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
Keywords
Related Articles
- EP ID EP339245
- DOI -
- Views 131
- Downloads 0
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DILTIAZEM HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP- HPLC
A simple, specific, precise and accurate Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the estimation of Diltiazem Hydrochloride in bulk and pharmaceutical dosage f...
REGULATORY REQUIREMENTS FOR DRUG PRODUCTS REGISTRATION IN SOUTH AFRICA
The South African Pharmaceutical market is one of the emerging markets in the world and it is important to study on how to register a drug in the promising pharmaceutical market in Africa. The MCC is the regulatory body...
A review on ANDA submission requirements for Generic drugs: “Paragraph IV certification” as per FDA CDER guidelines
USFDA is one the most regulated agencies wherein the submission process is most critical. The study depends on how to submit ANDA application as per FDA, CDER guidelines in paragraph IV submission in Federal Food, Drug,...
A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility...
“ME-TOO” DRUG REVOLUTION: A PRODUCT OF REGULATORY IMPROPRIETY
Amidst all the brouhaha, often the regulatory agencies, for instance the United States Food and Drug Administration’s (US-FDA) role in bringing about what is being so cleverly termed as the ‘me-too drug revolution’, has...