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Applied Clinical Research, Clinical Trials and Regulatory Affairs

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

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Research Article

Need and Recommendations for Universal Guidelines on Regulatory Status and Quality Control/Safety of Probiotic Products

Author(s): Malika Arora*, Manish Arora, Parveen Bansal and Ashish Baldi

Volume 6, Issue 3, 2019

Page: [231 - 249] Pages: 19

DOI: 10.2174/2213476X06666190206120712

Abstract

Background: In today’s era, various health boosting products viz. probiotics, functional foods, dietary supplements and nutraceuticals are gaining great commercial interest. Although probiotics have traditional history of their use, their regulatory approval regimes across the globe are complicated and incoherent.

Objective: The present article has been compiled to give an overview of the existing approval guidelines for the probiotic products across the globe along with their associated ambiguities. Furthermore, suggestive consolidations for harmonized approval process to be implemented in future are proposed on the basis of their intended use.

Methods: The study was carried out by using secondary sources through literature survey from journals, market reports, proceedings, books and web pages of relevant regulatory authorities and a critical comparative study was conducted with respect to approval process of probiotics.

Results: As per the comparative account of the current regulatory guidelines, it has been evidenced that different countries have adopted diverse approval process for probiotics and; lack of uniformity is of great concern. But due to rapid emergence of probiotics as drugs, a harmonized approval process similar to other drugs covering all aspects of Investigational New Drug Application (INDA) and New Drug Application (NDA) has been proposed in which organisms falling under Generally Recognized As Safe (GRAS) category are exempted from INDA submission whereas non GRAS, GRAE or new organisms are not exempted. After submission of NDA and getting approval from Food and Drug Administration (FDA), product should be manufactured and marketed.

Conclusion: Regulatory bodies across the globe must ensure that probiotics based products should be regulated by lawful approval process in such a manner which will lead to maximal health benefits and minimal health risk for consumers.

Keywords: Probiotics, IND, INDA, GRAS, approval guidelines, regulatory bodies, consumers.

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