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.