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Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)


ISSN (Print): 2213-476X
ISSN (Online): 2213-4778

Research Article

Comparative Study of Regulatory Framework for Probiotics: Current Status and Future Recommendations

Author(s): Malika Arora and Ashish Baldi*

Volume 4 , Issue 2 , 2017

Page: [140 - 156] Pages: 17

DOI: 10.2174/2213476X04666170620100145

Price: $65


Purpose: The aim of this paper is to look into current regulatory specifications and to collect comparative data of probiotics across the globe for understanding the ambiguities related to these regimes. Ultimately it will provide a platform, to develop harmonized guidelines for assurance of quality, premarketing safety assessment and for framing satisfactory regulatory requirements for future.

Methods: The study was carried out by using secondary sources by doing literature survey from journals, market reports, proceedings, books and web pages of relevant regulatory authorities. Information from the recently published sources (indeed official regulations) was used instead of older. For acceptance of probiotics based products with uniform quality, greater safety of patients, with established scientific evidences for holistic therapeutic benefits in treatment of various ailments, drafting of comprehensive regulatory guidelines is the need of the hour. So in this context, already prescribed guidelines from various countries have been collected for common point selection and reviewed critically.

Results: The comparative representation clearly shows that all countries have approached probiotic regulations differently. Hence it has been found that there is urgent requirement of internationally accepted definition, well established categorization as well as separate guidelines addressing identification, evaluation, manufacturing, labeling-health claims, approval process and dossier.

Conclusion: The most noticeable fact is that not even a single country is obliging all the necessary parameters required for the safe and judicious use of probiotics as foods and pharmaceuticals and hence a harmonized regulatory framework is need of the hour.

Keywords: Probiotics, pharmaceuticals, quality assurance, literature survey, holistic therapeutic benefits, labeling-health claims.

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