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Transcript of neutaceuticals
PROJECT REPORT ON
Production Planning, Distribution and
Logistics
SUBMITTED IN PARTIAL FULFILLMENT
OF
Degree of
Master of Business Administration
Submitted by:
Narendra Prakash
Under Supervision of
Amrendra P Singh
DGM- Distribution & Logistics
Cadila Pharmaceutical Ltd.
Department of Management Studies
JAMIA 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 UKMHRA
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
Cipla Doxicip, 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
Intas Ceftas, Atenolol, C-col, Intagesic, Kuff Q, NTCold,
Omey
Mankind Ranispas, 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 zutritional 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 A2. Vitamin D3. Vitamin E4. 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 C2. Vitamin B13. Vitamin B24. Vitamin B35. Vitamin B66. Vitamin B12
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 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
7. Folic acid8. Pantothenic acid 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. Calcium2. Iron3. Magnesium4. Phosphorous
Essential for building bones and teeth and Maintaining bone strength, important in nerve, Muscle and 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. Chromium2. 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 Essential for hemoglobin and collagen production, healthy functioning of the2. Iodine3. Selenium4. Zinc
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. Biotin2. L- Carnitine3. Choline Lipotropic agent4. Vitamin F5. 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
Ginkgo (Ginkgo biloba L.) Vasodilation, increased peripheral blood flow, treatment of
post-thrombotic syndrome, chronic cerebral vascular
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
17. Pelltech Health Care
18. Monex Internationl
19. Naturnutra Food Products
insufficiency, short term memory loss, cognitive disorders
secondary to depression, dementia, tinnitus, vertigo
Goldenseal (Hydrastis
canadensis L.)
Antimicrobial, astringent, antihemorrhagic, treatment of
mucosal inflammation,dyspepsia, gastritis
Horehound (Marrubium
vulgare L.)
Expectorant, antitussive, choleretic
Licorice(Glycyrrhiza
glabra L.,
G. uralensis Fisch.)
Expectorant, secretolytic, treatment of peptic ulcer
Melissa (Melissa
officinalis L.)
Topical antibacterial and antiviral
Plantago seed (Plantago
arenaria Waldst.,
Plantago arenaria Kit.
Plantago ovata)
Cathartic
Slippery elm(Ulmus rubra
Muhl.)
Mucilaginous demulcent, emollient and nutrient, used to
sooth irritated mucous membranes, ulcerations of the
digestive tract
St. John’s
wort(Hypericum
perforatum L.)
Anxiolytic, antiinflammatory, antidepressant, monoamine
oxidase inhibitor
Valerian (Valeriana
officinalis L.)
Spasmolytic, mild sedative, sleep aid
Willow bark(Salix alba L.,
S. daphnoides Villars,
S. pentandra L.)
Antiinflammatory, analgesic, antipyretic, astringent,
treatment of rheumatic and arthritic conditions, headache
and gout
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 DSHEAis
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 invivo
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.
ð 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