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  1. 1. Healthcare Products RESEARCH METHEDOLOGYSTATEMENT OF THE PROBLEM: - To study The Indian pharmaceutical market and study the effect of healthcare products on pharmaceutical market.OBJECTIVES 1. To get information about Indian pharmaceutical market. 2. To understand the healthcare products contribution and its effect on pharmaceutical market. 3. To evaluate the prescribed and OTC healthcare products market. 4. To evaluate consumers as well as doctors attitude (loyalty, retention) towards healthcare products. 5. To study how effective is the advertising campaign and other sales promotion tools for OTC products 6. To study the upcoming opportunities for healthcare products in domestic pharmaceutical market.RESEARCH DESIGN  Descriptive studies • Much of social research is conducted to explore a topic or to provide a beginning familiarity with that topic. • In planning and designing a specific research project, it is necessary to anticipate all the steps that have to undertaken to make the project successful.  Type of Sampling: Convenience sampling  Sample Size: 150  Location: AhmedabadNRIBM, AHMEDABAD 1
  2. 2. Healthcare ProductsDATA COLLECTION: Data collection is one of the most important factors that affect the project.  Primary Data: • Primary data would be collected only after the completion of secondary data collection. Interview with chemists, doctors. Also data would be collected on consumer preferences by interviewing consumers.  Secondary Data: The secondary data will be gathered through company brochures, company internal data already collected by the company researchers and websites. The main use of secondary data is in getting authenticated information. Like inthis case the secondary data would help in conducting structured interview. So it acts asinput for the primary data collection.BENEFICIARIES:-We as Researcher of management would be the most benefited. As this study will helpus to gain in depth and live knowledge and insight in to the Indian pharma market.The Organization, which showed interest to help me carry out this project, would alsobe benefited with the same. The Analysis of this project would give the organization thescope for the further updations of the information without flows.The colleagues will be benefited by this project as they will get chance to updates theirknowledge about Indian pharma market and healthcare products marketREASON FOR TAKEING UP THE PROJECT:- As we are more interested in healthcare products and its growing market, as well as opportunities for these products at OTC and direct selling. This project would provide us extra knowledge about the healthcare products market. This would certainly help me in adding value to my resume and also will help the company in which I will work with.HYPOTHESIS:NRIBM, AHMEDABAD 2
  3. 3. Healthcare ProductsHypothesis 1: More than 50% people seek information about drugs from chemist2.1 WORLD PHARMACEUTICAL MARKET  WORLD PHARMACEUTICAL MARKET TO CROSS $900 BILLION BY 2008 Though the pharmaceutical industry remains one of the most profitable and stableindustries, several macro-level variables are influencing fundamental changes in theindustry structure. The chief variables are: the increasing role of substitutes-genericpharmaceuticals threat; the threat of new entrants-emergence of bio-pharmaceuticals andgenome revolution; increasing buyer power-power of third party payers, governmentbuyers, and health maintenance organizations, and increased health awareness amongstpatients and changing suppliers-enhanced outsourcing in manufacturing and R&D.Additionally, changing world demographics (increasing graying of world population),stringent regulatory environment, declining R&D productivity, worldwide compliance ofGeneral Agreements on Tariffs and Trade (GATT) and Trade Related IntellectualProperty Rights (TRIPS) and emergence of e-pharmaceuticals is likely to reshape theindustry. The industry is comprised of 4 major sectors: ethical, generic, OTC andbiopharmaceutical. Ethical pharmaceuticals account for 74% of the total worldpharmaceutical market. The sector is growing at double-digit rates but is under increasingpressure owing to the strong competition from generic and biopharmaceutical sectors.The ethical sector is increasing by relying on blockbusters and innovative medicines todrive its growth. Life-style diseases will continue to drive the growth of this sector. Thechange in the life-styles would fuel demand for cardio-vascular agents, CNS (centralnervous system) and alimentary/metabolism products. The generic pharmaceutical sector currently valued at $30.5 billion, holds 6% ofthe total world pharmaceutical market. This sector is expected to increase its penetrationNRIBM, AHMEDABAD 3
  4. 4. Healthcare Productsin the world pharmaceutical market to 7% by 2008. The sectors growth will continue tobe fueled by patent expirations worth $80 billion through 2010. Global Diseases Most Neglected Diseases Neglected Diseases World pharmaceutical market > $646 bn in 2006Most neglected diseases lie outside the world pharmaceutical market Increasing health awareness, patent expiration, and increasing marketingactivities by the OTC manufacturers have fueled the growth of the OTC pharmaceuticalsector. The OTC pharmaceutical sector is valued at $73.8 billion and is expected to reach$101 billion by 2008. Biopharmaceuticals are an increasingly becoming popular mode oftreatment owing to their efficacy and ability to treat hard-to-treat conditions. The sector iscurrently valued at $31 billion and is growing at double the rate of the ethical sector. The industry is witnessing continued consolidation. The top 10 companies sharehas improved from 28% in 1990 to 46% in 2002. Companies are increasingly focusing onmergers and acquisitions, in-licensing activities, co-development, and co-marketingactivities in order to remain competitive and create value for their share holders. Leadingethical pharmaceutical companies are increasingly venturing into biopharmaceuticals,generic pharmaceuticals, etc. as a mode for organic growth. Generic pharmaceuticals areincreasingly becoming a formidable force in the market. They are increasingly becomingglobal in nature, segmenting (super generics, bio generics, specialty generics, etc.) inNRIBM, AHMEDABAD 4
  5. 5. Healthcare Productstheir quest for survival. Biopharmaceutical companies like Amgen and Genetech arecompeting head-on with the big pharma in the market place. North America is thebiggest market for pharmaceuticals with about 50% share of the total worldpharmaceutical market. Overall, the 10 leading markets cover 70% of the ethicalpharmaceutical market. Some key markets like Japan and Latin America are decliningowing to the economic crises affecting their countries. Asia in particular is emerging as aleading pharmaceutical market. The impending WTO/GATT implementation in 2005 isaligning the world pharmaceutical market into one global market.The pharmaceutical market world wide Among audited therapy classes, the top-ranked lipid regulators classincreased 7.5 percent to $35.2 billion, despite patent loss from simvastatin and pravastatinin major markets. New generics entries, growth of innovative products such as Crestor®NRIBM, AHMEDABAD 5
  6. 6. Healthcare Productsand Vytorin®, and the increasing demand for lipid regulators among Medicare Part Dpatients in the U.S. continued to drive volume gains for this class. Oncologics reached $34.6 billion in sales in 2006, up 20.5 percent. Thissignificant growth, the highest among the top ten therapeutic classes, was fueled bystrong acceptance of innovative and effective therapies that are reshaping the approach tocancer treatments and outcomes. In 2006, innovation in oncology was particularly active,with more than 380 compounds in development. Half of the oncology products in late-stage development are targeted therapies — treatments directed at specific moleculesinvolved with carcinogenesis and tumor growth. Targeted therapies have revolutionized the way cancer is being treated —openingup the possibility that many forms of the disease can be fought through long-termmaintenance therapy,” said Titus Plattel, vice president, IMS Oncology. “These therapiesare helping to win individual battles against cancer, enabling us to think of it as a chronicillness, rather than a life-ending one. With the industry’s innovation and ongoingscientific advances, growth in targeted therapies will continue to be very strong and theoutcomes even more impressive. Respiratory agents were the third-largest therapy class last year, with 10 percentgrowth in sales to $24.6 billion. Another therapeutic class experiencing high growth wasautoimmune agents, which grew at a 20 percent pace in 2006 to $10.6 billion in sales.Ranked twelfth in size among leading classes, growth in autoimmune agents was fueledby the increased use of anti-TNF agents such as Remicade® and Humira® and theexpansion of approved indications for these products. Despite continued expansion of thepharmaceutical market, underlying dynamics continue to alter the landscape. In 2006,products with sales in excess of $18 billion lost their patent protection in seven keymarkets — including the U.S., which represents more than $14 billion of these sales.With high uptake of lower-cost therapies replacing branded products in classes such aslipid regulators, antidepressants, platelet aggregation inhibitors, antiemetics andrespiratory agents, generics will assume a more central role as payers seek to restrict thegrowth of healthcare expenditures. Another factor influencing the market is theincreasingly active role of patients as they take charge of their health and demand greateraccess to therapies that will improve or prolong their lives.NRIBM, AHMEDABAD 6
  7. 7. Healthcare Products Total global pharmaceutical sales include audited and estimated unauditedinformation. These pharmaceutical sales are derived from IMS audits, which cover 94percent of the market, while the remaining 6 percent are estimates derived from IMSMarket Prognosis TM. Growth in sales is measured in constant dollars, enabling analyseswithout the influence of fluctuating currency exchange rates. Pharmaceutical sales figuresare measured in current US dollars, include prescription and certain over-the-counterdata, and reflect ex-manufacturer pricesNRIBM, AHMEDABAD 7
  8. 8. Healthcare ProductsWORLD SCENARIO • The world market for the pharmaceuticals was valued at US $ 250 billion in 1994 and it is expected to reach US $ 350 billion in the year 2000. • Estimated at 538 million, the world’s population in 1991 was 11% larger than in 1985 and almost 21% larger than a decade ago. • The USA, European Unions and Japan are the biggest markets for drug formulations (USA 30 billion, E.U. 40 billion, Japan 31 billion in 1992). • All new drugs are marketed first in one of these countries. The introductory prices are thus, related to the average per capita income of these countries and are generally out of reach of developing countries. • The Pharmaceutical market worldwide, valued at US $ 247.9 billion in 1994 is forecast to grow to US$ 342 billion by 1999 representing a compounded annual growth rate of 7.1%. • As per US FDA, of the 348 new drugs placed in the market in the 80’s by top 25 drug companies 91 (26%) were new molecules. Even of these, 60 were classified under “C” category. This means, only 10% of the drugs introduced in 80’s offered significant therapeutic gains over the existing drugs. • In the USA and Japan together constitute 45% sale on non-communist world pharmaceutical market. The 50 largest companies produced 66% of the world output of drugs and pharmaceuticals, and also supply 50% of the pharmaceutical requirements of the developing countries. • Among the world’s largest 200 odd pharmaceutical firms, 50 are Japanese and 33 are US firms. The world trade in pharmaceutics is also dominated by the developed countries, which account for over 90% of world exports and about 70% of world’s imports. • Though the imports of the developing countries are significant at 25% of total world pharmaceutical imports, their exports account for barely 6 to 8%.NRIBM, AHMEDABAD 8
  9. 9. Healthcare Products • The market for bulk pharmaceutical chemicals are estimated at US $ 32 billion in 1994, is expected to reach US$ 35 billion by 2000. • During the mid nineties more than US $ 100 billion worth of mergers and acquisitions, involving over 15 major companies have taken place worldwide. • The US market in generic, is growing at around 20% annually and will conservatively worth about US $ 15 billion by the year 2000. • The estimated figure for the generic markets worldwide is about $ 25 to 30 billion. In the next five years it is expected to increase $ 50 billion. • Globally, over the last 50 years, about 30% of the drugs have come from academic research while 70% of drugs have been from the product of industrial research. • In Germany, more than 50% of the prescriptions are for Generics, though they account for only 14% by value. • Worldwide, the business for OTC is estimated to be $ 44.8 billion and enjoys a market share of 28% in the US, 15% in the European Union. • The worldwide pharmaceutical market in 1996 reached US$296.4 billion at ex- manufactured prices, up by 4% over 1995. The highest growth was in North America and Latin America, which posted figures of 12% and 8% respectively, while sales in Africa, Asia, and Australia regions fell by 6%. Within North America US achieved 12% growth to US$ 98.6 billion, while sales in Canada by 5% to US$ 4 billion. • In 1996, the Italian market grew at 11%, US at 10% and Indian market at 15.8%. • In the US, about 40 drugs worth $ 16 billion are set to lose patent by the end of 2002. • The world pharmaceutical market is expected to grow at compounded annual growth rate of 6.2% and expected to reach $ 378 billion in 2001. Southeast Asia and China are likely to see the largest jump in market share during the period from 5% in 1997 to 7% in 2001. • The world exports of pharmaceutical has increased to US $ 14.4 billion in 1983 to US $ 35 billion in 1993 and is currently around US $ 50 billion giving aNRIBM, AHMEDABAD 9
  10. 10. Healthcare Products compounded annual growth rate of around 13%. The world trade in pharmaceuticals is dominated by the developed countries, which account for over 90% of the world’s export. • The developing countries together accounted for only 5 to 7% of world pharmaceutical exports; China, India, Hong Kong, Singapore and South Korea are the major exporters. Worldwide Pharmaceutical Market by Sectors, 2000-2003 and 2008 ($ Billions)NRIBM, AHMEDABAD 10
  11. 11. Healthcare Products2.2 Indian Pharmaceutical Industry“The Indian pharmaceutical industry is a success story providing employment formillions and ensuring that essential drugs at affordable prices are available to the vastpopulation of this sub-continent.”Richard Gerster In the early years after independence, the sole players in the industry weremultinationals such as Glaxo, Pfizer, and Parke-Davis. The companies both imported andmanufactured formulations. The industry saw the emergence of domestic companies afterthe passage of the Indian Patents Act in 1970, which offered protection against patentviolation charges. Thus was born in India the phenomenon of “reverse engineering,”whereby altering some stage in the process of manufacturing a molecule made it possibleto secure an Indian process patent. As a result, domestic firms copied Western productsovernight. Inherent domestic advantages included the availability of skilled scientificpersonnel; the low cost of raw material, production, and labor; and government policy(such as exemption from excise duties) that supported indigenous production in theprivate small-scale industry (SSI) sector. The speed at which new product technologieswere adopted and the ability of Indian companies to develop cost-effective processes andeffective distribution systems has been phenomenal. The industry can be divided into the organized sector and the SSI sector. TheIndian pharmaceutical industry is highly fragmented, with 15,000-plus licensedmanufacturing units. About 300 are in the organized sector, of which multinationalsaccount for about 40%. Together, the top ten industry players account for only 30% ofmarket share; the top company, Glaxo- Wellcome, has only 5.7%. The market share ofmultinationals has decreased from 75% in 1971 to approximately 35% at present, whilethat of Indian companies has increased to 65%.13 While in 2001 the top fivemultinationals grew at a rate of 7.2%, the top five domestic companies grew at 14%.14 ANRIBM, AHMEDABAD 11
  12. 12. Healthcare Productsreport by McKinsey predicts that the industry will further grow at a CAGR of 19% toreach $25 billion in revenue by 2010.15 It is expected that $18 billion to $19 billion willcome from existing operations and the rest from new drug discovery and researchservices. The market capitalization of Indian pharmaceutical companies is projected togrow dramatically to $150 billion from the present $15 billion to $20 billion. The newIndian Pharmaceutical Alliance (IPA) consists of 11 leading domestic companies,including Dr. Reddy’s Laboratories, Ranbaxy, and Cipla. They contribute about 30% ofthe country’s pharmaceutical exports and share over 30% of the domestic market. Theirannual R&D accounts for 92% of total pharmaceutical R&D expenditure in the privatesector. The alliance was formed primarily to lobby the government on policy issues, suchas price regulation, evolution of a patent regime that will honor TRIPS, and upgrading theregulatory framework to prepare Indian companies for international competition The Indian Pharmaceutical Industry today is in the front rank of India’sscience-based industries with wide ranging capabilities in the complex field of drugmanufacture and technology. A highly organized sector, the Indian Pharma Industry isestimated to be worth $ 4.5 billion, growing at about 8 to 9 percent annually. It ranks veryhigh in the third world, in terms of technology, quality and range of medicinesmanufactured. From simple headache pills to sophisticated antibiotics and complexcardiac compounds, almost every type of medicine is now made indigenously. Playing akey role in promoting and sustaining development in the vital field of medicines, IndianPharma Industry boasts of quality producers and many units approved by regulatoryauthorities in USA and UK. International companies associated with this sector havestimulated, assisted and spearheaded this dynamic development in the past 53 years andhelped to put India on the pharmaceutical map of the world. The Indian Pharmaceuticalsector is highly fragmented with more than 20,000 registered units. It has expandeddrastically in the last two decades. The leading 250 pharmaceutical companies control70% of the market with market leader holding nearly 7% of the market share. It is anextremely fragmented market with severe price competition and government pricecontrol. The pharmaceutical industry in India meets around 70% of the countrys demandfor bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets,capsules, orals and injectibles. There are about 250 large units and about 8000 SmallNRIBM, AHMEDABAD 12
  13. 13. Healthcare ProductsScale Units, which form the core of the pharmaceutical industry in India (including 5Central Public Sector Units). These units produce the complete range of pharmaceuticalformulations, i.e., medicines ready for consumption by patients and about 350 bulk drugs,i.e., chemicals having therapeutic value and used for production of pharmaceuticalformulations. Following the de-licensing of the pharmaceutical industry, industriallicensing for most of the drugs and pharmaceutical products has been done away with.Manufacturers are free to produce any drug duly approved by the Drug ControlAuthority. Technologically strong and totally self-reliant, the pharmaceutical industry inIndia has low costs of production, low R&D costs, innovative scientific manpower,strength of national laboratories and an increasing balance of trade. The PharmaceuticalIndustry, with its rich scientific talents and research capabilities, supported by IntellectualProperty Protection regime is well set to take on the international market.GOVERNMENT POLICIESIndias new product patent regime is the result of the WTOs Doha Round of negotiationsin 2001. Final agreement was reached on TRIPS ground rules for patent protection amongWTO member countries, stating that both processes and products should be protected.Subsequently, on March 22, 2005, Indias parliament approved the Patents (Amendment)Act 2005, bringing in a system of product patents backdated to January 1, 2005. The newregime protects only products arriving on the market after January 1, 1995, abolishing theprevious process patent system established by the 1970 Patent Act. The industry is alsowaiting to see whether the government will follow international guidelines governingcompulsory licensing, the process by which the TRIPS agreement permits governments,in special cases, to waive the patent on a particular medicine. Elsewhere in the world, thetrade treaty allows compulsory licenses to be issued in response to a national emergency,but in India they may currently be invoked due to factors such as the reasonability of aproducts price, and its potential for export and local manufacturing, among other issues.Government policy in this area needs to be more clearly defined In a country lacking the assurance of free health care for all (not to talk of aneffective health insurance system), it is the poor patients family who must pay the bill.This was the justification for the policy. But it killed any incentive to invest in R& DNRIBM, AHMEDABAD 13
  14. 14. Healthcare Products(Research and Development), which makes global drug manufacturers what they are:leader of mankinds war on disease. Indias per capital consumption of drugs is said to bejust $3. In the US its over $100 and in Japan, over $400. India has about 20% of theworlds disease burden (with just 16% of its population). Western spending is highbecause in a system where the government pays the bills, the patient gets themselvesprescribed all sorts of pills for ailments that arent terribly serious. But why is Indianspending so low? Only 35% of the population has access to modern (read allopathic)medicines. India has alternative system of medicines, Ayurveds, e.g. are not quacks,neither are homeopaths who make their own medicines. India also exports sizable quantities of drugs & pharmaceuticals. Morecompanies are now venturing into traditional health care systems beside modernmedicine. With the launching of new drugs policy, all bulk drug formulation andintermediaries except five bulk drugs have been de-licensed. Many drugs that were hitherto under price control have been taken out of such control. Actually the list of controlleddrugs has been halved and is limited to 73 items. Higher rate of return has been allowedfor those drugs that are still under price control. Companies with 51 percent foreignequity have been brought on par with wholly Indian companies; automatic clearancewould be given for 51 percent foreign equity automatic approval would be given forforeign technology agreement as well. Earlier such companies had restriction on theproduct they could manufacture or import. A National Drug Authority is to be set up tomonitor quality control and rational use of medicine. A national pharmaceutical pricingauthority is also to be set up to fix prices in respect of drug, which would continue to beunder price control (Ramaswamy & Meerakumari 1988). Recent budget proposal hasannounced a 10 percent drop in the peak customs duty, which will benefit formulatorsand transnational pharmaceutical companies with high raw material import contents, butfalling traffic barriers also threaten the future of the bulk drug players. However, the 8percent increase will not have a negative impact on formulators as the increase willenable a full set off under MODVAT (Modified Value Added Tax). Similarly, the 10percent reduction in the tax on income from royalty and technical fees paid to foreigncompanies may not affect domestic companies at all. But high spenders on R & D likeRanbaxyTM, CiplaTM and WockhardtTM will gain. This along with the rising ofNRIBM, AHMEDABAD 14
  15. 15. Healthcare Productsinvestment limits in overseas joint ventures and offices under the Export Earners ForeignCurrency Account, will provide a strong dose of incentive for Indias pharmaceuticalcompanies to go global.ADVANTAGE INDIA Competent workforce: India has a pool of personnel with high managerial andtechnical competence as also skilled workforce. It has an educated work force andEnglish is commonly used. Professional services are easily available. Cost-effective chemical synthesis: Its track record of development, particularly inthe area of improved cost-beneficial chemical synthesis for various drug molecules isexcellent. 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 solidlegal framework and strong financial markets. There is already an establishedinternational industry and business community. Information & Technology: It has a goodNRIBM, AHMEDABAD 15
  16. 16. Healthcare Productsnetwork of world-class educational institutions and established strengths in InformationTechnology. Globalization: The country is committed to a free market economy andglobalization. Above all, it has a 70 million middle class market, which is continuouslygrowing. Consolidation: For the first time in many years, the internationalpharmaceutical industry is finding great opportunities in India. The process ofconsolidation, which has become a generalized phenomenon in the world pharmaceuticalindustry, has started taking place in IndiaTHE GROWTH SCENARIO Indias US$ 3.1 billion pharmaceutical industry is growing at the rate of 14 percentper year. It is one of the largest and most advanced among the developing countries.Over 20,000 registered pharmaceutical manufacturers exist in the country. The domesticpharmaceuticals industry output is expected to exceed Rs260 billion in the financial year2002, which accounts for merely 1.3% of the global pharmaceutical sector. Of this, bulkdrugs will account for Rs 54 bn (21%) and formulations, the remaining Rs 210 bn (79%).In financial year 2001, imports were Rs 20 bn while exports were Rs87 bn.NRIBM, AHMEDABAD 16
  17. 17. Healthcare ProductsSTEPS TO STRENGTHEN THE INDUSTRY Indian companies need to attain the right product-mix for sustained future growth.Core competencies will play an important role in determining the future of many Indianpharmaceutical companies in the post product-patent regime after 2005. Indiancompanies, in an effort to consolidate their position, will have to increasingly look atmerger and acquisition options of either companies or products. This would help them tooffset loss of new product options, improve their R&D efforts and improve distribution topenetrate markets. Research and development has always taken the back seat amongstIndian pharmaceutical companies. In order to stay competitive in the future, Indiancompanies will have to refocus and invest heavily in R&D. The Indian pharmaceutical industry also needs to take advantage of the recentadvances in biotechnology and information technology. The future of the industry will bedetermined by how well it markets its products to several regions and distributes risks, itsforward and backward integration capabilities, its R&D, its consolidation throughmergers and acquisitions, co-marketing and licensing agreements. • In India, medicines account for 2.5% in hospitalization and .5% in domiciliary treatment cost. • India’s exports of bulk actives and intermediates is expected to grow from the current level of US $ 420 billion to about US$ 890 million in the year 2001. • The Indian Pharmaceutical market is expected to expand from the US$2.7 billion in 1995 to US$ 5.8 billion (+ 16%) in 2001 and US$ 13.billion (+18% by 2006). • There could be sharp dip in the growth rate in the population in India, which is already down to about 1.7% year and is projected to go down further to about 1.5% by the turn of the century and to roughly 1% by2010. • OTC Pharmaceutical business is India is expected to jump from Rs.10 billion at present to Rs.25 billion by 2002. • Indian’s per capita expenditure for healthcare remains Rs.115.5 compared to the US (Rs.6876.00) and Japan (Rs.14, 832).NRIBM, AHMEDABAD 17
  18. 18. Healthcare Products • In India the values for pharmaceutical production of bulk drugs and formulations in 1995-96 were US$499 million and US$ 2.5 billion respectively. • The Indian Pharmaceutical market ranks about 20th in the world and accounts for less than 1% of world market. It is expected by 2003; the market could be worth of $ 7-9 billion (Rs.280 billion to Rs.360 billion). • India accounts for 6% of all bulk drugs export. There are about 250 large/medium units and about 8000 small-scale units in operations, which form the core of the industry. There are about 350 bulk drugs i.e. active pharmaceutical molecules having therapeutic values and used for production of pharmaceuticals, which accounts for, majority of formulations produced in the country. • During the year ending March 1998, pharmaceutical companies for various bulk drugs, formulations and intermediates filed 265 IEMs. These IEMs are expected to generate employment for about 19000 people and there would be an investment of approximately Rs.4.1 billion on these projects. During the same period foreign investment proposal worth approx. Rs.1.6 billion were approved. • Between August 1991 and March 1998, Gujarat received 5174 proposals for the projects and topped the list in terms of value of investment, which was estimated to be Rs.1379 billion during that period. Next to Gujarat were Maharashtra and other States receiving more than 5% of the investment proposal are Tamil Nadu, Andhra Pradesh, Karnataka, Uttar Pradesh, Punjab and Madhya Pradesh. • The top 12 companies in India together will have a turnover of around 50 billion in the domestic market by 2005, or approximately 25% of industry turnover. About half a dozen companies with a turnover of Rs.35 billion by 2005 will be able to spend about 8% of their turnover on research.NRIBM, AHMEDABAD 18
  19. 19. Healthcare Products According to estimates, contract research and manufacturing (CRAMS) market inIndia was valued at US$ 532.10 million in 2005, of which contract manufacturing accounted for84% of the total market, while the remaining 16% was accounted by contract research excludingclinical trials. Both the segments of CRAMS have registered a robust growth of over 40% in2005 over the previous year. On clinical trials, the Paper comments that in 2005, the industry for clinical trials in Indiawas US$ 100 million. This market is growing at an accelerated pace. India offers a lot ofadvantages in the clinical trials domain such as cost advantage compared to Western countries. On advantages offered by India in CRAMS and clinical trials domain as per the Paper say“today the cost of hiring a medicinal chemist in the US is very high, approx. US$250,000-300,000 per year. The US pharma industry employs roughly 50,000 chemists. Indiandiscovery research outfits charge global pharma companies around US$ 60,000 per chemistwhich is roughly one-fifty of what the pharma companies pay abroad. While it is difficult to pindown an average pay for chemists in India for doing a similar work, conservative estimates NRIBM, AHMEDABAD 19
  20. 20. Healthcare Productssuggest it to be around Rs. 1 million per annum. So it is a win-win situation the overseas pharmasaves about 50% cost and the Indian company makes it about 50% margin. On increasing R&D spend of Indian companies, the Paper highlights “majorpharmaceutical companies in India are the main R&D investor in the country. The R&D spend(capital and current) of these major companies has grown at CAGR of 38% during the period2000-01 to 2005-06. In 2005-06, the R&D expenditure of 50 major companies totaled US$495.19 million growing at a rate of 26% over the previous year. The higher growth rate isattributed to product patent implementation in the country in January 2005”. NRIBM, AHMEDABAD 20
  21. 21. Healthcare ProductsNRIBM, AHMEDABAD 21
  22. 22. Healthcare Products2.3 THE GUJARAT SCENARIO • On 1st May 1960 Gujarat State got separated from greater Bombay State. Prior to that, about hundred years, Gujarat based Companies like Alembic Chemical Works Ltd. And Sarabhai Chemicals were producing Galenicals, Syrups, Elixirs, Powders, and Extracts etc. • At the time of independence, India was not self-sufficient for medicines. Many of formulations and bulk drugs were imported. Exports of medicine were almost negligible. Total production of Pharmaceutical products in 1947 – the year of independence - was in the tune of Rs.100 million only. • Both – Government and Pharmaceutical Industry to increase production of bulk drugs and formulations, made rigorous efforts. Entrepreneurship of manufacturers helped to make the country almost self-reliable and today about 95% of the bulk drugs and formulations are produced locally. • Gujarat accounts for about 40% of pharmaceutical production. • Total 4196 manufacturing units engaged in manufacturing of Allopathic, Ayurvedic, HomeopathicNRIBM, AHMEDABAD 22
  23. 23. Healthcare Products3.1 INDIAN OTC MARKETDoes India need more OTC drugs? – An IDMA viewIndian Drug Manufacturers’ Association (IDMA) is of the opinion that the products to besold through OTC route should an absolute minimum as the country does not have therequired infrastructure nor qualified pharmacists. Low literacy and education amongst theconsumers of medicines also makes it all the more necessary to be extremely cautions onthis-front.In an effort to tackle the issue an expert committee formed by IDMA worked out a draftproposal on the problems of expanding OTC drug list and submitted to the DGC (I) on28th October 2005. The following is the text of the proposal.OTC-SCENARIO The Indian market for over-the-counter medicines (OTCs) is worth about $940million and is growing 20 per cent a year, or double the rate for prescription medicines.The government is keen to widen the availability of OTCs to outlets other thanpharmacies, and the Organisation of Pharmaceutical Producers of India (OPPI) has calledfor selling OTCs in post offices. Developing an innovative new drug, from discovery to worldwide marketing, nowinvolves investments of around $1 billion, and the global industrys profitability is underconstant attack as costs continue to rise and prices come under pressure. Pharmaceuticalproduction costs are almost 50 per cent lower in India than in Western nations, whileoverall R&D costs are about one-eighth and clinical trial expenses around one-tenth ofWestern levels. Indias long-established manufacturing base also offers a large, well-educated, English-speaking workforce with 700,000 scientists and engineers graduatingevery year, including 122,000 chemists and chemical engineers, with 1,500 PhDs. Theindustry provides the highest intellectual capital per dollar worldwide, says OPPI. The industrys exports were worth more than $3.75 billion in 2004-05 andthey have been growing at a compound annual rate of 22.7 per cent over the last fewNRIBM, AHMEDABAD 23
  24. 24. Healthcare Productsyears, according to the governments draft National Pharmaceuticals Policy for 2006,published in January 2006. The Policy estimates that, by the year 2010, the industry hasthe potential to achieve $22.40 billion in formulations, with bulk drug production goingup to 5.60 billion from $1.79 billion. "Indias rich human capital is believed to be thestrongest asset for this knowledge-led industry. Various studies show that the scientifictalent pool of 4 million Indians is the second-largest English-speaking group worldwide,after USA." In India the prescription drugs are listed under Schedule H. There are about570 modules in this category that are stocked in a total of 5 to 8 lakh retail chemists.Currently, non pharmacy stores can sell a few drugs on the schedule K of the Drugs &Cosmetics Act in rural areas in villages, whose population is below 1,000,LEAGAL ASPECTSCODE OF STANDARDS FOR ADVERTISING OF MEDICINES AND TREATMENT: 1. Rule 106 of the Drugs Rules, 1945, provides that, no drug may convey to the intending user thereof any idea that it may prevent or cure one or mere of the diseases or ailment specified in Schedule J. this Schedule includes: Blindness, bright diseases, cancer, cataract, deafness, delayed menstruation, diabetes, epilepsy, hydrocele, infantile paralysis, leprosy, leucoderma, lockjaw, locomotor ataxia, insanity, tuberculosis, tumours, venereal diseases(in general),fevers (in general),fits glaucoma, goiter,gonorrhea,soft cancer, heart diseases, high blood pressure, lupus,obesity,paralysis,lague,rupture,sexual impotence and small pox. 2. No drugs may purport or claim to procure or assist to procure or may convey to the intending user there of any idea that it may procure or assist procure miscarriage in woman. Thus drug or formulation meant for any of the conditions as listed in schedule J is not suitable and to be permitted for marketing it as OTC.In 2005 the Indian OTC segment is Rs 4500 crore it could be considered as Rest 17000crores if cosmeceuticals & neutraceuticles are also included. The global OTC market isprojected to be USD 75 billion (roughly INR 375,000 crores) with a cumulative annualgrowth rate (CAGR) of 4.5%. the CAGR for Indian OTC markets is currently hoveringbetween 12% and 15% and this is much faster than OTC market growth of mostdeveloping countries.NRIBM, AHMEDABAD 24
  25. 25. Healthcare ProductsDue to changing trends and consumer awareness, the OTC market is contemplated asfuture growth driver. Besides India has the lowest per capita medicine spend of USD 0.5vis-a vis USD 55 for USA. The present low per capita medicine spend couled with thefast growth of Indian OTC market is the basis on which the MNCs are pushing worthmeasure to enhance the OTC market- basically by increasing the number of drugs thatcould advertised. Recently, the Organization of Pharmaceutical Producers of India (OPPI)has submitted a list of 11 molecules to the Drugs Controller General (India) (DCGI) to beexcluded from Schedule as art of its campaign to expand OTC segment.In India, Good Pharmacy Practices (GPs) are not followed by majority of the chemistshops, let alone the other outlets which could technically stocks OTC medicines. Badstorage, non compliance with the date of expiry and wrong advise on dosages can beextremely harmful to the consumer patient. The problem is not only of precipitatingserious side effects leading even to fatality, but that of meeting specified bioavailabilityand bioequivalence criteria of drugs, the sources said. Even an iron preparation can betoxic in normal doses, as improper storage can lead to oxidization. The government alsothinks that with over 7 lakh retail medical stores in the country which is too insufficient.This defeats the very premise of OPPI’s argument that more drugs be in OTC list so as tofacilitate their wider availability as far as adherence to prescription norms is concerned. Itis common knowledge that is developed countries. Indian chemists are too strict withrespect to having a warren prescription.Requirements of OTC marketingFor any product to be sold as OTC, it must be fulfill the following three criteria:-it must be safe.-it must be effective.-it must be for a condition that the patient can manage without supervision by licensedhealth professionals. Any drug which is to be shifted schedule H to OTC category isnaturally expected to be effective. The concerns would however be its safety and issuespertaining to unsupervised intakeSUPERVISION OF OTC DRUGSNRIBM, AHMEDABAD 25
  26. 26. Healthcare ProductsA key issue in OTC marketing is dispersing information pertaining to their safe usage asthese drugs will be taken without medical advice label claims with regards to diseasesymptoms, direction for use, warning, etc. is extremely important.The issues pertaining to OTC drugs’ safe usage are many in India:Drastic change in the labeling practices of DTC medicines have to be compulsorilyenforced if they have to e sold outside medical shops. Firstly, labeling of OTC medicineshas to be in local languages and all the instruction have to be in simple and easilyunderstandable words. At present, very few pharma companies are printing labels in locallanguages.Generally labels on OTC products also do not indicate specified dose forchildren. It has to be ensured that all OTC drugs specify the correct needs for children interms of qualities, frequency and duration of their intake.Some basic knowledge about medicines is also crucial amongst the traders who will beselling OTC products. This is an unachievable task knowing fully well that qualifiedpharmacists do not continuously man the chemist shops selling OTCs, let aloneknowledgeable sales force educating customers in other than chemist’s stores stockingsuch products.In absence of safe guards to facilities safe OTC products, the inclusions of NSAIDs likeibuprofen, mefenamic acid, ketoprofen & dictlofenac, gastrointestinals especially such asdomperidone and loperamide, as well as prochloreaine in particular, in the alreadyexisting non- prescription category is besieged with lurking dangers.WHY NEW DRUGS WHEN ALTERNATIVES ARE AVAILABLE?For diarrheas suitable options such as ORS are recommended as first line and areavailable. Then, why should Ioperamide is considered as OTC?In cough & cold segment instead of bromhexine, suitable cough-cold formulate arealready advertised. Even adhatoda vasica, from which bromhexine is derived, is availableas –OTC. Prochlorperazine is unthinkable as OTC. We already have suitable options tomanage the various causes of vomiting such as antacids for gastritis associated vomitingetc.3.2 HEALTHCARE GOODSNRIBM, AHMEDABAD 26
  27. 27. Healthcare ProductsINTRODUCTIONReduction in the time available for tending to personal health among the consumer hasled to the realization that some medicines and health supplement need to be present in thehome at all times. These have become a part of the monthly household grocer list.Examples of these products are chyawanrash, skin hygiene, sugar substitutes,rejuvenators, cough syrup, tablets like Crocin and balms for body aches.These kinds of products are the ones that are labeled as ‘fast moving health goods’. BothFMCG & pharma companies have products in this category; Many Ayurvedic pharmaplayers also enter in this market. E.g. P&G is FMCG Company which has products Vicks& crocin. While Paras pharmaceutical has D-cold brand & adusol from Dabur.CATEGORIESPAINKILLERIntroductionAnalgesics or painkillers are very common medications that doctors prescribe or a personmay buy over the counter to help relieve pain (of any kind). Over the counter pain killers(analgesics) such as Aspirin and Tylenol have become so common that theyare notconsidered “real medication”. Their lace in just about every household has made thebusiness of analgesics a very competitive one.There are three main types of analgesic (painkiller) available over the counter in apharmacy. These are aspirin, paracetamol and ibuprofen.What are painkillers? Painkillers (ANALGESICS) are substances that give temporary relief from painwithout causing a loss of consciousness. There are two major categories of painkillers:non-narcotic and narcotic.The most commonly used nonnarcotic painkillers are aspirinand other salicylates, acetaminophen, and nonsteroidal anit-inflammatory drugs such asibuprofen, which are available in both prescription and nonprescription forms.Nonnarcotic painkillers are by far the most commonly used of all medications. In additionto controlling pain, these analgesics also lower fever and counter inflamation.NRIBM, AHMEDABAD 27
  28. 28. Healthcare ProductsNarcotic painkillers include opiates and opioids, which are natural or artificial forms ofopium. Codeine, propoxyphene (e.g. Darvon and Wygesic), meperidine (Demerol), andmorphine are common examples. These drugs are usually used on a short-term basis tocontrol severe pain. Many prescription analgesics contain a combination of narcotic andnonnarcotic painkillers. Common combinations include acetaminophen and codeine (e.g.Tylenol with Codeine and Tylox), aspirin and codeine (e.g. Empirin with Codeine),propoxyphene and aspirin (e.g., Darvon Compund-65); and aspirin, caffeine, andbutalbital (Florinal). These drugs are used as an alternative to preparations that containonly narcotic ingredients for painful conditions that are not adequately alleviated bynonnarcotic agents.How do painkillers work? Opiates and Opioids apparently work through specific receptors in the centralnervous system. Aspirin and the other nonprescription drugs are thought to work byblocking the bodys production of particular types of prostaglandins, hormone-likesubstances that are produced throughout the body.Side effects The most common side effect of aspirin and the stronger nonsteroidalantiinflammatories is gastrointestinal irritation. This can be minimized by taking themwith meals or milk.Acetaminophen does not cause as many intestinal side effects asaspirin, but it should be used with caution by persons who have liver or kidney disorders.The combination of aspirin and acetaminophen is especially damaging to the kidneys, asis heavy alcohol consumption and long-term acetaminophen use to the liver. Codeine often causes nausea, dizziness, and constipation. A more serious problem,however, involves the tendency of codeine and other narcotics drugs to producedrowsiness. Thus, these agents should not be taken by anyone who must remain alert. Inaddition, narcotic drugs should never be taken by anyone who must remain alert. Inaddition, narcotic drugs should never be taken in combination with alcohol,antihistamines and other allergy or cold pills, anticonvulsants, tranquilizers, muscleNRIBM, AHMEDABAD 28
  29. 29. Healthcare Productsrelaxants, or any other agent that depresses the central nervous system. Narcotics increasethe effects of these drugs on the brain, and a fatal overdose can result from theircombined use. The potentially addictive effect of opiates and other narcotic agents is themajor drawback to their long-term use. However, overconcern about addiction hasresulted in their underuse in the control of severe pain. Some painkillers have beneficialsecondary effects. for example, low-dose aspirin may help prevent a heart attack or strokeby preventing clot formation. By the same token, aspirin can cause bleeding problems.Treatments Alternative pain therapies that may be used independently or in conjunction withpainkillers include: Accupuncture, Acupressure, and Massage. Electrostimulation, byimplanting electrodes at certain sites in the body and then stimulating them to preventpain messages from reaching the brain. Relaxation, Biofeedback, Meditation. Surgery, bydestroying nerves responsible for pain sensation.What can be done?A person who suffers from a chronic pain disorder learns by trial and error how best tomanage the pain. If aerobic exercise is tollerated, secretion of endorphins, brainchemicals that are natural painkillers, are released. If you do take a painkiller, make surethat you follow all instructions.Examples of painkillersNonsteroidal anti-inflammatory drugs (NSAIDs) are available in prescription and OTCform. No one has been proved superior, but people respond differently to each, so it maybe necessary to try several.NSAIDs include:clofenamate (Meclomen)diclofenac (Voltaren)ibuprofin (Motrin and OTC Advil, Nuprin, and others)nabumetone (Relafen)NRIBM, AHMEDABAD 29
  30. 30. Healthcare Productsnaproxen (Naprosyn, in both prescription and OTC forms, and Anaprox)piroxicam (Feldane)sulindac (Clinoril)ANTACID Many OTC products are advertised to relieve heartburn or acid reflux. Theseinclude antacids, bismuth subsalicylate, H2 blockers, proton pump inhibitors andcombination medicines.How do antacids and acid reducers work? Antacids neutralize the acid in your stomach. They can provide fast, short-termrelief. Many OTC drugs combine different antacids. H2 blockers reduce the amount ofacid your stomach makes. While they don’t relieve symptoms right away, H2 blockersrelieve symptoms for a longer period of time than antacids. Some products combineantacids and an H2 blocker. One example combines famotidine, calcium carbonate andmagnesium hydroxide (brand name: Pepcid Complete). These combination medicines canrelieve symptoms right away and the relief can last for many hours. Bismuth subsalicylateworks by balancing the way fluid moves through your bowels. It also binds toxins(poisons) from bacteria so that they are not harmful and helps kill germs. It’s also used asan antiemetic (medicine to treat nausea and vomiting) and as an antidiarrheal (medicineto treat diarrhea). Proton pump inhibitors stop your body’s production of acid. This typeof drug requires 1 to 4 days to work. Only people who have heartburn often—at least 2days a week—should use this drug.What problems can OTC antacids and acid reducers help? These medicines can help relieve heartburn or dyspepsia (pain or anuncomfortable feeling in the upper middle part of your stomach). Heartburn is also calledacid reflux disease or gastroesophageal reflux disease (GERD). OTC antacids and acidreducers may also be used as part of a plan to treat ulcers. For treating ulcers, thesemedicines may be used together and/or combined with antibiotics (drugs that killbacteria) prescribed by your doctor. If you aren’t getting enough calcium from your diet,your doctor might suggest that you take additional calcium to help treat or preventNRIBM, AHMEDABAD 30
  31. 31. Healthcare Productsosteoporosis. Antacids that contain calcium carbonate can be used with vitamin D tosupplement the calcium in your diet.Side effects Antacids and acid reducers usually cause only minor side effects that go away ontheir own. These may include headaches, nausea, constipation or diarrhea. Bismuthsubsalicylate can cause your tongue or stool to turn dark. This is a short-term side effect.If side effects make it hard for you to take medicine for heartburn, talk to your familydoctor. He or she may suggest a different drug or have ideas about how to make the sideeffects less of a problem.Contraindications Don’t take these drugs if you have an allergy to any of the ingredients.Phenylalanine is an example of an ingredient in some antacids that can cause a problemfor certain people. If you have a condition called phenylketonuria, you shouldn’t take amedicine that contains phenylalanine. Don’t take bismuth subsalicylate if you’ve ever hadan allergy to aspirin or any other product that contains salicylates. Also don’t givebismuth subsalicylate to children who may have the flu or chickenpox because they willhave a higher risk of Reye ’s syndrome. Other ingredient-related warnings concern yourdiet while you’re taking an antacid or acid reducer. For example, unless your doctor tellsyou it’s OK, don’t use products that contain sodium bicarbonate or aluminum hydroxideand magnesium carbonate if you’re on a low-salt diet. Don’t take magnesium hydroxideif you’re following a magnesium-restricted diet. If you have kidney disease, youshouldn’t use products containing calcium carbonate or aluminum hydroxide andmagnesium carbonate without your doctor’s recommendation If certain drugs are takenat the same time, they can react with each other and change the way your body processesthem. This is called a drug interaction. When this happens, the risk of side effectsincreases. Don’t use more than one antacid or acid reducer at a time. Don’t mix acidreducers and antacids without first talking to your doctor. If you take any prescriptiondrugs and you’re thinking about taking an antacid, H2 blocker or proton pump inhibitor,talk to your doctor first. These drugs can cause problems with other medicines you take.NRIBM, AHMEDABAD 31
  32. 32. Healthcare ProductsThe following drugs may be of special concern for people who are taking H2 blockers orproton pump inhibitors: • Theophylline (oral asthma drug) • Warfarin (brand name: Coumadin) (blood-thinning drug) • Phenytoin (brand name: Dilantin) (seizure drug) • Prescription medicine for fungal or yeast problems • Diazepam (anxiety drug) • Digoxin (heart drug)Bismuth subsalicylate may affect some drugs so that they don’t work as well. It also maycause side effects if combined with other drugs. If you take any of the following drugs,talk to your doctor before taking bismuth subsalicylate: • Blood-thinning drugs • Drugs to treat gout • Drugs to treat arthritis • Drugs for diabetesAlso, check with your doctor or pharmacist before taking bismuth subsalicylate if youtake pain relievers, cold products or some prescription drugs. These medicines maycontain aspirin, which is a salicylate, or they may contain some other type of salicylate.Because bismuth subsalicylate contains salicylate, you may take more salicylate than youintend if you take more than one of these products.ANTIEMETIC DRUGS Antiemetic drugs are medicines that can help relieve nausea and vomiting. SeveralOTC drugs are used as antiemetics. • Bismuth subsalicylate (brand names: Kaopectate, Pepto-Bismol) may help treat some types of nausea and vomiting, such as from the flu (influenza). It’s also used for upset stomach and as an antidiarrheal (medicine to treat diarrhea). • Certain antihistamines may help prevent nausea and vomiting caused by motion sickness. These include dimenhydrinate (one brand name: Dramamine) and meclizine hydrochloride (one brand name: Dramamine Less Drowsy).NRIBM, AHMEDABAD 32
  33. 33. Healthcare ProductsHow do antiemetic drugs work? Bismuth subsalicylate works by coating the stomach lining. Antihistamines appearto dull how the inner ear senses motion. They “block” messages to the part of the brainthat controls nausea and vomiting. This is why they work best if you take them beforeyou think you might have a problem with motion sickness.Side effects Side effects from antiemetic drugs aren’t common for healthy adults. Side effectscan be a concern for older adults or people who have health problems. Bismuthsubsalicylate can cause your tongue or stool to turn dark. This is a short-term side effect.Antihistamines may make you feel sleepy. This can affect your ability to drive or operatemachines. It can make it hard for you to think clearly. Antihistamines may also causeyour mouth and eyes to feel dry.Contraindications Alcohol can increase the drowsiness caused by antihistamines. Also, be verycareful if you drive a car or run machines while taking an antihistamine. Antihistaminesmay slow your reactions without you even being aware of it. Don’t take bismuth subsalicylate if you’ve ever had an allergy to aspirin or any otherproduct that contains salicylates. Also, don’t give bismuth subsalicylate to children whomay have the flu or chickenpox because they will have a higher risk of Reye’s Syndrome.If certain drugs are taken at the same time, they may interact with each other and changethe way your body processes them. This is called a drug interaction. When this happens,the risk of side effects increases. Bismuth subsalicylate may affect some drugs so thatthey don’t work as well. It also may cause side effects if combined with other drugs. Ifyou take any of the following drugs, talk to your doctor before taking bismuthsubsalicylate: • Blood-thinning drugs • Drugs to treat gout • Drugs to treat arthritis • Drugs for diabetesNRIBM, AHMEDABAD 33
  34. 34. Healthcare Products Also, be sure not to “double up” on salicylate. Some pain relievers, cold medicines andprescription drugs contain aspirin, which is a salicylate, or some other type of salicylate.Some cold medicines and prescription drugs may also contain aspirin or another type ofsalicylate. Because bismuth subsalicylate also contains salicylate, you may take moresalicylate than you intend if you take more than one of these products.COUGH MEDICINE OTC cough medicines are grouped into two types: antitussives and expectorants.Antitussives are cough suppressants. They relieve your cough by blocking the coughreflex. Dextromethorphan (some brand names: Triaminic Cold & Cough, RobitussinMaximum Strength, Vicks 44 Cough Relief) is a commonly used antitussive.Expectorants thin mucus. This may make coughing work better to clear the mucus fromthe airway. The only expectorant available in OTC products is guaifenesin (two brandnames: Mucinex, Robitussin). Dextromethorphan and guaifenesin are sometimescombined with each other (one brand name: Robitussin DM). They are also available incombination with other drugs, such as pain relievers, decongestants or antihistamines.These combination products, such as multisymptom cold medicines, are meant to treatmany symptoms at once. However, if your main symptom is cough, be careful of thedrying effect of antihistamines and decongestants in combination medicines. This effectcan make mucus thicker and harder to clear from the airways, which can make a coughworse.How do cough medicine work? Most of the time, a cough doesn’t require treatment. It will go away on its own.Cough medicines may be helpful if your cough is caused by a cold or the flu (influenza).Some types of cough should not be treated with cough medicines because the cough ishelping to keep the lungs clear so you can breathe. Examples include cough fromsmoking, emphysema, asthma or chronic bronchitis.Side effectsNRIBM, AHMEDABAD 34
  35. 35. Healthcare Products Side effects from OTC cough medicines aren’t common for healthy adults. Sideeffects may be a concern for people who have health problems, are elderly or use coughmedicines for long periods of time.Contraindications If certain drugs are used at the same time, the way your body processes them canchange. When this happens, your risk of side effects increases. Talk to your doctor orpharmacist before taking dextromethorphan if you take a monoamine oxidase inhibitor(MAOI). This is a type of prescription drug used to treat depression and other conditions.MAOIs include isocarboxazid (brand name: Marplan), phenelzine (brand name: Nardil),selegiline (brand names: Eldepryl, Carbex) and tranylcypromine (brand name: Parnate).Dextromethorphan interferes with the way MAOIs work. Dextromethorphan may causeproblems while you are taking an MAOI or within two weeks of taking one. Coughmedicine is often combined with decongestants, antihistamines and/or pain relievers. Ifyou take one of these combination medicines, it’s important to understand each of theactive ingredients and the interactions they may have with other drugs you’re taking. Besure not to “double up” on cough medicine. Many OTC cold and allergy products containcough medicine, as do some prescription drugs. If you take more than one of theseproducts, you can take more cough medicine than you intend.LAXATIVES Many products are advertised to relieve constipation, including bulk-forminglaxatives, lubricants, stool softeners, saline laxatives, stimulant laxatives andcombinations. Download the PDF file below for examples of these types of laxatives.How do laxatives work? Bulk-forming laxatives add bulk and water to your stools. The larger stools helptrigger the bowel to contract and move the stools out. You must use bulk-forminglaxatives daily for them to work. Start slowly and drink plenty of fluids. GraduallyNRIBM, AHMEDABAD 35
  36. 36. Healthcare Productsincrease how much you use to reduce the chance of having any side effects. Lubricantlaxatives work by coating the surface of the stools. This helps the stools hold in water sothey move out of the body more easily. Glycerin suppositories lubricate the inside of theanus (the outside opening to the intestine) to make it easier to pass hard stools. Stoolsofteners help mix fluid into stools to soften them. This makes stools easier to pass out ofthe body. Saline laxatives draw fluid into the bowel from nearby tissue. This softensstools and helps the bowel move them out. Stimulant laxatives are the harshest laxatives.They cause the bowel to squeeze or contract to move the stools out. Stimulant laxativesshould generally be used only when your doctor recommends them, such as if you’repreparing for a bowel exam or if you’ve just had surgery and shouldn’t strain to have abowel movement.Should a laxative treat constipation? Most of the time, constipation doesn’t require treatment with laxatives. It will goaway on its own or if you make changes in your diet and other habits. For example, youcan treat constipation by eating enough fiber, drinking enough fluids and getting enoughexercise. See Constipation: Keeping Your Bowels Moving Smoothly for moreinformation. Laxatives aren’t meant for long-term use. Don’t use laxatives for longer than1 week unless you’re following your doctor’s advice. Long-term use or overuse oflaxatives can cause health problems. Also, using laxatives too much may hide symptomsthat would be important for your doctor to know about. This could delay finding outabout problems you have and delay the treatment you need. One exception is bulk-forming laxatives. They can be used on a daily basis to help ease symptoms of irritablebowel syndrome, hemorrhoids and other bowel problems.Side effects Most laxatives don’t have side effects if you use them correctly. Sometimes they cancause cramping, gas, bloating, nausea or diarrhea. Stimulant laxatives are most likely tocause side effects. These can include abdominal discomfort, faintness and cramps. WithNRIBM, AHMEDABAD 36
  37. 37. Healthcare Productsbulk-forming laxatives, you may notice some bloating, gas or cramping at first. This ismore likely if you take too much or increase the amount you’re using too quickly. Thesesymptoms should go away in a few weeks or less. If mineral oil is accidentally aspirated(breathed into the lungs), it can cause a type of pneumonia. Older adults or anyone whomight have trouble swallowing generally shouldn’t use this type of laxative.Contraindications Don’t take laxatives if you have an allergy to any of the ingredients. Some peoplemay be allergic to psyllium, a key ingredient in one type of bulk-forming laxative.Phenylalanine is another example of an ingredient that can cause a problem for certainpeople. If you have a condition called phenylketonuria, you shouldn’t take a laxative thatcontains phenylalanine. Other ingredient-related warnings concern your diet while you’retaking a laxative. Unless your doctor tells you it’s OK, don’t use products that containsodium bicarbonate and potassium bitartrate if you’re on a low-salt diet. Don’t takemagnesium hydroxide if you’re following a magnesium-restricted diet. Look on the labelin the “Active Ingredient” and “Inactive Ingredient” sections to find out what ingredientseach product contains. In general, don’t take any other medicines within 2 hours of takinga laxative. If you’re taking a prescription medicine of any kind, talk to your doctor beforetaking a laxative. You also shouldn’t mix different types of laxatives. Don’t takebisacodyl within 1 hour of taking antacids or drinking milk. While mineral oil and castoroil may have their place as laxatives, they shouldn’t be used often. If mineral oil is usedoften, it can cause deficiencies of vitamins A, D, E and K. Castor oil can also lead toserious problems if it’s used regularly.4.1 PORTER’S FIVE FORCE ANALYSIS Porter’s five forces analysis for pharmaceutical Industry in IndiaNRIBM, AHMEDABAD 37
  38. 38. Healthcare Products Threat of New Entrants  Very low Barrier to entry  Government polices supportive for entry but price regulation exists  Economies of scale exists  Proprietary technology Suppliers’ Bargaining and product will exist Power after 2005 Buyers’ Bargaining Power Volume benefit occur End consumers do not have Intensity of Rivalry among Inputs standard, available bargaining power existing competitors locally Brand identity exists but is in Numerous suppliers switching the hands of influencer Lower fixed cost and high working cost low (Doctors) capital Suppliers can go for forward Rice sensitivity is less Highly competitive integration Highly fragmented market, so Top five players have mere 18% of Raw material cost constitute buyer concentration v/s market share more than 50% of the total industry is low expenses Pressure from Substitute Products No substitute for the medicines Biotechnology is a threat to synthetic pharma productsPORTER’S FIVE FORCEPower of suppliers:Volume benefit occurNRIBM, AHMEDABAD 38
  39. 39. Healthcare ProductsInputs standard, available locallyNumerous suppliers switching cost lowSuppliers can go for forward integrationRaw material cost constitute more than 50% of the total expensesBarrier to entryVery low Barrier to entryGovernment polices supportive for entry but price regulation existsEconomies of scale existsProprietary technology and product will exist after 2005Industry competition  Highly competitive  Top five players have mere 18% of market share  Lower fixed cost and high working capitalThreat of substitute  No substitute for the medicines  Biotechnology is a threat to synthetic pharma productsPower of buyers  End consumers do not have bargaining power  Brand identity exists but is in the hands of influencer (Doctors)  Rice sensitivity is less  Highly fragmented market, so buyer concentration v/s industry is lowPower of suppliers:The pharma industry depends upon several organic chemicals. The chemical industry isagain very competitive and fragmented. The chemicals used in the pharma industry arelargely a commodity.The suppliers have very low bargaining power and the companies in the pharma industrycan switch from their suppliers without incurring a very high cost.However, what can happen in that the supplier can go for forward integration to becomea pharma company. Companies like Orchid Chemicals and Sashun Chemicals werebasically chemical companies, who turned themselves into pharmaceutical companies.NRIBM, AHMEDABAD 39
  40. 40. Healthcare ProductsPower of buyersThe unique feature of pharma industry is that the end user of the product is different fromthe influencer (Doctor). The consumer has no choice but to buy what doctor says.However, when we look at the buyer’s power, we look at the influencer they have on theprices of the product.Barrier to entryPharma industry is one of the most easily accessible industries for an entrepreneur inIndia. The capital requirement for the industry is very low; creating a regional distributionnetwork is easy, since the point of sales is restricted in this industry in India. However,creating brand awareness and franchisee among doctors is the key for long term survival.Also, quality regulations by the government may put some hindrance for establishing newmanufacturing operations.Going forward, the implementing new patent regime will raise the barrier to the entry.But it is unlikely to discourage new entrants, as market for generics will be as huge.Threat of substituteThis is one of the great advantages of the pharma industry. Whatever happens, demandfor pharma products continues and the industry thrives.One of the key reasons for highcompetitiveness in the industry is that as an on going concern, pharma industry seems tohave an infinite future.However, in recent times, the advances made in the field of biotechnology, can rove to bea threat to the synthetic pharma industry.4.2 SWOT ANALYSIS OF PHARMA SECTORStrengths • Cost effective technologyNRIBM, AHMEDABAD 40
  41. 41. Healthcare Products • Strong and well-developed manufacturing base • Clinical research and trials • Knowledge based, low- cost manpower in science & technology • Proficiency in path-breaking research • High-quality formulations and drugs • High standards of purity • Non-infringing processes of Active Pharmaceutical Ingredients (APIs) • Future growth driver • World-class process development labs • Excellent clinical trial centers • Chemical and process development competenciesWeaknesses • Low Indian share in world pharmaceutical market (about 2%) • Lack of strategic planning • Fragmented capacities • Low R&D investments • Absence of association between institutes and industry • Low healthcare expenditure • Production of duplicate drugsOpportunities • Incredible export potential • Increasing health consciousness • New innovative therapeutic productsNRIBM, AHMEDABAD 41
  42. 42. Healthcare Products • Globalization • Drug delivery system management • Increased incomes • Production of generic drugs • Contract manufacturing • Clinical trials & research • Drug moleculesThreats • Small number of discoveries • Competition from MNCs • Transformation of process patent to product patent (TRIPS) • Outdated Sales and marketing methods • Non-tariff barriers imposed by developed countries Paras pharmaceuticals Pvt. Ltd.It is this incessant desire on part of people that has inspired Paras to dedicate itself toissues that might appear to be trivial, but in reality, are quite significant in life. The rangeof such issues is extensive. To identify them, one simply needs to be sensitive towardssuch problems. And make the right solutions available. At Paras, the process behindfinding every such solution is backed by extensive consumer research, often carried out inNRIBM, AHMEDABAD 42
  43. 43. Healthcare Productsan obsessive manner. While identifying these real life problems and related behavioralpatterns, the health aspects are also put on high priority, so that the end result is not just acosmetic one, but a truly healthy solution.The result of these efforts is that today, Paras has a diverse range of innovative products,many of which have created totally new categories by themselves. Not to mention, theyhave been enormously successful. So much so, that today, Paras products have not onlyfound a place on the shelves of most households, but in the hearts of people as well. Inshort, the philosophy at Paras, of providing solutions that care about you, is quite visiblein its many works of art - the many brands that truly enhance life.New categories. New promises. What makes the customer believe in them all?It’s the faith that comes with time, with a positive experience of using a product/serviceoffered by the company. By realizing that the promises were indeed fulfilled. Butwinning this faith isnt easy. It comes after plenty of research and consumer study done ona large scale.In case of Paras, the entire process of advanced research hinges on one focal point toprovide care, and not just cure. To serve people with value added products and not justcosmetic makeovers. And to create new product categories. All this has made Paras areliable and favoured name amongst the masses.For Paras, this long journey of many years has indeed been a glorious one. And withmore and more dreams taking shape at Paras, its glorious streak will continue to brightenup many more lives.Products: Afterbath FreshnessCream Afterbath, which helps in keeping the morning freshness with you all day long, is also a fresh category by itself. The newest entrant in the long list of Paras products, it’s a freshness cream in every way. To be applied on the face after the morningNRIBM, AHMEDABAD 43
  44. 44. Healthcare Productsbath, the cream makes your skin naturally refreshing, as if you have just stepped out of ashower (another irresistible proposition for women). Adding to the charm of Afterbath isits mild fragrance that lingers on for quite a long time. Thus delighting the senses andmaking the skin feel special. And just like any other Paras offering, Afterbath too, has itsshare of health benefits, as it comes infused with essential vitamins, beauty oils and a skinconditioner. Afterbath, in other words, helps you say ‘Good Morning’ to good, healthyskin and a day long fresh feeling. BoroSoft Non-sticky, Antiseptic cream BoroSoft was launched at a time when all the other creams in this category were made with a sticky formulation, which resulted in accumulation of dirt and grime in the skin pores. This made the skin greasy, and the face, dull and dark. But rather than just providing a non-sticky cream for chapped dry skin, BoroSoft went further to offer themoisturing property of Aloe Vera. This concept of providing a value-add beyond mereremedial action, fit well with the expectations of the new generation. Hence, the markethold of Paras was boosted further.Soon, BoroSofts skin care solution also came in the form of BoroSoft dry skin soap -another revitalizing touch for skin, by Paras. Krack Krack entered the market, when there was no complete, dedicated solution for cracked heels. Caused due to dryness, prolonged exposure to water, etc., cracked heels were always subjected to traditional, home remedies or cold creams - a fact revealed through research. In some cases, the problem was outrightly ignored, as cracked heels were thought to be either a natural phenomenon or an incurable medical condition. Under such circumstances, Krack was no less than abreakthrough in the personal care products’ segment. It brought to everyones notice, thatcracked heels was indeed a problem that could have a solution: a simple, effective one.Driven by strong belief in nature and a constant desire to deliver better products,continuous value additions were made to upgrade the formulation of Krack. The result -Krack SR. This new upgraded version aimed at imbibing the ingredient benefits ofAyurveda, handpicked and chosen to create the cream formulation. And today, Krack SRis the reason behind millions of smiling faces, and beautiful feet! D’cold D’Cold takes great pride in providing its consumers with effective cold and cough remedy at an affordable price. In aNRIBM, AHMEDABAD 44
  45. 45. Healthcare Productsmarket where competition is rampant, in a short span of 10 years DCold has becomesynonymous with cold and cough relief. DCold understands the dynamics of its customerbase and it is that understanding that helped it carve a niche for itself.DCold is available in two variants.DCold Cough Syrup, an alcohol free non-drowsy formula, is targeted at children andadults. It is the safest medicine for cold and cough for children and reduces painful throatirritation, gives fast relief from cough and clears chest congestion. It relieves the tensionof every mother when her child gets ill. It contains a fast action formula which is broughtto life by the Kansi ka fighter - DC Man, who fights Khansiwale monsters curing coughand cold effectively.DCold Total Tablets, are targeted to adults and helps in curing 4 symptoms associatedwith cold - nasal congestion, headache, body ache and sore throat pain. Its Non DrowsyFormulae makes it friendly for all active adults, because work is not interrupted.Today, millions of customers trust DCold to provide effective and holistic relief for themost common ailments. ItchGuard Why didn’t anyone think of it before? It was a problem that always existed with us, around us. May be we never thought it needed a ‘solution’. In medical terminology, It is called ‘Intertrigo’. We know it simply as the ‘itching’ caused due to sweat. In a country like India, where heat and humidity are the order of the day, the skin has a tendency to sweat a lot. As a result,the need to itch increases, and could become a cause of social embarrassment. Parasoffered a solution that was aptly named - ItchGuard. The response to this new productwas overwhelming. And within no time, ItchGuard rose to become a star performer atParas. It had addressed an issue, which was so common, so personal to everyone, yet sounspoken. And by doing this, it projected, in a very strong manner, the philosophy ofParas of providing solutions where none existed, to make lives healthier.Today, ItchGuard as a brand encompasses both medical as well as lifestyle values.Because, sweat is integral to a hectic routine. And so, ItchGuard is now being lookedupon as part of daily hygiene, complimenting active life! Moov 14 years since its foray into the rubfacient category, MOOV has carved a niche for itself in the consumers life and has become synonymous with backaches. MOOV is the preferred choice as a pain relieving ointment. This specialised ayurvedic product contains active ingredients such as oil of Wintergreen, Tarpin oil, Nilgiri oil and Mintflowers to provide a ‘soothing warmth’ in order to relieve pain.NRIBM, AHMEDABAD 45
  46. 46. Healthcare ProductsMOOV has become the Indian housewifes soul mate by underlining the seriousness of abackache. It has elevated her social status by making her family appreciate her relentlesscontribution to their well-being, while ignoring her own.MOOV, also lives up to its pain relieving imagery through its promise of “Ek minuteMOOV ki malish” (one minute MOOV massage). By recognising current high-stress,hectic lifestyles of the male as well as women, MOOV contributes to saving manyvaluable minutes rendered painful by backaches, making their life a super hit.Moov sprayMOOV is also available in an aerosol spray. Ideal for consumers with hectic lefestylesprone to recurring backaches, they can now avail of instant pain relief by means of aspray. Ideal for sports persons, this spray is convenient and easy to use.Part and parcel of daily active life, MOOV reassures users that an effective andimmediate pain-reliever is always within reach. RingGuard Prolonged exposure to water, humid environment and excessive heat, results in a skin affliction called ringworm, commonly know as daad. And in a country like ours, where this is a common occurrence, people had been largely unaware of the fact that ringworms are infectious too. This ignorance just aggravated the problem. Fortunately Paras developed RingGuard.A broad spectrum, antifungal cream, RingGuard has a clinically advanced formulation,which enables it to provide complete relief within seven days. Available in a tube,RingGuard is simple to use as well.Due to its extremely effective formulation, RingGuard has been well received. Also, itspopularity has resulted in a widespread awareness about ringworms, making people takeright steps to prevent it. And thus fulfilling a promise of spreading love and care! Stopache Stopache is an analgesic pill that provides relief from headaches. But at the time of its launch, Stopache didnt just take care of headaches, its revolutionary single pill dosage also destroyed the myth that pills can cure headaches only if taken two at a time. As Stopaches popularity increased among the masses it left the competition grappling for its space on the pie-chart. A marketing breakthrough in the true sense, Stopache completelyNRIBM, AHMEDABAD 46
  47. 47. Healthcare Productsaltered the dynamics of the analgesic business. To an extent that people even began tolook at the two-pill treatment as an ‘overdose’ of the medicine.It came as no surprise then that the competition began to follow suit. Meanwhile, Parascontinued to march ahead, as a company dedicated to innovation.Dabur India Limited is the fourth largest FMCG Company in India with interests inHealth care, Personal care and Food products. Building on a legacy of quality andexperience for over 100 years, today Dabur has a turnover of Rs.2233.72 crore withpowerful brands like Dabur Amla, Dabur Chyawanprash, Vatika,Hajmola & Real. Dabur India Limited is a leader in manufacturing and marketing herbal,nature-based products. Today Dabur’s products are available for people in more than 50countries across the world, helping them move towards a healthy, natural and holisticlifestyle. Our products are available in the markets of the Middle East, South-East Asia,Africa, the European Union and America. Products: Dabur Glucose-DNRIBM, AHMEDABAD 47
  48. 48. Healthcare ProductsGet a jump start on your day by filling up with the extra energy of Dabur Glucose-D.Enriched with Vitamin D and Calcium for easy assimilation and replenishment ofessential nutrients. Its a ready source of energy to fight tiredness and refresh youinstantly. Dabur Hajmola tablets Originally Ayurvedic digestive medicine. First to be branded as a product Mix of traditional Indian culinary herbs, spices and edible salts.Market leader with 75% share of the digestive tablets segment in India.Can be taken at any time of the day. Chewing slowly improves the taste. Dabur Hingoli The natural way to relief from gas. Containing herbs and spices like hing, trusted and used for generations to stimulate digestion. Hing (Asafoetida) Kali Mirch (Black Pepper) - gastro-intestinal stimulant Zeera (Cumin) – antispasmodic Saunth (Ginger extract) - digestive and tonic Nimbu Saar (Lemon extract) - digestive stimulant Pudin Hara Dabur Pudin Hara gives quick relief fromstomachache, gas and indigestion. Its is a trusted fast actionremedy for stomach disorders. Pudin Hara is completelynatural and safe. Pudin Hara-G Daburs Pudin Hara G - for quick relief from gas and acidity. Completely natural, herbal and safe. And reinforced with the extra goodness of mint (pudina) for instant action against conditions of flatulence.NRIBM, AHMEDABAD 48
  49. 49. Healthcare Products Dabur Shankha Pushpi Dabur Shankha Pushpi is a natural tonic for mental development of children. It has been used for centuries in Ayurveda for rejuvenating nervous functions. And Dabur brings this natural remedy that is completely safe and prepared under the strictest quality guidelines. Shilajit Gold Shilajit Gold is a unique combination of Shilajit, Gold, Kesar and other important herbs like Ashwagandha, Kaunch Beej and Safed Mushali. Shilajit Gold is a powerful sex stimulant, which improves sexual health and acts as a rejuvenator to increase stamina, vigour and vitality. Dabur Sarbyna Strong Dabur Sarbyna Strong - with a unique combination for quick and effective relief from headaches and body aches.NRIBM, AHMEDABAD 49
  50. 50. Healthcare Products Keeping in line with Morepens commitment to healthier future for all, TheCompany has taken another step to come closer to the consumers with the launch of "Dr.Morepen", a range of self health products. MLL has now entered the Rs.4500 crore of fastMoving Health Goods (FMHG) market. The category of self health has been identified after lot of research on modernbehaviour and preferences and Morepen sees a huge opportunity in this segment. Dr.Morepen is envisaged as a forward looking, futuristic, lifestyle driven brand thatempowers the modern customers to be in charge of their own health and live life withoutany stops. The brand is positioned on a simple philosophy of "health in your hands" A mantrafor contemporary life, full of hectic schedules, impending deadlines and toughcompetition. The brand is being promoted by a new subsidary Dr. Morepen Ltd whichhas a vast sales & marketing network that reaches to over a lakh of retail outlets alreadyNRIBM, AHMEDABAD 50
  51. 51. Healthcare Productsand the count is growing everyday. With the launch of Dr. Morepen the distribution ofMorepen has moved beyond pharmacist, to super stores, retail outlets & neighbourhoodshops. The growing list of Dr. Morepens Self Health FMHG product includes DAB(instant antacid), SAT ISABGOL (Natural laxative), GOL GOLI (Hajma Candy),LEMOLATE (Cold relief ), BURNOL ( for burns and cut) to take care of minor day today problems, where as product like C SIP (refreshing energy drink), Y SUGAR (Lowcal sweetener), and 2 KOOL, (Throat drops), and C-CANDY (Health candy) are life stylecompanions that vitalizes and keep people fit. Many more products are being launchedsoon, thus building up the FMHG category. In a step that would expand Dr. Morepensfranchise into a retail format, Morepen acquired LIFESPRING, the renowned chain ofhealth & beauty stores. Lifespring is an internationally styled, health and beauty chain ofretail stores offering a range of nearly 15,000 domestic and international brandedproducts under one roof. Lifespring stores are located at high retail density areas in NewDelhi, catering to a wide ensemble of health and beauty customers. The Stores have threesections - Personal Care and Beauty, OTC and Prescription Medicines and OpticalCenter.Range of Dr. Morepen products Dab Range Aaj ki acidity - aaj ka jawaab For the first time in India, a complete range of antacids Dab Fizz: Effervescent Antacid in two flavours - Regular and Orange. Available in sachet and 100gm bottle. Dab Gel: Antacid antigas Liquid available in two flavors - Orange and Mint Dab Tab:Antacid antigas Tablet available in two flavors Orange and Mint. Sat – IsabgolNRIBM, AHMEDABAD 51