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Probiotics the healthy bugs are increasingly used as pharmaceuticals now- a- days rather than as a component of our daily diet. The rising trend in probiotic market value generates a need for proper regulations as like drugs. The present review focuses on the need for harmonized evaluatory guidelines for probiotics across the globe. The existing regulations on probiotics and recommendations for the future are discussed in this Guidance Document. Apart from the wide range of beneficial effects of probiotics they are contraindicated in certain group of population.
The safety aspect of probiotics is taken into consideration.
This Guidance Document defines a set of parameters essential for a product to be called as Probiotic'. The parameters include identity test, pathogenicity test, viability check, probiotic screening, safety considerations etc. With rising trend in probiotic market value, chances of proliferation of misbranded, counterfeit products and product with inferior quality increases. The global probiotics market had increased by US 31.1billion dollars in 2015 with the Europe and Asia accounting for nearly 42 and 30% of the total revenues respectively as published by Markets and Markets as 'Probiotics Marketџ (2009-2014) [1].
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Europe and Asia are the first and second largest probiotic markets respectively. Emergence of probiotics as drug products and growing interest in consumers for promotion and maintenance of good health leads to greater requirement for safety, purity, potency, stability and efficacy assessment. There is a strong need for submission of evaluatory data to regulatory authority (FDA) for INDA, NDA to get approval for manufacturing marketing and sale of product.
Further evaluatory tests are essential for scientific substantiation of health claims.
The present review aims to generate and recommend criteria and methodology for evaluation of probiotics including preclinical and clinical data for substantiation of safety and efficacy via different in vivo and in vitro studies. This also further identifies and outlines the minimum requirements needed for declaration of probiotic status. This guidance document is prepared in context to people of all age groups including the adults, geriatric and pediatric population. This document will address the quality of probiotics in foods and pharmaceuticals as it involves the various in vivo and in vitro tests for safety and efficacy assessment in both animal and human models. This document will provide a systematic approach to deal with the concept of quality presumption of safety along with the inventory of microbes with a documented safe history of use. Basic probiotic evaluation starts with the evaluation of probiotic culture media followed by microbial identification, pathogenicity test the safety considerations and in vivo and in vitro tests for safety and efficacy.Till date there are no harmonized regulatory guidelines for probiotics across the globe.
They are regulated under different categories in different countries like as Natural Health Products in Canada, Dietary Supplements in U.S.A, FOSHU in Japan and SFDA in China. In India probiotics are regulated as functional foods as they are mainly used as a component of food items. But now they are widely used as pharmaceuticals in the treatment of a range of clinical disorders. They are largely replacing antibiotics from the market shelves due to their negligible side effects accompanied with low cost. So, proper regulations on identification, safety, evaluation, GMP, approval process, health claims and labeling etc. is the need of the hour. However, the evaluatory guidelines for probiotics are given by FAO/WHO which are internationally accepted. Some Indian organizations such as ICMR Delhi, ILSI, NDRI Karnal also gives evaluatory guidelines for probiotics. But there are certain loop holes in the already existed guidelines. So, there is a need for a revised guidance document containing all the parameters necessary for the evaluation of probiotic formulations.
Probiotic microbes need to be grown on an appropriate culture media prior to conduction of any specific tests. The culture medium meant for probiotic growth should not contain substances known to have toxic or allergic potential especially in human subjects. Use of animal derived products should be discouraged. However, if necessary, approval of the National Regional Authority (NRA) should be sought and the materials should comply with current policy on Transmissible Spongiform Encephalopathies (TSE) [3-8]. A TSE risk assessment would need to be included for the materials of the culture medium. The WHO revised guidelines on TSE in relation to biological and pharmaceutical products [3] provide guidance related to risk assessments for master and working seeds and should be consulted. Substances used in that medium meant for production and growth of microbes, should meet such specifications of NRA, as per prescription.
The probiotic microbe in the master record as well as in working seed lots whether an NME (New Microbial Entity) or a microbe with a long history of safe use should be identified using microbiological techniques. Identification testing can be carried out by using a polyphasic approach which may include phenotypic tests in combination with the molecular biology based genotypic techniques (e.g. PCR test, RAPD, AFLP, 16SrRNA sequencing etc.) for identification of the specific probiotic strain. Relevant information to ensure genetic consistency in production, from master seed through working seed and to final product is also provided by the said techniques.
Pathogenicity testing involves the testing of any kind of pathogens. This can be tested via: 1. Initial microscopic examination, visual examination of culture media followed by genotypic techniques for pathogen detection. 2. Pyrogen testing in suitable animal models.3. Determination of hemolytic potential
Viability check is a key factor to check number of culturable organisms in a starter culture [37]. The probiotic product should contain the expected viable probiotic count till mentioned date i.e. Best before date/Expiry date. An appropriate method approved by the NRA should be used to determine the number of culturable particles on a solid medium of each final bulk. Viability assessment can be tested by opting any of the following methods: Plate counting; [38,39] Reverse transcriptase polymerase chain reaction (RT-PCR) and nucleic acid sequence based amplification (NASBA); [40] Real time PCR; [41] Flowcytometry,[42]Fluorescence In Situ Hybridization (FISH) and fluorescence techniques that uses two fluorochromes with different emission wavelength to discriminate between intact and viable cells, injured or damaged or dead cells; [44] Viability test kits such as LIVE/DEAD® BaclightTM are commercially available which contains two nucleic acid stains: the green fluorochrome SYTO 9 (small molecule that can penetrate all membranes) and fluorochrome propidium iodide (large molecule penetrates only compromised membranes). Cells renders to be green when they are viable and red when they are dead Assessment of intracellular esterase activity and maintenance of intracellular pH, membrane integrity are some of the other methods to check cell viability.
Bioluminescense: A rapid test for viability; Bioluminescense is an biochemical method which can be used as an alternate to colony counting method for viability test; provided that the method is properly validated against the culturable particles. If such tests are properly validated, they may be considered by the NRA to replace the other methods used for culturable particle test. The bioluminescence reaction takes place due to the presence of adenosine triphosphate (ATP), luciferin luciferase, oxygen and magnesium ions. This reaction can be reproduced by mixing these components in vitro. If all components except ATP are present in excess, the amount of light emitted is proportional to the amount of ATP coming from the probiotic microbial preparation. ATP proves to be a reliable marker for living cells, since ATP is present in all living cells and is immediately destroyed when the cell dies.
Probiotics Market Value. (2019, Aug 20). Retrieved from https://studymoose.com/probiotics-market-value-essay
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