSSA |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| 9 (RLIN) | 4639 |
| Topical term or geographic name entry element | PHARMACEUTICS |
| 773 0# - HOST ITEM ENTRY | |
| International Standard Serial Number | 0031-6849 |
| Title | Pharma times |
| Place, publisher, and date of publication | New Delhi Indian Pharmaceutical Association |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| URL | https://ipapharma.org/wp-content/uploads/2021/03/Pharma-Times-March-2021-Low-Resolution-2.pdf |
| Link text | Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | |
| Koha item type | Articles Abstract Database |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Permanent Location | Current Location | Shelving location | Date acquired | Barcode | Date last seen | Price effective from | Koha item type |
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| School of Pharmacy | School of Pharmacy | Archieval Section | 2022-06-24 | 2022-0870 | 2022-06-24 | 2022-06-24 | Articles Abstract Database |