PROBIOTIC FUNCTIONAL FOOD VS DRUGS: IMPACT OF INDIAN REGULATORY STATUS ON DESIGN OF QUALITY CONTROL GUIDLINES FOR PROBIOTICS
Journal Title: International Journal of Drug Regulatory Affairs - Year 2015, Vol 3, Issue 3
Abstract
Probiotic now a day's generally utilized all around the globe because of headway as a part of the relationship in the middle of nourishment and wellbeing other than their promising helpful advantages and irrelevant reactions. Indian probiotic industry is accomplishing its pace at relentless rate with open doors for fast development in not so distant future. Indian probiotic business sector is esteemed at US $310 million in 2011, is required to witness US $522.8 million by 2018. Presentation of a scope of pharmaceutical probiotic definitions in the business sector further expanded the turnover of probiotic industry. The eventual fate of probiotic sustenance's is notwithstanding encouraging, as current buyers are concerned to keep up their own wellbeing, and expect the nourishment that they eat to be solid and equipped for counteracting ailment. this is the time when Indian regulatory bodies/ authorities should prepare a guideline to evaluate efficacy claims rigorously, and by consumers interested in potential therapeutic and preventive health benefits. The Indian marketplace is a mixed bag of products, some well-defined and properly evaluated in controlled clinical studies and others with unsubstantiated claims of efficacy. Validation of probiotic contents in commercial products is needed to ensure consumer confidence. Probiotics must be identified to the level of strain, must be characterized for the specific health target, and must be formulated into products using strains and doses shown to be efficacious. Several characteristics commonly presumed to be essential to Probiotics, such as human origin and the ability to improve the balance of the intestinal microbiota, are discussed.
Authors and Affiliations
Singh Neetu, Gupta Manish
PREPARATION AND REVIEW OF CHEMISTRY, MANUFACTURING AND CONTROL (CMC) SECTIONS OF CTD DOSSIER FOR MARKETING AUTHORIZATION
The present article summarizes & simplify the marketing application requirements i.e. the critical aspects of marketing application in different CTD using countries, Process to prepare and review the requirements for CMC...
MARKETING AUTHORIZATION APPLICATION (MAA) FOR EUROPE MARKET
This article states requirement of Marketing Authorization Application to get registration of Drug Product to EEA. The procedures for application of marketing authorization are: Centralised procedure, National procedure,...
QUALITY BY DESIGN- A NEW APPROACH TO DRUG DEVELOPMENT
Quality by design is an essential part of the modern approach to pharmaceutical quality. A new approach to drug development could increase efficiencies, provide regulatory relief and flexibility, and offer important busi...
Regulatory aspects for Biologic product licensing in India
Biologics are the medicinal/ therapeutic/ diagnostic/ preventive preparations composed or derived from living organisms and their spin-off for human use. They include serums, vaccines, antitoxins, blood, antigens and blo...
MEDICINES HARMONIZATION IN WEST AFRICAN ECONOMIC AND MONETARY UNION (WAEMU) COUNTRIES
With the blessing of WHO, the different regions of West Africa engaged in Pharmaceutical regulation harmonization processes on the continent. Indeed, In west Africa, WAEMU actions on the matter ended in the production of...