PROJECT REPORT ON Production Planning, Distribution and Logistics SUBMITTED IN PARTIAL FULFILLMENT OF Degree of Master of Business Administration
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. XYZ 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. XYZ Product Manager of Plenteous Pharmaceuticals Ltd. for his valuable suggestion and constant encouragement. I am also thankful to Dr. XYZ Manager Product Development of Akums Pharmaceuticals Ltd. for their support and Miss XYZ 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
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, 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, Omidom, Mahacef
FDC Ltd.
Painadol 50SR, Painadol 100 SR, Painadol P
Nicholas
Acevah, Chupp, Floxip, Nicodroxil, Nicospas, RCID, and many more.
Movexx
Nucort,
Plus, Oflox,
Nobel
Spas,
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.
Market Growth, 2007-2009 27
US $ Bn
18.75
2007
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.
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 A:Fat Soluble Vitamins
Health Benefits
1.Vitamin A
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. 2:Vitamin D
Essential for formation of bones and teeth, helps the body absorb and use calcium
3:Vitamin E
Antioxidant, helps form blood cells,boosts the immune system
4:Vitamin K B:Water Soluble Vitamins
Essential for blood clotting
1:Vitamin C
Antioxidant, necessary for healthy bones, gums, teeth and skin,helps in wound healing,may prevent common cold and attenuate its
2:Vitamin B1
Helps to convert food in to energy, essential in neurologic functions
3:Vitamin B2
Helps in energy production and other chemical processes in The body, helps maintain healthy eyes, skin and nerve function
4:Vitamin B3
Helps to convert food in to energy and maintain proper Brain function
5:Vitamin B6
Helps to produce essential proteins and convert protein in to energy
6:Vitamin B12
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 7:Folic acid
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,
8:Pantothenic acid
Aids in synthesis of cholesterol, steroids and fatty acids crucial for
intraneuronal
synthesis of acetylcholine C:Minerals 1:Calcium
Essential for building bones and teeth and Maintaining bone strength, important in nerve,Muscleand glanddular functions
2:Iron
Helps in energy production, helps to carry and transfer oxygen To tissues
3:Magnesium
Essential for healthy nerve and muscle function and bone formation,may help prevent premenstrual syndrome (PMS)
4:Phosphorous
Essential for building strong bones and teeth,help in formation of genetic material, energy production and storage
D:Trace elements 1:Chromium
With insulin helps to convert carbohydrates and fats into energy
2:Cobalt
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 the
heart,energy production, absorption of iron from digestive tract 2:Iodine
Essential for proper functioning of the thyroid
3:Selenium
Antioxidant,
essential
for
healthy
functioning of the heart muscle 4:Zinc
Essential for cell reproduction, normal growth and Development In children, wound healing,production of sperm and testosterone
F:Vitamin like compounds 1:Biotin
Required for various metabolic functions
2:L- Carnitine
Oxidation of fatty acids, promotion of certain organic acid excretion and enhancement of the rate of oxidative phosphorylation
3:Choline Lipotropic agent
used to treat fatty liver and disturbed fat metabolism
4:Vitamin F
Involved in proper development of various Membranes and Synthesis of prostaglandins,leukotrienes and various hydroxy fatty acids
5:Inositol Lipotropic agent
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 Aloe vera gel(Aloe vera L.
Therapeutic activity Dilates capillaries, anti-inflammatory, emollient, wound
N.L. Burm.)
healing properties
Chamomile(Matricaria
Antiinflammatory, spasmolytic, antimicrobial, wound
recutita L.)
healing
Echinacea(Echinacea
Immunostimulant, treatment of cold and flu symptoms
purpurea L.) Eleuthera(Eleutherococcu
Adaptogen
s senticosus Rupr. & Maxim., Maxim) Ephedra(Ephedra sinica
Bronchodilator, vasoconstrictor, reduces bronchial edema,
Stapf.,
appetite suppressant
Ephedra intermedia Schrank., Ephedra equisetina Bunge.) Evening primrose oil
Dietary supplement of linoleic acid, treatment of atopic
(Oenothera biennis L.)
eczema
Feverfew (Tanacetum
Treatment of headache, fever and menstrual problems,
parthenium L.)
prophylactic to reduce frequency, severity and duration of
Garlic (Allium sativum L.)
migraine headaches Antibacterial, antifungal, antithrombotic, hypotensive, fibrinolytic, antihyperlipidemic, antiinflammatory
Ginger (Zingiber
Carminative, antiemetic, cholagogue, positive inotropic,
officinale Rosc.)
treatment of dizziness
Ginseng(Panax ginseng ,
Adaptogen
Panax quinquefolius L.) Ginkgo (Ginkgo biloba L.) Vasodilation, increased peripheral blood flow, treatment of post-thrombotic syndrome, chronic cerebral vascular insufficiency, short term memory loss, cognitive disorders
secondary to depression, dementia, tinnitus, vertigo Goldenseal (Hydrastis
Antimicrobial, astringent, antihemorrhagic, treatment of
canadensis L.)
mucosal inflammation,dyspepsia, gastritis
Horehound (Marrubium
Expectorant, antitussive, choleretic
vulgare L.)
3.3 Major nutraceutical player Licorice(Glycyrrhiza 1. Amway, glabra L.,
Expectorant, secretolytic, treatment of peptic ulcer
G. uralensis Fisch.) 2. GlaxoSmithKline Melissa 3. (Melissa Pfizar officinalis L.) 4. Dabur India Plantago seed (Plantago 5. Cadila Health care arenaria Waldst.,
Topical antibacterial and antiviral
Cathartic
Plantago arenaria Kit. 6. Ranbaxy Plantago ovata) 7. Himalaya Herbal Healthcare Slippery elm(Ulmus rubra Mucilaginous demulcent, emollient and nutrient, used to Muhl.) sooth irritated mucous membranes, ulcerations of the 8. Zandu Pharmaceuticals digestive tract 9. Twin Labs, St. John’s Anxiolytic, antiinflammatory, antidepressant, monoamine 10. General Nutrition Centers wort(Hypericum oxidase inhibitor perforatum L.) 11. Solgar Inc. Valerian (Valeriana 12. EID Parry’s officinalis L.) 13. Sami labs Willow bark(Salix alba L.,
Spasmolytic, mild sedative, sleep aid
Antiinflammatory, analgesic, antipyretic, astringent,
S. daphnoides Villars, treatment of rheumatic and arthritic conditions, headache 14. Elder pharmaceuticals S. pentandra L.) 15. Raptakos 16. Paras
and gout
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 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 be
treatment of any kind would
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 Mashelkar
in Committee
the
Country.
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 necessary
to
include
if
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 the
Drugs &
Cosmetics
under
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
Regulation on products of ISM& H
shelf
life
where
relevant. 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. Obesity
Diabetes
Hypertension
Constipation
Q.2 What are the common ailments in nuclear family of metro city? Mention priority basis. Constipation Morning Fatigue
Sleeplessness
1, 2,3,4,5 on
Depression
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 Promoted unscientifically
Lack of awareness
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
Q.6
No
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