The document summarizes probiotic regulations and guidelines in India. It provides definitions of probiotics from 2001 and 2014 as live microorganisms that confer health benefits. It describes guidelines developed in India for probiotic evaluation, including the ICMR-DBT Guidelines and ILSI Guidelines. The status of regulations in India is discussed, noting there were no specific regulations until 2016. Key aspects of the 2016 FSSAI Regulations are outlined, including essential composition requirements, labeling rules, and that probiotic products are classified as foods and not drugs in India.
Dr. Ray Matulka, Director of Toxicology at Burdock Group, presents the hurdles of probiotics when being classified from a regulatory standpoint. Dr. Matulka discusses when a probiotic is considered a food, supplement or drug, as well as a potential path forward for the U.S. FDA to implement a probiotic monograph system for probiotics, similar to Health Canada's system.
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...Swapnil Fernandes
- Nutraceutical market has shown steady increase in the last decade.
- The import, manufacture and marketing regulations for nutraceuticals in India have been streamlined with the updation of the FSSAI regulations 2016.
- RDA’s are a collection of values to express a person's nutrient need based on their life stage & gender.
- The RDA recommendations for the Indian population has been provided by the ICMR on the basis of scientific studies and subsequent data generated.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
CDSCO Biologicals - Rules, Regulations, Guidelines and Standards for Regulato...Mohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Regulations and Legislation for Biologics (MRA 104T)
Unit 2 - Rules, Regulations, Guidelines and Standards for Regulatory Filing of Biologicals
CDSCO Biologicals
Dr. Ray Matulka, Director of Toxicology at Burdock Group, presents the hurdles of probiotics when being classified from a regulatory standpoint. Dr. Matulka discusses when a probiotic is considered a food, supplement or drug, as well as a potential path forward for the U.S. FDA to implement a probiotic monograph system for probiotics, similar to Health Canada's system.
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...Swapnil Fernandes
- Nutraceutical market has shown steady increase in the last decade.
- The import, manufacture and marketing regulations for nutraceuticals in India have been streamlined with the updation of the FSSAI regulations 2016.
- RDA’s are a collection of values to express a person's nutrient need based on their life stage & gender.
- The RDA recommendations for the Indian population has been provided by the ICMR on the basis of scientific studies and subsequent data generated.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
CDSCO Biologicals - Rules, Regulations, Guidelines and Standards for Regulato...Mohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Regulations and Legislation for Biologics (MRA 104T)
Unit 2 - Rules, Regulations, Guidelines and Standards for Regulatory Filing of Biologicals
CDSCO Biologicals
In this slide contains introduction, amendments of FD&C act, HACCP system and different department of USFDA.
Presented by: R.Bhanu Teja (Department of pharmaceutical analysis),
RIPER,anantapur.
This presentation contains the legal or regulatory aspects of nutraceuticals Nutraceuticals first coined by Stephen De Felice, Founder and chairman of Innovation in medicine.
Regulatory aspects of nutraceuticals in India governed by FSSAI
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
The Food Safety Modernization Act (FSMA), signed into law on Jan. 4, 2011, expands the power of the Food and Drug Administration (FDA) to oversee food safety with a focus on prevention. Each year, about 48 million people get sick, 128,000 are hospitalized and 3,000 die—all from foodborne diseases that are preventable.
The FSMA is designed to reduce those numbers by radically updating industry practices to ensure food safety and defense in an evolving global economy. Because of how vast and interconnected food supply has become, these regulations will impact a number of industries.
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
The use of animals in research is currently an essential component of the drug discovery process.
Animals help us advance our scientific understanding, serve as models to study disease, help us develop and test potential new medicines and therapies.
Animal testing has benefited researchers in understanding how to treat and prevent various conditions such as high blood pressure, diabetes, tuberculosis, polio, muscular dystrophy, and Parkinson's disease.
Education:
Undergraduate teaching to demonstrate effects of various drugs although this has been phased out in most institutes.
Postgraduate teaching to demonstrate the effects of various drugs, to determine the nature of an unknown drug for bioassay, screening methods and to learn skills e.g. administering drugs.
Research:
A larger number and a greater variety of animals are used in pure research than in applied research. This usually involves studies on embryogenesis, developmental biology, behaviour and breeding in Fruit flies, nematodes, mice and rats.
INTRODUCTION
The motto of Prevention of Cruelty to Animals (PCA) Act 1960 as amended in 1982 is to prevent infliction of unnecessary pain or suffering on animals.
The Central Government has constituted a Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), which is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them.
The goal of these guidelines is to promote the human care of animal used in biomedical and behavioural research and testing.
To avoid/minimize pain and suffering inflicted on experimental animals
Inspection of animal house facilities
It provides guidelines for -
Proper care, housing, breeding, maintenance, handling and use of experimental animals.
Source of experimental animals
Acceptable experimental procedures for anaesthesia and euthanasia.
Registration of establishments conducting animal experimentation or breeding of animals for this purpose.
Selection and assignment of nominees for the Institutional Animal Ethics Committees (IAEC) of the registered establishments.
Approval of Animal House Facilities on the basis of reports of inspections conducted by CPCSEA.
Permission for conducting experiments involving use of animals.
Recommendation for import of animals for use in experiments.
Action against establishments in case of established violation of any legal norm/stipulation.
Conduct of Training Programmes for the Nominees of CPCSEA.
Conduct/Support of Conference/Workshop on Animal Ethics.
To assure quality maintenance and safety of animals used in laboratory studies while conducting biomedical and behavioural research and testing of products.
Quarantine
2. Personal hygiene
3. Environment
4. Physical facility
5. Animal husbandry
6. Animal disposal
7. Documentation
The recently enacted Food Safety Modernization Act is the greatest expansion of FDA’s food regulatory authority since the enactment in 1938 of the Federal Food, Drug, and Cosmetic Act. This presentation discuses the scope, impact and implementation of the Act. Presented by FDAImports.com Founder and CEO, Benjamin England.
For more on the Food Safety Modernization Act and how it affects companies, manufacturers and importers please visit:
http://www.fdaimports.com/FSMA
PROBIOTIC FUNCTIONAL FOOD VS DRUGS: IMPACT OF INDIAN REGULATORY STATUS ON DES...Neetu singh
Review Article- PROBIOTIC FUNCTIONAL FOOD VS DRUGS: IMPACT OF INDIAN REGULATORY
STATUS ON DESIGN OF QUALITY CONTROL GUIDLINES FOR PROBIOTICS
By
Singh Neetu*, Gupta Manish
School of Pharmacy, Lloyd Institute of Management and Technology
Greater Noida (Delhi/NCR), India.
*Corresponding Author’s E-mail: neetusinghkumar@yahoo.in
In this slide contains introduction, amendments of FD&C act, HACCP system and different department of USFDA.
Presented by: R.Bhanu Teja (Department of pharmaceutical analysis),
RIPER,anantapur.
This presentation contains the legal or regulatory aspects of nutraceuticals Nutraceuticals first coined by Stephen De Felice, Founder and chairman of Innovation in medicine.
Regulatory aspects of nutraceuticals in India governed by FSSAI
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
The Food Safety Modernization Act (FSMA), signed into law on Jan. 4, 2011, expands the power of the Food and Drug Administration (FDA) to oversee food safety with a focus on prevention. Each year, about 48 million people get sick, 128,000 are hospitalized and 3,000 die—all from foodborne diseases that are preventable.
The FSMA is designed to reduce those numbers by radically updating industry practices to ensure food safety and defense in an evolving global economy. Because of how vast and interconnected food supply has become, these regulations will impact a number of industries.
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
The use of animals in research is currently an essential component of the drug discovery process.
Animals help us advance our scientific understanding, serve as models to study disease, help us develop and test potential new medicines and therapies.
Animal testing has benefited researchers in understanding how to treat and prevent various conditions such as high blood pressure, diabetes, tuberculosis, polio, muscular dystrophy, and Parkinson's disease.
Education:
Undergraduate teaching to demonstrate effects of various drugs although this has been phased out in most institutes.
Postgraduate teaching to demonstrate the effects of various drugs, to determine the nature of an unknown drug for bioassay, screening methods and to learn skills e.g. administering drugs.
Research:
A larger number and a greater variety of animals are used in pure research than in applied research. This usually involves studies on embryogenesis, developmental biology, behaviour and breeding in Fruit flies, nematodes, mice and rats.
INTRODUCTION
The motto of Prevention of Cruelty to Animals (PCA) Act 1960 as amended in 1982 is to prevent infliction of unnecessary pain or suffering on animals.
The Central Government has constituted a Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), which is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them.
The goal of these guidelines is to promote the human care of animal used in biomedical and behavioural research and testing.
To avoid/minimize pain and suffering inflicted on experimental animals
Inspection of animal house facilities
It provides guidelines for -
Proper care, housing, breeding, maintenance, handling and use of experimental animals.
Source of experimental animals
Acceptable experimental procedures for anaesthesia and euthanasia.
Registration of establishments conducting animal experimentation or breeding of animals for this purpose.
Selection and assignment of nominees for the Institutional Animal Ethics Committees (IAEC) of the registered establishments.
Approval of Animal House Facilities on the basis of reports of inspections conducted by CPCSEA.
Permission for conducting experiments involving use of animals.
Recommendation for import of animals for use in experiments.
Action against establishments in case of established violation of any legal norm/stipulation.
Conduct of Training Programmes for the Nominees of CPCSEA.
Conduct/Support of Conference/Workshop on Animal Ethics.
To assure quality maintenance and safety of animals used in laboratory studies while conducting biomedical and behavioural research and testing of products.
Quarantine
2. Personal hygiene
3. Environment
4. Physical facility
5. Animal husbandry
6. Animal disposal
7. Documentation
The recently enacted Food Safety Modernization Act is the greatest expansion of FDA’s food regulatory authority since the enactment in 1938 of the Federal Food, Drug, and Cosmetic Act. This presentation discuses the scope, impact and implementation of the Act. Presented by FDAImports.com Founder and CEO, Benjamin England.
For more on the Food Safety Modernization Act and how it affects companies, manufacturers and importers please visit:
http://www.fdaimports.com/FSMA
PROBIOTIC FUNCTIONAL FOOD VS DRUGS: IMPACT OF INDIAN REGULATORY STATUS ON DES...Neetu singh
Review Article- PROBIOTIC FUNCTIONAL FOOD VS DRUGS: IMPACT OF INDIAN REGULATORY
STATUS ON DESIGN OF QUALITY CONTROL GUIDLINES FOR PROBIOTICS
By
Singh Neetu*, Gupta Manish
School of Pharmacy, Lloyd Institute of Management and Technology
Greater Noida (Delhi/NCR), India.
*Corresponding Author’s E-mail: neetusinghkumar@yahoo.in
Dr. Ray Matulka presented these slides at the Consumer Health Products Association's (CHPA) Regulatory, Scientific and Quality Conference in May 2015. Dietary supplements, by definition, are meant to “supplement the diet” in order to maintain a healthy body and mind. Probiotics confer an extensive diversity of different health benefits, which raises the question: do probiotics technically “fit” within the confines of the dietary supplement definition? As recent evidence increases for the beneficial effects of certain probiotics, these supplements may have the potential to transition into Over-The-Counter (OTC) medication. This session will present recent studies on the health benefits of probiotics, compare efficacy claims substantiation needed for probiotics as a supplement or as an OTC, and discuss the potential marketing benefit of obtaining OTC status for a probiotic.
Creative Enzymes is a professional and experienced supplier of probiotics. In the past decade, Creative Enzymes mainly provides enzyme-related products and services. With the continuous expansion of business areas and scale, we have set foot in other areas and established a sound probiotic production and supply chain. Based on our high-quality products and services, as well as the unique advantages of large-scale production, our probiotic products are widely favored by industrial customers and scientific research customers.
Probiotics are combinations of good bacteria or/and yeasts that naturally live in your body so as to help you maintain a healthy balance in your body, including fighting off bad bacteria when you have too much of it, helping you feel better. Probiotic-supplements prove to be a good way to add good bacteria to your body.
Purpose:
The purpose of this webinar is to raise awareness among common people about probiotics, their characteristics and daily life advantages. Webinar also aims to get people aware of foods or drinks that can be used to increase naturally occurring good microbes in their body.
Similar to Regulatory status probiotics india chennai2016 (20)
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
3. Probiotic Guidelines - The Start
“Guidelines for the Evaluation of
probiotics in Food. Report of a Joint
FAO/WHO Working Group on
Drafting Guidelines for the Evaluation
of probiotics in Food.” London Ontario,
Canada. April 30 and May 1, 2002.
Joint Food and Agriculture Organization/World Health
Organization: Guidelines for the evaluation of probiotics
in foods. London, Ontario, Canada; 2002, 1-11.
4. “live microorganisms that,
when administered in adequate
amounts, confer a health
benefit on the host”
Hill C et al (2014) Nat Rev Gastroenterol Hepatol 11:506–514.
Definition in 2014
5. Framework For Probiotic ProductsFramework For Probiotic Products
Live culturesProbioticProbiotic
Not
probiotic
Not
probiotic
Probiotic drugs
Probiotic medical foods
Probiotic foods
Non-oral probiotics
Probiotic animal feed
Defined microbial consortia
Probiotic dietary supplement
Probiotic infant formula
Fermented
foods with
undefined
microbial
content
Undefined
consortia,
including
faecal
microbiota
transplant
Hill C et al (2014) Nat Rev Gastroenterol Hepatol 11:506–514.
6. Probiotic Classification - Intended Use
• Food - Component of human diet for millennia with no
evidence of any harm
•Dietary Supplement - contains a “dietary ingredient”
intended to supplement the diet (DSHEA of 1994,
amendment to the FD&C Act)
•Drug - intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease (Food
Drug & Cosmetic Act of 1938)
•Medical Food
Sanders et al (2014) Ann N.Y. Acad Sci 1309:19-29.
10. Level 1 (Basic Level – may not be a probiotic depending on
definition)
Microorganisms used as starter cultures in
preparations, such as Dahi /yogurt whose role is
to ferment a food, and which then die in the
stomach or upon exposure to bile.
• (Third Meeting Summary
Federal Regulation of Probiotics: An Analysis of the Existing Regulatory
Framework and Recommendations for Alternative Frameworks – Meeting #3
February 16 and 17, 2012 University of Maryland Baltimore)
11. Level 2 (Safe But Not Clinically Proven Probiotic)
• Products which themselves (or the microbial
species they contain) have a long history of safe
use, but have not specifically been clinically
tested. Or, the evidence is only of increased
numbers of those species in stool.
• These and all strains at Levels 2-5 must be
genetically identified and meet safety standards
of the regulatory agency in the country of use.
12. Level 3 (Clinically Documented Probiotic)
• Microorganisms whose utilization (by mouth,
skin, vaginal or other target site), and delivery
(dairy, powder, food, cream, medical device,
other) confer a basic effect that benefits health,
as shown in human studies,
• e.g., production of
compounds that help create, restore or maintain
homeostatic pH or host cell barrier function, or
benefit general immunity, and thereby may
provide a benefit to all consumers.
13. Level 4 (Specific Probiotic Health Benefit)
• Microbial strain(s) that have an additional
specific function not conveyed by all
organisms that can be safely used by all
consumers, but may or may not benefit
everyone, and for which mechanisms of action
are somewhat understood and proven.
14. Level 5 (Narrow Use)
• Microbial strain(s) with very targeted usage
(e.g elevating certain neurochemical levels in
the brain to relieve stress).
• Not for all consumers but not in the drug
category.
16. Guidelines for Probiotics in Food
Joint initiative by Indian Council of Medical
Research and Department of Biotechnology,
Government of India.
•Developed for scientific purpose with
the main aim to guide the regulatory
authority for evaluating probiotic
products in our country
•Definition of probiotics – “live
microorganisms which when
administered in adequate amounts
confer a health benefit on the host”
•These guidelines are not meant for probiotics
which by definition would come under drugs,
beneficial microorganisms not used in foods or
genetically modified microorganisms (GMO).
ICMR/DBT (2011). Guidelines for Regulation of Probiotics in Food. Indian Council of Medical
Research/Department of Biotechnology, India.
17. ICMR – DBT Guidelines - Highlights
Ministry of Health
and Family Welfare
Ministry of Health
and Family Welfare
Genus, Species, Strain
Strain Identification
by Phenotypic and
Genotypic Methods
Genus, species and
strain
Deposit strain in
an Internationally
recognized
collection center
Strain Identification
by Phenotypic and
Genotypic Methods
Genus, species and
strain
Deposit strain in
an Internationally
recognized
collection center
Screening of
potential
probiotic
strains
In vitro
tests
Screening of
potential
probiotic
strains
In vitro
tests
In vivo
studies in
validated
animal
models for
Safety
Efficacy
In vivo
studies in
validated
animal
models for
Safety
Efficacy
Labeling Requirements
Health claims
In vivo
studies in
humans for
clinical
evaluations
Phase 1 -
Safety
Phase 2
-Efficacy
Phase 3
-Effectiveness
In vivo
studies in
humans for
clinical
evaluations
Phase 1 -
Safety
Phase 2
-Efficacy
Phase 3
-Effectiveness
ICMR-DBT Guidelines for Evaluation of Probiotic Foods,
2011
ICMR-DBT Guidelines for Evaluation of Probiotic Foods,
2011
Probiotic
Foods
Probiotic
Foods
Minimum viable
numbers
Serving size
Storage
conditions
18.
19. The International Life Sciences
Institute (ILSI) - India
ILSI-India has developed the ‘Guidelines and
Criteria for Evaluation of Efficacy, Safety
and Health Claim of Probiotic in Food
Products in India.
ILSI. Guidelines and Criteria for Evaluation of Efficacy, Safety and Health Claim of Probiotic in Food
Products in India. International Life Sciences Institute – India.
21. Status
• There is no regulation or standard in India on
the use of probiotics in foods
• There is a regulation now from Nov 2016
22. FSSAI Regulations
These regulations may be called as the
Food Safety and Standards (Food or Health
Supplements, Nutraceuticals, Foods for
Special Dietary Uses, Foods for Special Medical
purpose, Functional Foods, and Novel
Food) Regulations, 2016.
23. (a) Foods containing prebiotic
ingredients means foods that contain
approved prebiotics and are a non-
viable food component which confers
a health benefit to the consumer by
modulation of gut micro biota.
24. (b) “Foods containing Probiotic Ingredients” means foods
with live microorganisms beneficial to human health,
which when ingested in adequate amounts (as a single
strain or as a combination of cultures) confer one or more
specified/or demonstrated health benefits in human
beings;
and the
microorganism strain used in these foods shall be deemed
to possess probiotic property when it is capable of
surviving passage through the digestive tract, and
has the capability to adhere and proliferate in the gut and
be able to confer a physiological benefit.
25. CHAPTER - VII
9. Foods containing Probiotic Ingredients. -
(1) Essential Composition. -
(i) Only probiotic cultures of specific strain of the
microorganisms as specified in
Schedule X of these regulations or those approved by the
Food Authority from time to time may be used.
(ii) The Food Authority may enlist specific probiotic
microorganisms after proper
scientific evaluation from time to time.
26. The presence of commonly used starter culture of lactic
acid producing bacteria such as Lactococcus spp. (earlier
known as Streptococcus spp.), Lactobacillus spp. and
others used in the preparation in curd and related
products shall not be considered as probiotics, if the
probiotic properties have not been substantiated.
(iv) Any new strains of microorganisms, possessing
probiotic properties, may be approved by the Food
Authority after proper scientific evaluation, and the
Food Authority may from time to time enlist specific
microorganisms possessing probiotic properties
(Schedule X).
27. Labelling.
(i) The labelling of probiotic foods shall
follow Food Safety and Standards
(Packaging and Labelling) Regulations,
2011.
.
28. Food Not Drug
(iii) The labelling, presentation and advertising shall not
attribute the property of preventing, treating or curing a
human disease, or refer to such properties to
Probiotics and the statements relating to structure or
function or for the general well-being of the body are
allowed as long as they are truthful and are
also supported by generally accepted scientific data and
in addition, the product shall bear a statement, “This
product is not intended to diagnose, treat,
cure or prevent any diseases.”
29. Every package of probiotic foods shall carry the
following information on the
label, namely:-
(a) the words “PROBIOTIC FOOD”;
(b) genus, species, strain designation or International
Culture Collection Number (International Culture Deposit
Number in the bracket where probiotics are mentioned in
the ingredient lists);
(c) minimum viable numbers of probiotics strain at the
level at which the efficacy is claimed and at the end of the
shelf-life; ( ? ≥ 108
/ CFU/g)
30. (d) the recommended serving size which must deliver the
effective dose of probiotics related to the health claim and
duration of use to have the optimal effect.
(e) proper storage temperature conditions and time limit
for ‘Best Use’ after opening the container.
(f) a warning or any other precautions to be taken while
consuming,
Known side effects if any, contraindications and product-
drug interactions, as applicable; and
g) expiry date.
31. Use of additives. - The additives specified
in Schedule VIII (a) to VIII (e) of
these regulations may be permitted to be
used in probiotics also.
(4) Contaminants, Toxins and residues. -
The product shall conform to the Food
Safety and Standards (Contaminants,
Toxins and Residues) Regulations, 2011.
32. CHAPTER- VIII
10. Foods containing prebiotic
ingredients. –
(1) Essential composition.-
(i) Only prebiotics specified in Schedule XI or those
approved by the Food Authority from time to time
may be used in the manufacture of foods containing
prebiotics.
(ii) The Food Authority may enlist specific prebiotic
components after proper scientific evaluation from
time to time.
33. (iii) The prebiotic component (not an
organism), to which the claim of being prebiotic
is attributed, must be characterized for any
given product by providing the source, origin,
purity, chemical composition and structure,
vehicle, concentration and amount in which it
is to be delivered to the host.
35. Schedule – X
(See regulation 10)
List of Strains as Probiotics (Live Micro-
organisms)
1 Lactobacillus acidophilus
2 Lactobacillus planatrum
3 Lactobacillus reuteri
4 Lactobacillus rhamnosus
5 Lactobacillus salivarius
6 Lactobacillus casei
7 Lactobasillus brevis
8 Lactobacillus infantis
9 Lactobacillus johnsonii
10 Lactobacillus bulgaricans
11 Lactobacillus asporogenes
12 Lactobacillus fermentis
13 Lactobacillus caucasicus
14 Lactobacillus helvetucs
15 Lactobacillus lactis
16 Lactobacillus amylovorus
17 Lactobacillus gallanarum
18 Lactobacillus debrueckii
19 Bifidobacterium bifidum
20 Bifidobacterium lactis
21 Bifidobacterium breve
22 Bifidobacterium longum
23 Bifidbacterium animalis
24 Bifidbacterium infontis
25 Streptococcus thermophilus
26 Streptococcus bouraldi
27 Saccharomyces species (as in
codex)
PS: These organisms may be used either singly or in
combination but must be declared on the label with full
information and has to be non-GMO.
36. Schedule – XI
(See regulation 11)
List of Prebiotic
Compounds
1 Polydextrose
2 Soybean Oligosaccharides
3 Isomalto-oligosaccharides
4 Fructo-oligosaccharides
5 Gluco-oligosaccharides
6 Xylo-oligosaccharides
7 Inulin
8 Isomaltulose
9 Gentio-ologsaccharides
10 Lactulose
11 Lactoferrin
12 Sugar alcohols such as lactitol, sorbitol, maltitol, etc.