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Probiotics in India: Current status and future prospects
Article · September 2013
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DRUG THERAPY/ MEDICAL UPDATES
PROBIOTICS IN INDIA: CURRENT STATUS AND FUTURE PROSPECTS
Sujata Sharma, Malika Arora, Ashish Baldi*
Department of Quality Assurance, ISF College of Pharmacy, Moga, Punjab, India 142001
E mail: baldiashish@gmail.com.
ABSTRACT
Probiotics are microorganisms which confer a series of innate health benefits to the host, having a wide range of
applications. These are widely used globally due to advancement in the relationship between nutrition and health
besides their promising therapeutic benefits and negligible side effects. Indian probiotic industry is achieving its
pace at steady rate with opportunities for rapid growth in near future. Indian probiotic market is valued at $12
million in 2011, is expected to witness a CAGR of 11 per cent by 2016. Introduction of a range of pharmaceutical
probiotic formulations in the market further increased the turnover of probiotic industry. The future of probiotic
foods is even promising, as modern consumers are worried to maintain their personal health, and expect the food
that they eat to be healthy and capable of preventing illness. This paper offers a brief overview of the current market
situation of probiotics in India, range of products available, key players involved in this business along with some
critical comments on existing guidelines for probiotics with recommendations for strict regulations to ensure patient
safety and survival of such products as pharmaceuticals.
KEYWORDS: Probiotics, Probiotic categories, Regulatory status, Harmonized guidelines.
INTRODUCTION
Probiotics is a broad term used for a very large
number of microorganisms which includes bacterial
cell preparations of single or multiple bacteria which
when ingested confer health benefits. In human body,
gastrointestinal tract contains about 100 trillion
bacteria that are important for helping us stay
healthy. The balance of this microbial flora greatly
influences the intestinal environment [1] and is a
necessary component to maintain intestinal
homeostasis [2]. Probiotic ingestion can be a
preventative approach to maintaining the balance of
the intestinal microflora [3]. Probiotics have a wide
range of therapeutic benefits and increased
familiarity, due to which expansion of research and
the market value of probiotics increases sharply in
the past few years. Probiotics have been used
therapeutically to modulate immunity, lower serum
cholesterol, treat athereosclerosis and arteriosclerosis,
rheumatoid arthritis, cancer, Helicobacter pylori
infections, improve lactose intolerance, and prevent
or reduce the effects of atopic dermatitis, treat,
diarrhoea, and constipation, candidiasis, urinary tract
infections etc. [4-5]. Increased commercial interest in
exploiting the proposed health attributes of probiotics
has contributed significantly to the growth and
expansion of this market sector.
Since last two decades, probiotic microbes have been
included in various types of products, especially in
fermented milk [6]. Human probiotics are delivered
via dairy products from centuries ago particularly in
Europe and Asia. Now a day, the range of
commercially available probiotic dairy products
expands including cheese, ice-cream, frozen yoghurt,
ISF College of Pharmacy, Moga, Punjab
probiotic chocolates and even some non dairy food
and drinks [7-8]. Due to all above enlisted therapeutic
attributes,
probiotics
founds
a
place
in
pharmaceutical formulations and are commercialized
as pharmaceutical products.
Probiotic status is still not clear in health industry as
they are used both as preventive and curative therapy.
In India the market for food applications of probiotics
is clearly larger than that for probiotics sold in the
form of probiotic sachets, capsules and other
pharmaceutical preparations. It is expected that
probiotic yogurt sales will cross 100,000 Thousand
packets by 2015. Amul is the leader in Probiotic
yogurt sales in India and in probiotic drink sales,
Yakult is way ahead than Mother Dairy. Being a
lonely player in the probiotic ice cream market in
India, Amul is gaining advantage. In India probiotics
drug market of worth Rs 80 crore has been crafted by
Indian companies with a yearly growth of 41.1
percent. The market will grow in every coming year
because many of the Indian pharmaceutical
companies are in the process of their development
and in-licensing probiotic drugs [9]. As per current
scenario, food and drugs are regulated by PFA
(Prevention of Food Adulteration Act) and FDA
respectively in India. The Food Safety and Standards
Act of 2005 (FSSA) defines the foods for special
dietary uses or functional foods, nutraceuticals or
health supplements (IMNA, 2010).
But in the probiotic industry what so ever be the
category of probiotic, i.e. dietary supplements,
functional foods or drugs, the major challenge is the
lack of appropriate studies required for the
PharmAspire: 4 Oct. 2013
development of probiotics as modern therapeutic
drugs. Probiotic formulations deal with a more
complex pharmacology in comparison to the inert
drugs and require detailed pharmacokinetic studies
[10]. The development and maintenance of these
products is complex, expensive and risky, as special
requirements for manufacturing, labeling and safe
delivery are required. Besides potential technological
obstacles, legislative aspects, as well as consumer
demands need to be taken into consideration when
developing functional food or probiotic based
pharmaceuticals. Although there are formidable
challenges to be encountered, the prospects of the
market expanding in a steadfast way look bright.
In India, there were no regulatory guidelines for
probiotic foods. In the absence of any such standards
and guidelines, there was great scope of products
being marketed with false claims. So an approach
was therefore needed for formulating guidelines and
regulations for evaluating the safety and efficacy of
probiotics in India. Keeping in view the above, a
Task Force was constituted by Indian Council of
Medical Research (ICMR), comprising of experts
from varied fields to develop guidelines for
evaluation of probiotics in food in India. An attempt
has been made by ICMR/DBT to frame the
guidelines for probiotic ingredients in food. The
guidelines deal with the use of probiotics in food and
provide requirements for assessment of safety and
efficacy of the probiotic strain and health claims and
labelling of products with probiotics [11].
COMPOSITION OF PROBIOTICS
DRUG THERAPY/ MEDICAL UPDATES
Probiotics are used for the benefit of humans since
Vedic times; its uses are as old as human civilization.
These products are aimed at delivering live bacterial
cells
to
the
gut ecosystem of humans and other animals.
Probiotics composition may contain bacteria, moulds
or yeast. But most probiotics are consisting bacterial
species. Lactic acid bacteria are most popular
amongst bacterial species. Commonly used bacterial
probiotic strains include Lactobacillus acidophilus, L.
casei, L.lactis, L. helviticus, L. salivarius, L.
plantrum, L. bulgaricus, L. rhamnosus, L. johnsonii,
L. reuteri, L. fermentum, L. del-brueckii,
Streptococcus thermophilus, Enterococcus faecium,
E. faecalis, Bifidobacterium bifidum, B. breve, B.
longum and Saccharomyces boulardii. So a probiotic
may be composed of a single bacterial strain or it
may be a combination of two or more than two
species as well. Probiotics can be in powder form,
liquid form, gel, paste, granules and are generally
available in the form of capsules, sachets, etc [12-13].
CATEGORIZATION OF PROBIOTICS
Probiotics are categorized under different categories
in different countries. They are considered under
different categories as natural health products
(Canada), dietary supplements, drugs, medical food,
live biotherapeutic agent, biological agent (USA),
functional food (Japan, China, Malaysia and India)
and also as food supplement (Sweden, Denmark, and
Finland), biotherapeutic/pharmaceuticals (European
countries like Belgium and Germany). These
categories for probiotics are defined separately by
different countries and are given in Table 1.
Table 1: Probiotic categories and their definitions
S.No
Category
Definition
1.
Probiotics
The live microorganisms which when administered in
adequate amounts confer a health benefit on the host.
2.
Functional foods
Food that has physiological functions, including regulation
of biorhythms, the nervous system, the immune system
and bodily defense beyond nutrient functions
3.
Dietary supplements
These are intended to supplement the diet; containing one
or more dietary ingredients (including vitamins; minerals;
herbs or other botanicals; amino acids; and other
substances) or their constituents and also to be taken by
mouth as a pill, capsule, tablet, or liquid; and is labeled on
the front panel as being a dietary supplement.
4.
Drugs
An article intended for the cure, mitigation, treatment,
diagnosis, or prevention of disease.
ISF College of Pharmacy, Moga, Punjab
Reference
[14]
[15]
[16]
[16]
PharmAspire: 4 Oct. 2013
DRUG THERAPY/ MEDICAL UPDATES
5.
Biological product
Product containing a virus, serum, or toxin applicable to
the prevention, treatment, or cure of a disease.
[16]
6.
Medical food
[17]
7.
Live biotherapeutic agent
8.
Natural health products
Products intended for external use in the dietary
management of a disease or condition for which distinctive
nutritional requirements have been established by medical
evaluation and is formulated to be administered under the
supervision of a physician.
A biological product that contains live organisms, such as
bacteria and is applicable to the prevention, treatment, or
cure of a disease or condition of human beings excluding a
vaccine.
It is defined as a substance, or a combination of
substances, a homeopathic medicine or a traditional
medicine, that is intended to provide a pharmacological
activity or other direct effect in:
• diagnosing, treating, mitigating or preventing a disease,
disorder or abnormal physiological
state or its symptoms in humans;
• restoring or correcting organic functions in humans; or
• modifying organic functions in humans, such as
modifying those functions in a manner that maintains or
promotes health.
MARKET POTENTIAL OF PROBIOTICS
ACROSS THE GLOBE
Probiotics is a growing segment of the industry,
employing bacterial culture as diet additives and/or
pharmaceuticals. As per the market survey, Europe
represents the first rank in terms of number of
products as well as the fastest-growing probiotic
market and Japan stood second in probiotics market.
In Japan also, probiotics are available as both foods
and drugs [19].
In European countries, the tradition of consumption
of natural probiotic products like fermented milk is
quite high. European consumers consume probiotics
in the form of foods and food supplement as well.
Within Europe, the dairy sector is the most developed
segment of the market having probiotic yoghurt and
fermented milk, and is used routinely as daily dose
by consumers. Probiotic dietary supplements have
been slow to gain acceptance, but new applications
are emerging all the time. Thus, it is no wonder that
the market for fermented dairy products with
probiotic bacteria has been successfully gaining
profit. The functional food market of probiotics is
clearly larger than that for probiotics sold in capsules,
sachets, and other pharmaceutical dosage forms.
Yogurt-type or fermented milk related drinks are the
fastest-growing product category, but the diversity of
probiotic food applications is not limited to milkbased products. Other products in market including
ISF College of Pharmacy, Moga, Punjab
[16]
[18]
probiotic fruit juices, berry soups, and soy- and
cereal-based fermented products are also sold. The
consumer market for probiotic foods is 11.4 billion
euros in Western Europe. Yoghurt and desserts, with
sales of ∼1 billion euros comprises the biggest sector,
and the probiotic milk market shares the major part.
Annual growth of sales is forecasted at ∼7–8% over
the next five years.
Japan is regarded as the birthplace of functional
food; the market of functional foods and probiotic
assisted products is significant and very well
developed [20]. On an average more than 1700
products under the category of functional food have
been launched in Japan between 1988 and 1998 with
an estimated turnover of around 14 billion US$ in
1999 [21]. The market was estimated to be 5 billion
US$ in 2003 [22] and 5.73 billion US$ in 2006, while
there are more than 500 products commercially
available and are marketed under the FOSHU label in
2005 [22-24].
The market in USA is also growing rapidly due to the
greater acceptance and affinity of the US population
towards the probiotic products along with the concept
of preventive health care. The USA currently
possesses the largest and most rapidly expanding
functional food and nutraceutical market around the
globe [25]. In 2006, industrial value of probiotics was
$21.3 billion [26]. This supports major imports from
Japan, North and South Korea, China, India, Brazil,
PharmAspire: 4 Oct. 2013
DRUG THERAPY/ MEDICAL UPDATES
the European Union (EU), Australia, New Zealand
and other parts of the World [25]. It has been
suggested for USA that about 50% of its highly rich
multi-billion dollar food market belongs to
nutraceuticals and functional food products [27], in
which probiotics are one of the major component.
Canadian market for nutraceutical and functional
food is relatively young and is growing steadily.
During the year 2003, Canadian trade in
nutraceuticals and functional foods assisted products
represented 3% of the global market compared to the
USA (35%) and EU (32%) [28]. Statistical data
shows that in 2002, the majority of Canadian
functional food and nutraceutical exports are to the
USA, Japan and the EU.
China emerges as the largest producer of nutritional
supplements globally and it is difficult for imported
products to compete on price alone. Companies
looking to produce nutraceuticals look forward to
establish production facilities in China to supply the
Chinese market or export to markets of other
countries. In China, more than 3,000 domestic
manufacturers of nutritional supplements accounting
for about 559 foreign brands and over 10,000 health
food products on the market. An estimated annual
increase in health food market value in china was
reported from RMB 133 to RMB 450 during the year
2010 and 2015 respectively. For the last decade sales
of vitamin and dietary supplements in China have
been increasing and are expected to grow at over 10
percent per annum by 2013. Japan, for the first time
introduced functional foods to the world in the 1980s,
comprises the largest percentage of the Asia-Pacific
market. But a dramatic growth in the sales of
functional foods products was seen in China over the
next several years. To elaborate, many companies
find it logical to use dairy products as a "delivery
vehicle" for functional ingredients, with effect of
which the dairy probiotic market in China has nearly
doubled in the past four years. The sales of probiotics
and other functional ingredients follow the
impressive growth of dairy products in China [25].
CURRENT STATUS OF
INDIA
PROBIOTICS
IN
Food industry of India is one of the hot spot for
investors. Since the awareness about the probiotic
and its health benefits has grown tremendously
among Indian population, demand for probiotic foods
has gained much popularity. Indian and multinational
companies are coming in to the picture since they
entered the Indian food industry in 2007. Indian
probiotic market was valued at $2 million as per 2010
estimates. According to figures released by US-based
research firm, Frost and Sullivan, in August 2012,
probiotic products in India generated revenue of US
$310 million in 2011. The market value supposed to
increase up to US $522.8 million by 2018. Currently
Milk and fermented milk products have 62% of the
market share in probiotic products (Indian Consumer
Survey, 2010).
Major pharmaceuticals companies have become
active and are trying to formulate newer drugs and
products, and packaged products like probiotic-based
nutritional supplements with special needs for
conditions
such
as
lactation,
pregnancy,
immunodeficiency etc and products specifically for
pediatric and geriatric patients. In India Amul, Nestle
and Mother Dairy are contributing a lot to probiotics
dairy products and acceptance amongst urban
population is helping to increase companies focus to
produce probiotics products [29]. Several probiotics
based pharmaceutical products are already available
in market. Some of them are given in Table – 2.
In India, probiotics are often widely used as animal
feed supplements for dairy animals like cattle,
poultry and piggery. Lactobacilli suspension is an
example of a probiotic formulation, usually given to
paediatric patients in India for wide variety of
therapeutic benefits. ViBact is the latest and recent
addition to the list of probiotics in India (composed
of genetically modified Bacillus mesentricus), which
acts as an alternate to B-complex capsules.
Sporulating lactobacilli are produced and are sold
with some of the antibiotic preparations in India.
Inspite of tremendous growth in last 3 years, Indian
market still has larger scope of commercial success in
near future as compared to western countries.
Table -2: Some commercial probiotic formulations in India.
Trade name/Dosage form and Name of manufacturing
associated use
unit/company
Eubioz (powder for oral Lupin
solution)
ISF College of Pharmacy, Moga, Punjab
Organisms used
Lactobacillus acidophilus
L. rhamnosus
Bifidobacterium bifidum
B. longum
Streptococcus thermophillus
Saccharomyces boulardii
PharmAspire: 4 Oct. 2013
DRUG THERAPY/ MEDICAL UPDATES
Bifilac (Tablet)
Diarrhoea as well as the
associated bloating, latulence
and constipation
Econova(Capsules)
Antidiarrhoeal
Goodlac (Capsules)
Tablets, Tamil nadu , India
Actigut (Capsules)
Alembic
Becelac (Capsules)
Lactisyn ( Injection)
Dr. Reddy Lab
Franco-Indian
Vi Bact (Sachet)
Unique Biotech Ltd
Vizyl (Capsules)
Unichem
Ecoflora (Capsules)
Tablets India Ltd

Allianz Biosciences (P) Ltd 
Sanzyme Ltd
Rexcel (Ranbaxy Laboratories
Ltd.)
Sporolac (Capsules and Sachet)
Binifit (Capsules)
Darolac (Sachet)
Glenmark
Biomilcom
Aristo
Ltd
pharmaceuticals
Pvt
L. sporogenes
S. faecalis
Clostridium butyricum
Bacillus mesentricus
L. Reuteri
L. Rhamnosus
L. acidophilus
L. rhamnosus
B. longum
S.boulardii
L. acidophilus
L. rhamnosus
B. longum
B. bifidum
S. boulardii
S. thermophillus
L. acidophilus
L. acidophilus
L. lactis
S. thermophillus
S. lactis
S. faecalis
C. butyricum
B. mesentericus
L. sporogenes
B. mesentericus
C. butyricum
L. sporogenes
S. faecalis
L. rhamnosus
L. reuteri
L. sporogenus
C. butyricum
S. faecalis
B. mesentricus
L. sporogenes
Lactic acid bacteria
CURRENT PLAYERS IN INDIAN PROBIOTIC
MARKET
its ice-cream sales and 25% of its Dahi (Indian
yoghurt) or pouched Lassi sales.
Amul
Gujarat Co-Operative Milk Marketing Federation
(GCMMF) is managing the Amul brand. Amul is the
largest food brand in India and was the first to foray
into the category with its probiotic ice creams
becoming widely popular prolife in February 2007.
Amul, on the other hand, becomes successful in the
probiotics category with its ice cream in February
2011, and is already in the process of test-marketing
pouched Lassi (sweetened curd) in Gujarat and some
parts of Maharashtra, and they have the future plans
of introducing it in the other parts of the country
soon. Probiotic products contribute to nearly 10% to
Yakult Danone
Yakult Danone India Pvt. Ltd has a rich heritage and
introduced its first product to India with the product
name Yakult in 2007. This is a collaborative effort of
Yakult (Japan) and Danone (France). Yakult is a
world leader in probiotic drinks having bacteria
belonging to Lactobacillus and Bifidobacterium
group. Bacteria Lactobacillus casei constitutes the
major part of this product. 65-ml Yakult drink consist
6.5 billion probiotic bacteria. Current availability of
this brand is in Delhi, Mumbai, Chandigarh and
Jaipur. The entry of Yakult in Indian market is
ISF College of Pharmacy, Moga, Punjab
PharmAspire: 4 Oct. 2013
expected to increase the visibility and growth of
probiotic category in India.
Nestle
Nestle, having recently declared dairy as its key area
of growth, is all set to introduce probiotics in its other
dairy products as well such as fermented milk,
yoghurt etc. The total packaged probiotic yoghurt
market in India is estimated at 40,000-60,000 tonnes
per annum, of which Nestle has a 30 per cent market
share. Depending on the country and business
internationally, the average contribution of probiotic
products to total dairy products is estimated between
10-20%. Nestlé‘s international dairy expertise, also
has introduced various flavors of probiotic products
specifically named as ‗Nesvita‘ and ‗Actiplus‘ in the
field of probiotic foods.
Mother Dairy
Under the Operation Flood Programme, a wholly
owned subsidy of the National Dairy Development
Board (NDDB), has settled Mother Dairy in 1974.
Currently, it is one of the largest milk
(liquid/unprocessed) distributing plants in Asia
selling more than 25 lakh liters of milk per day,
thereby enjoying a good market share of 66% of the
branded milk sales in New Delhi, capital of India. In
the year 1995, Mother Dairy ice-cream was launched
and which shows continuous growth over the years,
and today it boasts approximately 62% market share
in Delhi and NCR. b-Activ probiotic Dahi, b-Activ
probiotic Lassi, b- Activ curd and nutrifit (Strawberry
and Mango) are some of the company‘s marketed
probiotic products.
Karnataka Milk Federation (KMF)
KMF is the largest co-operative dairy federation
started in South India. Recently two probiotic
products of this industry are available in Karnataka
and Andhra Pradesh. Nandini Sugar Free Probiotic
frozen food is a first functional food, whose
characteristics are similar to ice-cream and it consists
ingredients such as probiotic bacteria (Lactobacillus
acidophilus and B. bacter), pre-biotic insulin and
fructooligosaccharide along with malt dextrin.
Probiotic Pharmaceutical Industries:
In India, as per current affairs, more than 30
pharmaceutical companies have launched probiotic
based drugs and dietary supplements. Almost every
pharmaceutical company has a brand of probiotic
drug and some are even being commercially
marketed off the counter. Recently a distribution
agreement have been signed within USV India
(which is a leading Indian pharmaceutical company)
ISF College of Pharmacy, Moga, Punjab
DRUG THERAPY/ MEDICAL UPDATES
and Swedish Biotechnology research company Probi,
which develops probiotics with well-documented
beneficial health effects, As per agreement, USV
recently launched Vibact IBS, based on the probiotic
formulation Probi Digestis, in India. Another major
player of pharmaceutical probiotic industry is Allianz
Biosciences (ABPL), which has launched an
exclusive Probiotic -Nutraceutical research &
manufacturing facility in India and is dedicated to
manufacturing high quality probiotic –nutraceutical
formulations complying with global quality
standards.
REGULATORY STATUS OF PROBIOTICS IN
INDIA
Probiotics is not new to us; they are exploited for the
benefit and well being of humans since very long
time. Probiotics is the rapidly expanding, active area.
There has been an increased influx of probiotic
products in probiotic revolution in India. During the
last decade probiotic products are growing
tremendously but acceptance is growing slowly. It
will take some time to change mindset of Indian
consumers.
Earlier
Probiotic
pharmaceutical
preparations were rarely used for human beings, but
now pharmaceutical formulations like Sporolac,
Saccharomyces boulardii and yogurt are commonly
used examples. In India, sporulating lactobacilli are
sold basically to prevent antibiotic induced diarrhea
especially for pediatric patients in market along with
some antibiotic preparation. As per current status,
probiotics are consumed as food and pharmaceutical
as well in the country and their regulatory status
differs due to their varying categories. In India,
Currently food and drugs are regulated by Prevention
of Food Adulteration Act (PFA) and Food and Drug
administration (FDA) respectively. The Food Safety
and Standards Act of 2005 (FSSA) defines the foods
for special dietary uses or functional foods,
nutraceuticals or health supplements (IMNA, 2010).
Probiotics in India are characterized as functional
food and currently are regulated by food laws that
regulate general food items rather than
pharmaceuticals or drugs. The Food Safety and
Standards Act (FSSA), 2005 was enacted out
considering the need for a single regulatory body and
consolidated food law. FSSA was passed by the
Indian government with the purpose to integrate and
streamline
the
many
regulations
covering
nutraceuticals, foods and dietary supplements.
According to FSSA, functional food were define
legally but still there was no differentiation between
different food categories, such as nutraceuticals,
biotherapeutic agent and hence there is further
PharmAspire: 4 Oct. 2013
requirement of effective well defined regulations;
guideline and suitable protocols. Clarification and
formulation of regulatory framework is very
necessary. Expansion of Indian standards like Indian
Pharmacopoeia should be there so that the final
product related to functional food/nutraceuticals
complies with or should be in accordance with their
safety and quality standards. Minimum standards
related to quality and content for food products are
set down by presently enforced PFA Rules. The PFA
regulates labeling and packaging of food products in
order that maximum information including the
ingredients, nutritional information, date of expiry,
manufacturer and manufacturing unit details and
country of origin and importer (for imported food)
with regard to the food product should be disclosed to
the consumer [19].
In India, earlier there were no specific regulatory
guidelines and systematic approach for probiotic
products as well, so in the absence of any such
standards and guidelines, there was great scope of
false claims being marketed. So an approach was
therefore needed for formulating guidelines and
regulations for evaluating the safety and efficacy of
probiotics in India. Keeping in view the above, a
Task Force was constituted by Indian Council of
Medical Research (ICMR) along with the
Department of Biotechnology (DBT), comprising of
experts from varied fields to frame regulatory
guidelines for evaluation of probiotics in food in
India. These guidelines have described set of
parameters to define a product/ strain as actual
‗probiotic‘. The guidelines deal with the use of
probiotics in food and provide requirements for
assessment of safety, health claims and labeling of
probiotic strains which would be helpful to the
consumers to safeguard their own interest [11].
ICMR-DBT Guidelines recommended for evaluation
of probiotics in food are as follows:
1. The probiotic strain nomenclature should be
in accordance and must conform to current
internationally recognized names.
2.
3.
Identification guidelines are given because
the effects of probiotics are strain specific.
Strain identification is identified as most
important parameter to check specific health
effect of a strain, to enable accurate
surveillance and epidemiological studies as
well. It should involve:
 Phenotypic identification
 Genotypic identification
Screening of putative probiotic strains by
following In vitro tests:
 Resistance to gastric acidity.
ISF College of Pharmacy, Moga, Punjab
DRUG THERAPY/ MEDICAL UPDATES


4.
5.
6.
7.
8.
9.
Bile acid resistance.
Antimicrobial activity against
potentially pathogenic bacteria
(acid and bacteriocin production).
 Ability to reduce pathogen
adhesion to surfaces.
 Bile salt hydrolase activity.
In vivo safety studies in animal models are
suggested to be carried to access acute,
subacute and chronic toxicity of ingestion of
extremely large amounts of probiotics for all
potential strains.
In vivo efficacy studies in animal models to
substantiate in vitro effects.
Evaluation tests for safety of probiotics for
human use are important and should be
carried to assure safety, even for bacteria
that are Generally Recognized as Safe
(GRAS), and strains needs to be
characterized at a minimum with the
following tests:
 Determination
of
antibiotic
resistance patterns.
 Assessment of undesirable sideeffects.
 Tests for toxin production and
hemolytic activity respectively if
strain belongs to similar category.
Evaluation of efficacy studies in humans
should be carried by human trials. The data
related to statistically and clinically
significant improvement in condition,
symptoms, signs, well-being or quality of
life, reduced risk of disease or longer time to
next occurrence or faster recovery from
illness should be recorded.
Minimal effective dosage of probiotic strain
/ strains or the level of viable cells or the
probiotic strain in terms of cfu/ml/day that
required for general health promoting
functions or specific health claims in target
population should be clearly indicated.
Labeling requirements must follow general
labeling requirements and the following
information must be mentioned on the label:
 Genus, species and strain designation
following the standard international
nomenclature.
 The minimum viable numbers of each
probiotic strain should be specified at
the level at which efficacy is claimed
and at the end of shelf- life.
 Evidence-based health claim(s) should
be clearly stated.
PharmAspire: 4 Oct. 2013



DRUG THERAPY/ MEDICAL UPDATES
The suggested serving size to deliver the
minimum effective quantity of the probiotic
related to the health claim.
Proper storage conditions to be mentioned.
Good Manufacturing Practices must include
adequate quality assurance programmers.
Good Manufacturing Practices should be
followed in the manufacture of probiotic
foods, hazard analysis and Critical control
point.
These guidelines have a provision to access the
efficacy, safety and health benefits of probiotic food
ingredients and fulfill some essential prerequisite
conditions before being used for the internal use by
humans.


ILSI (International Life Science Institute) has also
given guidelines for probiotics in food products. As
per the FAO/WHO and ICMR/DBT, these guidelines
also had considered the evaluatory part, which
involves the genus, species and strain identification
by phenotypic as well as genotypic methods. Then
test methods are given to check the potential of
bacteria for possessing probiotics properties. These
guidelines had demonstrated in vivo tests to correlate
in vitro tests for evaluation of safety of probiotics to
humans and also had considered scientific committee
report on revision on essential requirements of infant
food formula. Under the part of efficacy evaluation
demonstration of dose or cfu ingested per day, period
of use and scientific substantiation of health claims
are also mentioned [30].
Strain Identification by Phenotypic and Genotypic Methods
Genus, Species and Strain
Deposit strain in an Internationally Recognized collection
Screening of Potential Probiotic Strains
 In vitro Tests
-
In vivo studies in validated animal models for:
Safety
- Efficacy
In vivo studies in humans for clinical evaluations
Phase1-safety/Phase 2-efficacy/Phase 3-effectiveness*
PROBIOTIC FOODS




Labeling Requirements
Genus, Species, Strain
Minimum viable numbers of probiotics at the level at which efficacy
is claimed and at the end of shelf- life.
Health claim(s)
Serving size for efficacy and stability conditions
Figure1: Evaluation of probiotics in food [Adopted from ICMR-DBT guidelines].
ISF College of Pharmacy, Moga, Punjab
PharmAspire: 4 Oct. 2013
DRUG THERAPY/ MEDICAL UPDATES
products are good for the child‘s health but
these products may have adverse effects on
child health as immune system of the child
has not evolved completely. Along with
child health, these products may have
adverse effect on the persons having
compromised immune system because of
another disease like diabetes, cancer or
AIDS, probiotics may have ill effects.
PROBLEMS ASSOCIATED WITH CURRENT
REGULATIONS
Indian probiotic market has variety of probiotic
products, made by companies like Nestle, Mother
Dairy, Amul and Yakult and hence Indian probiotic
market is going to presents a rosy picture in the
future. According to market research firm, Markets
and Markets, the probiotics market is expected to be
worth US $32.6 billion globally by 2014. Probiotic
food products entered the Indian market six years
back but there are no regulations to ensure the safety
for all kind of probiotic products although the Indian
Council for Medical Research and the Department of
Biotechnology have drafted guidelines for probiotics
in food. Still there are some unresolved issues that
prompt the regulators to set a full-fledged set of
guidelines to govern use of probiotics in food as well
as drugs.

In India, food products are sold as food but
the therapeutic effect that they intend to
have takes these products beyond the limit
of ordinary food articles.

The purpose of the use of probiotic product
is not to replace drugs rather the therapeutic
claims by manufacturers has made an
unavoidable force on the authorities to
define parameters and guidelines separately
in order to regulate their quality and claims.

Due to rapid commercialization and increase
in market turnover and use of probiotics as
pharmaceuticals, their strict regulation like
medicines is the need of the hour.
The commercial strains currently used in
India are procured from other countries and
hence these are of foreign origin. New
species and more specific strains of
probiotic bacteria are constantly being
reported as novel probiotics products due to
their novel health benefits. So the use of
these novel strains into our own food and
pharmaceuticals need to have a careful
evaluation of their efficacy and safety
assessment.


It is too complicated to prove certain health
effects claimed by different companies or
impact of probiotics on various diseases due
to lack of conclusive evidence about them
and in this state, one cannot comment
whether the claims made by firms are true or
not true.

Companies glorify their products by
advertisement before marketing and
customers have a misconception that their
ISF College of Pharmacy, Moga, Punjab

Another associated problem is that Gut
microflora varies from individual to and
hence single probiotic strain or food cannot
have a more than 60 per cent success rate.
FUTURE RECOMMENDATIONS
With large number of multinational companies
entering the probiotic business, an erroneous increase
in market value is there. Today markets are flooded
with a range of commercial probiotic products. Due
to wide therapeutic benefits and their use in treatment
and prevention of clinical disorders with negligible
side effects, probiotics are much more preferred over
the conventional dosage forms such as antibiotics.
So, proper well defined regulatory guidelines must be
there for the manufacturing and sale of probiotics to
increase consumer acceptance. US Food and Drug
Administration and the European Food Safety
Authority have stringent regulations to monitor
products entering the market; no such regulations
exist in India, which should be drafted based on
following recommendations.
1. Adoption of the definition of probiotics.
2. There must be a list of microbes with safe
history of use as like that proposed by
EFFCA (as under inventory of microbes
with documented history of use).
3. Further development of methods (in vitro
and in vivo) to evaluate the efficacy and
safety.
4. While
assessing
probiotic
function,
validation of biomarkers should be done.
Testing of predictions based on biomarker
studies with actual results in human clinical
evaluations is needed. Biomarker validation
in the areas of immune system, cancer, and
gut micro-ecology is especially important.
Once validated, biomarkers will be useful
tools to assess dose-dependence and strainspecific responses.
5. A list of allowable and non allowable health
claims must be there which is further
supported with scientific data.
6. Clinical trials of probiotics of exogenous
origin must be carried out on Indian
PharmAspire: 4 Oct. 2013
population as there are gut to gut variations
in people.
7. GMP issues along with site and product
licensing need to be included in ICMR
guidelines. Before delivery to consumers,
they must be able to be manufactured under
industrial conditions and then survive and
retain their functionality during storage as
frozen or freeze-dried cultures and also in
the food products into which they are finally
formulated.
8. A complete approval process must be there
covering all aspects of INDA and NDA
submission along with the dossier
requirements.
9. A logo/symbol/mark should be there which
symbolizes that a particular probiotic
product is of a standard quality and is
manufactured well in accordance with GMP
practices and pass through the various
clinical trial phases assuring its safety and
efficacy.
10. Use, adoption and promotion of revised
guidelines in future for safety of consumers
and better product acceptance.
Currently Indian consumer is in dilemma about the
acceptability of probiotic foods due to lack of
awareness and the credibility of health claims
associated with probiotic products. In the absence of
any regulatory standards, there would always be a
possibility of spurious and ineffective products with
false claims entering the market that can shatter the
confidence of Indian consumers in probiotic
products. So the government needs to take step
forward to draft guidelines specifically for probiotic
pharmaceutical preparations rather considering as
food. After making the desired regulations if some
products don‘t meet the regulated criteria, they will
surely be taken off the shelves. If the companies
standardize the sale procedures and create the right
kind of awareness, the players will surely be with a
winning proposition. Excellent growth opportunities
exist for domestic and foreign companies to
capitalize the prevailing situation and produce
resounding results. This will prevent the flooding of
markets with misbranded products.
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