Harmonized Regulatory Guidelines for Probiotics.

      Аннотация: Probiotics is a broad term used for friendly bacteria, more appropriately defined as live microorganisms, which when administered in adequate amounts confer a health benefit on the host. These are increasingly used as food as well as pharmaceuticals due to their wide range of health benefits accompanied with low cost and negligible side effects. The tremendous growth of probiotic products in the global market has necessitated encountering formidable challenges posed due to lack of appropriate regulatory standards. 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. The proposed work is to take lead in current international scenario by framing a comprehensive and harmonized guideline to be accepted universally.

Ключевые слова: Draft, Probiotics, validation, regulatory guidelines