Accepted Manuscript

The emergence of India as a blossoming market for nutraceutical supplements: An

overviewoverview

Swapnil Dylan Fernandes, Narayana Charyulu R, Anoop Narayanan V

PII: S0924-2244(18)30565-X
DOI: https://doi.org/10.1016/j.tifs.2019.02.017
Reference: TIFS 2423

To appear in: Trends in Food Science & Technology

Received Date: 10 August 2018

Revised Date: 6 November 2018
Accepted Date: 6 February 2019

Please cite this article as: Fernandes, S.D., Charyulu R, N., Narayanan V, A., The emergence of India
as a blossoming market for nutraceutical supplements: An overviewoverview, Trends in Food Science &
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THE EMERGENCE OF INDIA AS A BLOSSOMING MARKET FOR
NUTRACEUTICAL SUPPLEMENTS: AN OVERVIEW

Swapnil Dylan Fernandes, Narayana Charyulu R, Anoop Narayanan V*

Department of Pharmaceutics, NGSM Institute of Pharmaceutical Sciences, NITTE
(Deemed to be university), Paneer, Mangalore, Karnataka, INDIA.

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Corresponding author
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Dr. Anoop Narayanan V

Department of Pharmaceutics,
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NGSM Institute of Pharmaceutical Sciences,

Nitte University, Paneer, Deralakkatte,
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Mangalore, Karnataka, India – 575018

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Email: [email protected]
Mob: +919902823433
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THE EMERGENCE OF INDIA AS A BLOSSOMING MARKET FOR
NUTRACEUTICAL SUPPLEMENTS: AN OVERVIEW

ABSTRACT

Background: In today’s world where chronic lifestyle diseases are on a rapid ascent among

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the masses, nutraceuticals have firmly established themselves as key to human health owing
to their disease prevention advantages. India, in particular, has witnessed an upswing in the

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acceptance of nutraceuticals as a viable option for maintaining optimum health.

Nutraceutical Market in India: In the last five years, the nutraceutical market here has

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flourished into a $3 bn industry and is expected to grow to a $6.1bn by the year 2022. Until

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the turn of the century, the existence of innumerable laws with respect to the nutraceutical
industry created a state of uncertainty in the minds of nutraceutical manufacturers in India.
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The regulations: However, the introduction of the Food Safety and Standards Act (FSSA)
has reinforced regulations with respect to nutraceuticals, creating a regulated space for
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manufacturers to conduct their business in.

Conclusion: Today, the Food Safety and Standards authority of India (FSSAI) ensures that
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regulations for nutraceuticals in India are at par with the international standards.
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KEYWORDS

Nutraceuticals; FSSAI; Food Safety Standards Act; Nutraceutical Regulation; Dietary

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Supplements.

1. INTRODUCTION
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Since time immemorial, man has looked towards a wide variety of raw materials procured
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from both naturally occurring substances as well as synthetic origins, in an effort to produce
medicines. About 2000 years ago, the father of contemporary medicine, Hippocrates,
considered one of the most highly regarded physicians that the world has seen,
conceptualised the correlation between food and optimum health. He regarded food as the
key to maintaining peak health conditions in human beings and eventually reached the
conclusion that food can act as medicines for the human race. “Let food be thy medicine, and

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medicine be thy food.”, this statement by Hippocrates served as the very basis for the notion
of nutrition-based pharmaceuticals or Nutraceuticals, as we know them today. The word
nutraceutical was initially defined in 1989 by Dr. Stephen L. DeFelice, chairperson of the
Foundation of Innovation Medicine, which was also known as the FIM. Dr. DeFelice coined
the term nutraceutical as an amalgamation of the words ‘nutrition’ and ‘pharmaceutical’,
meaning a substance that is obtained by isolation or purification of foods and is sold in forms

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that are usually not related to food and bear a resemblance to pharmaceuticals, having
potential physiological advantages. (Gupta, Chauhan, Mehla, Sood, & Nair, 2010)

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The early denotation of nutraceuticals as a supplemental food has now evolved to specify a
broad range of substances such as tablets, capsules, powders (potions) etc. containing a wide

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array of vitamins, minerals, herbs and other botanicals, and dietary products meant to be

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utilized by human beings as a supplement diet. In fact, Health Canada defines nutraceuticals
as “a product prepared from foods, but sold in the form of pills, or powder or in other
medicinal forms, not usually associated with foods.”
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Today, the nutraceutical industry has blossomed into an expansive entity fuelled by intensive
efforts to recognise characteristics and prospective uses of nutraceutical products, coupled
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with consumer interest and requirements. (Keservani et al., 2010) This upward progression of
the nutraceutical industry can primarily be attributed to the emergence of ‘lifestyle diseases.’
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Food practices, in particular, have suffered due to changes in the lifestyles of individuals. The
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consumption of unhealthy food, or junk food, as is commonly referred to, has witnessed a
massive surge which has resulted in an array of nutritional deficiencies in the public. This has
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inadvertently led the public towards adopting nutraceuticals, considering that it is a safer and
quicker approach for making up any deficiency in nutrition. (Pandey & Saraf, 2015)
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Although the concept of nutraceuticals has gathered steam with the turn of the century, the
original nutraceutical revolution started back in the early 1980’s when a clinical study
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publicised the probable clinical merits of calcium and fish oil. At the same time, registered
practitioners of various medical branches took it upon themselves to educate their colleagues
and the public about the potential benefits associated with the adoption of nutraceuticals, via
the mass media. (Majaz, I, Nazim, Asir, & Shoeb, 2012)

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2. NUTRACEUTICALS IN INDIA

India, presently the second most populous nation in the world, is set to become the most
populated nation by the year 2024. Currently, it is estimated that India is home to over 1.25
billion people. Nutrition care, which is an essential element of preventive health care, is
simultaneously experiencing a major evolution in India. Given the switch in food practices, a
relative lack of awareness in a swiftly growing middle-class population, and an alteration in

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the public choices when it comes to health, food alone cannot completely service the
nutritional requirements of the human body. Therefore, supplementing it with health

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supplements and nutraceuticals has become imperative. In India, the prevalence of Ayurveda,
the ancient Indian medicinal system, has also helped in the acceptance of modern-day

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nutraceuticals. Ayurveda, which has its roots in herbal sciences, has long promoted the use of

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products such as Chyavanprash, containing fortified ingredients aimed at improving the
overall health of an individual, and botanicals like ashwagandha, triphala etc. Ingredients
such as turmeric, chillies and garlic have been added to the Indian diet for centuries now due
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to their nutritional and therapeutic benefits. Apart from this, in recent years, fortified products
such as Vanaspati with vitamin A and salt with iodine have also been made available in the
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market. (“Potential for functional foods in the Indian market,” 2018)

From the viewpoint of a consumer, nutraceutical products host an array of benefits and
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advantages some of which are as stated below:

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• Consumption of nutraceuticals will increase the health value of an individual’s diet.

• An increase in health value will, in turn, help increase the lifespan of individuals.
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• Also, nutraceuticals will aid in evading particular medical conditions.

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• Nutraceuticals may pose psychological benefits.

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• Nutraceuticals are considered to be less likely than traditional medicines to produce adverse
effects and in some cases are identified recognised as more natural.

• Nutraceuticals may provide people with special needs with food options. (e.g. nutrient-rich
food for geriatric consumers).(Pandey & Saraf, 2015)

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2.1. Nutraceuticals in India – A Brief Look at the History

India lays claim to being one of the largest harvesters of fruits and vegetables on the planet,
however, only a minuscule portion of these products are processed. The percentage of
perishable agricultural products processed in India stands at approximately 2%.(Kumar,
Rajiv, & Proudyogiki, 2014) This shockingly low percentage is a representation of issues
such as poor infrastructure and inflexible laws that have been plaguing the nutraceutical

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system in India over the years. Multiple policy designers and a confusing regulatory scenario
created by the regulatory agencies were equally responsible for lacklustre growth of this

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sector.

However, the early 90’s saw the framing of food processing laws in a genuine and authentic

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manner, that for the first time, provided the food and nutraceutical sector in India with an

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established framework of regulations. This framework of regulations was an amalgamation of
both state as well as national laws, some of which included the Export Act 1963, the
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Insecticide Act 1968, Meat Food Products Order 1973, Bureau of Indian Standards (BIS) Act
1986 as well as the Food Product Order 1995. Apart from the above-mentioned laws, the
framework incorporated several other rules, acts and orders such as the Agriculture Produce
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Act and the Essential Commodities Act 1995.

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In the year 1998, a single consolidated food regulatory authority was endorsed by a
subjective committee set up by the Prime Minister’s office. The reason for this endorsement
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was to do away with the confusion created by a multidepartment approach and to merge all
rules and acts with regards to the food sector. This endorsement was backed by several public
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experts and also representatives of the Standing Committee of the Parliament. (Kumar et al.,
2014)
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A report presented by the Ministry of Health in the year 2003 emphasised on the need to
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devise new categories for carrying out the effective regulation of functional foods and dietary
supplements. It also stated that safety inspection and evaluation of such products should be
made obligatory and that the discretionary standards be brought under the BIS and the
National Standards body. In 2005, several committees of the government once again stressed
on the need for a single regulatory authority for the food, governed by a single unified law
and this need was acknowledged by the passage of the Indian Food Safety Standard Bill,

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2005. The bill was enforced as an Act in 2006 with the aim of ushering in an era of major
scientific development with regards to the functional foods and dietary supplements industry.

2.2. Nutraceutical Regulation in India

The Food Safety and Standards Act (FSSA), 2006 provided for the establishment of the

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FSSAI i.e. the Food Safety and Standards Authority of India, for devising scientific standards
for food substances and to supervise all aspects associated with the food industry. The

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Ministry of Health and Family Welfare was the Administrative Ministry for the enactment of
the FSSAI. Since the FSSAI was tasked with the responsibility of overseeing activities

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carried out with regards to the manufacture, storage, sale and distribution of the substances
meant for human consumption, this brought dietary supplements as well as nutraceuticals

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under its jurisdiction. (Smarta, 2017)

The FSSAI is an apex regulatory authority, that comprises of 22 members and is headed by
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the Chairperson. It is ably served in its endeavour by the Central Advisory Committee
(CAC), Scientific Panels and a Scientific Committee, each having its own set of tasks and
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duties to carry out. The Government of India, on September 2008, notified the establishment
of the scientific panel and committee and also put in place their executive procedures.
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Some of the key highlights of The Food Safety and Standards Act, 2006 are as stated below:
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1. The FSSA provides for the creation of scientific panels. These scientific panels will
consist of the independent scientific experts.
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2. The scientific panel can ask industry and public representatives to be a part of its
contemplations.
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3. The Food Authority can create as many panels as it deems fit, as long as it is not
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found to be prejudiced towards the regulations under sub-section (1). The additional
panels may include panels on-
a. Food additives, materials in contact with food and processing aids.
b. Pesticides and antibiotic residues.
c. Genetically modified organisms.
d. Functional foods, nutraceuticals, and other similar products.
e. Biological hazards

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f. Labelling
g. Sampling and analysis methods.
4. The FSSAI may, as it sees fit, re-organise the Scientific panels by the addition of new
members or by the omission of old members.
5. As per the regulations stated under this Act, an individual is not permitted to carry
out the manufacture, sale, distribution and import of any food which is considered

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novel, irradiated, organic, functional or food for special dietary uses, nutraceuticals
etc., which the Government of India may notify with this respect.(M. C. Singh &

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Gujar, 2013)

In India, due to the absence of a clearly outlined regulatory framework, the regulations for the

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manufacture, marketing, import and exports of nutraceuticals are yet to be conceptualised.

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However, with the introduction of a distinct third category for “Foods for Special Dietary
Uses/Functional Foods/ Nutraceuticals/ Health Supplements” apart from the categories for
“conventional foods” and “drugs” by the FSSA, there now exist distinct regulations that will
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have to be met by all individuals engaged in the development of these products. Presently, the
Prevention of Food Adulteration Act, 1954 and its subsequent amendments govern the
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nutraceutical sector in India. GSR No. 664(E), that allows certain claims based on health and
nutrition, and certain specific provisions of the Drugs and Cosmetics Act in particular play an
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important role in the governance of activities related to the development of nutraceuticals.

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(Palthur, Sajala Palthur, & Chitta, 2010) Table 1 illustrates the definitions of the categories of
food as per the FSSAI and their respective uses.
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2.3. Current Regulatory Requirements

According to the Food Safety and Standards Regulations, 2015, Nutraceuticals have been
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defined as “Substances that are intended to furnish physiological benefits to the consumers
and help nurture good health.” These can include capsules, chewables, powders and tablet
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forms and the regulations also specify that “a food business operator (FBO) may extract,
isolate and purify nutraceuticals from both food and non-food sources.” The FSSAI has now
regulated the nutraceutical sector by creating a separate set of rules and regulations with
respect to the manufacture, licensing, registration and claims for nutraceuticals. (Dalmia,
2018)

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FBO’s engaged in the manufacture of nutraceuticals need to expressly follow the new
standards laid down by the FSSAI. It has stated that ingredients used in the manufacture of
nutraceuticals shall be identified under Schedules I, II, IV, VI, VII, or VIII of the regulations.
Schedule I comprises of a series of vitamins and minerals whilst Schedule II is composed of
essential amino acids and various nutrients. Ingredients of botanical origin including plants
are stated under Schedule IV and Schedule VI provides the complete list of ingredients used

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in nutraceuticals. Schedules VII and VIII state the series of probiotic and prebiotic
compounds that can be utilised in the preparation of nutraceuticals.

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With respect to the amount of nutrients that can be inculcated in a nutraceutical, the
Recommended Dietary Allowance (RDA) provided by the ICMR shall be referred to. When

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the RDA does not specify such standards for a specific nutrient, then the Codex Alimentarius

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Commission shall be made use of. The Codex Alimentarius Commission is an international
food standards body that provides information on the adequate amount of a particular
ingredient that can be inculcated during the manufacture of a nutraceutical. The FSSAI states
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that no ingredient apart from those mentioned in Schedule VI shall be made use of as a
nutraceutical. In case of ingredient extracts being used, only those that are mentioned under
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Schedule IV can be utilised and the utilisation of such extracts shall be in ratios that are in
accordance to the day-to-day nutritional value. For additives used in the formulation of
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nutraceuticals, Schedules VA or VE or VF shall be referred to. The FSSAI, in its regulations,

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clearly states that the daily minimum and maximum usage levels shall be kept in mind when
formulating nutraceuticals. If these levels aren’t specified, then the manufacturer or the FBO
must adopt appropriate utilisation levels based on appropriate scientific evidence and
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documentary data and shall provide the same to the FSSAI as and when required.(“FSSAI
Key Requirements for Manufacturing Nutraceuticals in India,” 2017)
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Each individual FBO in the food sector requires appropriate licenses or registration
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certificates from the local authorities prior to proceeding with the sale of nutraceuticals.
Import licenses, manufacture licenses and any further clearances from the regulatory
authority should be obtained prior to introducing these products in the market. The FSSAI
has ensured that the licensing and registering of the nutraceuticals will be a simple process in
spite of various parameters being involved.(FSSAI, 2017)

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The registration of nutraceuticals can be carried out by means of an online portal created by
the FSSAI. The application for registration shall be submitted by the FBO to the respective
state regulatory office of the FSSAI. This application shall be submitted to the authority
within 15 days of submitting the online application. Along with the application, the requisite
fees and documentary evidences shall be furnished as a part of the submission package. The
entire list of documentary evidence required for nutraceutical registration is as follows:

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(Yadav, Mittal, & Pandey, 2014)

Form B duly signed by the Authorised Body.

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Blueprint/Layouts plan for the processing unit.
List of Directors with the complete contact information.

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Name and list of the equipment and machinery used.

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Photo I.D. with address proof issued by the Government.
Food category to be licensed.
Water analysis report.
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Proof of premises possession.
Food Safety Management System Plan.
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NOC from the Manufacturer.

Food Recall Pan.
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DGFT registration certificate of Importer Exporter.

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NOC’s from municipality/local body.

The procedure for carrying out the registration of nutraceutical products in India is as
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illustrated in Figure 1. (Yadav et al., 2014)

2.4. Global Nutraceutical Laws in Comparison to India

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The United Nations Food and Agricultural Organisation (FAO) and the WHO in the Codex
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Alimentarius provided the landmarks and guidelines for determining the safety and
applicability of nutraceuticals. Many major global bodies and countries make use of these
guidelines, which characterise health claims with respect to nutrient function, enhanced
function and reduction of risk. Here, the nutrient function claim does not expressly refer to
the favourable health effects of the nutrient.

In the USA, the FDA, which is the regulatory authority for dietary supplements, applies the
regulations under the Dietary Supplement Health and Education Act, 1994 to regulate
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nutraceuticals. On the other hand, in the EU, the EFSA i.e. European Food Safety Authority
governs the regulations of nutraceuticals. Whilst the FDA and the EFSA are both premier
nutraceutical regulatory bodies, there exist certain differences in the manner in which they
carry out their functions. With respect to health claims, the FDA has to be notified at least 4
months prior to introduction of the supplement in the market and this claim can be sanctioned
based on appropriate statement issued by the Academy of Sciences. However, the same

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mandate is not followed in the EU as the EFSA must compulsorily approve of the health
claims associated with the supplement. The supplement will then be set particulars by each

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member state of the EU for approval.

In comparison, the FSSAI in India under the draft regulations for nutraceuticals and foods for

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special diets and medical purposes, 2015, has made it mandatory for manufacturers of

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nutraceuticals to establish adequate data for health claims and submit the same as evidence
for establishing the health claim. The product can be released to the market only after
approval of the health claim by the FSSAI. However, currently, nutraceuticals have not been
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ascribed any particular legal status in India and are considered similar to food products
without any disclosures about nutraceuticals with clinical trial results.
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In general, several nations including Australia, China and Brazil regulate nutraceuticals as a
category of food with the regulations established for food products being applicable.
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However, these countries have stricter regulations which require the conduct of animal and
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human clinical study before a valid health claim for the nutraceutical can be attributed.
(Santini et al., 2018)
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Further comparison of the regulations of India with more developed countries like the USA,
EU and Australia illustrate that the registration of nutraceutical products in such countries is
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inherently easier because of the fact that the requirements stated are more specific and
thereby less time consuming than in India where there still exists uncertainty with regards to
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submission procedures and documents for registration of nutraceuticals and dietary

supplements.

3. PRESENT DAY SCENARIO OF NUTRACEUTICALS IN INDIA

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Today, the nutraceutical market in India is advancing at a brisk CAGR of 17.1% and is nearly
worth a whopping Rs 22000 Cr ($3.0 billion). (“Potential for functional foods in the Indian
market,” 2018) Nutraceuticals have bested the pharma dominated supplement market, which
is evident by the 67% share occupied by the nutraceutical market. Increased public
understanding and health responsiveness have contributed to this shift in consumerism
towards nutraceuticals. As per recent estimates, the nutraceutical market in India is

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significantly condensed in the South, followed by the East and is gaining serious traction in
rural areas as well with the population there getting familiar with the concept of lifestyle

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diseases. (India Infoline News Service, 2018)

3.1. Current Trends in nutraceutical formulations in India

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i. Development of new dosage form trends.

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One of the difficulties faced by nutraceutical products is with regards to their
formulation. In addition to flavour and fragrance, the manufacturer needs to ensure
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that the active ingredient stays stable in the finished product for prolonged durations.
Also, consumers are always on the lookout for additional benefits from delivery
techniques. Considering all this, the nutraceutical industry needs to put in extreme
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efforts to carve a niche for itself and to manufacture a product that can act as an
answer to all consumer needs and industry requirements. Hence, today it can be seen
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that traditional dosage forms such as tablets and chewable tablets are gradually being
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succeeded by capsules.(Shirwaikar & Khan, 2011)

ii. The emergence of Capsules
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The emergence of capsules as dosage forms for nutraceuticals is majorly public

driven. The public, in general, tends to side towards capsules as dosage forms due to
their relative ease in swallowing. Also, they have been proven to be quicker and more
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effective than tablets and chewables, in terms of exhibiting action, particularly the
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liquid filled capsules. Apart from consumer interest, manufacturer interest also comes
into play as capsule preparation requires a lesser number of excipients and process
steps, which will directly lead to quicker development of nutraceutical products. To
top it all, capsules provide brand recognition in a nutraceutical market that is already
jam-packed with several nutraceutical products.(Amit Verma, 2017)
iii. Liquid Encapsulation Technique: The future

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With each passing day, rapid advances are being achieved in encapsulation techniques
employed for the manufacture of nutraceuticals. The core objective is to provide
enhanced moisture protection, bioavailability, and stability. In addition to this, FBO’s
want to offer nutraceuticals that are capable of providing a timed release and also a
targeted release, if and when needed. The Liquid Encapsulation Technique, also
known as LET, is establishing a brand-new standard for encapsulation of dietary

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ingredients in capsules. Apart from this, nutraceutical companies are provided with
the possibility of inculcating liquids, pellets, and powders in capsules, by means of

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adopting novel formulations.(Amit Verma, 2017)
iv. Novel Liquid-Filled Capsules

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Liquid filled capsules offer a wide array of benefits to consumers as mentioned above.
They are highly convenient in case of supplements containing extracts and oils. Apart

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from this, certain nutraceutical compounds such as omega-3-fatty acids are poorly
soluble substances. This is a major concern for nutraceutical manufacturers, as such
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substances are likely to drive up the investment in developing technologies for the
formulation of these fat/oil-based supplements. Hence, liquid encapsulation provides
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an ideal solution for this difficulty. The liquid encapsulation technique also offers
manufacturers the ability to present enhanced protection to the dietary ingredients
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present within the capsules. The capsules will also be able to mask taste and fragrance
by virtue of this encapsulation technique. Evidence has also been presented that states
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that the bio-availability of certain nutraceutical ingredients is found to improve when

liquid filled capsules are used.
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In terms of product differentiation, capsules are found to be visually distinct and

attractive which also aids in decreasing the instances of counterfeiting.(Amit Verma,
2017)
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3.2. Key Stakeholders

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i. General Practitioners and Dieticians

In modern-day India, where urban classes and also certain sections of the rural classes
are health and fitness conscious, dieticians and general practitioners have a key role to
play in urging the public to adopt nutraceuticals. Dieticians have assumed the role of
influencers, as diets play an important role in developing the health of an individual.
Similarly, general practitioners play an equally important role considering that they

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continuously evaluate the prevalence of lifestyle diseases in individuals and prescribe
appropriate supplements to counter the effects. These stakeholders are contemplated
to be highly influential as their recommendations are considered ‘Medical Advice.’
Prescription behaviour across different cities of the country varies vastly, as can be
evidenced by the example of tier 1, tier 2 and tier 3 cities. In tier 1 cities, the
probability of nutraceuticals being prescribed to patients is higher as compared to tier

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2 and 3 cities. However, this is accompanied by higher chances of side effects that
may arise due over-consumption. Similarly, prescription behaviour is also affected by

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the age of the patient. For instance, an individual aged 18 or below is prescribed pure
protein by practitioners.(Amit Verma, 2017)

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ii. Emerging Trends in Value Chain/ Distribution
For emerging sectors such as nutraceuticals, distribution chains are crucial to ensuring

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their success. An efficient distribution system plays a major role in establishing and
maintaining customer confidence, brand development and precipitating the outreach
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of such products. Modern-day distribution channels include merchandising
nutraceutical products, which helps improve its availability amongst the masses. Most
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of the times, nutraceuticals are sold as Over the Counter substances, and therefore
pharmacies are recognised as standard channels for procuring nutraceutical products.
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Apart from this, several outlets have been established all over the country solely for
the purpose of making functional foods and dietary supplements available to the
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masses. Gymnasiums these days too procure and maintain a stock of nutraceuticals in
order to encourage their use amongst members of the gym whilst numerous
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nutritionists also serve as dispensation points for such substances.(Amit Verma, 2017)
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4. THE FUTURE OF NUTRACEUTICALS AND CHALLENGES AHEAD

The nutraceutical industry in India has an extremely bright future ahead. It is expected to
achieve more than double its current valuation in the coming years, which has provided
much-needed encouragement to researchers dealing with nutraceuticals to pursue
nutraceutical-based studies in different fields.(“Indian Nutraceuticals Market - Nutraceuticals
World,” 2009) In recent years, development of nutraceuticals has been taken to the next level

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by researchers bringing genetics into the picture. The recognition of Single Nucleotide
Polymorphisms (SNP’s) in the public has been key to speculating responses of individual
human beings to drugs. Thus, pharmacogenetics has given rise to Nutritional genomics, a
branch that inculcates both ‘Nutrigenomics’ and ‘Nutrigenetics.’ Whilst Nutrigenomics deals
with the interaction of dietary compounds with genomes, Nutrigenetics refers to the studying
of gene-based distinctions in reply to the dietary compounds and utilising this data to produce

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nutraceuticals that are highly suitable to human health. Both Nutrigenomics and Nutrigenetics
can make way for a new chapter in this history of nutraceuticals and functional foods in India

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as well as across the world.
In addition to newer developments in the nutraceutical field, disease deterrence is another

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aspect that is constantly monitored by researchers. Edible oils, in particular, have taken a
leading position in this area, with high PUFA oils being used to reduce the risk of cholesterol

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and heart diseases. Herb-based nutraceuticals are not far behind in terms of consumption by
consumers to keep their cholesterol and sugar levels in check. These segments are only going
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to show an exponential increase in the years to come in the Indian market, owing to the
lifestyle changes in the urban population as well as some sections of the rural population,
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leading to a surge in the number of heart-related conditions, stress and obesity. (“India: A
Challenging Growth Market - Nutraceuticals World,” n.d.)
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In terms of challenges faced by the Nutraceutical sector in India, two major aspects that need
addressing are the establishment of clear regulatory directions and authenticity of labelling
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claims. Since food regulations are meant to secure the consumer interest and improve
economic feasibility whilst encouraging fair trade amongst countries, it is essential that these
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issues be dealt with immediately. Recommendations on this front are as follows –

Improved collaboration between Indian producers on the research and development
(R&D) front. This enables the Indian nutraceutical industry to market itself as a brand
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to the world. However, for this ambition to be realised, increased coordination is

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warranted amongst all stakeholders and policy developers and authorities involved.
Manufacturing regulations, analytical processes, and R&D procedures require
standardisation.
Inclusion of safety and quality standards for nutraceuticals in the Indian
Pharmacopoeia or a similar standards book.

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Nutrition labelling regulations need to be updated by the Government of India in
order to increase the awareness of the public towards safety information with respect
to nutraceuticals.
Clinical research processes shall be subjected to higher levels of validation, newer
retailing programmes, increased media awareness and corporate involvement, and
newer methods of marketing nutraceuticals are some of the other recommendations

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that can be adopted. (J. Singh & Sinha, 2012)

Apart from the aforementioned challenges, a certain set of challenges exist that are unique to

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nutraceutical products in the Indian market. First is tailoring products to meet local tastes and
choices. In terms difference in taste preferences, India is one of the foremost nations due to

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the presence of different communities and religions, each having their own practices and

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beliefs with regards to food. Here, popular food companies that are already established in this
sector will be able to further capture the market in comparison to the Pharma companies,
which may need to enter the fray by utilising the means joint ventures and acquisitions.
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The Indian public is a price sensitive public. Hence it is essential for companies engaging in
the manufacture of nutraceuticals to ensure appropriate pricing of nutraceuticals as higher
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costs of nutraceuticals may render them as practical options only for the urban population.
The government too will have to chip in by reducing the import costs and various other taxes
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on nutraceuticals if nutraceuticals are to be accepted by the masses on a large scale.(Dwyer,

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Coates, & Smith, 2018)

Overall, it is essential for key players in India’s nutraceuticals market to be determined,

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flexible and sensitive along with being patient. The Indian government in the last few years
has signaled its intent to support regional investments in nutrition research and development,
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with the passing of the Food Safety and Standards Act. Also, the Indian government carries
out timely revisions of the RDA and health claim regulations as well as various other claims
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in order to ensure the safety and efficacy of nutraceuticals and to provide FBO’s a regulatory
pathway for carrying out their activities. The Government of India eventually intends to
transform India into a global hub of ‘Nutraceutical and functional food.’ And therefore, it is
more than likely that, in the near future, the government will ease all scientific and regulatory
issues involved in the process of carrying out nutraceutical development which will provide
the companies with a conducive environment to carry out their businesses.(Yates, 2016)

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5. CONCLUSION

It was the breakthrough in comprehending the correlation between health and nutrition that
gave an impetus to the notion of nutraceuticals as a viable and reliable approach to attain
optimum health as well as decrease the risks associated with certain diseases. The enactment
of the FSSA, 2006 has provided for the safety and quality of nutraceuticals to a large degree
and has aided in clearing any uncertainty created by the existence of numerous regulations

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and legislation. The formation of the FSSAI has further provided positive outcomes by
facilitating the registration of nutraceuticals through an online portal, thereby ensuring that

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new applicants for nutraceutical products shall abide by the regulations put forth by the
FSSAI. While the prospects of nutraceuticals today are promising and refreshing in contrast

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to the facile and prejudiced approach employed in the previous century, the reality is that

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nutraceutical manufacturers are also viewing functional foods as a marketing tool or a
gimmick to coerce money from innocent consumers by making false claims or by simply
marketing non-efficacious products. This is where health departments and committees of the
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government need to step in to secure consumer interests and protect consumer health.

There is no doubt that, in the years to come, nutraceuticals are bound to play a prominent part
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in advances in medicinal therapy developments and the success of these developments will be
dictated by the purity, efficacy and safety controls put in place, without causing any
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hindrance to the innovative ideas and designs. Researches have concluded that nutraceuticals
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play a critical role in mitigation and curing of various ailments. Since most of the population
prefers to be cured of their ailments in natural ways with zero side effects, the adoption of
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nutraceuticals appears to be the best choice that there is. Also, nutraceutical products provide
an auxiliary option for consumers looking to avoid chemical-based treatments. In addition to
this, marketing reports from around the world and in India have indicated that the consumer
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response towards nutraceuticals is on the rise with each passing day. Therefore, it can be said
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that the nutraceutical sphere, without doubt, has a substantial amount of concealed value
affiliated with it. All that remains to be done is to tap into its enormous potential.

6. REFERENCES

Amit Verma, (Vantage Nutrition). (2017). Indian Nutraceuticals Industry Current Scenario &
Future Trends. Retrieved November 6, 2018, from
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http://www.mrssindia.com/uploads/reports/pdf/assocham-knowledge-report-on-
nutracuticals-released-at-3rd-national-symposium-6.pdf

Dalmia, V. (2018). India : Law Of Nutritional & Supplemental Food Products In India - The
Conflict : Food Or Drug ?, 1–2.

Dwyer, J. T., Coates, P. M., & Smith, M. J. (2018). Dietary supplements: Regulatory

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challenges and research resources. Nutrients, 10(1), 1–24.
https://doi.org/10.3390/nu10010041

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FSSAI. (2017). Licenses Required for the Manufacture of Nutrition and Healthcare Products.

FSSAI Key Requirements for Manufacturing Nutraceuticals in India. (2017).

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Gupta, S., Chauhan, D., Mehla, K., Sood, P., & Nair, A. (2010). An overview of

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nutraceuticals: current scenario. Journal of Basic and Clinical Pharmacy, 1(2), 55–62.

India: A Challenging Growth Market - Nutraceuticals World. (n.d.).

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India Infoline News Service. (2018). indian Nutraceutical Market: Poised from Neutral Gear
to Top Gear.
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Indian Nutraceuticals Market - Nutraceuticals World. (2009). Retrieved from

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https://www.nutraceuticalsworld.com/issues/2009-10/view_market-research/indian-
nutraceuticals-market
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Keservani, R. K., Kesharwani, R. K., Vyas, N., Jain, S., Raghuvanshi, R., & Sharma, A. K.
(2010). Nutraceutical and Functional Food As Future Food: A Review. Der Pharmacia
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Lettre, 2(1), 106–116.

Kumar, A., Rajiv, S., & Proudyogiki, G. (2014). Nutraceutical and Functional Food
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Regulations in India. In D. Bagchi (Ed.), Nutraceutical and Functional Food

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Regulations in the United States and Around the World (2nd ed., pp. 327–341).

Majaz, Q., I, M. K., Nazim, S., Asir, Q., & Shoeb, Q. (2012). Nutraceuticals : Importance and
Advances in Medicine and Health. International Research Journal of Pharmacy, 3(4),
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Palthur, M. P., Sajala Palthur, S. S., & Chitta, S. K. (2010). Nutraceuticals: Concept and
regulatory scenario. International Journal of Pharmacy and Pharmaceutical Sciences,
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2(2), 14–20.

Pandey, M., & Saraf, S. (2015). Nutraceuticals : new era of medicine and health
Nutraceuticals : new era of medicine and health, 3(November).

Potential for functional foods in the Indian market. (2018).

Santini, A., Cammarata, S. M., Capone, G., Ianaro, A., Tenore, G. C., Pani, L., & Novellino,

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E. (2018). Nutraceuticals: opening the debate for a regulatory framework. British
Journal of Clinical Pharmacology, 84(4), 659–672. https://doi.org/10.1111/bcp.13496

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Shirwaikar, A., & Khan, S. (2011). The changing face of nutraceuticals – An overview.
International Journal of Pharmacy & Life Sciences, 2(7), 925–932.

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Singh, J., & Sinha, S. (2012). Classification, Regulatory Acts and Applications of

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Nutraceuticals for Health. International Journal of Pharmacy and Biological Sciences,
2(1), 177–187.
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Singh, M. C., & Gujar, K. N. (2013). Nutraceuticals: Uses, risks and regulatory scenario.
International Journal of Pharmacy and Pharmaceutical Sciences, 5(Suppl 3), 23–26.
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Smarta, R. B. (2017). Nutraceuticals Regulatory Purview.

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Yadav, V., Mittal, V., & Pandey, P. (2014). Marketing nutraceuticals in India: an overview
on current regulatory requirements. Asian Journal of Pharmaceutical and Clinical
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Research, 5(1).

Yates, M. (2016). Nutraceuticals in India: A Challenging Opportunity. Retrieved from

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https://social.eyeforpharma.com/column/nutraceuticals-india-challenging-opportunity
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Table 1 : Definitions of eight categories of food as per the FSSAI. (Young, n.d.)
CATEGO 1. Foods for special 4. Foods for 5. Foods with 6. Foods with 7. Novel 8. Specialty
RY dietary uses or special added added Food food
& 2. Nutraceuticals or purpose probiotic prebiotic containing
DEFINITI 3. Health ingredients ingredients plant or
Supplements botanical
ON
ingredients

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.
CONTEN Specially processed or Specially Food with live Food that Does not Food which is
TS formulated foods that processed or micro- contains added contain shown to be
contain one or more formulated organisms prebiotics any of the containing

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of the following beneficial to which are foods or plant or
ingredients: human health nonviable food ingredient botanical
• Plants or components. s ingredients.

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botanicals prohibited.
• Minerals or
vitamins

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• Substances from
animal origin
• Dietary
substances
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USE • To satisfy • For any Confers one or Confers health Foods for Having a
particular dietary particular more specified benefits to the which history of safe
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ingredients. dietary use. or demonstrated consumer by standards usage.

• Not to cure or • Dietary health benefits modulation or are not
mitigate any managemen in human microbiota specified
specific disease, t under beings. but which
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disorder or medical are not

condition as may advice. unsafe.
•
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be permitted by Exclusive
the regulations. or partial
feeding or
specified
persons.
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• Other
medically
determined
nutrient
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requirement
s.
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Figure 1: Nutraceutical registration procedure in India. (Yadav et al., 2014)

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HIGHLIGHTS

“Let food be thy medicine, and medicine be thy food”; thoughts of Hippocrates.

The term “Nutraceutical” which is combination of nutrition and pharmaceutical.

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Food Safety & Standards Authority of India devices the scientific standards for food

substances.

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The draft regulations formulated by the FSSAI in 2015 were similar to those followed

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by the FDA and the EFSA.

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Clear regulatory directions & authenticity of label claims are major challenges.
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