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
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.