World Journal of Pharmaceutical Research et al. SJIF ... · Indian nutraceuticals market is set to...

www.wjpr.net Vol 5, Issue 5, 2016.

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Mishra et al. World Journal of Pharmaceutical Research

A REGULATORY ASSESSMENT OF MARKETED NUTRACEUTICAL

PREPARATION

Abhishek Mishra1*, Neel Kamal Kumar

2 and

Nishi Prakash Jain

3

1,2

Student of B. Pharm., Sagar Institute of Research and Technology-Pharmacy, Ayodhya

Bypass Road, Bhopal (India), 462041.

3Associate Professor, Sagar Institute of Research and Technology: Pharmacy, Ayodhya

Bypass Road, Bhopal (India), 462041.

ABSTRACT

Indian nutraceuticals market is set to grow over fold to 6.1billion dollar

by 2020 as consumers become conscious towards health and fitness.

Initially India does not had any kind of regulatory guidelines for

approval or monitoring of Nutraceuticals1, although Food Safety and

Standards Authority of India (FSSAI) has draft a draft regulations shall

be taken into consideration for nutraceuticals in India. According to

this Nutraceuticals are classified as (a) the vitamins and minerals (b)

the Amino acids (c) the Plants or botanicals (d) the substances from

animal origin and (e) the nutraceuticals as specified in Schedule IX of

these regulations, which may be used in the manufacture of food

containing nutraceuticals without prejudice to modifications for one or

more of these nutrients rendered necessary by the intended use of the

product. The objective of this paper is to assessment the regulatory structure and status of

regulation of currently issued guidelines for nutraceuticals in India. The survey study was

divided in two phases. First phase of study was surveying the awareness and value of

nutraceuticals in physicians and the objective of second phase were focused to product and

sale of nutraceuticals. This survey focuses on various issues like if very less therapeutic

effects produced by nutraceuticals then why they are prescribed with modern medicines.

Physicians are interested in quality of these products as good as pharmaceuticals but mute on

price matters. Nutraceuticals are available on almost all form of oral pharmaceutical dosage

forms and taken by patient as a therapeutic substance.

World Journal of Pharmaceutical Research SJIF Impact Factor 6.805

Volume 5, Issue 5, 1085-1100. Research Article ISSN 2277– 7105

Article Received on

09 March 2016,

Revised on 28 March 2016,

Accepted on 17 April 2016

DOI: 10.20959/wjpr20165-6122

*Corresponding Author

Abhishek Mishra

Student of B. Pharm.,

Sagar Institute of

Research and Technology-

Pharmacy, Ayodhya

Bypass Road, Bhopal

(India), 462041.

http://www.wjpr.net/


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KEYWORDS: Nutraceuticals, FSSAI (Food Safety and Standards Authority of India),

NPPA (National pharmaceutical pricing Authority of India), Regulatory, Assessment.

INTRODUCTION

Indian nutraceuticals market is set to grow over fold to 6.1billion dollar by 2020 as

consumers become conscious towards health and fitness. Initially India does not had any kind

of regulatory guidelines for approval or monitoring of Nutraceuticals[1]

, although Food Safety

and Standards Authority of India (FSSAI) has draft a draft regulations shall be taken into

consideration for nutraceuticals in India.[2]

According to notification by FSSAI,

“Nutraceuticals” means a naturally occurring chemical compound having a physiological

benefit or provide protection against chronic disease, isolated and purified from food or non-

food source and may be prepared and marketed in the food-format of granules, powder,

tablet, capsule, liquid or gel and may be packed in sachet, ampoule, bottle, etc. and to be

taken as measured unit quantities. Nutraceuticals are classified as (a) the vitamins and

minerals (b) the Amino acids (c) the Plants or botanicals (d) the substances from animal

origin and (e) the nutraceuticals as specified in Schedule IX of these regulations, which may

be used in the manufacture of food containing nutraceuticals without prejudice to

modifications for one or more of these nutrients rendered necessary by the intended use of the

product.

Dietary factors play an important role in premature chronic disease appearance, disease

progression, morbidity and mortality. Approximately 40-50% proportion in cardiovascular

disorders, 35-50% proportion in cancers and 20% proportion in osteoporosis is attributable to

dietary factors. Use of food as medicine for treatment and prevention of various disorders is

not a recent development. Fortification of table salt with iodine and wheat flour with

iron/folic acid has been used with specific aims of prevention of iodine deficiency goitre and

anaemia for long.[3]

Labelling of Nutraceuticals are most important aspects in India to monitor the sale and use of

Nutraceuticals. The Guideline for Nutraceuticals shall comply with the packaging and

labelling requirements as laid down under Food Safety and Standards (Packaging and

Labelling) Regulations, 2011. According to regulations, i) No person shall manufacture,

pack, sell, offer for sale, market or otherwise distribute or import any package or container

containing any nutraceuticals, if the package or container does not bear a label containing all

the particulars required by these regulations ii) The labelling, presentation and advertising



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shall not attribute the property of preventing, treating or curing a human disease to

nutraceuticals, iii) Every package of food containing nutraceuticals shall carry the following

information on the label[4,5]

., namely:-

(a) The words “NUTRACEUTICAL”;

(b) The common name of the nutraceuticals;

(c) The amount of the active nutraceuticals in the product that either has a nutritional or

physiological effect;

(d) Where it is appropriate the quantity of nutrients shall be expressed in terms of percentages

of the relevant Recommended Daily Allowances as prescribed in India by the Indian Council

of Medical Research even when it is present along with a nutraceuticals as an adjunct and

shall bear a warning “not to exceed the stated recommended daily dose”;

(e) The term “Recommended usage” shall be used on the label;

(f) A warning or any other precautions to be taken while consuming, known side effects if

any, contraindications and product-drug interactions, as applicable;

(i) A statement to the effect that the products shall be stored out of the reach of children;

This regulation have thin line between the other categorized segment like Foods containing

prebiotic ingredients, Foods containing Probiotic Ingredients, Foods for Special Dietary Uses

(FSDU) (other than infants and those to be taken under medical advice), Food or health

supplements, Foods for Special Medical Purposes and Novel Foods.[6]

In such scenario the

specific research is required before prescribing the products as co prescriptions with modern

medicines.

Huge customer base, increasing co-prescription with regular drugs, focus on preventive

healthcare, rapid retail growth and e-commerce are some of the major drivers for the growth

of the nutraceuticals.[7]

The Food Safety and Standards Authority of India (FSSAI

recommendations get the nod from the authority, all manufacturers in the country falling

under this category will have to get a no objection certificate and approval from the Centre

prior to manufacturing and marketing the products. NPPA (National pharmaceutical pricing

authority of India) is mute spectator for pricing of nutraceuticals being food products and

nutraceuticals companies, prescribing physicians are getting advantages of this

muteness.[8,9,10]



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MATERIAL AND METHODS

The objective of this paper is to assessment the regulatory structure and status of regulation

of currently issued guidelines for nutraceuticals in India. Assessment can be defined as “A

process of measuring and analysing a performance or product to provide quality, timely

feedback for improvement. For the assessment of regulatory quality we need to examine a

mapping between desirable inputs and desirable outcomes. This provides us a framework to

study the performance of regulatory regimes in a country. But India lacks data on these

parameters which constrains assessment.[11]

This study is designed to keep in mind the time of physician and chemist .This survey is

divided in 4 Steps.

1. Awareness about Nutraceuticals

2. Preparation of question for survey

3. Selection of doctors

4. Preparations of survey form for chemist and physician

The study was divided in 2 parts

1. The doctor survey and

2. Chemist & druggist survey

The titled study was started by selecting the registered medical practical in Bhopal city the

selection of doctors was on the basis of their qualification and who prescribe Nutraceuticals.

A. Doctors survey form Objective of doctor‟s survey was to analyse that the Doctor was

aware about food supplement Have therapeutic value or Not; focus his mind to price of

supplement.

B. Chemist & Druggist survey form

This study may be incomplete if we will not survey the chemist and druggist surrounded by

selected physician who prescribe Nutraceuticals & food supplement.

In this study we want to assess whose physicians prescribe nutraceuticals in his prescription

Which nutraceuticals are most prescribe by doctor we want to conformation to chemist

regarding to food product.



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RESULTS AND DISCUSSIONS

This study was performed in two phases

A. Physicians survey with objective of awareness of Nutraceuticals and need of prescription

as a co-therapy. Total 300 physicians across the Madhya Pradesh were surveyed. The

responses from physicians were mixed. Few Physicians raised the question for such study

while few have appreciated for this study. The results of questioners asked from physicians

are as follows:

1. Is there necessity to prescribe food supplements in your valuable prescription?

Table: 1.

Figure: -1 (Necessity to prescribe food supplements).

Result:-In first question 76.6% physicians having impression that there is a necessity to

prescribe food supplement while 17.33% physicians have opinion that there is a no necessity

to prescribe the food supplement while & 6% physician are not sure.

Q (2) Do you think that food supplement are having therapeutic value.

Table: - 2.

Yes No Cannot say

230 52 18

76% 17.33% 6%

Yes No Cannot say

192 102 6

64% 34% 2%



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Figure: - 2(food supplement are having therapeutic value).

Result:-In second question 64% physician‟s says food supplement have therapeutic value and

34% physician says have not therapeutic value and 2% are not sure.

Q (3) If food supplement„s does not have therapeutic value, even though there is need to

prescribe

Table:- 3.

Yes No Cannot say

65 154 81

21.66% 51.33% 27%

Figure: - 3 (food supplement need to prescribe).

Result:-In third question 21.66% physician are accepted that the food supplement have not

therapeutic value but there is need to prescribe and 51.33% says not need to prescribe and

27% are not sure.

Q (4) Are you agree that various food supplement available in market as an allopathic dosage

forms.



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Table: - 4

Figure: - 4(Food supplement available in market as an allopathic dosage forms).

Result;-In fourth question 46% physician are agree for accepting that the food supplements

are available in market as an allopathic dosage form and 37.33% are not accepting and

16.66% are not sure.

Q (5) is there need to such therapeutic valued food product must fall in separate category like

Nutraceuticals.

Table: - 5.

Figure: - 5(Food product must fall in separate category like Nutraceuticals.).

Yes No Cannot say

218 72 10

72.66% 24% 3.33%

Yes No Cannot say

138 112 50

46% 37.33% 16.66 %



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Result:-In fifth question 72.66% Physician are supported that the food Supplement have a

separate category like Nutraceuticals and 24 % not agree and 3.33% are not reply.

(6) Is there need to such therapeutic valued food product must fall in category of drug.

Table: -6.

Figure: - 6(Food product must fall in category of drug).

Result:-In sixth question 45.33% physician support that the therapeutics valued food product

must fall in category of drug and 31% are not agree and 21.66% are not reply.

Q (7) Do you think such food product quality monitored as Drug-?.

Table: - 7.

Yes No Cannot say

136 92 71

45.33% 31% 23.66%

Yes No Cannot say

221 71 8

73.66% 23.66% 2.66%



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Figure: -7(Food product quality monitored as Drug).

Result: - In seventh question 73.66% physician says that the food product quality monitored

as drug and 23.66% are negative response and 2.66% are not responses.

Q (8) Do you think such food product„s pries must be controlled as drug -?

Table: 8.

Figure: - 8(Food product‘s pries must be controlled as drug).

Result:- In eighth question 84% physician are agree that the price of nutraceuticals must be

controlled as drug, 13.33% are not accepting 2.66% are not sure.

B. Phase two survey were most important because it analysed the tangible situation of

products available in the market and type of prescribers. The information collected from

Chemist and druggist across the Madhya Pradesh. Total 500 Chemist and druggist were

surveyed. Chemist and druggist were selected on the basis of vicinity with physicians and

leading in sales. Approximately 175 nutraceuticals brands (product) identified for analysis of

result for this study. The results with discussion are as follows:

Yes No Cannot say

252 40 8

84% 13.33% 2.66%



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1. Dosage form of nutraceuticals is important factor in terms of patient compliance and

patient satisfaction. Nutraceuticals are available in the form of pharmaceutical dosage forms

and gives an impression of being a therapeutic substance. As per definition it may be

prepared and marketed in the food-format of granules, powder, tablet, capsule, liquid or gel

and may be packed in sachet, ampoule, bottle, etc. and to be taken as measured unit

quantities. The result of dosage form of studied nutraceuticals as follows: quantities. The

result of dosage form of studied nutraceuticals as follows:

Table: - 9.

Figure: - 9.1 (Solid dosage form)

Figure: - 9.2(Liquid Dosage form).

Liquid Dosage form Solid dosage form

Syrup Solution/others Tablet Soft gelatin

capsule

Hard gelatin

capsule

Powder/

granules

Biscuits

/others

48 4 14 81 7 17 4

28.23% 2.29% 8% 46.28% 4% 9.71% 2.3%



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Result:-Nutraceautical are available in all types of oral dosage form about 30.52% are liquid

dosage form (28.23% syrup and 2.29% other), rest 69.48% are solid dosage form .soft

gelation capsule are most preferred dosage form for nutraceuticals.

2. As per draft of the Food Safety and Standards (Food or Health Supplements,

Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical purpose,

Functional Foods and Novel Food) Regulations, 2015, which the Food Safety and Standards

Authority of India proposes to make in exercise of the powers conferred. The draft has

divided Food or Health supplements as if they contain vitamins and minerals as specified in

Schedule I, and in the forms as given in Schedule II; Amino acids specified in Schedule III;

Plants or botanicals as specified in Schedule V; substances from animal origin as listed in

Schedule VI; Mineral or metal sources as specified in Schedule VII; and the enzymes as

specified in Schedule IX of these regulations, which may be used in the manufacture of food

supplements without prejudice to modifications for one or more of these nutrients rendered

necessary by the intended use of the product. The result of schedules of studied nutraceuticals

as follows:

Table: - 10.

Schedule

I

Schedule

II

Schedule

III

Schedules

V

Schedules

VI

Schedule

VII

Schedule

IX Combinations

42 3 0 15 7 7 3 98

24 1.71 0 8.57 4 4 1.71 56

Figure: - 10 (Schedules as per FSSAI).



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Result :- Nutraceautical are classified as per FSSAI are schedule in many groups. about 56%

falls in the category of combination of various schedules followed by 24% formulation falls

in the category of schedule I.

3. Food or health supplements means the foods which are intended to supplement the normal

diet of a person and which are concentrated sources of one or more nutrients, like minerals,

vitamins, proteins, mineral complexes, amino acids or enzymes, other dietary substances,

plants or botanicals, substances from animal origin or other similar substances with known

and established nutritional or beneficial physiological effect and which are presented as such

and are offered alone or in combination, but Therapeutic used products are drugs as defined

in the Drugs and Cosmetics Act, 1940 and the rules made thereunder. Hence it was important

those physicians are using nutraceuticals for which purpose.

Table: - 11.

Therapeutic use Food or health supplements

15 160

8.57% 91.43%

Figure: - 11 (Therapeutic use and Food or health supplements).

Result :- Nutraceautical are dietary supplements even though only 91.41% marketed

preparation are able to declare as food are dietary supplements ,rest of the formulation still

used as therapeutic formulations.

4. Indians are very sensitive about type of foods. A large group of Indians believe in

vegetarian foods while others who believe in non-vegetarian food they focus on Halal,

therefore purpose of type of food (Nutraceuticals) plays an important role.



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Table: - 12.

Vegetarian product Non-vegetarian product

78 97

44.57% 55.43%

Figure: - 12 (Vegetarian product and Non-vegetarian product).

Result: - In this study 55.43% formulation were having brown mark (source from animal

origin) and rest from plant origin.

4. According to IMA (Indian Medical Association) a large group of health care professionals

are indulge in prescribing the modern medicines. Modern medicines should be prescribed by

Allopathic physician having the qualification of MBBS, BDS, or other higher qualifications;

other physician cannot prescribe modern medicines. There is no guidelines are given for

nutraceuticals by controlling authorities hence everybody are prescribing Nutraceuticals

without having its co-therapeutic effects with modern medicines or other type of

medicaments.

Table: - 13.

Physician(Allopathic) Physician (Ayurvedic

& others) Dietician Over the counter

109 58 0 8

62.28% 33.14% 0% 4.57%



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Figure: - 13 (types of nutraceuticals prescribers).

Result:- This study focuses on surprising results that modern medicine prescriber are

prescribing the Nutraceuticals most (62.28%) while no prescription by Dieticians were found.

33.14% prescription were prescribed by Ayurvedic and others. A small share of sale of

nutraceuticals found as OTC (4.57%).

SUMMARY AND CONCLUSION

Nutraceuticals means a naturally occurring chemical compound having a physiological

benefit or provide protection against chronic disease, isolated and purified from food or non-

food source and may be prepared and marketed in the food-format of granules, powder,

tablet, capsule, liquid or gel and may be packed in sachet, ampoule, bottle, etc. and to be

taken as measured unit quantities. Initially India does not had any kind of regulatory

guidelines for approval or monitoring of Nutraceuticals, although Food Safety and Standards

Authority of India (FSSAI) has draft a draft regulations shall be taken into consideration for

nutraceuticals in India. Dietary factors play an important role in premature chronic disease

appearance, disease progression, morbidity and mortality.

The objective of this paper is to assessment the regulatory structure and status of regulation

of currently issued guidelines for nutraceuticals in India. Assessment can be defined as “A

process of measuring and analysing a performance or product to provide quality, timely

feedback for improvement. The survey divided in four steps a) Awareness about

Nutraceuticals, b) Preparation of question for survey, c) Selection of doctors and d)

Preparations of survey form for chemist and physician.



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The survey study was divided in two phases. First phase of study was surveying the

awareness and value of nutraceuticals in physicians. Total eight questions were asked by

physicians, results were surprising that physicians need quality of nutraceuticals as drugs but

no interference of price control by government. Physicians are not sure about therapeutic

efficacy of nutraceuticals even though they are prescribing the nutraceuticals.

In second phase survey was conducted through chemist and druggist, the objective of second

phase was focused to product and sale of nutraceuticals. Nutraceautical are available in all

types of oral dosage form as liquid dosage form and solid dosage form. Soft gelation capsule

are most preferred dosage form for nutraceuticals. As per draft of the Food Safety and

Standards (Food or Health Supplements, Nutraceuticals are classified as various schedules as

per their contents, but most of nutraceuticals preparations were found combinations. During

phase one, Physicians were prescribing the nutraceuticals for therapeutic effects but chemist

and druggist survey reveals that more than 90% formulation were dietary supplement. Source

of dietary supplements (Nutraceuticals) affect it most, more than half of the total preparations

wearing brown mark of animal source. According IMA to modern medicines should be

prescribed by Allopathic physician having the qualification of MBBS, BDS, or other higher

qualifications; other physician cannot prescribe modern medicines and vice versa in case of

Ayurvedic and others. There is no guidelines are given for nutraceuticals by controlling

authorities hence everybody are prescribing Nutraceuticals without having its co-therapeutic

effects with modern medicines or other type of medicaments. Surprisingly about two third of

the nutraceuticals are prescribed by modern medical degree holders without consulting to

dietician.

Nutraceuticals certainly having health benefits and their consumption (within their acceptable

Recommended Dietary Intakes) will keep diseases away and allow humans to maintain an

overall good health. In present era patients and physicians are profoundly concerned about co

prescriptions of nutraceuticals. Although Food Safety and Standards Authority of India

(FSSAI) have passed draft regulations shall be taken into consideration for nutraceuticals in

India but the use of these products must be properly prescribed.

REFERENCES

1. articles.economictimes.indiatimes.com › Collections › India.

2. The Food Safety and Standard Authority of India New Delhi,

India.http://www.fssai.gov.in/Announcements/ViewAnnouncements.aspx.



1100


3. Eskin N A M and Tamir S Dictionary of Nutraceuticals and Functional Foods, CRC

Press, Boca Raton, USA. 2006.).

4. www.fssai.gov.in/.../Draft_Regulation_on_Nutraceuticals_WTO_23_07.

5. Kumar GS, Regulatory Roadmap for Herbal Medicine, 1st

edition, 2007, Business Horizons, New Delhi.

6. Food and Drug Administration. Development and approval process (drugs). Available

from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm [Last

accessed on 2013 Aug 30].

7. Arora, M., Sharma, S., Baldi, A., (2013). Comparative Insight of Regulatory Guidelines

for Probiotics in USA, India and Malaysia: A Critical Review. Int Jr Biotech. For

Wellness Industries., (2): 51-64.

8. Ernst & Young. (2012). Nutraceuticals: A critical supplement for building a healthy

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9. Techsi Research. (2013). Indian nutraceuticals market forecast and opportunities, 2017.

10. www.medicarenews.in/.../Paradigm-Shift-in-Indian-nutraceuticals-market.

11. Vinay R. Kamata, Mark Nichterb, Pharmacies, self-medication and pharmaceutical

marketing in Bombay, India, Social Science & Medicine, 16 September 1998; 47(6):

779–79.


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