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Calcium Market in Mumbai

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CHAPTER 1 EXECUTIVE SUMMARY 1 This project focuses on the growth of Calcium supplement segment over two decades. This project gives us an insight into the dietary segment of pharmaceutical industry particularly the calcium supplement segment. The project is started with the introduction of Indian pharmaceutical industry and it‘s growth from three decades. Moreover in this project, the rising importance of patents & its effects (advantages & disadvantages) on the pharmaceutical industry has been discussed.

Entering further in this project, we get an idea about the brand performance of the products of calcium supplements, future market size of calcium supplement market size and then perception of doctor‘s (Orthopaedic & Gynaecologist) about the calcium supplement products. At the end of the project, data analysis has been done with graphical charts so that any person related or unrelated to this industry gets a clear idea about the project.

We have always seen that when the need arises for anything we humans then start the search for that thing and pharma companies focusing more on cardiac & oncology segment it is most important to understand the importance of calcium supplements before the market has been taken over by foreign multinationals.

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Usually, the emphasis on product development is the key to commercial success. However, in the market like India and also other competitive markets like all emerging markets where high competitiveness exists, speed to market with newness either for patented or generic products can bear rewards.

It’s also equally true that in markets like India where 2 more generics and competitive brands are available, it is difficult to reward investment. As a result, it is really important to develop a strategic balance between older brands might not have even matured at all and new products in such a way that a strong brand portfolio is built up and strategic assets are created. You can see this happening in stock markets for Coke, Nokia, General Electricals, Intel, Ford and McDonald.

Each brand almost becomes synonymous to the organisation and hence, we as pharma industry need to look at brands with that perspective and also think of corporate branding along with branding for new products or existing products. 3 CHAPTER 2 INTRODUCTION 4 Introduction: Overview of the Indian Pharmaceutical Industry – The Pharmaceutical Industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies can deal in generic and/or brand medications. They are subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs.

History: The earliest drugstores date back to the Middle Ages. The first known drugstore was opened by Arabian pharmacists in Baghdad in 754,and many more soon began operating throughout the medieval Islamic world and eventually medieval Europe. By the 19th century, many of the drug stores in Europe and North America had eventually developed into larger pharmaceutical companies. Most of today’s major pharmaceutical companies were founded in the late 19th and early 20th centuries. Key discoveries of the 1920s and 1930s, such as insulin and penicillin, became mass-manufactured and distributed.

Switzerland, Germany and Italy had particularly strong industries, with the UK, US, Belgium and the Netherlands following suit. General Chain for Pharmaceutical Industry. Figure 1 depicts the basic components of the pharmaceutical global value chain. All of these functions can be carried out by a large, vertically integrated pharmaceutical firm, or certain segments (typically with the lesser value-add) can be contracted out to other firms. The trend of contracting other, lower-cost firms for certain segments of production has grown recently over the past decade. 5

Figure 2. 1: General Chain for Pharmaceutical Industry Location: The major firms that pioneered the industry back in the early 20th century were located in Switzerland, Germany, UK, and the US. Today, these countries are still the location of the major firms. Since the industry requires sophisticated manufacturing techniques and intensive, highcost R&D, the most profitable firms are in predominantly advanced, developed economies. Even with a growth in the industry, and changing trends in international trade, the early pioneers are still in the lead. 6 FIGURE 2. 2 7

Market leaders in terms of sales The top 15 pharmaceutical companies by 2008 sales are: Rank Company 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Pfizer GlaxoSmithKline Novartis Sanofi-Aventis AstraZeneca Sales ($m) Based/Headquartered in 43,363 36,506 36,506 35,642 32,516 US UK Switzerland France UK/Sweden Switzerland US US US US US US Israel Germany Hoffmann–La Roche 30,336 Johnson & Johnson Merck & Co. Abbott 29,425 26,191 19,466 Eli Lilly and Company 19,140 Amgen Wyeth Teva Bayer 15,794 15,682 15,274 15,660 8 15 Takeda 13,819 TABLE 2. 1 Japan PHARMA COMPANIES IN INDIA ? Dishman Pharmaceuticals ?

Elder Pharmaceuticals ? J B Pharmaceuticals ? Torrent Pharmaceuticals ? Sun Pharmaceuticals ? Ranbaxy India ? Cadila Pharmaceutical Limited ? Wockhardt ? Strides Arcolab ? IPCA Laboratories ? Alembic ? Amrutanjan ? Virchow Laboratories ? Polydrug Laboratories ? Dr. Reddy’s Laboratories ? Aurobindo Pharma ? Jubilant Organosys ? Astrazeneca Pharma ? Divis Laboratories ? Merck Ltd. ? Astrazen Pharma ? Abbott India 9 ? Aventis Pharma Limited ? Glenmark Pharmaceutical Ltd. ? Clarion Drugs ? Blue Cross Laboratories ? Intas Pharmaceuticals Limited ? Lincoln Pharmaceuticals Ltd ?

Matrix Laboratories Indian Pharmaceutical Industry ?The Indian pharmaceutical Industry is a success story providing employment for millions and ensuring that essential drugs at affordable prices are available to the vast population of this sub-continent.? Richard Gerster The Indian Pharmaceutical Industry today is in the front rank of India‘s science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology. A highly organized sector, the Indian Pharma Industry is estimated to be worth $ 4. 5 billion, growing at about 8 to 9 percent annually.

It ranks very high in the third world, in terms of technology, quality and range of medicines manufactured. From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made indigenously. The pharmaceutical industry in India is one of the largest & most 10 advanced among the developing countries. The Indian pharmaceutical industry is estimated to be $6 billion in size, projected to grow to $25 billion by 2010. The Indian pharmaceutical industry is now valued at USD 30 million, compared to USD 2. 3 million in 1901. There are 24,000 licensed pharmaceutical companies.

Of the 465 bulk drugs in India, approximately 425 manufactured here. Indian pharmaceutical industry occupies third position in the world from the production angle. The industry has wide range of over 100,000 drugs which include vitamins, antibiotics; antibacterial, cardiovascular drugs etc. and nearly 80% of manufacturers have sales less than Rs. 1 billion. The top 10 companies control of about 31% of the market. The industry is highly fragmented, with largest formulation players having a market share of less than 6%. India‘s healthcare spending is roughly 6% of GDP of almost three – fourths is spent from private resources.

By comparison the healthcare spending in the USA is about 11% of GDP, majority of which is from the government or third party funds. The expenditure of medicines is roughly 16% of all healthcare spending. The size of Indian Pharmaceutical industry has increased from Rs. 4 billion in the year 1971 to Rs. 250 billion in the year 2005. The Indian Pharmaceutical sector has been meeting almost 95% of the country‘s pharmaceutical needs. The key categories that have driven growth are the large segment like anti – infectives & gastrointestinal segments. 11

The per capita consumption in India, stands at US $3, is among amongst the lowest in the world, as compares to Japan – US $412, Germany – US $222 in 2002. In 2002 the Indian Pharmaceutical industry was valued at over $4 billion and grew by 8 – 9 percent. Generic means off – patent. Generic drugs are capturing the volumes of branded drugs in the pharma sector. A generic medicine is the one that is manufactured using a slightly different chemical composition of the original patented drug & it costs fraction of the price of its patented equivalent.

The low cost is due to the minimal expense incurred in developing a copy of original drug & a generic drug maker can come out with his drug by just proving that its therapeutic effect on the human body is same as that of the patented drug. The international market for generics valued at $23 billion accounts for 11% of the total market for pharmaceuticals. With products worth $82 billion going off – patent by 2008, US is an attractive market for generic companies. The fact that generics business has been booming on the back of increasing demand for cheaper drugs had been giving tough competition to the pharma majors.

Now in generics, delivery is all more important, as the first company to introduce a generic substitute can corner 60 – 80 percent of the market. 12 ADVANTAGE INDIA Competent workforce: India has a pool of personnel with high managerial and technical competence as also skilled workforce. It has an educated work force and English is commonly used. Professional services are easily available. Cost-effective chemical synthesis: Its track record of development, particularly in the area of improved cost-beneficial chemical synthesis for various drug molecules is excellent.

It provides a wide variety of bulk drugs and exports sophisticated bulk drugs. Legal & Financial Framework: India has a 53 year old democracy and hence has a solid legal framework and strong financial markets. There is already an established international industry and business community. Information & Technology: It has a good network of world-class educational institutions and established strengths in Information Technology. Globalization: The country is committed to a free market economy and globalization. Above all, it has a 70 million middle class market, which is continuously growing.

Consolidation: For the first time in many years, the international pharmaceutical industry is finding great opportunities in India. The process of consolidation, which has become a generalized phenomenon in the world pharmaceutical industry, has started taking place in India. 13 The size of Indian pharmaceuticals industry is poised to grow from Rs. 30,200 crores in 2007 to Rs. 33,500 crores in 2008 and further to Rs. 140,000 crores in 2020 as exhibited in Chart-2 (Source: IMS Health, McKinsey, ABLE, as quoted by the Financial Express 29. 12. 08). FIGURE 2. 3

Investment of Indian Pharmaceutical Industry for 2009-10: ? Domestic investment in the Pharmaceuticals sector is estimated at Rs. 31. 43 thousand crores which is equivalent to US $ 7. 14 billions (Source: Ministry of Commerce & Industry). 14 ? The Pharmaceuticals sector has been able to attract FDI amounting to US $ 1401. 60 million in the sector during 2000-01 to 2008-09 (upto September), of which, there has been an inflow of US $ 125. 30 million during the first half of 2008-09 (Source: Ministry of Commerce & Industry). ? There has been an upward trend in FDI inflows in the sector.

In 2007-08, the FDI inflow at US $ 334. 09 million (Rs. 13264. 28 million) has been the highest (Source: Ministry of Commerce & Industry). ? In so far as domestic industrial proposals between August 1991March 2008 are concerned, total IEMs filed including LOI & DIL add upto Rs. 31257 crores in Drugs & Pharmaceutical Sector (Source: Ministry of Commerce & Industry). ? The Pharmaceutical sector is estimated to have created 2. 20 lakh employment opportunities (Source: Ministry of Commerce & Industry). ? The aggregate sectoral income grew by 18. % during the quarter ending June 2008 while the growth in net profits during 2007-08 was 8. 2% (Source: CMIE). 15 Pharmaceutical Product Categories: Ophthalmic Drugs Anti Allergic Drug Gastrointestinal Drug Genito Urinary Drug HIV Drug Hypertensive Drug Metabolic Drugs Musculoskeletal System Drug Respiratory Drug Skin Medicine Surgical Drug Anti Diabetic Drug Antihistamine Antineoplastic Agent Antiviral Drug Cancer Drugs Cardiovascular Drug 16 Vaccines Pain Relief Drug Cough Medicine Endocrine Disorder Drug Fertility Drugs Anti-Infective Drugs Central Nervous System Drug

CHAPTER 3 CURRENT SCENARIO 17 Indian pharma market zooms to US 21. 83 billion (Rs 1,00,611 cr. ) in 2009-10(February 25th, 2010) The Indian pharmaceutical industry currently values about Rs 1,00,611 crore, as the industry sector growth is back in track following revival of the economy, according to the latest Economic Survey 2009-10 report. The pharmaceutical industry in India has leap-frogged from Rs. 1500 crore in 1980 to approximately Rs. 1,00,611 crore in 2009-10, thanks to the revival of overall industrial growth to 7. 7% during April November 2009-10.

India‘s pharma sector now ranks 3rd in terms of volume of production with 10% share of the global pharmaceutical market and occupies 14th position by value, says a news release issued by Press Information Bureau from the Ministry of Finance, government of India. The Indian pharma industry growth has been fuelled by exports which registered a growth of 25% in 2008-09. Retails sales in the Indian pharmaceutical market grew by 18% in the month of March 2009, despite fears of stalling industrial growth following the slowdown across economies. The value growth of Indian pharma market as per secondary ales for the month of Mar 2009 was higher at 18. 4%, as compared to 13. 3% growth in the month of Feb 2009, according the latest data from ORG IMS, a business intelligence firm. 18 The value growth as per Mar 2009 MAT once again touched the doubledigit mark of 10. 1%, with marginally higher growth, as compared to 9. 8% as per Feb 2009 MAT. The value growth in the month of Mar 2009 was higher at 16. 8%, as compared to 12. 5% in the month of Feb 2009. The value growth as per Mar 2009 MAT (14. 1%) was marginally higher as compared to Feb 2009 MAT (13. 6%). In October 2008, sales in the Rs 35,000-crore drug retail market had dipped by 1. %, the first time in many years, due to consumers shifting to cheaper brands and stockists facing a financial crunch. However, retail sales has gradually strengthened and in February, it rose 13. 3%. Despite the brief slowdown in growth in 2008, ORG had projected the Indian pharmaceutical industry to grow at 15-20% over the next few years. The industry has been growing at 14-15% over the last few years. Due to economic prosperity, a lot more customers are entering organised healthcare, antibiotics and acute therapies are normally the first line of defence, say analysts.

While India‘s metros and class I cities drive the growth tier II cities and rural market add to the growth momentum. Rising disposable income, improving health infrastructure such as the government‘s incentives to set up 100-bed hospitals in non-metro towns, and the general increase in health awareness due to deep penetration of the electronic media are the corner stones of sales expansion. To promote excellence in pharmaceutical education and research, 6 new National Institute of Pharmaceutical Education & Research (NIPERs) have been set up, in addition to the existing one at Mohali. 19 Sector structure/Market size

India’s pharmaceutical industry is now the third largest in the world in terms of volume and accounts for 10 per cent of the world‘s production. According to the Mr Srikant Kumar Jena, Minister of State for Chemicals and Fertilisers, the Indian pharmaceutical industry is now over US$ 20 billion. India ranks fourteenth in terms of value. The country ranks fourth in terms of generic production and seventeenth in terms of export value of bulk actives and dosage forms, according to Mr Jena. According to a detailed research by Angel Broking, by 2015, India is expected to rank among the top 10 global pharmaceutical markets.

The industry is typically growing at around 1. 5-1. 6 times the country‘s gross domestic product (GDP) growth. Moreover, according to a FICCI-Ernst & Young study, the increasing population of the higher-income group in the country will, by 2015, open a potential US$ 8 billion market for multinational companies selling costly drugs. Besides, the report said the domestic pharma market is likely to touch US$ 20 billion by 2015, making India a lucrative destination for clinical trials for global giants. The Indian pharmaceutical offshoring industry is slated to become a US$ 2. billion opportunity by 2012, thanks to lower R&D costs and a hightalent pool in India. 20 Exports India’s exports of drugs, pharmaceuticals and fine chemicals grew by 29 per cent in 2008-09 to US$ 8. 25 billion compared to 2007-08. According to Mr Anand Sharma, Union Minister of Commerce and Industry, the Indian pharmaceutical sector has emerged as one of the major contributors to Indian exports with export earnings rising from a negligible amount in the early 1990s to US$ 6. 08 billion by 2007-08. A report by industry research firm, RNCOS, forecasts that pharmaceutical exports will grow at a compound annual growth rate (CAGR) of 18. per cent between 2007-08 and 2011-12. This growth will be fuelled by multi-billion dollar patent expirations and growth in the global generics market. Growth The domestic pharma market will outshine the global market, growing at a compounded annual rate of 12-15 per cent as against a global average of 4-7 per cent during 2008-2013, according to a study by market research firm IMS. According to detailed research by Angel Broking, socio-economic factors such as rising income levels, increasing affordability, gradual penetration of health insurance and the rise in chronic diseases would see the Indian formulation market touch US$ 13. billion by 2013, at a CAGR of 12. 2 per cent over the period from fiscal year 2008 to 2013 (estimated). Denmark-based world leader in diabetes care, Novo Nordisk, is looking at making India the hub for manufacturing insulin for the sub-continent. 21 The company has set up a dedicated facility with a capacity of 26 million vials per annum in partnership with Ahmedabad-based Torrent Pharmaceuticals Ltd. Rural Market According to estimates, rural areas account for 21 per cent of the country’s pharmaceuticals market. In 2006-07, the rural Indian pharmaceuticals market was estimated at around US$ 1. billion, having grown at about 40 per cent in 2006-07 against 21 per cent in the previous year. French company Aventis Pharma has launched a rural market division with 10 products and a sales team of 300 people as it eyes a bigger share of the fast growing Indian rural market. Pharmaceutical Retail The Indian drug retail market grew by a 29. 24 per cent in value terms in October 2009 over the same period a year ago. This is more than double the average monthly revenue growth rate of 13-14 per cent posted in the recent past, as per market research firm ORG IMS.

Generics According to a report by IMS Health, the Indian generic manufacturers will grow to more than US$ 70 billion as drugs worth approximately US$ 20 billion in annual sales faced patent expiry in 2008. With nearly US$ 80 billion worth of patent-protected drugs to go off patent by 2012, Indian generic manufacturers are positioning themselves to offer generic versions of these drugs. 22 Indian generic drug makers received half a dozen more approvals from the US Food and Drug Administration (FDA) in 2009, over the previous year.

Dr Reddy’s Laboratories received the highest number of tentative and final approvals in 2009 at 32, followed by Aurobindo at 26 and Wockhardt at 23. Diagnostics Outsourcing/Clinical Trials The Indian diagnostics and pathology laboratory business is presently around US$ 864 million and is growing at a rate of 20 per cent annually, according to industry experts. Moreover, the US$ 200 million Indian clinical research outsourcing market is estimated to reach up to US$ 600 million by 2010, according to a joint study done by KPMG and the Confederation of Indian Industry (CII). Research & Development

The search for innovative drug molecules and better technologies by pharmaceutical MNCs is expected to offer a windfall for the smaller research-oriented Indian firms. With their drug pipelines drying up and more blockbuster drugs going off-patent, MNCs are looking at alliances for drug co-development, buying or licensing out innovative molecules which can further be developed into finished drugs. 23 Moreover, in a bid to boost R in the pharmaceutical sector, the government will provide US$ 422. 96 million for establishing six National Institutes of Pharmaceutical Education and Research over the next five years.

Government Initiative The government has taken various policy initiatives for the pharmaceutical sector: ? The government has offered tax breaks to the pharmaceutical sector. Units are eligible for weighted tax deduction at 150 per cent for the research and development (R) expenditure incurred ? Steps have been taken to streamline procedures covering development of new drug molecules and clinical research ? The government has launched two new schemes—New Millennium Indian Technology Leadership Initiative and the Drugs and Pharmaceuticals Research Programme—especially targetted at drugs and pharmaceutical research.

According to Mr Ashok Kumar, Pharmaceuticals Secretary, the government is planning to set up a US$ 439. 94 million corpus fund for the pharma industry soon. The fund would be set up with the help of the government and the industry and will be used for helping the pharma industry in R. Investment ? According to the Ministry of Commerce, domestic investment in the pharmaceutical sector is estimated at US$ 6. 31 billion. 24 ? The drugs and pharmaceuticals sector has attracted foreign direct investment (FDI) worth US$ 1. 43 billion between April 2000 and December 2008.

Road Ahead The Indian pharmaceutical industry will see tremendous growth in the coming years as consumer spending on healthcare increases in India. Consumer spending on healthcare is expected to increase to 13 per cent of GDP by 2015, up from 7 per cent in 2007. ORG IMS Indian Pharmaceutical Audit helps to identify potential therapeutic categories, monitoring performance of specific brands in relation to competing brands, segmenting the market by 4 zones, 18 states, 30 metros and all town classes. IMS Indian Pharmaceutical Audit tracks the primary sales of harmaceutical companies on monthly basis through stockists purchase. The value growth of Indian pharma market as per secondary sales for the month of Dec‘09 was recorded higher at 27. 6% as compared to Nov‘09 month (20. 4%). The value growth for Dec‘09 MAT was also recorded higher at 17. 0%, as compared to 15. 7% as per Nov‘09 MAT. The value growth recorded in the month of Dec‘09 MAT (13%) was higher at 17%, as compared to 9. 1& in the month of Nov‘09. The value growth as per Dec‘09 MAT (13%) was comparable to Nov‘09 MAT (13. 1%). Cipla has maintained its top position and market share of 5. 8%, as per Dec‘09 MAT. Among the top 25 companies, Mankind has 25 jumped one rank to move upto rank 8. Wockhardt Merind has jumped to 14th rank. Elders surpassed the other fast-growing players including Mankind (27. 9%), Wanbury (25. 2%), Micro Labs and Alembic (24. 7%). Pharma Companies (updated – 10 Feb 2009) Drug company Cipla maintained its top position in the domestic market for the 12 months ended December, 2009, with a market share of 5. 38 per cent — up 18 per cent over the year and ahead of Ranbaxy Laboratories and GlaxoSmithKline (GSK). The total domestic drug market is valued at Rs 40,051. 4 crore, an increase of 17 per cent over the previous year, according to data from drug sales tracking agency, ORG-IMS. The agency tracks drug sales among more than 500,000 traders in the country, through stockist data. Cipla‘s domestic market share grew 18 per cent during the year, thanks to its product basket of 924 products, which is way ahead of Ranbaxy‘s 565 and GSK‘s 177 products. 26 Ranbaxy got a market share of 4. 91 per cent and GSK had a market share of 4. 35 per cent, with a growth of 13. 7 per cent and 18 per cent, respectively, in 2009. During the period, Cipla had sales of Rs 2,155. 9 crore in the domestic market, ahead of Ranbaxy‘s Rs 1,968. 24 crore and GSK‘s Rs 1,743. 15 crore. Cipla had overtaken Ranbaxy and GSK India to become the largest pharmaceutical company in the domestic market for the first time in May,2007, according to sources. GROWTH TONIC No products of Domestic turnover (Rs cr) 2,155. 29 Market share (%) 5. 38 Growth* (%) Company Cipla 924 18 Ranbaxy 565 1,968. 24 4. 91 13. 7 GSK 177 1,743. 15 4. 35 18 Piramal Health 750 1,644. 26 4. 11 22. 8 Zydus Cadila 735 1,484. 84 3. 71 21. 2 Sun Pharma 516 1,449. 83 3. 62 22. 9

Source: ORG-IMS data *Change in 2009 market share over 2008 TABLE3. 1 27 Piramal Healthcare, Zydus Cadila, Sun Pharma, Alkem Laboratories, Mankind, Lupin and Aristo Pharma occupied the 4th-10th positions in ORG-IMS rankings, respectively. Interestingly, Elder Pharma emerged as the fastest growing company in the domestic market among the top 50 players, with a year-on-year (YoY) growth rate of 28. 1 per cent over the previous year. Elders‘ growth in the domestic market is ahead of Mankind (27. 9 per cent), Wanbury ( 25. 2 per cent), Piramal Healthcare (22. 8 per cent), Zydus Cadila (21. per cent), Sun Pharma (22. 9 per cent), Micro Labs and Alembic (24. 7 per cent). ?A focused approach on promoting flagship brands like Shelcal, which grew 22 per cent, along with Chymoral Forte (30 per cent) and Formic-O (100 per cent), and prioritising the market opportunities helped us achieve this growth,? Elder Healthcare Director Alok Saxena said. Among brands, Pfizer‘s cough syrup, Corex, regained its position as the largest drug brand in the country with sales of close to Rs 182 crore. 28 India’s Domestic Pharmaceutical Market (12 Months Ended January 2009) Company

Size ($ Billion) Market Share (%) Growth Rate (%) 100. 0 5. 3 5. 0 4. 3 3. 9 3. 6 9. 9 13. 4 11. 5 -1. 2 11. 7 6. 8 Total Pharma Market 6. 9 Cipla Ranbaxy Glaxo Smithkline Piramal Healthcare Zydus Cadila Source: ORG IMS . 36 . 34 . 29 . 27 . 24 TABLE 3. 2 Future Scenario With several companies slated to make investments in India, the future scenario of the pharmaceutical industry in looks pretty promising. The country’s pharmaceutical industry has tremendous potential of growth 29 considering all the projects that are in the pipeline. Some of the future initiatives are: ?

According to a study by FICCI-Ernst & Young India will open a probable US$ 8 billion market for MNCs selling expensive drugs by 2015 ? The study also says that the domestic pharma market is likely to reach US$ 20 billion by 2015 ? The Minister of Commerce estimates that US$ 6. 31 billion will be invested in the domestic pharmaceutical sector ? Public spending on healthcare is likely to raise from 7 per cent of GDP in 2007 to 13 per cent of GDP by 2015 ? Dr Reddy’s Laboratories has tied up with GlaxoSmithKline to develop and market generics and formulations in upcoming markets overseas ?

Lupin, a Mumbai based pharmaceutical company is looking to tap opportunities of about US$ 200 million in the US oral contraceptives market Due to the low cost of R&D, the Indian pharmaceutical off-shoring industry is designated to turn out to be a US$ 2. 5 billion opportunity by 2012. 30 CHAPTER 4 PROFILES OF COMPANIES OF LEADING CALCIUM BRANDS 31 INTRODUCTION There are many calcium molecules present in the Indian Pharmaceutical Industry. Molecules works in the market due to its efficacy, its absorption or unavailability of any other brands in the market along with pricing strategies created by company to attract the customers.

Top Calcium Brands in the market are: ? SHELLCAL (Elder Pharmaceuticals) ? SUPRACAL (Pharmed) ? CALCIMAX (Meyer) ? MACALVIT (Novartis) 32 ELDER PHARMACEUTICALS INTRODUCTION Elder Pharmaceuticals ranked as the 29th (ORG-IMS) largest pharmaceutical company commenced operations in 1989. It is rated as the third fastest growing company, by revenue, in the pharmaceutical industry in FY 2007 in India. Elder Pharmaceuticals principal activities include the manufacturing and marketing of prescription pharmaceutical brands, surgical and medical devices.

Shelcal Elder‘s No. 1 brand is one of the top brands in the Indian Pharmaceutical industry. We believe that we are one of the leading players in the pharmaceutical formulation market in India, being a market leader in three therapeutic segments – Women’s Healthcare, Wound Care and Nutraceuticals. Our strategic alliances with a number of international pharmaceutical entities for marketing their products in India and overseas international acquisitions have strengthened and enabled us to become a true-global pharmaceutical company. 33

Internationally benchmarked plants Elder manufactures API and formulations across 6 manufacturing plants in India and one in Nepal possessing a capability to manufacture various dosage forms like tablets, capsules, syrups, injectibles, topical creams and ointments. Over the years, Elder upgraded its capacities in line with international standards to cater to the requirements of a wider patient community. Even as it upgraded its facilities, it also invested in capacity expansion through investments in internationally benchmarked greenfield facilities. PHARMED INTRODUCTION 34

Healthcare is our charter. Pharmed Limited is a dynamic and rapidly growing pharmaceutical company that is dedicated and committed to deploy every maneuver to enhance the quality of human life by quality products. Today‘s green Pharmed Gardens in Whitefield, Bangalore started its eventful journey in 1946. Since inception, we have carried the motto of quality pharmaceutical manufacturing process right from our origin. We were partners of large multinationals, such as, Smithkline, Boots, Pfizer, and Schering, to name a few. Pharmed started its own marketing in the year 1976.

Since then, Pharmed continues to invest in novel technologies, new processes, innovative product manufacturing, and talented people to help its customers get the best in healthcare. This encompasses facility set amidst the sylvan greenery of its corporate headquarters. The warmth of its interior speaks about generation of outstanding concepts, constant and relentless endeavor in the research and development, painstaking and rigorous quality processes, and drawing on the expertise of key partners trying to overcome the barriers of technological impossibilities. MEYER

INTRODUCTION Our research team produces quality pharmaceutical formulations based on latest research methods using IP (Indian Pharmacopoeia)/ BP (British Pharmacopoeia)/ USP (United States Pharmacopoeia) grade raw 35 materials. Over the course of our history, the development of new products at Meyer has been fuelled by a fundamental desire to deliver natural healthcare solutions that are safe, effective, and relevant to our customers needs. The Meyer team draws on a wealth of professional healthcare experience, spanning the fields of nutrition, clinical medicine, biochemistry and pharmaceutical science.

This expertise helps us to continue delivering a consistent stream of innovative new products in diverse areas of healthcare, including the menopause, joint mobility, pregnancy, and the circulatory system. NOVARTIS INTRODUCTION Novartis was created in 1996 as a result of the merger of the Swiss companies, Ciba-Geigy and Sandoz. Headquartered in Basel, Switzerland, Novartis is one of the fastest growing healthcare companies worldwide, operating in over 140 countries with over 91,000 employees. The name, ? Novartis? , derived from the Latin novae artes, meaning “new 36 kills,” reflects our commitment to focus on research and development to bring innovative products to the communities we serve. On 7 March 1996, an earthshaking announcement was made to the business world: Sandoz and Ciba-Geigy, the two Swiss-based chemical/life sciences giants, had agreed to become one. Novartis, as the new company was called, was at that time the result of the largest corporate merger in history. Both Sandoz and Ciba-Geigy already had a rich history of their own. Novartis (1996-present) In 1996 Sandoz and Ciba joined to form Novartis in one of the largest corporate mergers in history.

Since then, Novartis has been marked by many interesting events and success stories. Purpose We want to discover, develop and successfully market innovative products to cure diseases, to ease suffering, and to enhance the quality of life. We also want to provide a shareholder return that reflects outstanding performance and to adequately reward those who invest ideas and work in our company. 37 Novartis Vision • We want to be recognized for having a positive impact on people’s lives with our products, meeting needs and even surpassing external expectations. We strive to create sustainable earnings growth, ranking in the top quartile of the industry and securing long-term business success. • We want to build a reputation for an exciting workplace in which people can realize their professional ambitions. • We strive for a motivating environment where creativity and effectiveness are encouraged and where cutting-edge technologies are applied. • In addition, we want to contribute to society through our economic contribution, through the positive environmental and social benefits of our products, and through open dialogue with our stakeholders. 8 CHAPTER 5 CALCIUM & Its SOURCES 39 CALCIUM A balanced diet provides the body with all the necessary nutrients, minerals and vitamins. But, in case of malnutrition, pregnancy, post-operative care, prescription of liquid diet etc. , external supplements of calcium, protein and vitamins become necessary. Calcium (primarily found in milk & milk products) is a mineral required for bones and teeth. A certain amount of calcium is also present in an ionised form in the blood and it acts as a catalyst for many vital functions like muscle contraction and blood coagulation.

Deficiency during childhood causes rickets and in adults it causes osteoporosis. Severe deficiency can be fatal due to spasm of muscles in the respiratory system. Proteins (found in meat, pulses, egg, etc. ) are composed of amino acids. They are essential for tissue repair including skin and hair care. Deficiency leads to stunted growth and loss of muscle strength. In case of calcium deficiency, calcium and its compounds are prescribed. The domestic market size for calcium supplements is estimated to be over Rs 100 crore and is growing at 15 per cent per annum.

The domestic market size for protein supplements is estimated to be close to Rs 130 crore and is growing at about 13 per cent per annum. 40 With increasing awareness of the need to have a balanced diet, the market for calcium / protein supplements will have average growth prospects. However, with assured prescriptions during pregnancy, post operative care etc. , the market for ethical products is expected to notch 15-20% year-to-year growth. The average adult‘s weight is made up of about two per cent calcium. Most of this is found in the skeleton and teeth; the rest is stored in the tissues or blood.

Calcium is vital for healthy teeth and bones. It also plays a crucial role in other systems of the body, such as the health and functioning of nerves and muscle tissue. Good sources of calcium include dairy foods and calcium fortified products such as soymilk and breakfast cereals. People at different life stages need different amounts of calcium – young children, teenagers and older women all have greater than average requirements. According to the Australian Nutrition Survey, about 90 per cent of women and 70 per cent of children do not achieve the recommended dietary intake (RDI) for calcium. 41 The role of calcium Calcium plays a role in: ? Strengthening bones and teeth Regulating muscle functioning, such as contraction and relaxation ? ? ? ? Regulating heart functioning Blood clotting Transmission of nervous system messages Enzyme function. Calcium and dairy food Australians receive most of their calcium from dairy foods. If milk is removed from the diet, it can lead to an inadequate intake of calcium. This is of particular concern for children and adolescents, who have high calcium needs. Calcium deficiency may lead to disorders like osteoporosis (a disease of both men and women in which bones become fragile and brittle later in life).

Too little calcium can weaken bones If the body notices that not enough calcium is circulating in the blood, it will use hormones to reduce the amount put out by the kidneys in the urine. If not enough calcium is absorbed through the gastrointestinal tract, calcium will be taken from the bones. 42 If your dietary intake of calcium is constantly low, your body will eventually remove so much calcium from the skeleton that your bones will become weak and brittle. Calcium needs vary throughout life The recommended dietary intake of calcium is different for people of different ages and life stages: Babies – from 7–12 months, babies are estimated to need 270mg per day if breastfed and 350mg per day if bottle fed. The calcium in infant formula may not be absorbed as efficiently as that found in breast milk. For children aged 1–3 years, the amount needed rises to 500mg per day. ? Young children – skeletal tissue is constantly growing, so young children have high calcium needs. Children aged 4–8 years need around 700mg per day. This rises to 1,000mg per day for those aged 9–11 years. 43 ? Pre-teens and teenagers – puberty prompts a growth spurt. This group needs more calcium, with a ecommended dietary intake of 1,300mg per day for both boys and girls between the ages of 12 and 18 years. ? Peak bone mass years – from before the onset of puberty to around the mid-20s, the skeleton increases its bone mass. If the skeleton is strengthened with enough calcium during these years, diseases like osteoporosis in the later years are thought to be less likely. During mid-life, women and men both need around 1,000mg per day. ? Pregnant women – although a developing baby needs a lot of calcium and this is taken from the mother‘s bones, most women rapidly replace this bone loss once the baby has stopped breastfeeding.

There is no additional dietary calcium requirement for pregnancy, except for the pregnant adolescent, who requires an additional 1,300mg per day of calcium to meet the requirements of both her own growth and the foetus. 44 ? Breastfeeding women – there is no increased requirement for calcium during breastfeeding, except for the breastfeeding adolescent, who needs an additional 1,300mg per day. ? Elderly people – as we age, the skeleton loses calcium. Women lose more calcium from their bones in the five years around the age of menopause.

However, both men and women lose bone mass as they grow older and need to ensure an adequate amount of calcium in their diet to offset these losses. While a diet high in calcium cannot reverse age-related bone loss, it can slow down the process. The recommended dietary intake for calcium is 1,300mg per day for women over the age of 50 years and men over the age of 70 years. ? Non-Caucasian populations – populations with smaller frame sizes may need less calcium than Caucasian populations, who have larger frame sizes and higher intakes of animal foods, caffeine and salt. 5 Good sources of calcium ? ? Good dietary sources of calcium include: Milk and milk products – milk, yoghurt, cheese and buttermilk. One cup of milk, a 200g tub of yoghurt or 200ml of calcium fortified soymilk provides around 300mg calcium. Calcium fortified milks can provide larger amounts of calcium in a smaller volume of milk – ranging from 280mg to 400mg per 200ml milk. Leafy green vegetables – broccoli, collards, bok choy, Chinese cabbage and spinach. One cup of cooked spinach contains 100mg, although only five per cent of this may be absorbed.

This is due to the high concentration of oxalate, a compound in spinach that reduces calcium absorption. By contrast, one cup of cooked broccoli contains about 45mg of calcium, but the absorption from broccoli is much higher at around 50–60 per cent. Soy and tofu – tofu (depending on type) or tempeh and calcium fortified soy drinks. Fish – sardines and salmon (with bones). Half a cup of canned salmon contains 402mg of calcium. Nuts and seeds – brazil nuts, almonds and sesame seed paste (tahini). Fifteen almonds contain about 40mg of calcium. 46 ? ? ? ? ?

Calcium fortified foods – including breakfast cereals, fruit juices and bread: ? 1 cup of calcium fortified breakfast cereal (40g) contains up to 200mg of calcium ? ? cup of calcium fortified orange juice (100ml) contains up to 80mg of calcium ? 2 slices of bread (30g) provides 200mg of calcium. Calcium supplements It is much better to get calcium from foods (which also provide other nutrients) than from calcium supplements. If you have difficulty eating enough foods rich in calcium, you might consider a calcium supplement, especially if you are at risk of developing osteoporosis.

It‘s a good idea to discuss this with your health care professional. If you do take calcium supplements, make sure you don‘t take more than the amount recommended on the bottle (usually 600–1,500mg per day). Too much calcium may cause gastrointestinal upsets, such as bloating and constipation. 47 Lifestyle can affect bone strength Some of the factors that can reduce calcium in your bones and lower bone density (weaken bones) include: ? ? High salt diet More than six drinks per day of caffeine-containing drinks – for example coffee, cola and tea (although tea has less caffeine) ? ? Excessive alcohol intake Very low body weight Very high intakes of fibre (more than 50g per day, from wheat bran) ? ? Low levels of physical activity Low levels of vitamin D – this may be an issue for people who are housebound or for women who cover their bodies completely when they are outside, as they do not get enough sunlight on their skin. Where to get help ? ? Your doctor An accredited practising dietitian, contact the Dietitians Association of Australia ? Nutrition Australia www. nutritionaustralia. org 48 Things to remember ?

The average adult‘s weight is made up of about two per cent calcium. ? Good sources of calcium include dairy foods, calcium fortified foods (such as soy products) and, to a lesser degree, some leafy green vegetables. If you don‘t have enough calcium in your diet, you may be at increased risk of developing osteoporosis. ? Absorption of Calcium Vitamin D – a steroid vitamin, which promotes absorption and metabolism of calcium and phosphorus. Under normal conditions of sunlight exposure, no dietary supplementation is necessary because sunlight promotes adequate itamin D synthesis in the skin. Deficiency can lead to osteomalacia in adults and bone deformity (rickets) in children. Dietary sources of Vitamin D are: fish liver oils, fatty fish (herring, mackerel, salmon, sardines, pilchards, tuna), fortified margarine, infant milk formulae and eggs. Vitamin D Vitamin D plays an important role in helping the body to absorb calcium through the small intestine. Our bodies need calcium to help them develop and maintain healthy bones, muscles and teeth. Ultraviolet (UV) radiation from the sun is the best natural source of vitamin D. 9 Most people get enough vitamin D through exposure to sunlight during normal day-to-day outdoor activities. However, some people have very low levels of daily sun exposure. This can lead to low vitamin D and, in some cases, longer term deficiency. It is important to remember that too much sun exposure can increase the risk of skin cancer. You need to find a sensible balance between sun exposure and protection. There are very small amounts of vitamin D in some foods and drinks, but it is difficult to get enough vitamin D from diet alone.

Only a few foods (such as fish and eggs) naturally contain vitamin D. Margarine and some types of milk have added vitamin D, but most people only get 10–25 per cent of their vitamin D from food. Health effects of low vitamin D Low vitamin D and vitamin D deficiency may have no obvious symptoms but, without treatment, they can have significant health effects. They can increase a person‘s risk of musculoskeletal conditions such as: ? ? ? Bone and muscle pain Rickets (soft, weakened bones) in children Osteomalacia (weak, fragile bones) in older adults.

Low vitamin D also contributes to osteoporosis. Vitamin D deficiency has recently been linked to various types of cancers (particularly colon cancer), heart disease, stroke, altered immunity and autoimmune diseases; however, more research is needed 50 to confirm this link. At-risk groups People who are at risk of low vitamin D and deficiency include: ? People with naturally very dark skin. The pigment in skin (melanin) acts as a filter to UVB (Ultraviolet B) radiation and reduces the amount of vitamin D the body makes (synthesises). ? ? People with little or no sun exposure.

This group includes: Older adults – people who are frail, in medium to long-term residential or aged care and housebound people ? People who wear concealing clothing for religious and cultural purposes ? People who deliberately avoid sun exposure for cosmetic or health reasons ? ? ? ? People at high risk of skin cancers People who are in hospital for long periods People with a disability or chronic disease People in occupations with little sun exposure such as taxi drivers, factory workers or night-shift workers. ? Breast-fed babies with other low vitamin D risk factors.

Breast milk is the best type of feed for babies, but it does not contain much vitamin D. Babies get their initial store of vitamin D from their mothers, so they are at risk of low vitamin D if their mother has low vitamin D. See your doctor See your doctor if you think you may be at risk of vitamin D deficiency. A simple blood test can assess your risk. If you are at risk, make sure you 51 have regular medical check-ups to monitor your levels. The doctor may recommend that you take vitamin D supplements. If so, take the supplements strictly as directed. Where to get help ? ? Your doctor Maternal and Child Health nurse An Accredited Practising Dietitian, contact the Dietitians Association of Australia Nurse-on-Call Tel. 1300 606 024 – for expert health information and advice 24 hours, 7 days ? ? SunSmart Things to remember ? ? The sun is the best natural source of vitamin D. Some people are at increased risk of low vitamin D: this includes people with naturally very dark skin and people who have very low exposure to sunlight, such as those who cover their skin for cultural or religious purposes or spend most of their time indoors. ?

Low vitamin D increases the risk of rickets in children and osteomalacia in older adults. ? People with low vitamin D also need adequate calcium in their diet. Low vitamin D can be a long-term problem. Once low vitamin D is treated, the aim is to maintain normal vitamin D levels. People with risk factors for low vitamin D should have their levels checked every year and may need lifelong supplements 52 CHAPTER 6 CALCIUM SUPPLEMENT USES & INDICATIONS 53 Calcium supplements are taken by individuals who are unable to get enough calcium in their regular diet or who have a need for more calcium.

They are used to prevent or treat several conditions that may cause hypocalcemia (not enough calcium in the blood). The body needs calcium to make strong bones. Calcium is also needed for the heart, muscles, and nervous system to work properly. The bones serve as a storage site for the body’s calcium. They are continuously giving up calcium to the bloodstream and then replacing it as the body’s need for calcium changes from day to day. When there is not enough calcium in the blood to be used by the heart and other organs, your body will take the needed calcium from the bones.

When you eat foods rich in calcium, the calcium will be restored to the bones and the balance between your blood and bones will be maintained. Pregnant women, nursing mothers, children, and adolescents may need more calcium than they normally get from eating calcium-rich foods. Adult women may take calcium supplements to help prevent a bone disease called osteoporosis. Osteoporosis, which causes thin, porous, easily broken bones, may occur in women after menopause, but may sometimes occur in elderly men also. Osteoporosis in women past menopause is thought to be caused by a reduced amount of ovarian estrogen (a female hormone).

However, a 54 diet low in calcium for many years, especially in the younger adult years, may add to the risk of developing it. Other bone diseases in children and adults are also treated with calcium supplements. Calcium supplements may also be used for other conditions as determined by your health care professional. A calcium “salt” contains calcium along with another substance, such as carbonate or gluconate. Some calcium salts have more calcium (elemental calcium) than others. For example, the amount of calcium in calcium carbonate is greater than that in calcium gluconate.

To give you an idea of how different calcium supplements vary in calcium content, the following chart explains how many tablets of each type of supplement will provide 1000 milligrams of elemental calcium. When you look for a calcium supplement, be sure the number of milligrams on the label refers to the amount of elemental calcium, and not to the strength of each tablet. Injectable calcium is administered only by or under the supervision of your health care professional. Other forms of calcium are available without a prescription.

Once a medicine or dietary supplement has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, calcium supplements are used in certain patients with the following medical condition: 55 For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods.

If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement. The daily amount of calcium needed is defined in several different ways. For U. S. — vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person’s age, sex, and physical condition (e. g. , pregnancy). indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

For Canada— amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease. Normal daily recommended intakes in milligrams (mg) for calcium are generally defined as follows: 56 Persons U. S. (mg) Canada (mg) Infants birth to 3 years of age Children 4 to 10 years of age Adolescent and adult males Adolescent and adult females Pregnant females 400 to 800 250 to 550 800 700 to 1100 800 to 1200 800 to 1100 800 to 1200 700 to 1100 1200 1200 to 1500 Breast-feeding females 1200 1200 to 1500 TABLE6. Getting the proper amount of calcium in the diet every day and participating in weight-bearing exercise (walking, dancing, bicycling, aerobics, jogging), especially during the early years of life (up to about 35 years of age) is most important in helping to build and maintain bones as dense as possible to prevent the development of osteoporosis in later life. The calcium content of these foods can supply the daily RDA or RNI for calcium if the foods are eaten regularly in sufficient amounts. Vitamin D helps prevent calcium loss from your bones.

It is sometimes called “the sunshine vitamin” because it is made in your skin when you are exposed to sunlight. If you get outside in the sunlight every day for 57 15 to 30 minutes, you should get all the vitamin D you need. However, in northern locations in winter, the sunlight may be too weak to make vitamin D in the skin. Vitamin D may also be obtained from your diet or from multivitamin preparations. Most milk is fortified with vitamin D. Do not use bonemeal or dolomite as a source of calcium. The Food and Drug Administration has issued warnings that bonemeal and dolomite could be dangerous because these products may contain lead.

The following table includes some calcium-rich foods. Food (Amount) Nonfat dry milk, reconstituted (1 cup) Lowfat, skim, or whole milk (1 cup) Yogurt (1 cup) Sardines with bones (3 ounces) Ricotta cheese, part skim (? cup) Salmon, canned, with bones (3 ounces) Cheese, Swiss (1 ounce) Cheese, cheddar (1 ounce) Cheese, American (1 ounce) Cottage cheese, lowfat (1 cup) Tofu (4 ounces) Shrimp (1 cup) Ice milk (? cup) 58 Milligrams (mg) of calcium 375 290 to 300 275 to 400 370 340 285 272 204 174 154 154 147 132 TABLE6. 2 This product is available in the following dosage forms: spension Before using, we should also take into account the precautions of medicines (calcium supplements) on the person‘s health condition, 59 disease the person is suffering from, age, sex etc. Following precautions should taken: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Problems in children have not been reported with intake of normal daily recommended amounts. Injectable forms of calcium should not be given to children because of the risk of irritating the injection site. Geriatric Problems in older adults have not been reported with intake of normal daily recommended amounts. It is important that older people continue to receive enough calcium in their daily diets. However, some older people may need to take extra calcium or larger doses because they do not absorb calcium as well as younger people.

Check with your health care professional if you have any questions about the amount of calcium you should be taking in each day. Pregnancy It is especially important that you are receiving enough calcium when you become pregnant and that you continue to receive the right amount of calcium throughout your pregnancy. The healthy growth and 60 development of the fetus depend on a steady supply of nutrients from the mother. However, taking large amounts of a dietary supplement during pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breastfeeding It is especially important that you receive the right amount of calcium so that your baby will also get the calcium needed to grow properly. However, taking large amounts of a dietary supplement while breastfeeding may be harmful to the mother and/or baby and should be avoided. Drug Interactions Using dietary supplements in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. ine 1 Other Interactions Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Other Medical Problems The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially: Extra calcium or specific calcium preparations may be necessary in these conditions. —Calcium by injection may increase the chance of irregular heartbeat. 62 —Calcium supplements may make these conditions worse. —Calcium supplements may increase the chance of hypercalcemia (too much calcium in the blood). —Use of calcium phosphate may cause high blood levels of phosphorus which could increase the chance of side effects. —Too much calcium may increase the chance of kidney stones. To avoid the side – effects and to follow precautions properly, the calcium supplements should be used properly.

For proper use of calcium supplements following should be done: Drink a full glass (8 ounces) of water or juice when taking a calcium supplement. However, if you are taking calcium carbonate as a phosphate binder in kidney dialysis, it is not necessary to drink a glass of water. This dietary supplement is best taken 1 to 1? hours after meals, unless otherwise directed by your health care professional. However, patients with a condition known as achlorhydria may not absorb calcium supplements on an empty stomach and should take them with meals.

For individuals taking the chewable tablet form of this dietary supplement: 63 For individuals taking the syrup form of this dietary supplement: before meals. This will allow the dietary supplement to work faster. Take this dietary supplement only as directed. Do not take more of it and do not take it more often than recommended on the label. To do so may increase the chance of side effects. Dosing The dose medicines in this class will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of these medicines.

If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. solution, oral suspension, syrup, tablets, extended-release tablets, tablets for solution): o To prevent deficiency, the amount taken by mouth is based on 64 normal daily recommended intakes (Note that the normal daily recommended ntakes are expressed as an actual amount of calcium. The salt form [e. g. , calcium carbonate, calcium gluconate, etc. ] has a different strength): For the Indian people. —800 to 1200 milligrams (mg) per day. -feeding females—1200 mg per day. —800 mg per day. —400 to 800 mg per day. For U. S & Canada —800 to 1100 mg per day. teenage females—700 to 1100 mg per day. -feeding females—1200 to 1500 mg per day. —700 to 1100 mg per day. —600 mg per day. —250 to 550 mg per day. 65 o To treat deficiency: —Treatment dose is determined by prescriber for each individual based on severity of deficiency.

Missed Dose However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storage from heat, moisture, and direct light. Keep from freezing. Precautions If this dietary supplement has been ordered for you by your health care professional and you will be taking it in large doses or for a long time, your health care professional should check your progress at regular visits. This is to make sure the calcium is working properly and does not cause unwanted effects.

Do not take calcium supplements within 1 to 2 hours of taking other medicine by mouth. To do so may keep the other medicine from working properly. 66 Unless you are otherwise directed by your health care professional, to make sure that calcium is used properly by your body: amounts of calcium, phosphates, magnesium, or vitamin D unless your health care professional has told you to do so or approved. eating large amounts of fiber-containing foods, such as bran and whole-grain cereals or breads, especially if you are being treated for hypocalcemia (not enough calcium in your blood). containing beverages (usually more than 8 cups of coffee a day), or use tobacco. Some calcium carbonate tablets have been shown to break up too slowly in the stomach to be properly absorbed into the body. If the calcium carbonate tablets you purchase are not specifically labeled as being “USP,” check with your pharmacist. He or she may be able to help you determine which tablets are best. Side Effects Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Although the following side effects occur very rarely when the calcium supplement is taken as recommended, they may be more likely to occur if it is taken in large doses, if it is taken for a long time or if it is taken by patients with kidney disease. 67 Check with your doctor as soon as possible if any of the following side effects occur: More common Rare ea or vomiting (continuing) 68 Early signs of overdose Late signs of overdose 69 Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. 0 CHAPTER 7 BRAND PERFORMANCE Of CALCIUM PRODUCTS 71 Strong brands in the domestic market and global alliances will ensure a 20 per cent growth for Elder Pharma. Pharmaceuticals are considered to be a growth area in India, with a large population and skills in research and development. Just the right environment for companies like the Mumbai-based Elder Pharma, operating in formulations, bulk drugs and consumer products, to expand its presence in the domestic market. If Elder‘s overseas forays gather speed it could open up new opportunities for the company.

Alok Saxena, director (international), says, ? We hope to maintain a 20-25 per cent growth per annum over the coming years.? So far, Elder seems to be making the right moves. Currently, the company has licenses from about 25 international companies to sell their products in India. The licenses from international players, analysts say, is not important just because of the potential it holds in terms of domestic sales. ?These licenses could lead to contract research and manufacturing service (Crams) agreements in the long-term,? says a recent report by domestic broking firm, Sharekhan.

Analysts feel that the company‘s strength lies in its sales reach in India, which is helping it in becoming the manufacturing and marketing partner of foreign companies in the country. Going forward, too, re-organisation of its sales force would push the new products and drive growth. 72 On the manufacturing side too, Elder is making investments in increasing capacities. The company has four manufacturing facilities near Mumbai in Maharashtra, including the recently purchased undertaking for manufacture of injectables in liquid oral dosage from Elder Projects.

And now, it is setting up three more plants in the tax havens of Uttaranchal and Himachal, which would give it a seven-year excise duty benefit, along with octroi exemption, according to Saxena. While the new capacities would reduce the company‘s dependence on outsourcing and thus control costs, there would be increased depreciation cost due to greater investments in plant and machinery. The move would also improve cash flows. According to Sharekhan, operating profit margins are likely to improve from 14. 7 bps in FY05 to 20. 3 bps in FY08.

Although the company is not into backward integration of making empty capsules or injections, it has got into manufacture of some raw materials for its formulations. Captive consumption of bulk drugs and launch of higher-margin products will also add to the bottomline. Currently, the company‘s areas of business include formulations, bulk drugs and consumer products. Within pharma formulations that account for over 75 per cent of its sales, Elder‘s areas of operation are women‘s health care, nutraceuticals and some areas in the cardiovascular segment. 73

One key driver of growth for the company is Shelcal, which is a calcium supplement. This product commands a market share of 29 per cen