PROJECT REPORT ONProduction Planning, Distribution and

Logistics

SUBMITTED IN PARTIAL FULFILLMENT OF

Degree of

Master of Business Administration

Submitted by:Narendra Prakash

Under Supervision ofAmrendra P Singh

DGM- Distribution & LogisticsCadila Pharmaceutical Ltd.

Department of Management StudiesJAMIA HAMDARD

NEW DELHI

ACKNOWLEDGEMENT

Every mature individual in professional life is keenly aware of his sense of indebtness to many

people who have stimulated and influenced his intellectual development. Ordinarily, this feeling

is expressed in customercy gesture of acknowledgement. Therefore it seems as a right to

acknowledge my gratitude with sense of veneration to Almighty God.

I am grate full to Mr. Sanjeev Kumar Director of Akums pharmaceuticals Ltd. for his

innovative guidance and blessings and providing all facilities related to my project work.

It is delightful moment for me to put into all my gratitude to my esteemed guide Mr. Shahbaz

Alam Product Manager of Plenteous Pharmaceuticals Ltd. for his valuable suggestion and

constant encouragement.

I am also thankful to Dr. Vivek Srivastav Manager Product Development of Akums

Pharmaceuticals Ltd. for their support and Miss Kopal Gupta Product Executive of

Plenteous Pharmaceuticals Ltd.

I am also thankful to Department of Management Studies for nurturing & shaping my skills to

meet the complexities of my project.

I acknowledge my profound thanks to my friends and my family who encourage me to complete

my project

Mohd. Mubashshir Ali

MBA (HM)-2nd Semester

Jamia Hamdard

New Delhi

TABLE OF CONTENT

Acknowledgement

Declaration

1. Executive Summary………………………………………………………….1

2. Nutraceuticals Industrial Profile……………………………………………7

3. Review of Literature…………………………………………………………9

3.1 What Are Nutraceuticals?.........................................................................9

3.2 Nutraceuticals Global Status…………………………………………….21

3.3 Major Nutraceuticals Player at Global Presence……………………....31

3.4 Nutraceuticals Brand In India & World Wide………………………....32

3.5 Nutraceuticals and Supplementation…………………………………....33

3.6 Regulatory Requirement in Different Continents like US, EU,

Mediterranean countries………………………………………………....35

3.7 DCGI……………………………………………………………………...41

4. Research Methodology……………………………………………………….44

4.1 Objective of Study………………………………………………………..44

4.2 Duration of Study………………………………………………………...44

4.3 Area of Study……………………………………………………………..44

4.4 Research Design…………………………………………………………..45

5. Analysis of Study……………………………………………………………...46

6. Conclusion……………………………………………………………………..50

7. Suggestion/Recommendation…………………………………………………51

8. Annexure………………………………………………………………………53

9. Bibliography

1. EXECUTIVE SUMMARY

It is a fundamental idea of marketing that organization survives and prospers through meeting the

needs and wants of the customer. This important perspective is commonly known as marketing

concept. It is about matching a company’s capabilities with customer wants.

The Plenteous Pharmaceutical Ltd. has planned to venture in the field of nutraceuticals and

decided to the following products for which I have done a pre launch survey in south area of

Delhi including Physician, Dietician, Slimming Center and Gym.

During my entire tenure of summer training I visited various doctors, dietician, slimming center

& gym. And fill up the questionnaire about nutraceuticals and analyses the data which is

collected during summer training.

According to data I have personally observed there is a great demand of nutraceutical especially

in slimming center and gym.

It is better to have relevant interaction with the patient too to sensitize the people regarding the

products.

COMPANY PROFILE

Plenteous belongs to Rs 400 Cr. Group of company. Plenteous has significant presence in

international pharmaceutical market. Plenteous has set up for the purpose of international

business and also to make available a number of exclusive products, not presently available in

India.

The pursuit of innovation is basic to plenteous culture. Plenteous discovers, develops,

manufactures and market pharmaceuticals and nutraceuticals branded drugs.

Company is going to launch Following products:-

a) BBT-SLIM Caps

b) DH-2 Caps

c) STF-FRESH Caps

d) GULPHALA

e) HEPOWELL Caps

AKUMS PHARMACEUTICAL LTD.

Founded in 2004, Akums Drugs & Pharmaceuticals Ltd., is a reliable name in the arena of

pharmaceutical development. Akums Pharma are a progressive manufacturer, supplier and

exporter of more than 4000 products with approximately 1000 formulations in the form of

tablets, capsules (plain & sustain release), soft gelatin, dry syrup, dry powder injections, pre

filled syringe, eye & ear drops, etc. product range also includes antihypertensive drugs,

antibiotics formulations, and analgesics / anti-ulcerants / antifungal / antimalarial / antiallergics /

antidiabetic drugs and formulations. Akums Pharma are also into contract manufacturing on

loan, license & P to P basis, in collaboration with more than 50 national and multinational

pharma companies including Wochardt, Nicholas, Cipla, Cadila, Biochem Pharma.

The company has three production divisions of varied capacities. Together, all units can produce

40 million tablets, 10 million capsules, 2.5 million softgelatin capsules, 1 million bottles of liquid

orals/dry syrups and expectorants in a day.

Designed as per UK-MHRA and US-FDA norms, our units are accredited with the ISO

9001:2000, ISO 14001:2004 and WHO-GMP certifications. Akums are also accredited with UK-

MHRA certificate. During the last fiscal (07-08), our annual turnover stood at US $ 82 million,

with a net profit of US $ 10 million, showing a 17% surge, compared to the profit registered last

year for the same period.

Company’s Products

Akums Drugs & Pharmaceuticals Ltd. is a name to reckon with in the pharmaceutical and drug

industry. The company develops more than 4000 products with approximately 1000 formulations

in various forms. Akums Pharma are a distinguished pharmaceutical development entity,

engaged in the manufacture, supply and export of following products:

Oral doses/parenterals: Tablets, Capsules, Oral-Liquids, Dry Powder Solutions, Sachets

for Oral Solutions, Soft-Gelatin Capsules, Dry Powder Injections, Liquid-Ampoules,

Liquid-Vials, Eye & Ear Drops, etc.

Other Formulations & Drugs like:

o Anti-Inflammatory Drugs

o Analgesics & Antipyretics Drugs

o Antimalarial Drugs

o Multivitamin-Mineral & Anti-oxidants Drugs

o Anti-Emetics

o Sedatives  & Tranquillizers Drugs

o Nutritional Supplements

o Anti-Allergic & Decongestants Drugs

o Cardiovascular Drugs

o Anti-Bacterial & Antibiotics

o Cough & Cold Preparations

o Antacids & Anti-Ulcerates Drugs

o Gastro-Intestinal & Anti-Diarrhea Formulations

o Anti-Diabetics Drugs

o Haemostatic Drugs

o Anti-Fungal Drugs.

Various Brands Manufactured by Akums

Akums Pharma are also involved in contract manufacturing and have produced for many brands,

both national and international. The following is the brief account of the same:

Company Brand

CiplaDoxicip, Megaclox, Movexx Plus, Oflox, Pantosec, Pansec RX

Zydus Cadila Cefinar, Cadithro, Hipen P, Levodus, Nimo MR

Wochardt Aeroc, Top, Merifol, O-powercef, Prexon

Lupin Ltd.Odoxil, Ceff, ignoflam, Atenova, Gatispan, Lupisuilide P

IntasCeftas, Atenolol, C-col, Intagesic, Kuff Q, NT-Cold, Omey

MankindRanispas, Ranidom, Nucort, Nobel Spas, Omidom, Mahacef

FDC Ltd. Painadol 50SR, Painadol 100 SR, Painadol P

Nicholas Acevah, Chupp, Floxip, Nicodroxil, Nicospas, RCID, and many more.

INFRASTRUCTURE

Akums pharma possess three outstanding production units at Haridwar, the spiritual city of

Uttrakhand. The company can produce upto 40 million tablets, 10 million capsules, 2.5 million

soft gelatin capsules, 1 million bottles of liquid orals/dry syrups and expectorants in a day. Only

a few companies in India have such a huge production capacity. We can also manufacture 1

million liquid ampoules & vials of injectables, 0.5 million dry powder vials, 0.2 million ear/eye

drops, and 50 thousand small volume parenterals in international FFS packs in a day.

CLIENTS

Akums quality is trusted by many leading pharmaceutical companies including:

Cadila Pharma

Cipla

Aventiss

Blue Cross

Intas

Lupin

Mankind

Shreya Life Sciences

Sun Pharma

Wockhardt

Sarabhai Chemicals

Flamingo Pharmaceuticals

Zydus Cadila, and many more.

2. NUTRACEUTICAL INDUSTRIAL PROFILE

Along with the growing healthcare industry in India there is an emerging trend in ‘Fast Moving

Healthcare Goods (FMHG)’ in India; worldwide known as Nutraceuticals, which are by

definition, ingredients with human health benefits beyond basic nutrition. Nutraceutical and

functional food ingredients are ingredients with human health benefits beyond basic nutrition.

According to Cygnus estimates, Nutraceuticals market in 2007 was INR18.75 billion and

expected to grow at 20% CAGR to achieve a market size of INR27 billion in 2009.

Source: Cygnus Report

Global Nutraceuticals market is estimated at USD120 billion in 2007 growing at 7% (CAGR).

The US has been the major market for Nutraceuticals with India and China becoming fastest

growing markets. Nutraceuticals are gaining acceptance for their ability to address several

diseases. Vitamins, Minerals and Nutrients constitute about 85% of the market while

antioxidants and anti-agents account for 10% other segments such as herbal extracts occupy 5%

of the market, globally.

Market Growth, 2007-2009

18.75

27

2007 2009

US $ Bn

Source: Cygnus Report

With the increasing trend of health awareness and enhancement among the consumer, the Nutraceutical or the

dietary supplement industry is on the upswing

though Nutraceuitical industry is currently very small and at nascent stage, as around Rs 500 crore. The rising

consumer awareness for healthy lifestyle, nutritional diet, increasing Nrbanisation etc is driving the demand for

Nutraceutical.

Global demand for Nutraceuticals is estimated to reach US $5.5 billions by the end of 2010. Both

China and India are the leading markets for Nutraceuticals in the world. The United States of

America is the chief consumer of Nutraceuticals in the global market. Over 40 percent of

Americans (i.e. around 100 million) make use of alternative medical therapies, out of which

Nutraceuticals occupy a considerable proportion. Presently, the size of Nutraceuticals industry in

the America is worth US $ 86 billion. Nutraceuticals are the food components made from herbal

or botanical raw materials, which are used for preventing or treating different types of acute and

chronic maladies. Also know as functional foods and phytochemicals, Nutraceuticals are the

bioactive chemical and natural compounds that have the medicinal properties to treat and cure

number of disorders. Chitosan, whey protein, carotenoid, hyaluronic acid, chrondroitin sulfate,

and glucosamine sulfate are some of the widely used Nutraceuticals

3. REVIEW OF LITERATURE

a) What are NUTRACEUTICALS?

Nutraceuticals encompass a large group of preventive and curative health care ingredients that

have been predominantly derived from long-standing medical traditions such as Ayurveda,

Tibetan, Chinese and Japanese medical systems. Nutraceuticals are primarily obtained from

plants especially those with a well-established use as foodstuff. The blend of these

pharmaceutical and nutritional characteristics resulted in the name "Nutraceuticals,'' to denote the

nutritional origins and the design moulded on pharmaceuticals, that is, standardisation, efficacy

and predictability of action. The nutraceuticals owe their beginnings to alternative medicine

movement and to people who recognised that health care especially in the U.S., obtained from

physicians, pharmacists and other health professionals needed to be supported by safe, effective

cost effective and more accessible healthcare products.

Nutraceuticals are derived from nutritional compounds having therapeutic value in contrast to

straightforward "Pharmaceuticals.'' Nutraceutical need not only be derived only from plants.

Even vitamins, minerals and some synthetic compounds are classified as Nutraceuticals

Herbal extracts are products derived from herbs, that is, plants

Ayurvedic drugs not only include plant-based products mentioned in Ayurveda , but also

minerals in the form of "Bhasmas'' and the like.

Categories of nutraceuticals:

Nutraceuticals are non-specific biological therapies used to promote wellness, prevent malignant

processes and control symptoms. These can be grouped into the following three broad categories:

1. substances with established nutritional functions, such as vitamins, minerals, amino acids and

fatty acids - Nutrients

2. herbs or botanical products as concentrates and extracts - Herbals

3. reagents derived from other sources (e.g. pyruvate, chondroitin sulphate, steroid hormone

precursors) serving specific functions, such as sports nutrition, weight-loss supplements and

meal replacements – Dietary supplements.

Nutrients:

The most commonly known nutrients are antioxidant, water and fat-soluble vitamins. Many

potential benefits have been attributed to antioxidant use in the form of dietary intake or

supplementation Antioxidants, in general, may be useful in the prevention of cancer and

cerebrovascular disease. High dietary intake of vitamin E may prevent Parkinson’s disease. Agus

et al., determined that the oxidized form of vitamin C, dehydroascorbic acid, readily crosses the

blood brain barrier. These findings have implications for increasing the uptake of antioxidants in

the central nervous system; thus, some feel that this has the potential for improving the treatment

of Alzheimer’s disease. Jialal and Fuller found that the combination of vitamin E, C and beta

carotene has been useful in reducing low density lipoprotein oxidation and subsequent

atherosclerosis.

Vitamin supplement is associated with increased antibody titre response to both hepatitis B and

tetanus vaccines as a result of macrophage and T cell stimulation. Those genetically predisposed

to pancreatic cancer have low serum levels of selenium; thus, it is assumed that supplementation

with selenium may help to prevent this condition. Those suffering from asthma and skin cancer

have also been evaluated with selenium for its potential use, although results have been

inconclusive. Zinc is an essential component of more than hundred enzymes involving digestion,

metabolism and wound healing. L-arginine is a semi-essential amino acid that is a substrate for

nitric oxide production. Ceremuzynski demonstrated that supplementation of L-arginine

improved exercise capacity in patients, who had angina.

A list of common nutrients with their health benefits is given in Table.

Common used Nutrients and their associated health benefits.

Nutrients Health Benefits

A:Fat Soluble Vitamins

1.Vitamin A

.

2:Vitamin D

3:Vitamin E

4:Vitamin K

Antioxidant, essential, for growth and

development,maintain healthy vision,skin

and mucous membranes,may aid in

prevention and treatment of certain cancers

and in the treatment of certain skin

disorders.

Essential for formation of bones and teeth,

helps the body absorb and use calcium

Antioxidant, helps form blood cells,boosts

the immune system

Essential for blood clotting

B:Water Soluble Vitamins

1:Vitamin C

2:Vitamin B1

3:Vitamin B2

4:Vitamin B3

Antioxidant, necessary for healthy bones,

gums, teeth and skin,helps in wound

healing,may prevent common cold and

attenuate its

Helps to convert food in to energy,

essential in neurologic functions

Helps in energy production and other

chemical processes in The body, helps

maintain healthy eyes, skin and nerve

function

Helps to convert food in to energy and

maintain proper Brain function

5:Vitamin B6

6:Vitamin B12

7:Folic acid

8:Pantothenic acid

Helps to produce essential proteins and

convert protein in to energy

Helps to produce the genetic material of

cells,helps With formation of red blood

cells,maintenance of central nervous

system and synthesize amino acids and is

involved in metabolism of fats,protein and

carbohydrates

Necessary to produce the genetic materials

of cells,essential in first three months of

pregnancy For preventing birth defects,

helps in red blood cell formation,

Aids in synthesis of cholesterol, steroids

and fatty acids crucial for intraneuronal

synthesis of acetylcholine

C:Minerals

1:Calcium

2:Iron

3:Magnesium

4:Phosphorous

Essential for building bones and teeth and

Maintaining bone strength, important in

nerve,Muscleand glanddular functions

Helps in energy production, helps to carry

and transfer oxygen To tissues

Essential for healthy nerve and muscle

function and bone formation,may help

prevent premenstrual syndrome (PMS)

Essential for building strong bones and

teeth,help in formation of genetic material,

energy production and storage

D:Trace elements

1:Chromium

2:Cobalt

With insulin helps to convert carbohydrates

and fats into energy

Essential component of vitamin B12, but

ingested cobalt is metabolized in vivo to

form the B12

E:coenzymes

1:Copper

2:Iodine

3:Selenium

4:Zinc

Essential for hemoglobin and collagen

production, healthy functioning of the

heart,energy production, absorption of iron

from digestive tract

Essential for proper functioning of the

thyroid

Antioxidant, essential for healthy

functioning of the heart muscle

Essential for cell reproduction, normal

growth and Development In children,

wound healing,production of sperm and

testosterone

F:Vitamin like compounds

1:Biotin

2:L- Carnitine

3:Choline Lipotropic agent

4:Vitamin F

5:Inositol Lipotropic agent

Required for various metabolic functions

Oxidation of fatty acids, promotion of

certain organic acid excretion and

enhancement of the rate of oxidative

phosphorylation

used to treat fatty liver and disturbed fat

metabolism

Involved in proper development of various

Membranes and Synthesis of

prostaglandins,leukotrienes and various

hydroxy fatty acids

necessary for amino acid transport and

movement of potassium and sodium

Herbals

Herbals are as old as human civilization and they have provided a complete storehouse of

remedies to cure acute and chronic diseases. The knowledge of herbals has accumulated

over thousands of years so that today we possess many effective means of ensuring health

care. Numerous nutraceuticals are present in medicinal herbs as key components.

A list of commonly known herbal and phytochemical products with their therapeutic

activity is shown in Table

Compound Therapeutic activity

Aloe vera gel(Aloe vera L.

N.L. Burm.)

Dilates capillaries, anti-inflammatory, emollient, wound

healing properties

Chamomile(Matricaria

recutita L.)

Antiinflammatory, spasmolytic, antimicrobial, wound

healing

Echinacea(Echinacea

purpurea L.)

Immunostimulant, treatment of cold and flu symptoms

Eleuthera(Eleutherococcu

s senticosus

Rupr. & Maxim., Maxim)

Adaptogen

Ephedra(Ephedra sinica

Stapf.,

Ephedra intermedia

Schrank.,

Ephedra equisetina

Bunge.)

Bronchodilator, vasoconstrictor, reduces bronchial edema,

appetite suppressant

Evening primrose oil

(Oenothera biennis L.)

Dietary supplement of linoleic acid, treatment of atopic

eczema

Feverfew (Tanacetum

parthenium L.)

Treatment of headache, fever and menstrual problems,

prophylactic to reduce frequency, severity and duration of

migraine headaches

Garlic (Allium sativum L.) Antibacterial, antifungal, antithrombotic, hypotensive,

fibrinolytic, antihyperlipidemic, antiinflammatory

Ginger (Zingiber

officinale Rosc.)

Carminative, antiemetic, cholagogue, positive inotropic,

treatment of dizziness

Ginseng(Panax ginseng ,

Panax quinquefolius L.)

Adaptogen

3.3 Major nutraceutical player

1. Amway,

2. GlaxoSmithKline

3. Pfizar

4. Dabur India

5. Cadila Health care

6. Ranbaxy

7. Himalaya Herbal Healthcare

8. Zandu Pharmaceuticals

9. Twin Labs,

10. General Nutrition Centers

11. Solgar Inc.

12. EID Parry’s

13. Sami labs

14. Elder pharmaceuticals

15. Raptakos

16. Paras

Compound Therapeutic activity

Aloe vera gel(Aloe vera L.

N.L. Burm.)

Dilates capillaries, anti-inflammatory, emollient, wound

healing properties

Chamomile(Matricaria

recutita L.)

Antiinflammatory, spasmolytic, antimicrobial, wound

healing

Echinacea(Echinacea

purpurea L.)

Immunostimulant, treatment of cold and flu symptoms

Eleuthera(Eleutherococcu

s senticosus

Rupr. & Maxim., Maxim)

Adaptogen

Ephedra(Ephedra sinica

Stapf.,

Ephedra intermedia

Schrank.,

Ephedra equisetina

Bunge.)

Bronchodilator, vasoconstrictor, reduces bronchial edema,

appetite suppressant

Evening primrose oil

(Oenothera biennis L.)

Dietary supplement of linoleic acid, treatment of atopic

eczema

Feverfew (Tanacetum

parthenium L.)

Treatment of headache, fever and menstrual problems,

prophylactic to reduce frequency, severity and duration of

migraine headaches

Garlic (Allium sativum L.) Antibacterial, antifungal, antithrombotic, hypotensive,

fibrinolytic, antihyperlipidemic, antiinflammatory

Ginger (Zingiber

officinale Rosc.)

Carminative, antiemetic, cholagogue, positive inotropic,

treatment of dizziness

Ginseng(Panax ginseng ,

Panax quinquefolius L.)

Adaptogen

17. Pelltech Health Care

18. Monex Internationl

19. Naturnutra Food Products

3.4 Major brand in india & worldwide

1. Natural beta carotene

2. Nutrilite

3. Ag natural health(canada)

4. Vitaquest

5. Lipa

6. Joint expert,

7. Mega-pro,

8. Zenith nutritions,

9. Joint’s coach,

10. Alpha omega

11. d-td 2

12. glutacell

13. Methibion

14. Om 3 - omega 3 fatty acid

15. Isosven - isoflavonoids and calcium

16. Rubicarb capsules

17. Imbran (Rice Bran dietary supplement capsules)

3.5 Nutraceutical & Supplementation

Dietary Supplement as per DSHEA-

is a product that is intended to supplement the diet and contains one or more of the following

dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary

substance for use by man to supplement the diet by increasing the total daily intake, or a

concentrate, metabolite, constituent, extract, or combinations of these ingredients.

Supplement market nears maturity

The US, Europe and Japan will continue to drive the global nutraceuticals market, although

growth in dietary supplements is expected to slow.

Leading markets

According to GIA, the United States, Europe and Japan dominate the global market, with a

combined share estimated at 86 percent last year.

Primary reasons for the strength of these markets are the high-income levels of consumers,

greater awareness and widespread preferences for specialty nutritional and herbal products, and

trends promoting preventive medicine and self-treatment.

.

Growth drivers

According to the report, rising consumer desire for leading a healthy life continues to drive sales

of Nutraceutical products.

Consumers today are increasingly aware of health and nutrition, and the growing availability of

scientific evidence linking diet and health is a major contributor to market growth.

Other factors include an expanding elderly population, as well as escalating costs associated with

healthcare, which is pushing the demand for self-medication and healthy foods.

Functional Foods

According to the report, functional foods constitute a fast moving segment in the Nutraceuticals

market, driven by the rising health awareness among consumers.

"The demand for healthier foods or food ingredients is likely to intensify as baby boomers seek

ways to keep themselves free from age-related chronic health problems," said GIA.

Supplements

Growth in the dietary supplements segment is expected to slow, as the category fast approaches

maturity levels, said the report. This is particularly the case in developed regions.

"The maturity is expected to reflect in the future performance of the dietary supplements

segment in the form of relatively low growth, thereby adversely affecting the profit generation

capabilities of market participants."

As the global nutraceuticals industry continues to grow, competition will also increase. This will

be driven by factors such as price, safety, efficacy, packaging and brand loyalty,

3.5 REGULATORY REQUIREMENT IN DIFFERENT CONTINENT

European Regulatory Requirements - CE Marking

The "CE" symbol, also called the "CE Mark" is affixed to products that are

marketed in the European Common Market (European Union, EU).

The symbol indicates that the product meets the requirements of all the relevant

EU Directives and can be legally sold within the EU.

The individual national rules covering the sale of products have been replaced by a single set of

regulations known as Directives which require compliance with specific standards appropriate to

the various products.

The Directives themselves are not technical standards.

Individual countries are required to ensure that their laws governing product sale meet the

requirements of the Directives adopted by the Council of European Communities.

As of 1997 there were approximately 300 Directives. Each Directive contains unique

requirements for the manufacturer/supplier to demonstrate compliance. A product may be

required to meet the requirements of more than one Directive.

DSHEA (Dietary Supplement Health and Education Act) which was passed by the U.S.

Congress in 1994

In USA, watershed legislation was passed in 1994 to regulate the manufacture and marketing of

nutraceuticals. This law, known as the Dietary Supplement Health and Education Act, reversed

45 years of increasing FDA regulation of health related products. The FDA may establish good

manufacturing practices for nutraceuticals as long as these regulations are molded after the less

stringent regulations for foods as opposed to those for drugs. A draft law reminiscent of the

Dietary Supplement Health and Education Act is in development in India to regulate

manufacturing, importing and marketing of health foods/dietary supplements and other

nutraceuticals. Also the country's central drug control department has put some structures in

place for dietary supplements,

The Indian Health and Dietary Supplement Association was created to represent pharmaceutical,

nutraceutical, herbal, direct selling and other service oriented industry companies and plans to

affiliate with the International Alliance of Dietary Supplement Associations in the near future.

In 1994 Congress passed legislation known as the Dietary Supplement Health and Education Act

(DSHEA). The law restricted the Food and Drug Administration (FDA) in the regulations it

could enforce limiting label claims on dietary supplements. Specifically, DSHEA allows dietary

supplement labels to carry statements dealing with structure/function claims such as "supports

the immune system." Section 6 of DSHEA states that structure/function statements are

"statements of nutritional support . . . that describe the role of a nutrient or dietary ingredient

intended to affect the structure or function in humans."

Regulatory concerns on nutraceuticals: The Indian Scenario

The Drugs & Cosmetics Act 1940

The essential features of the current Drug Regulatory System in the Country more or less follows

the first Drugs Act passed in 1940 as a follow-up on Chopra Committee's recommendations for

setting up Drug Control Agencies at the Centre as well as in all the States to make appropriate

rules for the manufacture, distribution and sale of all drugs, in the interest of public health and

welfare. However, it was only in 1964, that the Act was amended to include Ayurveda and Unani

under its purview.

The original Act of 1940 and the Rules 1945 also had set up comprehensive Schedules covering

among others, Schedule G (labeling), Schedule H (Prescription), Schedule M (GMP), Schedule P

(Shelf Life), Schedule T (GMP Standards), Schedule V (Patent & Proprietary Medicines) and

Schedule Y (New Drugs & Clinical Trials). The Magic Remedies Act prohibits claiming

usefulness of Drugs for which there is no evidence that drug treatment of any kind would

be beneficial.

What have been lacking in the Indian Drugs & Cosmetics Act 1940 are provisions for covering

several other healthcare products used by human beings, including Nutraceuticals, widely

marketed in the Country.

Mashelkar Committee Recommendations

The Expert Committee for " A Comprehensive Examination of Drug Regulatory Issues,

Including the Problem of Spurious Drugs" set up by the Government deliberated among other

subjects the issues related to the need for setting up Regulatory Standards for Dietary

Supplements. it has been estimated that the market size of this segment was around Rs 2,300

crore in 2001 and Rs 4,500 crore in the current year. In other words they would constitute around

20 - 25 % of the country's pharmaceutical sales.

As of now, India has no legislation or even guidelines to regulate the manufacture and

marketing of Nutraceuticals, unlike in the U.S.A which has the Dietary Supplements and

Education Act (DSHEA), the European Union, which has the directive on Food Supplements and

Japan with its Foods For Specific Health Use (FOSHU).

India, however has specific Food Laws, of which only the Prevention of Food Adulteration

(PFA) comes under the purview of the Drugs & Cosmetics Act.

Certain types of Nutraceuticals which fall under "Patent & Proprietary Medicines", which may

or may not claim therapeutic properties and Cosmetics which have no therapeutic utility are

included under the Drugs & Cosmetics Act.

Even though there have been earlier recommendations by Committees constituted by the

Director General of Health Services (DGHS) and the Department of ISM & H of the Ministry of

Health in 2000 and 2002 respectively, no decisions have been taken so far on their

implementation by the Government.

The Mashelkar Committee considered all the previous recommendations for the planning and

implementation of an equitable regulatory system for Nutraceuticals. Unlike in other areas, there

are several aspects to regulating Dietary Supplements. They concern Raw Material Availability

and Quality, Safety, Efficacy, Product Quality, Labeling and Marketing Ethics and Practices.

Further, most Nutraceuticals have as their basic sources, materials from Plants, Animals,

Microbes, Minerals, and Chemicals, all of which having their own unique problems of

availability, accessibility and quality.

Even the same Dietary Supplement manufactured by different manufacturers do not often meet

the same standards and specifications Thus it is obvious that evolving a uniform standard for the

Dietary Supplement of identical composition whether classified under the Food or Drug category

is not easy.

The following recommendations when implemented will ensure that the Industry will provide

quality products manufactured under Good Manufacturing practices and supported by adequate

and sound evidence for their safety and efficacy.

1) All Nutraceuticals in the market or to be marketed to be classified as either Dietary (Food)

Supplements or as Drugs as defined under the Food Acts or the Drugs & Cosmetics Act.

2) Food Supplements, which do not have on their labels and /or are not promoted as having

therapeutic properties should be regulated under Food Laws which need to be amended if

necessary to include them.

3) Products which claim to have utility as prophylactics, diagnostics or therapeutic agents should

be considered as Drugs and would come under the purview of the Rules & regulations under

the Drugs & Cosmetics Act.

4) Whether they should be under Schedule H, Schedule K or under a new category of OTC drugs

is to be determined by their safety profiles and track record of use.

5) In both cases, adequate evidence consistent with the claims made should be provided to

establish their safety and efficacy in humans.

6) If retrospective data is not adequate, prospective studies should be carried out.

7) All products regardless of the categorization should meet minimum current Good

Manufacturig Standards (cGMPs).

8) The labels should have list of contents, their composition, warnings on safety and possible

adverse reactions and shelf life where relevant.

Regulation on products of ISM& H The

Department of ISM &H under the Ministry of Health, administers all the activities involved in

the revival and promotion of drugs based on ISM &H in the Country. At present products, which

originate from any of classical texts on ISM or in the Pharmacoepias do not have to establish

their safety and efficacy profiles using traditional or modern methods. These stipulations do

result in lack of uniformity in the quality of the products in the market leading to adverse effects

on the consumers.

Considering that the ultimate objective is to use these products based on ancient Systems of

Medicine for healthcare globally, it is imperative that a detailed study should be undertaken to

ensure their rationality based on available knowledge, good manufacturing process,

standardization and quality control before they are marketed for human consumption.

The scientific rationale for the development and marketing of ISM-based products need not

necessarily be based on modern scientific methods; they could very well be based on established

norms under the Indian Systems of Medicine. When the administered dosage forms are

'modernised' in the forms of tablets, capsules etc., they need to follow the processes dictated

under the modern system and should use only permitted excipients. Since in the case of

traditional processes, fermentation to produce alcohol happens in situ, resulting in having alcohol

content in the final product, as in the case of Asavas and Arishtas, extraction of natural material

using alcohol could be permitted to ensure that alcohol - soluble in addition to water-soluble

contents would be present in the extract used. It is important that adequate human clinical data is

generated for these products, which establishes beyond reasonable doubt their safety and

therapeutic usefulness.

Considering the track record of use of these products in humans for several centuries, most

regulatory agencies including the U.S. FDA do not insist on pre-clinical in-vitro and animal in-

vivo data for product approvals. Here again they could be approved for marketing as prescription

only or as OTC products, based on the same yardsticks applied for non-ISM drugs.

It is thus obvious that both Nutraceuticals, as well as products marketed under ISM labels, which

together could constitute as much as one-third of the pharmaceutical market in the Country,

should be brought under appropriate regulatory mechanisms and controls, so that they serve

effectively not only as alternate systems, but as complementary to modern medicine, thereby

filling the current gaps in therapeutics for many disease area.

3.6 DCGI (Drug Controller General of India)

India’s regulator DCGI plans inspection of overseas drug manufacturing

facilities

India is yet to start the practice of inspecting factories abroad that export drugs to the country. 

India’s drug regulator Drug Controller General of India (DCGI) is planning to start the practice

of sending its drug inspectors to countries which export drugs to India to ascertain and certify the

manufacturing quality of the pharmaceutical products.

Even though India is one of the leading exporters of pharmaceutical products to different regions

of the world, the country also imports drugs, active pharmaceutical ingredients (APIs) and drug

intermediates from foreign countries like China and Taiwan.

Last year, India imported pharmaceutical products worth Rs 1500 crore from various countries,

according to official figures.

However, it is not still a practice for India to visit the manufacturing facilities to conduct

inspections to ascertain the qulaity of medicines being sourced by Indian companies. 

Most of the countries importing pharmaceutical products made in India send their personnel to

visit Indian manufacturing facilities to verify and authenticate the manufacturing standards to

ensure quality of the products before giving okay for importing.

“Inspectors from other countries, from Nepal to the US, come to India to check manufacturing

facilities of Indian drug companies.

India also get drugs imported from many countries such as Taiwan and China for which we will

start sending our inspectors to examine whether they are following good manufacturing

practices,” stated Dr Surinder Singh, Drug Controller General of India (DCGI) who heads

India’s apex drug regulatory body.

India will also soon start this practice close in line with the other countries, said Dr Singh. But he

did not reveal much on the nature and time of such overseas inpections.

Currently, India has nearly 100 pharmaceutical manufacturing facilities approved the US Food

and Drug Adiministration. This is the largest number of facilities outside the US, approved to

source pharmaceuticals by USFDA -which sets one of the world’s most stringent quality

parameters. USFDA conducts inspections periodically before giving approval for each

pharmaceutical product to ensure that it follows the good manufacturing practice (GMP)

standards set by the federal regulator.

If caught for any lapses, even minor, including the errors in documentations, USFDA instantly

go for immediate action.

Show cause notices have been sent out by the US FDA for several of Indian manufacturing

facilities including that of Ranbaxy, Wockhardt, Sun, Lupin Cipla etc over the years, after

finding manufacturing errors during inspection in their USFDA approved facilities.

Most recently, US FDA even went to the extend of suspending the certification of Ranbaxy’s

formulations manufacturing facility Paonta Sahib for not following set procedures. This followed

a ban in importing products manufactured in Paonta Sahib, inflicting huge losses to Ranbaxy.

Ranbaxy, now a subsidiary of Daiichi-Sankyo of Japan is one of India’s leading drug exporters

to US.

Similarly, US FDA has also issued notices to Cipla, another big time export of pharmaceutical

products from India.

Manufacturing facilities of Indian drug makers are also inspected and audited by MHRA of UK,

ANVISA of Brazil, MCC of South Africa, TGA of Australia etc.

Therefore, it’s hightime India too started the practice of inspecting to bring in more transparency

into the drug approval system, the DCGI said.

The pharmaceutical exports from India for the first nine months of the fiscal 2008-09 have

peaked upto $1.2 billion, despite a slowdown in overseas trade across all industries owing to

recessional fears.

Total exports in pharmaceutical products from India in December 2008 surged by 46.3 per cent

to 1.01 billion dollars from 609 million dollars in the same month of the previous fiscal,

according to Pharmaceuticals Exports Promotion Council (PHARMEXCIL) - separate governing

body to oversee pharma exports under the Ministry of Commerce & Industry.

The overseas sales in the first nine months of 2008-09 went up by 21 per cent to 8.44 billion

dollars against 6.97 billion dollars in 2007-08.

Despite this, India’s pharma exports to US is severely hit in recent months by increasing

competition from other emerging markets like China, Israel and Korea, said a study conducted

by Federation of Indian Chambers of Commerce and Industry –an umbrella association

representing Indian businesses.

Pharmaceutical export business remains the worst hit among all the industries due to the

economic down turn in US. Indian exports of pharmaceutical products to the US fell almost 40

per cent in the five months between October last year and the end of February.

Exports of pharmaceutical products from India have been facing steady competition in the US

market from its Asian peers such as China and South Korea as well from Israel. In fact Indian

pharma companies are increasingly losing their relative share to firms from these emerging

economies.

The pharmaceutical exports from India for the first nine months of the fiscal 2008-09 have

peaked upto $1.2 billion, despite a slowdown in overseas trade across all industries owing to

recessional fears

4. RESEARCH METHODOLOGY

4.1 OBJECTIVE OF STUDY

Finding out the actual demand of Nutraceuticals in Delhi

To know the trends of Nutaceuticals in Indian market.

To know the individual preference of physicion, dietician, slimming

centers,& gym.

To know the different idea & demand for the product

To know the utilization of product of Nutraceuticals.

4.2 DURATION OF STUDY

45 Days from 1st of june to 15th of july

4.3 AREA OF STUDY

1. TRADE

i. Ashram

ii. Sarita Vihar

iii. Sukhdev Vihar

iv. Junkpura

v. Nizamuddin

vi. New Friends Colony

2. HOSPITAL:

i. Escort

ii. Apollo

iii. Sujan Mahindra

iv. Holy Family

4.4 RESEARCH DESIGN

The purpose of the study was to explore the market of the nuteceutical. For this

individuals were segmented based on doctors, slimming center and gym. To target this

position perception and future prospect of the drug, a survey was conducted through

which an analysis was drawn.

Sampling technique

The random sampling technique was used for the survey.

Questionnaire filled by physician, dietician, slimming center and gym

Time duration was 45 days for data collection.

Data collection

Data would be collected through primary and secondary sources

i. Primary source of data collection is through questionnaire.

ii. Source of secondary data is published reports, magazines & internet.

5. ANALYSIS OF STUDY

PHYSICIAN RESPONSE

DIETICIAN RESPONSE

OTHERS(SLIMMING CENTER &GYM) RESPONSE

6. CONCLUSION

After analyzing the data, it is concluded that there is great oppurtinity of Nutraceutical in Indian

market. There is a huge demand of these products in slimming center and gym.

There is lack of proper awareness among doctors about Nutraceutical and their products.

Nutraceuticals are destined to play an important role in future therapeutic developments but their

success will be governed by control of purity, safety and efficacy without inhibiting innovation.

Nutraceuticals will continue to appeal because they are convenient for today’s lifestyle. The

present accumulated knowledge about nutraceuticals represents undoubtedly a great challenge

for nutritionists, physicians, food technologists and food chemists. Public health authorities

consider prevention and treatment with nutraceuticals as a powerful instrument in maintaining

health and to act against nutritionally induced acute and chronic diseases, thereby promoting

optimal health, longevity and quality of life. A place for Nutraceuticals in clinical practice is

emerging.

The US alone accounted for 37 percent of 2007 Nutraceutical sales, but Asia Pacific is expected

to emerge as the fastest growing market, boosted by the "robust" Chinese and Indian markets,

and increasing economic prosperity, said the report

7. RECOMMENDATIONS

Indian Nutraceutical markets are in small stage. India can become a big player in this industry if

it develops clinical documentation and scientific basis to support claims of safety and efficacy.

following recommendations/suggestions are:

1. by developing awareness among Indian populations.

2. by creating awareness among physician about Nutraeutical and its product.

3. by scientific advertisement and promotion

4. To grow this segment of market, the company should initially focus on the slimming

center and gym

5. For winning doctors attitude, the company should make strategies for the TOP OF THE

MIND RECALL for the brand with different strategies which include brand building

through proper communication and advertisement.

6. Marketing department should be tight enough to generate awareness about plenteous and

its products.

7. Proper advertisement is one of the most important thing company should take care of

objectively.

This will become even more important if India wants to become a major player.

Areas of concern

The lack of quality control is a major area of concern for nutraceuticals. The quality of plant

material and manufacturing processes used for nutraceuticals are regulated by food laws, which

lack the specificity required for botanical drugs. This can have serious consequences.

Contamination, for instance, with toxins after fungal infection of raw plant material or with other

ingredients has been repeatedly reported and can have potential fatal consequences.

Adulterations and numerous other types of impurity of nutraceuticals conceivably remain

undetected simply because there is an almost total absence of specific quality control. Absence

of quality control not only increases the risk to the consumer, it also results in a total lack of

impetus to conduct adequate research that demonstrates the potential benefits of nutraceuticals or

ensures their safety. New clinical applications of nutraceuticals are increasingly being reported,

but there are fundamental differences between formulation, production and the evidence

supporting clinical use. Nutraceuticals generally fall within the novel foods and ingredients

regulations but their purity, dosage requirements and clinical consequences exceed those of most

‘healthfoods’. Replacement of one nutrient or antioxidant is unlikely to correct the cascade of

interconnected metabolic abnormalities associated with many diseases. Cost is another factor that

receives scant attention. These products sell for substantial amounts more than mainstream

products, in as much as botanicals are costly to produce

8.ANNEXURE

Nutraceutical Market Survey

Questionnaire

Q.1 Out of these following lifestyle diseases which is the most prevailing in India. Mention 1,2,3,4 on priority basis.

Obesity Diabetes

Hypertension Constipation

Q.2 What are the common ailments in nuclear family of metro city? Mention 1, 2,3,4,5 on priority basis.

Constipation Sleeplessness Depression

Morning Fatigue Body ache

Q.3 Why Indian Nutraceuticals market size is just 0.036 %(Rs. 2700 cr.)of global Nutraceutical Market(7,50,000 Cr.)? Mention 1, 2, and 3 on priority basis from the following options

Untapped Market Lack of awareness

Promoted unscientifically

Q.4. Obesity has become globesity and it stops us from doing our day to day performance and apart from this we suffer with other manifestation of diseases. BBT-SLIM Caps reduces body weight 1-3 kg in a month. It reduces LDL & TG (Bad Cholesterol) by 17%. Moreover it increases HDL (Good Cholesterol) by 37%, which no other product offers. Are you interested to take 15 days course free of cost?

Yes No

Q.5. Those who are obese, remain loaded with lot of diseases especially Hypertension, Diabetes

and Hypercholestereamia.DH2 Caps is a wonderful product recommended for overweight people

associated with diabetes and hypertension (age35+). Are you interested to take 15 days course

free of cost?

Yes No

Q.6 STF-FRESH Caps as the name indicates is the blend of precious valuable nutraceuticals.

Metro life is full of tension and people hardly get time to spare for lifrstyle management that

leads to lots of lifestyle diseses such as sleeplessness, morning fatigue,depression constipation,

body ache.STF-FRESH offers you not only sound sleep,energy, mood elevation but also gives

you freedom from constipation, morning fatigue and body ache. Are you interested to take 15

days course free of cost?

Yes No

9. BIBLIOGRAPHY

1) www.expresspharmaonline.com

2) www.whereincity.com

3) Indian Journal of Pharmacology 2003

4) www.indiabizclub.com

5) www.themedica.com

6) www.cygnusindia.com

7) www.springerlink.com

8) www.semilabspioneer.com

9) www.ingradient_usa.com

10) www.researchandmarkets.com

11) www.pubmed.com

12) www.nutraceutical.com

13) www.piribo.com

14) www.fnbnews.com

15) www.marketresearch.com

16) www.mynutramart.com