RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA
4th ‘T’ Block, Jayanagar, BANGALORE-560041
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1 / Name of the Candidate andAddress / ROHIT GUPTA
s/o RAMAN KUMAR GUPTA
H.No. 874; Sector 13;
Urban Estate;
Karnal;
Haryana (132001)
2 / Name of the Institution / AL-AMEEN COLLEGE OF PHARMACY
Hosur Road,
Lal Bagh main Gate
Bangalore – 560027
Karnataka
3 / Course of Study and
Subject / M.Pharm
(Pharmaceutical Marketing And Management)
4 / Date of Admission / 9th June 2008
5 / Title of the Topic:
“To Study the Market Dynamics of Artificial Sweeteners & Arrive at a Marketing Plan for the Launch of a Brand of Sucralose.”
6 / Brief resume of the intended work:
6.1 - Need for the study :
The sensory properties of food highly influence the selection and consumption of food in man. Taste, smell, texture and appearance of the food plays a crucial role in the regulation of human appetite and nutrient intake. Sucrose or 'cane sugar' is the direct table sugar that one uses daily. It is a disaccharide made up of glucose and fructose and it provides four calories per gram. A person with diabetes would not like to miss this sweet taste and cut out twenty-five percent of his eating pleasure. The main problem that a person with diabetes faces is an increase in the threshold level of sweetness compared to non-diabetics. Therefore a person with diabetes needs sweeter food than a person without diabetes to appreciate the same taste. A sweetener is a food additive which duplicates the effect of sugar on taste. Therefore they are also called 'sugar substitutes or artificial sweeteners'. In India the total artificial sweeteners’ market is valued at Rs. 75 crores of which 95 % of market is dominated by aspartame [1].
A global strategic business report reveals that a worldwide weight reduction effort is stimulating the $3.5bn global artificial sweeteners market, of which the US and Europe currently make up 65 per cent. According to the report, the global sweetener market is currently achieving a compound annual growth rate of 3.7 per cent. The global market for sucralose artificial sweeteners will allegedly grow the fastest, posting a CAGR of around 10 per cent. Aspartame market reached $3bn mark in 2008, expanding on its current 50 per cent hold of the global market [2].
Artificial sweeteners would have a significant market in the health sector considering the fact that India is the world capital of diabetes with more than 32 million diabetics - the highest number in the world. The World Health Organization estimates that the number will climb to 79 million by 2030[1]. Also, 5% of Indian population is reported to be obese, with a risk of developing diabetes and various other complications [3] .Thus there is a lot of opportunity for the artificial sweetener market to grow from present 75 crores. Sucralose a fairly new entrant in the artificial sweetener market has been mentioned as the safest sweeteners till now by the FDA. Our project will be aimed at studying the market dynamics (various factors that regulate the sales potential of a product) & arrive at a marketing plan for the launch of a brand of sucralose [4].
6.2 Review of literature
Artificial sweeteners are chemicals or natural compounds that offer the sweetness of sugar without as many calories. Because the substitutes are much sweeter than sugar, it takes a much smaller quantity to create the same sweetness. Products made with artificial sweeteners have a much lower calorie count than do those made with sugar. Artificial sweeteners can help consumers cut down on calories and control weight, help to manage chronic conditions such as diabetes, and potentially prevent cavities.[5] Sugar substitutes are used for a number of reasons including:
• To assist in weight loss; some people choose to limit their food energy intake by replacing high-energy sugar or corn syrup with other sweeteners having little or no food energy. This allows them to eat the same foods they normally would, while allowing them to lose weight and avoid other problems associated with excessive caloric intake.
• Dental care — sugar substitutes are toothing friendly, as they are not fermented by the microflora of the dental plaque.
• Diabetes mellitus — people with diabetes have difficulty regulating their blood sugar levels. By limiting their sugar intake with artificial sweeteners, they can enjoy a varied diet while closely controlling their sugar intake. Also, some sugar substitutes do release energy, but are metabolized more slowly, allowing blood sugar levels to remain more stable over time.
• Reactive hypoglycemia — individuals with reactive hypoglycemia will produce an excess of insulin after quickly absorbing glucose into the bloodstream. This causes their blood glucose levels to fall below the amount needed for proper body and brain function. As a result, like diabetics, they must avoid intake of high-glycemic foods like white bread, and often choose artificial sweeteners as an alternative.
There are about five artificial sweeteners (non-nutritive) in the world market today. They are:- Saccharin, Aspartame, Acesulfame-K, Stevia, Sucralose, Alitame and Neotame
Saccharin was discovered 100 years ago. It is a low calorie sweetener and 300 times sweeter then sucrose [6]. It is one of the most studied ingredients in the food supply. Saccharin is restricted in pregnancy as the placenta actively concentrates it[7]. It is reported that saccharin causes hypersensitivity. The Center Of Science In The Public Interest, US, in a study has reported that there is a correlation between a rise in tumor activity & saccharin intake [8].
Aspartame was introduced in 1965. It is a low-calorie sweetener and 180-200 times sweeter than sucrose[9]. Aspartame is a non-nutritive sweetener used in management of diabetes and is approved by FDA [10]. Aspartame is made from two amino acids: L-phenylalanine and L-
aspartic acid. It is reported that there are health risks are to people who suffer from phenylketonuria (PKU), who cannot metabolize the L-phenylalanine [8]. Aspartame is restricted in children as this compound diffuses easily across the blood-brain barrier and high levels of this neurotransmitter causes alteration in brain activity. Aspartame was found to have no adverse effect on fetal exposure but it is restricted in pregnant women with hyperphenylalaninemia. "Not recommended for children. Not for phenylketoneurics" is the mandatory label currently used on aspartame [5].
Other reported side effects are depression, headache [11], seizure and gastrointestinal disturbance after consuming products that contain aspartame [9].
Acesulfame-K (ace-K) was introduced in 1967. It is 200 times sweeter than sucrose [12]. A study conducted by Center for Science in the Public Interest (CSPI) US, reports that the product can break down to acetoacetamide. This chemical has been shown to affect the thyroid in rats, rabbits, and dogs [8].
Stevia is obtained from the leaves of Stevia rebaudiana. It is up to 300 times sweeter than sucrose, does not impact blood sugar and has zero calories [12]. It is approved as a 'dietary supplement by the FDA. It is used widely in South America and the Orient. It is popular in Japan, China and Korea and has been used there for more than three decades [8].
Sucralose is a chlorinated sugar that is about 300-1000 times as sweet as sucrose [12]. It is produced from sucrose when three chlorine atoms replace three hydroxyl groups. Unlike other artificial sweeteners, it is stable when heated and can therefore be used in baked and fried goods. Sucralose does not promote tooth decay. It is minimally absorbed by the body and most of it passes out of the body unchanged. The FDA approved sucralose in 1998[13]. It is found in low levels in the placenta. It is safe in pregnancy. Sucralose apparently has no adverse effect in children and is considered safe. It is approved by FDA for the children having dental problems [14].
Sucralose has been accepted by several national and international food safety regulatory bodies, including
1. The U.S. Food and Drug Administration (FDA),
2. Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives,
3. The European Union's Scientific Committee on Food,
4. Health Protection Branch of Health and Welfare, Canada.
5. Food Standards Australia-New Zealand (FSANZ).[15]
Sucralose is now permitted for use in over 60 countries. Sucralose is the only artificial sweetener ranked as "safe" by the Center for Science in the Public Interest[16]. According to Canadian diabetic association “One can consume 15 mg/kg/day of Sucralose on a daily basis over a lifetime without any adverse effects”[17].
Pharmacokinetics[18]
Absorption: Studies have shown that about 15% of ingested sucralose is passively absorbed through the small intestine. Most ingested sucralose passes through the digestive system unchanged and without causing gastrointestinal side effects.
Distribution: The small amount of sucralose that is absorbed is distributed to essentially all tissues. Studies show that there is no active transport of sucralose across the blood-brain barrier, across the placental barrier, or from the mammary gland into milk.
Metabolism: Although derived from sucrose, sucralose is not perceived by the body as a carbohydrate. Unlike carbohydrates, sucralose is not broken down during its passage through the body. In humans, approximately 2% of the amount consumed is biotransformed into toxicologically insignificant components that are rapidly excreted in urine.
Elimination: Most ingested sucralose is excreted unchanged in feces, without gastrointestinal effects. Of the small amount that is absorbed, most is eliminated unchanged in urine within about 24 hours.
Alitame and Neotame: These non-nutritive sweeteners are awaiting approval from the FDA. They are structurally similar to aspartame. Alitame is 2,000 times sweeter than sucrose whereas neotame is 8,000 times sweeter than sucrose. Both are already in use in beverages and soy-based, nutritionally fortified products, respectively[7].
Brands of artificial sweeteners’ in India[19]
Brand name / Manufacturer / Active ingredient / Dosage form / Pack size / Price
1 UP / Torrent / Aspartame / Pellets / 100 x 1 / 34.4
ASPASWEET / Intas / Aspartame / Pellets / 100 x 1 / 19.5
EQUAL / RPG / Aspartame / Pellets / 20x1g x1 / 25
GLUTAMMUNE / Claris / Aspartame / Pellets / 1 / 125
PROXY / IDPL / Aspartame / Tablet / 18mg x 100 / 42
SUGAR FREE / Zy. Cadila / Aspartame / Tablet / 100 / 36.5
ZUCRIL GOLD / Mandar / Aspartame / Pellets / 100 / 40
SUCRALITE / FDC / Sucralose / Granules / 25 g / -
KALOREE 1* / Mankind / Sucralose / - / - / -
MAJESTA* / Alkem / Sucralose / - / - / -
STUGAR* / Naturell / Stevia / - / - / -
* products are yet to be launched
6.3:Objectives of the study:-
Our study is aimed at achieving the following objectives :
1. To find out the role of artificial sweeteners in the health sector.
2. To study the various sweeteners and their brands in the market.
3. To determine the position of sucralose in the artificial sweetener market.
4. To study the potential of prescribers in pushing product sales.
5. To study the role of chemists in pulling product sales.
6. To arrive at a market plan for launching a brand of sucralose.
7. Methodology:-
Material And Methods
7.1 Source Of Data :The source of market research will involve :
7.1.1 Primary data: Primary data will be obtained through market research which will be carried out by self-administered questionnaire method.
DOCTORS:
Inclusion criteria: The doctors’ sample will consists of Diabetologists, Dentists, Physicians, Gynecologists, General practitioners
Exclusion criteria: Doctors of other specialties other than those specified will be excluded from the survey.
CHEMISTS:
Inclusion criteria: Registered pharmacist at wholesale outlets, retail outlets, including hospital pharmacists.
Exclusion criteria: Ayurvedic, Homeopathic and Unani retail medical stores
OTHERS: Nutritionists, Dieticians
7.1.2 Secondary data:
Articles from Pharmaceutical Journals (British Medical Journal, Lancet, International Journal Of Diabetes In Developing Countries etc)
Books On Pharmaceutical Marketing
Websites from Internet
Pharma biz
Pharma pulse
Current Index of Medical Specialties
Method of data collection:
1) Preliminary communication with all categories of respondents as mentioned above.
2) Personal interview with all categories of respondents as mentioned above.
3) Sampling technique: Convenience sampling.
4) Sample size: 200
· Doctors : 100
· Chemists : 100
· Others : 25
5) Sample area: Bangalore.
7.3 Dose the study require any investigational or interventions to be conducted on patient or other humans or animals? If so briefly describe.
Doctors, Chemists and Nutritionists / Dieticians will be interviewed; hence prior permission of the interviewee will be sought.
7.4 Has ethical clearance been obtained from your institute?
Applied for ethical clearance .
8.0 / List of References :
1. Seshan GK. The other Face of Wipro. May 2007
URL: http://www.rediff.com/money/2007/may/16spec.htm. [cited on 2008 Nov 07]
2. Prance L. Artificial Sweetener Market Driven By Obesity Concerns. URL http://www.foodnavigator.com/Financial-Industry/Artificial-sweetener-market-driven-by-obesity-concerns. [Cited on 2008 Nov 10].
3. URL: http://hindu.com./2007/10/12/stories/2007101260940600.htm. [Cited on 2008 Nov 07].
4. Kotler P. Marketing Management. 11th ed. Pearson Education; 116-7.
5. Raymond Formane K Jr. Artificial Sweetener: No calorie Sweet. FDA Consumer Magazine. July-Aug 2006; 40(4). URL: http://www.fda.gov. [Cited on 2008 Nov 8]
6. Extra Pharmacopoeia. Martindale. 35th ed. [1].London: Pharmaceutical Press: 1798.
7. Modi SV, Borges VJ. Artificial Sweeteners: Boon or Bane? Int J of Diab Dev Ctries. 2005; 25:12-9.
8. URL http://www.everydiet.org/articles/sugar_and_alternatives.htm [Cited on 2008 Nov 07].
9. Extra Pharmacopoeia. Martindale. 35th ed. [1].London: Pharmaceutical press: 1769.
10. Herfidal E. Textbook of Therapeutics: Drug and Disease management. 6th ed: 372.
11. Michael E J Lean; Catherine R Hankey. Aspartame and Its Effects on Health. BMJ.2004; 329(7469); 755-6.
12. Extra Pharmacopoeia. Martindale. 35th ed.[1].London: Pharmaceutical Press;1768,1806.
13. URL: http:// www.fda.gov/bbs/topics/ANSWERS/ANS00859.html.[cited on 2008 Nov 06].
14. URL: http://www.eatright.org/ada/files/Sucralose.pdf. [Cited on 2008 Nov 08].
15. URL http://www.cspinet.org/new/pdf/additives.pdf. [Cited on 2008 Nov 7]
16. URL http://www.cspinet.org/new/200804291.html. [Cited on 2008 Nov 7]
17. URL: http://www.diabetes.ca/cpg2003/chapter.aspx?table/acceptabledailyintakeofsweeteners.htm [Cited on 2008 Nov 7]
18. URL: http://www.cfsan.fda.gov/~lrd/fr980403.html [Cited on 2008 Nov 08]
19. Current Index of Medical Specialties. July-Oct. 2008.p. 493-5
9. / Signature of the candidate: / (ROHIT GUPTA)
10. / Remarks of the Guide: / Recommended for approval
11. / Name and Designation of:
11.1. Institutional Guide: / Dr. Asha A N
Professor
Dept of Pharmaceutical
Marketing and Management
Al- Ameen College of Pharmacy
Hosur Road
Bangalore – 27
11.2. Signature:
11.3. Co-Guide / Mr. G. Seshagiri
GM-Marketing
MICRO LABS LIMITED
No. 27, Race Course Road
Bangalore- 560001
11.4. Signature:
11.5. Head of the Department: / Dr.V.Kusum Devi
Professor,Dept. of Pharmaceutical
Marketing and Management
AL-Ameen College of Pharmacy
Hosur road, Bangalore-560 027
11.6. Signature
12. / 12.1. Remarks of the Principal / Forwarded to the University
12.2. Signature
/
Prof. B. G. Shivananda
PrincipalAl Ameen College of Pharmacy
Hosur Road, Bangalore – 560 027.
2