Final Management Thesis


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Final Management Thesis

  1. 1. 685800571500FINAL REPORT<br />A Survey on response of 20 pharmacists toward launch of new Molecule in Vadodara market by Elysium Pharmaceutical Ltd.for Asthmatic Patients.<br /> <br /> <br />SUBMITTED TO: AMOL RANADIVE<br />SUBMITTED BY: PRIYANKKUMAR PATEL (8NBVD031) $$ <br />Preface <br />Contents <br />Preface--------4 <br />Acknowledgement --------5<br />1. Introduction of Pharmaceutical industry--------6<br />1.1 About Pharmaceutical Industry <br />1.2 Advantages in India<br />2. Introduction of Indian Pharmacy Industry--------11<br />2.1 Overview<br />2.2 History & Development<br />2.3 Growth Drivers of Indian Pharmacy Industry<br />3. Emergence of Indian Pharmaceutical MNCs--------23<br />3.1 Global MNCs<br />3.2 Emerging Indian Pharmacy Industry<br />3.3 Entering Global Generic Market <br />4. WTO & Indian Pharmaceutical Industry--------28<br />5. Introduction of EPL --------41<br />5.1 General Information<br />5.2 History<br />5.3 Mission<br />5.4 Vision<br />5.5 Core Value<br />5.6 Organization Chart <br />5.7 Products List & Its Usages<br />5.8 Team Force <br />6. Project Abstract--------60<br />7. Introduction to Project--------62<br />7.1 Objective <br />7.2 Limitation<br />7.3 Methodology<br />8. Analysis of the content --------66<br />8.1 Data Collection<br />8.2 Facts & Findings<br />9. Suggestion--------71<br />10. Conclusion--------76<br />11. Bibliography & Reference--------78<br />12. Glossary of terms --------80<br />13. Appendices--------82<br />Preface<br />“Knowledge & human power are synonyms” once said the great philosopher Francis Bacon. However based on the experience within today’s global market he would probably say.”The ability to capture, communicate & leverage knowledge to solve problems is human power”. This raises the question how exactly one can best capture, communication& leverage knowledge, especially within world of system engineering.<br />The answer probably has in statement itself- by communication your ideas & devising ways and means to give shape to your plans in to reality, which required a long term investment, & shrewd thinking.<br />This report that I am submitted intends to highlight my versatility in sustaining the pulls & pressure of the day to day professional life & put to perspective the fact that I am capable enough to deliver whenever a challenge is thrown to me.<br />At the end I have provided a short list of reference books that proved useful during the project.<br />Acknowledgement <br />With a sense of gratitude & respect, I would to extend my heartiest thanks to all those who provided help & gratitude to make this project a big success. It was pleasant & highly educative to work have at Elysium Pharmaceutical Ltd.<br />From the bottom of my heart, I am very thankful to Mr.K.P.Shah – i.e. my project guide for his help & guidance during the project .He gave me the detail information about the organization and provided me with all the resources I needed. He was always there to help me whenever I was any kind of fix.<br />I am also grateful to my center head ( INC, Vadodara) Mr. A.Ghose and my companion throughout my project Mr. Amol Ranadeeve –MT guide without who’s my project won’t be a success and all our faculties members. Who always offered me careful hints and useful suggestion.<br />I would also like to thank my parents and all my friends who have helpful me, though indirectly, throughout the project duration and always have been a source of encouragement.<br />Chapter – 1<br />Introduction of Pharmaceutical Industry<br /><ul><li>About Pharmaceutical Industry
  2. 2. Advantages in India
  3. 3. About Pharmaceuticals</li></ul>Pharmaceuticals are medicinally effective chemicals, which are converted to dosage forms suitable for patients to imbibe .in the basic chemical form. Pharmaceuticals are called bulk drugs and the final dosage forms are known as formulations. Bulk drugs are derived from 4 types of intermediates (raw materials), namely<br /><ul><li>Plant derivatives (herbal products)
  4. 4. Animal derivatives e.g. Insulin extracted from bovine pancreas
  5. 5. Synthetic Chemicals
  6. 6. Biogenetic (human) derivatives e.g. Human Insulin</li></ul>They are substance known as medicine. Used in preventing and curing illness and disease. Usage of pharmaceutical is governed by underlying science of illness and disease. The branches of medical science are shown in figure<br /> <br /> (Figure 1.1 Branch of Medical Science)<br />Allopathy: It is known as a modern medicine and world over the pharmaceutical<br /> Industry is focused upon it.<br />Ayurveda: It is an ancient Indian medicine science and mainly uses herbal remedies .It is gaining importance in pharmaceutical market particularly in USA. <br />Unani : It has its origin in China & is prevalent in South East Asia. <br /><ul><li>Homeopathy: Is founded by a German Physician and was fairly popular in 19th century. It is still prevalent in third world countries.
  8. 8. Competent workforce : India has a pool of personnel with high management and technical competence as also skilled workforce .It has an educated workforce & English is commonly used Professional service are easily available
  9. 9. Cost-effective chemical synthesis: Its track record of development particularly in the area of improvement cost-beneficial chemical synthesis for various drug molecules is excellent .It provides a wide variety of bulk drugs and exports sophisticated bulk drugs.
  10. 10. Legal & financial Framework: India has a 58 years old democracy and hence has a solid legal framework and strong financial markets. There is already am established international industry and business community.
  11. 11. Information & Technology: It has a good network of world-class education institutions and established strength in information Technology.
  12. 12. 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.
  13. 13. 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.</li></ul>Indian Pharmaceutical Industry is on the way of a transformation that could see it exerting for greater influence on the world. It is the transformation of a $5.5 billion industry, mostly built on copying drugs other people patented, into a $25billion power house that will be respected not just for its superb process skills, but also for its research process<br />Indian Pharma companies are already in action setting up their own networks abroad, getting regulatory approvals for their manufacturing plants and generally learning how to play with the big boys.<br />The transition will not be easy because this is a period of discounting for the global pharma industry. The old method of drug discovery based on chemistry is giving diminishing return while the new method of drug discovery based on biotechnology much like custom designing are get to mature so, even as global R&D spends too much, new drug discoveries are becoming rare.<br />The drug discovery process is getting unbounded or big pharma turns to smaller companies to acquire license new molecules. There is unbundling happening where to contact research control manufacturing clinical trials.<br />There is something that could stop Indian pharma from taking its rightful place in the world. That is an inability to hang together articulate clear visions and market, the Indian story to the world and to the Indian themselves.<br /> Chapter -2 <br />INTRODUCTION OF INDIAN PHARMACEUTICAL INDUSTRY<br /><ul><li>2.1 Overview
  14. 14. 2.2 History and Development
  15. 15. 2.3 Growth drivers of the Indian
  16. 16. Pharmaceutical industry</li></ul>2.1 OVERVIEW <br /><ul><li>The pharmaceutical industry is a lifeline industry which plays a very crucial role in building a strong human capital of a country and is very essential for economic growth and development.
  17. 17. Today, it is at the top end of India’s science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology .The contribution of the pharmaceutical industry toward a nation’s growth cannot be undetermined.
  18. 18. The pharma industry in India is one of the largest and most advanced among the developing countries.
  19. 19. Today it is in the front of the rank of India’s science-based industries with wide ranging capabilities in the complex field of drug mfg & technology
  20. 20. The Indian pharma industry is highly fragmented, but has grown rapidly due to the friendly patent regime and low cost manufacturing structure.
  21. 21. Globally, the output of Indian pharmaceutical industry ranks in 4th in the terms of volume & 13th in terms of value.
  22. 22. India accounts for 6% of all bulk drugs exports. There are about 250 large/medium units and about 8000 small scale units in operations. Which core form core of the industry. There are about 350 bulk drugs i.e. active pharmaceutical molecule having therapeutic value and used for production of pharmaceuticals. Which account for majority of formulations produced in the country.
  23. 23. During the year ending March 1998, pharmaceutical companies for various bulk drugs, formulations and intermediates filed 256 IEMs. These IEMs are expected to generate employment for about 19000 people and there would be an investment of Rs. 4.1 billion on these projects. During the same period foreign investment proposal worth approx, Rs 1.6 billion was approved.
  24. 24. The growth in the Indian pharmaceuticals: Industry at around 15% p.a. compare well with the industry’s growth of 14% pa in North American Region. India is ranked 5th in the world and accounts for 8% of the world production of drugs and pharmaceuticals by volume
  25. 25. Globally the output of Indian pharma industry ranked 4th in terms of volume and 13th in term of value
  26. 26. In FY-02 the domestic Indian pharma market was valued at $4.5bn representation 1.6%of the global market and is growing at an annual rate of 8 to 9 %
  27. 27. The industry produces about 60,000 finished medicines and roughly 400 bulk drugs, which are used in formulations.
  28. 28. At the end of FY-01 the Indian pharmaceutical industry had over 23000 units although this number cannot be authenticated. Around 260 players constituted the organized sector while 6000-8000 players existed in the small scale sector.
  29. 29. The industry is highly fragmented with the largest formulation players having a market share of less than 6%.
  30. 30. The top ten players account for 36% of the formulation market in contrast with the global scenario where the top ten players account for 49% of the pharmaceutical market.
  31. 31. In FY-01,the total output of the Indian pharmaceutical industry was Rs229bn,which grew by 16% yoy, in FY-02 it was above Rs 260bn, of which bulk drugs accounted for Rs.54bn(21%) and formulations Rs 210bn(79%).
  32. 32. The demand for industry is mainly from urban areas (74%)
  33. 33. Urban areas witnessed a 15% increase in sales in FY-02 as against 13% in FY-01
  34. 34. The industry grew at 2.6% yoy during Oct 2002 and 9% during Jan to Oct 2002.
  35. 35. In FY-03 the industry would have grown by 10-15% increase in sales, production & exports, despite adverse global conditions.
  36. 36. The odd 400 bulk drugs make up 20% of total drug production. During FY91-FY01, the production of bulk drugs increased at a compounded annual growth rate (CAGR) of 20%.
  37. 37. On the other hand, formulations which are the end product of the medicine manufacturing process had a CAGR of 17% during FY-91 – FY-01.most of the domestic demand for formulations is met by the domestic industry.
  38. 38. </li></ul>2.2 History and Development <br />The history of Indian Pharmaceutical industry <br />Quinine extracted from the cinchona tree bark was used to treat malaria way back in year 1619.but; Sir Alexander Fleming discovery of penicillin in 1929 can be considered the real foundation of modern pharmaceutical research. Next major breakthrough came in 1932 with the synthesis sulphonamides in Germany by Klarer and Mietzsch. The 15-years period between 1938 and 1953 became to be known as the age of antibiotics, due to unprecedented number of new anti-infecting agents introduced during the period. Antibiotics and vaccines have played a major role in near eradication of 6 major debases namely: <br /><ul><li>Influenza/pneumonia
  39. 39. Tuberculosis
  40. 40. Syphilis
  41. 41. Diphtheria
  42. 42. Whooping
  43. 43. Cough
  44. 44. Measles </li></ul>Benefit to mankind: between 1920 -1960, the death rate due to diseases in a year fell from 12,120/million persons to 8,000/million persons. Every four years since 1965, one additional year has been added to life expectancy at birth due to advances in pharma R&D. presently in USA the average life expectancy is over 75 years. As antibiotics enabled people to survive more advanced ages, researchers focused on cell biochemistry to find cures for more complex chronic diseases. Drug researchers are now targeting to cure the underlying causes of diseases that are rooted in the human molecular structure <br />Since independence, the Indian pharma industry has evolved significantly. Initially the MNCs had a near monopoly. They improved and marketed formulations in India, mainly low cost generics for the masses and also a few specialties life saving high priced products with the government increasing pressure against imports of finished products, the MNCs set up formulating units and continued importing the bulk drugs. In the 1960, the Indian govt laid the foundation of the domestic pharmaceuticals industry by promoting Hindustan Antibiotics Ltd (HAL) & Indian Drugs & Pharmaceuticals Ltd (IDPL) for mfg of bulk drugs. However MNCs maintained a lead due to backing of their global R&D. high cost for basic research deterred local players in the private sectors.<br />The Indian pharmaceutical industry year 1970 is known as revolutionary year, because in this year Indian Patent Act (IPA) & Drugs Price control order were introduced. With the IPA cost of local manufacture reduced, due to absence of royalty payment in reverse engineered drugs. The DPCO effectively put a ceiling on prices of certain mass usage bulk drugs and their formulations so as to prevent any undue profiteering .this further deterred the MNCs as selling the products at much lower prices in India meant global repercussions and possible uproar in their home countries. As a result some of MNCs curtailed the scope of their operations. This further strengthened the position of local pharmaceutical companies.<br />The Indian Pharma Sector is highly fragmented with more than 20,000 registered units. It has increased drastically in last two decades. the leading 250 pharma companies control 70% of market with market leader having nearly 7% of the market share .it has become extremely competitive industry mainly due to lower affordability, fragmented market with severe price competition and govt. price control. The market share of MNCs has fallen from 75% in 1971 to around 35% in Indian pharma market .while the share of Indian companies has increased from 20%in 1971 to nearly 65%. The domestic pharma industry output exceeds Rs.170 billion, which accounts for merely 1.3% of the global pharma sector.<br />PRESENT STATUS OF INDIAN PHARMACEUTICALS<br />“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.”<br />The Indian pharma industry is in a state of transition. Companies are busy readying themselves for the revolutionary change .the year 2005 will bring in the form of product patents. The industry has witnessed several new trends. Domestic companies have been churning out new products at a never seen before frequency and have gone on a brand acquisition spree to strengthen their positions. Mergers and alliances have become hugely popular .An increased focus on generics and specialty segments are some of other current moves. MNCs meanwhile have begun their reorganization in a bid to regain their supremacy in the industry. <br />The Indian pharma industry today is in the front rank of India’s science-based industries with wide ranging capabilities in the complex field of drug mfg & technology. A highly organized sector, the Indian pharma industry is estimated to be worth $5 billion growing at about 8 to 9 percent annually.<br />The industry manufactures bulk drugs belonging to several major therapeutic groups requiring various manufacturing process and has developed excellent facilities for production of all dosage forms like tablets, capsules, liquids, ointment, orals & injectibles. The production of drugs and pharma industry is growing constantly. Just before a decade from now in 1992-93 the production of bulk drug was worth Rs.11.5 bn and formulation at Rs.60 bn which has been estimated to grow at Rs 65 Bn for bulk drugs productions and Rs 241 bn for formulation production during 2002-2003.<br /> Playing a key role in promoting and sustain development in the vital field of medicines, Indian pharma industry boasts of quality ,producers and many units approved by regulatory authorities in USA & UK. International companies associated with this sector have stimulated, assisted & spearheaded this dynamic development in the past 53 years and helped to put India on the pharmaceutical map to the world. <br />Following the de-licensing of the pharma industry, industrial licensing for most of drugs and pharmaceutical products has been done away with. Manufacturers are free to produce any drugs duly approved by the Drug control authority. Technologically strong & totally self-reliant, the pharmaceutical industry in India has low costs of production, low R&D costs, innovative scientific manpower, scientific manpower ,strength of nation laboratories ,and an increasing balance of trade .the pharma industry with its rich scientific talent & research capabilities, supported by intellectual Property Protection Regime is well set to take on the international market. <br />Two years ago, there was Bull Run on multination pharma companies’ stocks in India. But after April 2003, Indian pharma companies seem to have stolen the show from their multinational peers when it comes to their performance on the bourses.<br />Even retail investors and fund managers have all of a sudden become very bullish on the Indian pharma companies .the reasons for re-rating Indian pharma stocks could be many, but one of the important factors for the surge in the valuation of Indian companies is their prospective entry into the US & other developed countries markets that can offer huge potential to them after 2005.<br />Traditionally, there are two types of players in the Indian pharma market multinational companies and domestic pharma companies. The multination companies are brand focused and have developed very strong brand over the period. The Indian companies have developed molecules by adopting process re-engineering, with substation lower prices than the originally patented molecules. This could be one of the reasons why Indian pharma companies have registered comparative higher growth in their sales.<br />In fact ,as India has signed the WTO agreement on pharmaceuticals products patents, Indian pharma companies can no longer introduce molecule through process re-engineering after Jan 01,2005.but the same agreement ahs thrown open the doors for Indian companies to top the generic markets of the developed countries in the west. Generic medicines are considered as cheap bio-equivalent. Copies of molecules for which patents have expired.<br />It is estimated that after 2005, large number of many block buster-patented drugs are going to be off patents, whose market size $40 billion. After 2010, the size of the off-patent drugs market is estimated around $80billion. This will provide attractive opportunities to Indian companies to tap the international market for these products. As these markets will offer great potential to Indian drugs makers, most of the Indian companies, both large & medium sized, have started rolling up their sleeves to meet regulatory requirement of developed countries including the US food and Drugs Authorities (USFDA).<br />As per WTO, from the year 2005, India will grant product patent recognition to all new chemical entities (NCEs) i.e. bulk drug developed then onwards. The Indian Govt’s decision to allow 100% FDI into the research in the country. Technology transfer to 100 %Indian subsidiaries of MNCs is expected only in 2005.<br />2.3 GROWTH DRIVERS OF THE INDIAN PHARMACEUTICAL INDUSTRY<br />Indian pharma industry, which is highly fragmented due to various therapeutic segment and specialty of individual firm in each segment, drive it to following growth drivers in the present era.<br /><ul><li>Industry’s entrepreneurship & its scientific & technological skills:- Unique blend of these two key elements with innovation marketing strategies gave cutting edge to the Indian companies in the market.
  45. 45. Low Mfg.Cost Base:- The cost of manufacturing is lower in India due to labor costs and lower equipment cost.
  46. 46. High Process development skills:- Specialization of the companies by reverse engineering enables them to develop cost effective & non-infringing process for product going generic. India has a history of developing such processes due to the prevalence if process patents.
  47. 47. Business Environment:- The govt has recently allowed 100% FDI in drugs & pharma companies. This is expected to open floodgates of contract research work in the country.
  48. 48. Innovative Scientific manpower & competent workforce:- India has a pool of personnel with high managerial and technical competence as also skilled workforce. It has an educated work force & English is commonly used. Professional services are easily available.
  49. 49. Friendly Patent regime:- The current patent law in India relating to pharma providers for only process patents which encourage various small scale companies to go for reverse engineering & make the profit.</li></ul>Chapter 3<br />Emergence of Indian Pharmaceutical MNCs<br /> 3.1 Global MNCs<br /> 3.2 Emerging Indian Pharmaceutical Industry <br /> 3.3 Entering Global Generic Market<br />3.1 Global MNCs<br />Global leaders of the pharma industry which dominate all components of business & industrial activity in drugs. Including R&D, production and marketing are the MNCs located primarily in the US, western Europe and Japan. MNCs are defined as “Large Business Companies which operate in many countries”, these highly visible corporations which are generally regarded as product of the capitalists and free trade societies of the western world gained their dominance during the second half of the last country. Today they control the markets as well as the economies of not only the countries where they are based, but also of many other countries in the developed and developing countries.<br />In the pharma industry the top twenty companies of the western world command over 60%of the global market and due to various companies ,these companies are getting to be more and more dominant through arrangement between them .the global MNCs have some special characteristics, even through ,even within them, there are wide disparities.<br />For example, the UK MNCs have over 60% of their global sales coming from their domestic market, while the MNCs of the smaller European countries such as Switzerland ,Sweden ,& Denmark etc. Sell over 90% of their global production abroad. The third category of MNCs is illustrated by the case of Japan, which has over the last half a century adopted a policy of licensing their products to western MNCs for development & marketing in territories outside Japan.<br />3.2 Emerging Indian Pharmaceutical MNCs<br />Indian pharma companies need to satisfy the following condition if they are to graduate to the status of multinational corporations (MNCs):<br /><ul><li>A product range of relevance to major market abroad.
  50. 50. Access to these markets with generic (Patent Expired or none patented) products.
  51. 51. Costs and price advantage.
  52. 52. Production as per the regulatory requirements, such as adherence to Good Laboratory, Good Manufacturing & Good Clinic Practices.
  53. 53. R&D capabilities for discovery and total or partial development of drugs relevant to other markets.
  54. 54. Marketing facilities through subsidiaries of through tie-ups with local companies.
  55. 55. Abilities to get Abbreviated New Drugs Application (ANDA) approvals to enable early marketing of generic versions of patented drugs.</li></ul>Overall, considering the relatively low investment made by Indian companies, their track record should indeed be considered impressive.<br />3.3 Entering Global Generic Marketers<br />The 1970 Indian pharma Act enabled the Indian companies to master the process technologies for the production of most of the bulk drugs used in formulation. Exports of these products however have been restricted to only countries where no valid patients for the products are. The new strategies which Indian companies can adopt include the manufacturing & exports of generic drugs, which are outside patents for the global markets.<br />Between 2002-2005 drugs currently valued at $40 billion are going off patents, in USA alone .For example ,patents on several block-busters such as Prilosec for ulcer( $ 4 bn),Claritine for allergy($3.4bn),and Neurotion for epilepsy ($1.4bn), are expiring in 2002,Depakote for CNS disorders ($800 mn), Accupril ($650mn),in 2003.Glucovance for diabetes ($2 bn),Flovent for asthma($1.6 bn), Procirt for anemia($1.5 bn),and Diflucan for vaginal Candidiasis($1 bn) in 2004 & in 2005,provacid for Ulcer($3.7 bn),Zoloft for Depression($3 bn) & pravachol for hyper cholesterolemin($1.7 bn).<br />Indian has the capacity to produce al of these bulk drugs and offer them at competitive for the global generic market. Already the leading companies have made considerable process in this direction, which calls for early approval of Abbreviated New Drug Application (ANDA) to enable expires, for e.g. Ranbaxy have over no ANDAs and over 30 drug master files (DMFs) filed in USA & Europe, Dr .ready’s 7 & 35, Cipla over 40 DMFs, wockhardt has 5 ANDAs & 18 DMFs and sun pharma has 6 ANDAs.<br />Marketing strategy have involve direct selling & through subsidiaries as well as through major generic companies, such as Andrx ,Ivax, Eva ,Par, Warrick etc.the companies have been expediting their ANDAs so that benefit from the exclusivity for 180 days provided for ,under the Hatch-Waxman Act is available to them ahead of other major products which have been target several blockbusters such as Fluxetine, Omeprazok, Ciprofloxacin amlodipine, Steraline ,albendazol, metaformin,and, and some of the biotechnology products such as erythropoietin, human insulin and hepatitis is vaccine. <br />Chapter: 4<br />WTO & INDIAN PHARAMCEUTICAL INDUSTRY<br />WTO & INDIAN PHARAMCEUTICAL INDUSTRY<br />Introduction<br />Prior to 1970, Indian pharmaceutical industry was clearly dominated by foreign companies. This made the country exceedingly dependent on import for bulk drugs and formulations. As a result drug prices were among the highest in the world. The burden to the society on account of exorbitant prices for medication was explicit. To bring down the burgeoning prices and to break the MNCs domination, the government of the day introduces India patents Act, 1970.<br />Indian Patent Act, 1970 allowed for process patenting, which has fostered a self-reliant indigenous industry. Process patenting made new drugs available substantially cheaply and promoted import substitution by encouraging local companies to make copies of drugs, by developing their own process, followed by bulk drug production. In a way pharmaceutical industry in India was provided the protection much needed by it. <br />WTO & ITS RUB-OFF<br />The world has awakened to a new global order. Though many efforts were made in the post-depression era to agglomerate world business through an inter-government treaty like GATT ,it was not until the Uruguay Round resolution of the partner countries of GATT in end-1944 to establish a new trade order through the ensconcement of an international organization named world tread organization, did anything worthwhile materialize.<br />The WTO, an organization of multilateral trading system has in fact become the main vehicle of a few industrialized, developed countries for organizing and enforcing global economic governance. It is serving the purpose if the big countries, which use it a weapon to arm, twist their way into the markets of developing countries.<br />India has been amongst the first signatories to the WTO charter. An arrangement with WTO facilitates recourse to cross-relation for non-fulfillment of specific obligations. India which till today is minting money through exports of drugs, courtesy its process patenting law would suffer a severe setback once it has to comply with the rules and provisions made in the TRIPs. According to the WTO agreement, India has been given time u to year 2005 to amend its IPA to allow product patent instead of process patent. So new chemical entities introduced into after this period has to be accorded.<br />Some provisions of TRIPs with regards to pharmaceutical products that are of relevance to India are:<br /><ul><li>The minimum patent term will be twenty years from filing.
  56. 56. Patent production is to be extended to pharmaceutical products
  57. 57. Importation must be accepted as a working patent.
  58. 58. Compulsory licensing is relegated to special circumstances.
  59. 59. In infringement suits over process patents, the ‘burden of proof’ is reversed.
  60. 60. Provided traditional arrangement – deferment of the acceptance of pharmaceutical product patents by developing countries for ten years.
  61. 61. Limited exclusively is granted to developing countries for pharmaceutical products whose patent applications are filed after the enforcement of the TRIPs agreement.</li></ul>EMR ROUTE<br />The EMR route is a backdoor method of granting monopoly rights. To ensure a smooth transition from process patent regime to a product patent one, WTO has granted Indian a grace period of ten years. During this period ,all patent applications received by her would be put in a ‘ black box ’ for further future consideration. However, in the interim, pharmaceutical companies can apply for Exclusive Marketing Rights(EMRs) for their products for the period of five years, even before Indian’s transition is fully phased. Any company that has been registered for a patent and has received marketing rights in any of the WTO member countries can avail the EMR route in India.<br />EMR’S Implication<br />A mere grant of a patent and exclusive marketing rights by any member country would automatically qualify a company to avail EMR in India for that product ,for a minimum period of five years. This clause has a very serious implication. the company in question can happily experiment with the lives of poor Indian .if their experiment fails ,the drug can be withdrawn and in the process endangering the lives of millions of Indians. However ,if the drug proves successful, given the provision of the validity of a patent for twenty years, the company can take in enormous monopoly profits.<br />THE CURRENT SCENARIO<br />There are as many as 23,000 pharmaceutical firms in India, engaged In the production of 16,000 formulation and 700 bulk drugs. With over 28.60 lacs of manpower employed in the sector, it is growing drastically .the year India became a member signatory of WTO, in 1995 its investment in pharmaceutical industry was Rs.1380 crore in 1999-2000. These two indicators are proof enough to exhibit the panic in the industry. The Industry is growing by leaps and bounds to ensure that post 2005 it takes on its TNC competitors head on.<br />Individual companies like Ranbaxy, Dr.Reddy Laboratory, Cipla, Dabur, Aurbindo pharma ,Orchid chemicals & other are setting the pace and defining industry standard. Ranbaxy with its presence in 30 countries, with operations in 24 and manufacturing in 6 countries. With 7000 people across the global is the harbinger of the coming of the age of the Indian industry. Incidentally it spends double the industry standards on its R&D efforts. <br />Capital expenditure of the tune of millions is being incurred by the industry to modernize plants and machinery. Global marketing alliance ,mergers and acquisition have taken the industry by storm. Some companies like Cipla are examining their future role in path-breaking areas of research such as genetics, hoping to open up unexplored venues of global alliance for the introduction of new therapeutically agents.DRL and Ranbaxy are doing collaborative work with companies such as Novo-Novartis and Bayer. Path-Breaking work on agronomy and scientific development of traditional medicines is on. Companies are focusing on securing international patents for new processes, for novel drug delivery systems and innovative drug formulations.<br />Indian pharmaceutical industry is growing at the rate of 12-15% per years as against the global industry growth rate of 8% .this can be attribute to healthcare cost-containment pressures, keeping pharmaceutical prices low, while export opportunities and low domestic per capita consumption have provided higher growth potential, Exports were 192% higher then imports in the year 1999-2000.annual drug per capita expenditure is only $3 as compare to Japan’s $412, Germany’s $222,United State’s $191,Canada’s $124 & UK’s $97.<br />The pharmaceutical sector has undergone several policy changes in the past two years. It has largely benefited from the budget proposals made by the government. Some of the positive steps taken by the government apropos of the industry are:<br />Pharmaceutical industry has been recognized as a knowledge-based industry.<br />The government has plans to step up the R&D expenditure. Ironically only 4.3% of the projected Rs 1400 Crores proposed investment in R&D as in the ninth five year plan has been made. Given a year’s time from now for the 5 years plan to give way to thee tenth five year plan, this plan seems quite overdue.<br /> Rationalization of excise duty and reduction in interest rates in export financing.<br />Additional deductions under income tax laws for R&D expense.<br />Foreign Direct Investment permit up to 74% through automatic rout under powers delegated to the RBI of by the government as the case may be. Automatic route for FDI and/of for technology collaboration would not be available to those who have had any previous joint venture of technology transfer/trademark agreement in the same of allied field in Indian.<br />PRE 2005<br />The phase of transition has taken over . Establishment national pharmaceutical majors are gobbling up smaller companies through consolidations, acquisitions and mergers. The very nation of the entry of TNCs into post WTO has propped up Indian firms to follow the dictum: United we stand, divided us fall . Consolidation have become a buzzword in the industry. Smaller player unable to bear the brunt of heavy competition are giving up to large ones.<br />With only three odd years in hand, Indian pharmaceutical firms are losing on time in extensive copying to reap full advantage of the laxity in the current policy. Copying though a cheap practice, yet given the policy of price control, Pharmaceutical firms are left with no option to invest in research and development. Price control is a non incentive for innovation. Lower drug price might also increasing healthcare expenditure. On the one hand where global giants like Novartis & Hoechst have already set up 100% Indian subsidiaries. Some are increasing their stakes in existing ventures and some restructuring their operations. Quite contrary to these optimists are some pessimists who still linger with the rear that their top of the line products would find no ready market in India given the amount of policy and low product prices.<br />Companies are increasing investing in riskier, cutting edge technologies. SmithKline Beecham is one of the first such companies to leap into new technologies. Glaxo is also contemplating to develop broader portfolio of drugs. Indian pharma companies are in the process of building a strong distribution network and manufacturing facilities so that they can be in a better position to attract foreign partners post WTO. Also the would leverage their bargaining power.<br />POST 2005<br />Indian pharma industry would be have confront the reality of the implementations of TRIPs Agreement from the year 2005.The year would be a turning point, a defining one in India’s pharmaceutical trade. Post 2005 period would be a characterized by many business changes.<br />Most transnational companies are likely to introduce there new-patented drug once the product patent becomes fully operational Indian pharmaceutical would try to haggle with them and government might introduce compulsory licensing. This would lead to an increase in the bargaining power of the patent holder. Also it is likely that TNCs might not set up base in India but consider it as an assembly point of some drugs manufactured by them. However, new launches in the post-WTO period are a guaranteed fact. These new launches would primarily be high margin, low volume products.<br />Competition is likely to increase in the domestic market due to the entry of transnational companies. This would whittle down many manufacturers and small and medium enterprises would slowly decimate. They would lose the benefits enjoyed so far & forced to compete with the foreign firms. Not only would they lose their significance, & their existence would be jeopardized with the implementation of the TRIPs agreement.<br />The product sales of foreign transnational companies would increase at the expense of the local players. Local players would increase their research and development expenditure and try to expand their business overseas to enter the generic market due to their cost efficiency. Limitation is cheaper then innovation. Post-2005, drug discovery would be a costlier affair that Indian pharma companies cannot afford. Joint ventures would become the order of the day. Prizes of drugs would shoot high. IPR rules would enable TCNs to jack up prizes of their products far beyond cost and earn monopoly rents & profits. Higher prices would mean higher cost on medicament. This would lead to social chaos. People of a developing country like India can ill-afford to buy drugs, which are far beyond their reach. Social healthcare system would collapse. Only a pro-active intervention by the government can save the life of millions.<br />Masses would keep on going for the order, cheaper versions of the products, provided they are available, leaving the higher priced newer products. This I would term as ‘Patient’s Paradox’. The patient can neither afford highly effective, high priced products nor do the cheaper drugs help him in faster effective, high priced products nor do the cheaper drugs help him in faster recovery. Thought money spent on cheaper drug would be more, yet the patient is not burden, for his payment is made in phases quite convenient to him. More expensive drug may faster recovery, possibly eliminating future hospitalization and hence on the whole it may prove cost effective too.<br />Merger and joint venture would to less in jobs. Downsizing would be a card game to the pharma majors. Downsizing has its own implications. Society will have to bear the cost of unemployment. Effective demand would come down as result of survivors would be beast with problems like depression, fear of change, loss of loyalty minimum job requirements. Fear of bearing sacked would their beleaguered minds and as a result their personal lives would be jeopardizes.<br />Due to stringency in laws, counterfeit markets would evolve, product diversion practices would prosper and also there would be a splurge in counterfeit labeling practices. On the brighter side in the next 8 years an estimated 60 major pharma products in excess of $40 billion will lose patent protection, this will foster a robust growth in the generic bulk drugs and formulation industry. India has the advantage of lower manufacturing and manpower costs. Moreover, reverse engineered drugs even while under even while under patent would help Indian pharmaceutical manufacturers to target the first wave of generic competition to hit the market in developed nations when the drug goes off patent. <br />What Should the Government Do?<br />Since India has been a signatory to WTO it cannot come out to it as and when it wishes. It is bound by the rules and regulations of the multilateral trading body. Non fulfillment of the objectives set out by WTO in TRIPs agreement would invite cross retaliation in trade, Hence, it is advisable that apropos of ,Post WTO scenario ,the government should adopt a proactive approach, taking full advantage of the leniency set out in a few articles of the TRIPs agreement. Article 8 and Article 30 are such ones. This would provide the policy marker with recuperative pills to their earlier follies.<br />Taking advantage of the provision in this article the government can go for compulsory licensing of the ground of competition ,health pubic interest. Compulsory licensing would also allow certain scope for bargaining and pressure. Argentina and Brazil have already adopted this measure without any protest from the WTO .Also India has the discretion of non-granting of patents to a drug if it poses concern to public health.<br />Article 30 provides for some exceptions to the rights conferred, Following are the exceptions, which may be deemed legitimate.<br />Importation of protected product that has been legitimately put on the market elsewhere.<br />Acts carried out privately on a non-commercial scale or for a non-commercial purpose. <br />Use of an invention for research and experimentation and for reaching purposes.<br />Preparation of medicines for individual cases according to a prescription.<br />Compulsory Licensing.<br />Use of the invention by a third party who started or tool serious precautionary action. Before the application for the patent long before its publication <br />The exceptions provided are self explanatory and the government must take maximum advantage of them while framing the pharmaceutical policy.<br />To maintain an effective control the government must verify the international import price of all new drugs before fixing the selling price & promote the use of generic drugs at all levels. Also on all essential drugs, which list is had of by the government, a rigid price control is to be maintained keeping in view the poor affordability by Indian patients of overcharged drugs.<br /> A more novel practice would be if the government would purchase all the drugs and them distribute them through its own machinery. Government by dint of its authority and standing can be a good haggler and can procure the drugs at cheaper rates. This would solve the problem of individual affordability. But to do so is no mean task and it would require healthy coffers and a strong political will coupled with business acumen and immaculate diplomacy.<br />OPTIONS OPEN TO BUSINESS<br />In- house and individual research should be done away with. They simply add to the financial burden of the pharma company. Moreover, Adept that we are in copying. New drug discovery would take so long a time which companies can ill afford to spend given the dynamic world of open competition .Instead ,the scientific resources that we have should be coupled with foreign collaboration to ensure that the speed in the discovery of new drug as well as humanitarian touch is even poised. However, one can in no way discount the abilities of Indian scientists. It is exposure that matter.<br />India should get ready for contract researching. It can take up contracts from contract research organizations that would provide with no-holds barred independent product development base.<br />Transition from innovation of new process to innovation off new products is a cumbersome task. Pharmaceutical companies should step up their R&D expenditure if they are to prove that they are no minnows. <br />The Advantage POST 2005<br />Indian pharma companies have a Unique Cost Advantages that facilitates in the production of drugs at 1/20th of the cost incurred in other developed economies. The key ingredient the cost of manpower is unthinkably low enabling in the low cost manufacture of drugs. This could be extended to research function. Which is again ,manpower intensive. Scientists for R&D in India could be hired at 15-20% of the cost prevailing in US. <br />Even accounting for higher levels of uncertainties among Indian companies bring about blockbuster drugs. the low costs in conducting research makes them at par with the pharma companies in developed economies. There the uncertainly is relatively low but the cost of overall research is astronomically high due to bloated costs of research inputs.<br />Going by these trends , the signals are very clear in the industry. Companies in India could either be research outfits for MNCs or would become powerful players in niche segments with unmatchable price competitiveness. Contract research is already in vogue in India.<br />The sector is poised with a mammoth challenge of providing health care to the second most populous country of the world. Pharma companies. Be they domestically bred of form international parentage; have increasingly realized the significance of challenge lying ahead. Time is ripe to bring out hidden potential for both survival and also substance. The industry is poised to see more consolidations and mergers in the years to come. Such activities would give way to the industry’s maturity.<br />Pharmaceuticals are one of the most happening sectors in the next decade, globally in general and in India in particular, with advent of these trends.<br />Chapter: 5<br />INTRODUCTION OF THE ELYSIUM PHARMACUTICAL LTD.<br />5.1General Information<br />5.2History<br />5.3Mission<br />5.4Vision<br />5.5Core Value <br />5.6Organization Chart<br />5.7Products<br />5.8Team Force<br />5.1GENERAL INFORMATION <br />ELYSIUM PHARMACEUTICAL LTD. Began as a small pharmaceutical company 1995. Today, it is one of the leading pharmaceutical company in Gujarat. The strong foundation expertise and resource have helpful it to expire innovate and resource have helpful it to expire innovate seek new avenue for growth.<br />The diversity of its endeavors in the field in healthcare reflects the measure of the company’s success. A dominant presence in formulation of finished products. ELYSIUM PHARMACUTICAL’s mission to provide total healthcare solutions.<br />With a commitment to create healthier world ELYSIUM PHARMACUTICAL LTD emerges it’s proven strengths in technology product innovation and therapy management .This commitment also underline the core belief of being dedicated to life in all its various aspects.<br />Elysium pharmaceutical Ltd(EPL) established in1995,is engaged in manufacturing and marketing of pharmaceutical formulations finished products. The company has its own pharmaceutical formulation unit situated at Dabhasa. 17 KM away from Vadodara City with its unidirectional flow and the WHO (World Health Organization) GMP (Good Manufacturing Practice) certification had made the pharmaceutical manufacturing unit unique among the hub.<br />Elysium pharmaceutical Ltd. Has its state if the are manufacturing facility situated near Baroda in Gujarat State. The facility is widespread in a picturesque landscape on the state highway.<br />Elysium, an ultra modern Pharmaceutical Formulation plant with multi national company approved quality control and quality assurance departments with well defined parameters.One of the unique feature of the company are the manufacturing department with highly advanced facilities for Water System, Air Handling System, controlled man and material flow system to control particulate matter & steaming the product as per GMP guidelines of WHO ,MCA,US FDA ,EC with total Quality Assurance & model to watch Elysium plant one of the rarest well knitted plant.<br />The plant comprise if various departments positioned for unidirectional material flow pattern and segregated mind and material entries, equipped with fully automatic indigenously manufactured machinery. The departments are designed for manufacturing various formulations. Maintain high standards of GMP .The products facility types are followings.<br />Tablets<br />Capsules<br />Ointments & Creams <br />Liquid Orals<br />Injectibles including Vials, Ampoules.<br />In manufacturing plant , there is excellent facility provided which are following <br />Central Packing <br />Warehouse<br />Utility service Block<br />Service Floor<br />Administration<br />QC / QA<br />A separate B – Lactum Plant<br />Pharmaceutical industry is growing at 8-10% per annum out of which formulations’ contribution is 85% Drug controller of India has imposed revised schedule “M” Policy to ensure international quality standards and to convert from non-GMP pharmaceutical unit to revised schedule “M” or WHO GMP unit.<br />Scope of WHO companies will be unlimited as because of globalization DCI(Drug Controller of India) has imposed schedule ‘M’. So number of players (manufacturers) will be curtailed As per expert opinion, about 30,000 pharmaceutical concerns are presently in existence. Out of this just a third has their own plants & the remaining units are manufacturing their products either on third party or on loan license. Because of received Schedule ‘M’ this will further be reduced drastically. In view of this the surviving units who comply with WHO GMP requirement will be well supported.<br />Now the Government is about to implement TRIPS Agreement and GATT Agreement. Though this has been accepted in principle, because of number of complications, its full implementation is yet to take place. Once it is implemented further small scale /loan license units will have to wind up their business. In other words, existing manufacturing units will have an additional advantage to grow. <br /> <br />BELIFES & STRENGTHS OF ELYSIUM PHARMACEUTICAL LTD.<br />Build an excellent manufacturing facility which meets standards of GMP & Quality<br />Develop a team of competent persons who will raise the organization to a glorious summit in technical capabilities.<br /> To strive relentlessly for continues updating & up gradation of systems, technology & knowledge. <br />Continuous improvement for productivity & quality<br />Cater to leading Pharmaceuticals Company for contract manufacturing & grow as parents of multinational companies.<br />Serving the allying human with quality medicines.<br /> <br />Function of ELYSIUM PHARMACEUTCAL <br />EPL works as contract manufacturer for different multinationals and transnational concerns. Some of our reputed clients are <br />Sanofi – Aventis<br />Germen Remedies Ltd.<br />Cadila Laboratories Ltd..<br />Bayer Pharmaceutical Ltd.<br />Torrent Pharmaceutical Ltd. <br />Apart from above EPL is actively engaged in ethical domestic marketing. Their presence actively marketing in nine state which are <br />West Bengal<br />Orissa<br />Assam<br />Jharkhand<br />Uttar Pradesh <br />Andhra Pradesh<br />Kerala<br />Tamilnadu<br />Gujarat<br />EPL’s distribution channel is spread over all the above state including J&K.The flow of stocks from the central warehouse at Vadodara is efficient and follows the norms of IDMA & OPPI with maintenance of cold chain. Their logistic serves prompt delivery to the far distance channel partners within no time.<br />Distribution channel associates in nine in number called as consignee sales agents. The part of the company activity ensuring the growth of the company with its associated partner of 176 stockiest across the country. Catering to the requirements of about 5220 retail outlets. <br />ELP have established their presence in the segment of life-saving drugs, Nutraceutical, Anti-Ulcer ants, Cough & Cold, Pain Management, Anti-Histamine, Anti-Infective and Anti-Asthmatic.<br />EPL’s Clientele consists of approximately 14,000 through nation. Out of which specialty segment includes Cardiologist, Diabetologist, Gastroenterologist, Gynecologist, and Orthopedics & Physicians. Major share is contributed by our corporate customers accounted to 1700.<br />EPL’s Existing field force spread over the country, comprises 105 Professional Sales Representatives,21 Area Manager ,4 Regional Sales Manager ,1 Sr.Divisonal Manager & 1 Zonal Sales Manager respectively.<br />All EPL’s products are of international excellence and contributors of out turnover are – Easyplex Group, Sucrazen Group & other group consist of the products as under: <br />Omel 20 Cap<br />Feel Capsules & Liquid<br />Frelung<br />Elcodin <br />Elzone<br />Eltex<br />With EPL’s quality product, dedicated field force supported by professional Management, they are confident of capturing a sizeable business from institution like ESIC and other government hospitals/Research institute through rate contract.<br />As part of the corporate team marketing division is headed by Mr.K.P.Shah as President (Marketing) who is well assisted by Mr.V.Shiv Kumar, Sales Manager & Mr. Sanjay Verma, and Product Executive in marketing was planning. Strategic development and training. Mr.Girish Mistry as Senior Account Handles accounting and financing. Mr.Mukundan P.P as Secretary to President, co-ordinates with all department and Mr.Devang Shah, Executive –HR, takes care of human resources development.<br />With the able support and the association of their strong and highly qualified line managers accomplished with rich experience in the industry involves the name of Mr.P.Vijay Kumar(ZSM-south) and Mr.Amit Ray (SDM-North Eastern states)<br />EPL is planning to introduce two unique molecules which will help them to establish their products more strongly. They have facilities of WHO GMP & they are in the process of adding up compliance of MCA and stage-wise up to US FDA. This will help them to enter into export business. EPL is already registered in 9 countries and their efforts are on in registering their products globally. <br />PRINCIPLES OF ELYSUIM PHARMA LTD.<br />Quality Operations at EPL.<br />Team Building <br />Attitude<br />Observation<br />Determination<br />With input from each and every one present and beyond <br />Quality Wings<br />Quality Assurance <br />Quality Control<br />Primary Functions of quality Assurance<br />Validation<br />Change Control<br />Documentation Control<br />Manufacturing /Packing Deviation Control<br />Cleaning Validation <br />Annual Product Review<br />Labeling control<br />Batch History<br />Quality Assurance history<br />Training Records<br />S.O.P. Updating & Up gradation <br />Monitoring if Manufacturing Activity<br />Review of Batch Records Before Batch Release<br />Returned & Rejected Goods Control<br />Raw Material Retest & Bulk Strong Inventory Control<br />Market Complaint Review<br />Self Inspection<br />Primary Function of Quality Control<br />Analytical Testing <br />Test method Speciation Sheet, Quality control SOP Updating & Up gradation.<br />Calibration & Qualification of Analytical Instrument.<br />Quality Control Investigation <br />Quality Control Training <br />Analytical Method Validation <br />Working Standards Maintenance.<br />5.2History<br />The Beginning<br />The dawn of 50’s under in an era of awakening. Having broken free from the bondage of demand history. A need across for the country to be self-sufficient in all spheres.<br />Healthcare at this time was the sole domain of a few pharmaceutical giants. Coupled to this was the enormous task fighting the myth and malady by cutting across the batters of communication so as to reach out to people and to ensure the most effective cure in the shortest possible time. Under such circumstances, with tenacity of purpose and unfailing zone to achieve perfection in quality, Elysium was founded in 1995.<br />Emerging as a modest pharmaceutical company, Elysium in the early years came out with a wide range of innovative products.<br />Moving beyond pharmaceutical, the concept of total healthcare now forms the commercial heart of the group’s operations and activities. <br />It stands committed to its mission of supporting the hands that heal with innovative contributions in healthcare.<br />Elysium Pharmaceutical Ltd., established in the year 1996 as a formulation unit, situated at Dabhasa, 19 kms from Vadodara city, Gujarat State, India. The company commenced its manufacturing operations in the year 1997.<br />The company is involved in manufacturing of sterile formulations like Liquid and Dry Parenterals, and non sterile formulations like Tablets, Capsules, Liquid orals, Ointment, Dry Syrups. Elysium is committed to maintain and improve the quality of manufactured products to meet customer satisfaction.<br />5.3Mission<br />We care for your health and fulfillment of this commitment we shall go beyond the remain of the pharmaceutical offering products at the hands that hear with innovate contributions in patient care <br />We shall lead the way by harnessing taken to technology, drawing resource and research from every corner of the globe. <br />5.4Vision<br />Elysium Pharmaceutical Ltd. Aims becoming one of the ten players in the Indian healthcare industry by 2010.a leading Asian Player by 2020 and global player by 2030.<br />Build an excellent manufacturing facility which meets standards of C-GMP,GMP and Quality<br />Develop a team of core competence in their resources to drive Elysium the greater heights with glorious summit in technical capabilities.<br />To strive relentlessly for continuous updating & upgrading of systems, technology & knowledge. <br />Continuous improvement for Productivity & Quality.<br />Cater to leading Pharmaceutical Company for contract manufacturing & grow as partners of multinational companies.<br />Serving the ailing humans with quality medicines.<br />5.5CORE VALUES<br />The groups business operations include pharmaceutical, Positive responses to charge underline every aspect of the group operations. It is also evident in the culture thinking in the organization.<br />Elysium Pharmaceutical Ltd. Is a multi-product, multi-faceted group catering to a wide spectrum of healthcare needs ranging from drug manufacturing to drug administrative.<br />The Elysium Pharmaceutical Ltd. Group has adopted the model of a performing organization which self-reliant strategic business unit each cohesive team individually and collectively contributes in exchanging the overall performance.<br />CHAIRMAN & MANAGING DIRECTOR5.6Organization Chart<br /> <br />MEDICAL REPRESETATIVESENIOR REPRESENTATIVEZONAL SALES MANAGERAREA SALES MANAGERPRESIDENTSALES MANAGERBOARD OF DIRECTORREGIONAL SALES MANAGER <br />Distribution Networks<br />The ultimate buyers are however the company goes to the doctors.<br />Company<br />Consignee Sales Agent<br />Stockiest<br /> Retailer<br />Patient<br />5.6Product List & Its Usages :-<br />Sr.NoProductsUse1.Easyplex ForteDiabetic: Vitamin E&C-Improve insulin sensitivity & reduce blood pressure in diabetic.Orthopedic : Prevent cartilage damage and destruction of joints.Geriatric : Slow the ageing process by 15-20%2.Easyplex Drops/SyrupPediatric & Geriatric : Multi vitamin, Mineral & Lysine.3.SucrazenStress, Ulcer, induced ulcer, Gastro-Esophageal, Reflux Disease, Smoking & Alcohol, Induced Gastritis4.Sucrazen – ODuodenal Ulcer, Aphthous Stomatitis , Stress Bleeding Ulcer ,Reflux Oesphagitis ,Post Tonsillectomy Pain.5.OmelReflux Oesphagitis, Peptic Ulcer, Duodenal Ulcer, Drug-Induced Ulcer.6.Feel CapsuleFerrous Glycine ,Sulphate, Folic Acid 5 mg choline, Amino Acid, Zinc & Selenium7.Feel LiquidReplenishes Iron Stress, Compensates the mineral loss, Tissue Repair & Growth, Boost immunity factors.8.EldroxilUpper Respiratory, Tract Infection, Urinary Tract Infection, Post Surgical Infection, dental Infection9.FrelungIncrease Expectation, Reduces Frequency Of cough 10.ElcodinDry ,Irritant, Non-Productive Cough11.EltaxMulti-drug resistant, enteric fever, Bacterial Meningitis, Urinary Tract Infection, Gonococci. Urogential Infections, Surgical Infection.12.ElzoneAntibacterial, Beta-Lactamase, Producing Organisms, CSF Penetration.13.NopidolRheumatoid Arthritis, Osteoarthritis, Surgical Pain, Traumatic Pain.14.AcebrophyllineAsthma related Problem<br />5.8Team Force<br />Our Marketing Office is leaded by Mr.K.P.Shah, he is the president of marketing, and the team is as under:<br /> President MarketingMr. K.P.shah<br />Asst To AccountantMr.Gautam JoshiHR ManagerMr.Devang ShahAccountantMr.Girish MistryProduct ManagerMr.Sanjay VermaSales ManagerMr.Shiv Kumar VoletyAsst to PresidentMr. Mukundan .P.P.<br />Chapter - 6<br /> Project Abstract<br />Project Abstract<br />This Project basically for to find out the EPL’s new launched Molecule i.e. Acebrophylline , here I am find out the perception of the Pharmacists. In that I had take primary data for research, for that I had frame one questioner & then I have to find out the appropriate my target people because there was so many pharmacists but I have to meet only that kind of pharmacists who are already selling EPL’s product & basically that new launched molecule. For that purpose of research I have to choose the pharmacist of that criteria.& I had fill up the Questioner which is I enclosed in Appendices. During this research the time period is also less because of there was a more then 20 pharmacists who are selling all EPL’s Products. <br />The perception regarding new product is not initially well but they have confidence that this new product is also getting successfully as their existing product.<br />Now a day the company is covering Local market very well & also Domestic Market. They are starting export in few countries. If company is getting successful in more then one segment then. There is no any barrier in establishing their name as a worlds leading Company.<br />Chapter-7<br /> Introduction to Project<br />7.1 Objective <br />7.2 Limitation<br />7.3 Methodology<br />7.1Objective<br />The objective of this research is to find out the perception of the pharmacists regarding the new launched molecule that is ACEBROPHYLLINE.<br />7.2Limitation<br />To find out the perception of the pharmacist toward the new molecule is a tedious job. Because no more retailers have this product. So if I am going to the pharmacists but they are to selling this product then our discuss is meaning less.<br />The pharmacists are so busy in their daily schedule so they are not given me a more time so I have to not get more feedback.<br />Time constraint is also a less. <br />7.3Research methodology<br />Normally research design can be classified in to exploratory research, descriptive research, & casual research, here in this research use exploratory research method for data collection.<br />Exploratory Research <br />Exploratory research helps the management to identify the presence of potential opportunities and threats for the company .It is generally conducted with minimum expenditure of time & cost during the initial stage of decision making process. The data is obtained from books, journals, magazines, reports, case studies, etc.<br />By adopting exploratory the research methodology data can be obtained <br />Primary Data<br />Secondary Data<br />Primary Data<br />Primary data can be collected in five main ways through observation, focus group, surveys, behavioral data, & experiments. In the marketing plan, we had following surveys research method.<br />Survey Research<br />Companies’ understand surveys to learn about people knowledge, beliefs, preferences & satisfaction and to measure this magnitude in the general population.<br />Secondary Data<br />Secondary data is collected from the company’s internal & external resources. While the internal resources include the company’s literature, annual reports, etc. the external resources could be independent magazine, journal, legal documents, government gazettes, etc. here we used both company’s internal & external resources.<br />Internal resources: Literature, annual reports, company profile & office document<br />External resources: Internet, magazine & legal documents.<br />Research Instrument<br />Two main instruments for research in collecting primary data are as under:<br />Questioners<br />Qualitative measurement<br />The researcher have selected Questioners for the market survey which is some observational & some special formulated words used.<br />Chapter - 8<br />Analysis of the content <br />8.1 Data Collection<br />8.2 Fact & Findings<br />8.1 Data Collection<br />Stratified Random Sampling<br />In this research I have choose the pharmaceutical sector & in that sector I have choose particular segment that is Asthmatic Segment. That is why I have to choose this is method of Stratified Random Sampling .<br />Method Of Data collection <br />In this research I have taken primary data for this thesis.<br />Data Collection<br />During this thesis I have collected data from primary research in that I have take this data from my target audience that is Pharmacist.<br />Because of they are more attached with the doctors & the endures that is the patients. And the pharmacists are given me a authentic data because of there was no any privacy so they can easily given the information regarding their products which they are going to sell.<br />Time Period<br />Time period is so small because the local market is big so I have to get not more particular conclusion.<br />Sample Size<br />The sample size for this thesis is just 20 pharmacists. It is so small because of if I am consider the pharmacists who selling this product there was so many pharmacists more then 20 so I m not getting complete conclusion.<br />Open ended / Close ended Questionnaire<br />Open ended Questions-On the basic of that kind of questions I can find out their verbal feedback. & I can get more deeply feedback of that product.<br />Close ended Questions-on the basis of that kind of questions the target audience are responding me as par the questioner I have made in beginning in the research. <br />8.2 Facts & Findings.<br /> <br />How many other molecules / drugs do you have for Asthma?<br />Cipla<br />Sun Pharmaceutical Ltd<br />Torrent Pharmaceutical<br />Dr.Reddy Lab.<br />Lupin Lab.<br />Ranbaxy<br />Other ( EPL ,Asian Pharmaceutical Ltd, Etc.)<br />Which company’s drugs do you sell / suggest to your customer for Asthma treatment (In order of preference)?<br />Sun Pharmaceutical<br />Cipla<br />Torrent Pharmaceutical <br />Other ( ELP, Etc)<br />what are the positive aspects of the Company when compared to another company providing the same products and services?<br />Increasing the Quality level , Efficiency & Accuracy of the service<br />What are the negative aspects of the Company when compared to another company providing the same products and services?<br />.<br />The price of the competitors products are less at that time the company is reducing the Quality or Services to sustain in that competition. <br />How would you describe the Company’s image?<br />The image of the company is good in the mind of the doctor but company is small& their marketing related activity in not good because of the lacking of the marking parson. <br /> <br /><ul><li>Report Grade of the company by the Pharmacists?</li></ul>No. of PharmacistsRating the Product8927485613<br /> <br /> Chapter - 9<br /> Suggestion / Recommendation<br />Suggestion / Recommendation<br />Marketing Strategies that the Organization can adopt are as under:<br />Brand Building <br />Launching New Products<br />Sales Promotion ( in term of Doctor to prescribe the company’s product)<br />Sponsor Trip<br />Holidays<br />Gifts & Extra Benefits for a Supported<br />Journal Advertisement<br />Event management (In order to have direct access to the customer) <br />Symposium<br />CRM Activity<br />Clinical Meeting<br />Customer Service Cell (In focus services to key customers)<br />Attractive ,Short & Crisp Detailing (MR)<br />Some of The Most Prominent Performance Related Issues are Enlisted Below :-<br />Increased competition & shortened window of opportunity<br />Good product mix and excellent marketing strategies but poor customer acquisition, development and retention strategies.<br />Person dependant customer knowledge, which is not, shared enterprise wide.<br />Very high attrition rate of the sales Promotional <br />Very high territory development costs<br />High training and re-training costs of sales personnel<br />The number and the quality of medical representatives<br />Busy Physicians giving less time for sales calls<br />Poor Territory knowledge in term of business value at medical representative level<br />Unclear value of prescription from each doctor in the list of each sales person<br />Unknown value of revenue from each retailer in the territory <br />Virtually no mechanism of sales forecasting from field sales level leading to huge deviations<br />Absence of analysis on the amount of time invested on profitable and not-so-profitable customers and lack of time-share planning towards developing customer base for future markets.<br />Manual and cumbersome administrative system and process designing which don’t facilitate optimal efficiency level in sales team<br />And many more……<br />If the above factors are considered and requires action are taken, the position of the organization will definitely mould into a new shape that will be highly beneficial & effective in this era of Generic Market .<br />Some suggestion to the organization for different department that are well structured.<br />1.Human Resource :<br />The HR department should take care of the retention of the employee.<br />Motivation to the employee by every means for eg. Monetary, Emotional, Morally. Etc<br />Training & Development Program should be conducted for the betterment of the employees.<br />2. Marketing :<br />The field staff is again a responsibility of the marketing team, all the required needs of a PSR should be given a deliberate thought. <br />Motivate the field staff to receive the targets, which in turn will increase the sales for the organization.<br />Should enable the PSR with the required information for detailing and updating them regularly from the current market forces.<br />Should train the PSR for detailing in a quick, attractive & innovative manner.<br />3.Finance :<br />A proper system should be followed so that the funding & refunding of revenue can be managed easily & efficiently.<br /> Chapter - 10<br />Conclusion <br />Conclusion <br />The EPL the well know name in gynecology, pediatric & gastro logiest related segment they have successfully in that kind of segment. Now their R&D and top management people feel to penetrate in the Asthmatic segment because of now a days the pollution in increasing day by day so many of the peoples are suffering from the Asthma. In beginning they have done one survey to Doctor & get the feedback of their existing product & they get a feedback from that Doctors then after they are starting to research in Asthma related Drugs. Then after they become in leading company in this segment. The perception regarding new product is not initially well but they have confidence that this new product is also getting successfully as their existing product.<br />Now a day the company is covering Local market very well & also Domestic Market. They are starting export in few countries. If company is getting successful in more then one segment then. There is no any barrier in establishing their name as a worlds leading Company. <br />India thus will be the forth largest pharma force in the world, next only to USA, Western Europe & Japan, with around a Dozed companies in all the major markets of the world.<br />EPL has to start their own CRM department so they can also get more benefit from their existing customers.& this dept. is engage in Customer related Query.& fulfill their requirement. <br />Chapter – 11 <br />Reference<br />Reference<br /><br /><br /><br /><br /><br />ICFAI – Marketing Management Text Book<br />ICFAI – Business Research Methodology Text Book <br /> <br />Chapter - 12<br /> Glossary of Terms<br />Glossary of Terms:<br />ANDA- Abbreviated New Drugs Application.<br />CAGR-Compounded Annual Growth Rate<br />DMF-Drug Master Files<br />DPCO-Drugs Price Control Order<br />EMP-Executive Marketing Files <br />FDI-Foreign Direct Investment<br />GMP-Good Manufacturing Practice<br />HAL-Hindustan Antibiotics Ltd<br />IDPL-Indian Drugs & Pharmaceutical Ltd<br />IPA-Indian Patient Act.<br />Molecule-Generic Drug formula<br />NCE-New Chemical Entities<br />USFDA-US Food and Drugs Authorities<br />WHO-World Health Organization<br />WTO-World Trade Organization<br /> Chapter - 13<br /> Appendices<br />Appendices<br />Pharmacist’s perception toward the EPL.<br />Molecule:<br /><ul><li>How many other molecules / drugs do you have for Asthma?
  62. 62. Which company’s drugs do you sell / suggest to your customer for Asthma treatment (In order of preference)?
  63. 63. ____________________
  64. 64. ____________________
  65. 65. ____________________
  66. 66. ____________________</li></ul>What are your average consumption / sales for Asthma drugs per month?<br />Services:<br />Scale<br />= never<br />= sometimes<br />= often<br />= always.<br /> Never /sometimes/often/always<br />The sales staffs are always friendly and well mannered.<br />I feel valued and important.<br />The staffs are patient and treat me with respect.<br />The staffs are interested and attentive.<br />My wishes and expectations are taken into consideration.<br />The Staff have a problem solving mentality<br />The Staff that I need are easy to contact.<br />Whenever someone is unavailable it is clearly indicated when they will next be available.<br />The telephone is answered within three rings<br />The communications are transparent short and specific.<br />Questions are answered quickly.<br />Complaints are thoroughly analysed and quickly resolved.<br />Staffs ask questions before suggesting a solution.<br />The Staff are apologetic about complaints and mistakes.<br />The price list is very clear.<br />The monthly special offers are original.<br />The monthly special offers are a good reason for placing an order.<br />The fax special offers and general special offers are a good reason for placing an order.<br />Documents and quotations were provided within the agreed time frame.<br />My order was taken in a correct manner.<br />Once placed orders were handled with care until there delivery.<br />Products were in stock<br />When products were out of stock I was correctly informed as to when they would be back in stock.<br />There was sufficient effort made in reaching delivery dates.<br />When deliveries were delayed I was immediately informed.<br />The delivery service is friendly and competent.<br />The orders are delivered with care.<br />The delivered orders were complete.<br />The invoices corresponded correctly with the products delivered.<br />I am satisfied with<br />The priceyes no<br />The service providedyesno<br />The monthly special offersyesno<br />The fax and general special offersyesno<br />The contents of the price listyesno<br />The frequency of the price listyesno<br />The breadth of the selectionyesno<br />The depth of the selectionyesno<br />The Companies staffyesno<br />The approach of the organisationyesno<br />The involvement of the organisation<br />And its staff.Yesno<br />The Delivery serviceyesno<br />My satisfaction will ensure repeat ordersyesno<br />I would like to be visited by an Account <br />Manageryesno<br />Payment after sometime delivery (credit) yesno<br />1, what are the positive aspects of the Company when compared to another company providing the same products and services?<br />2,what are the negative aspects of the Company when compared to another company providing the same products and services?<br />3,in which ways does the Company satisfy your needs and wishes at this moment?<br />4, in which ways does the Company fail to satisfy your needs and wishes at this moment?<br />5,in your opinion what changes need to be made with in the company to satisfy your needs and wishes?<br />6,what, if any products are missing from the range?<br />7,what is your opinion of the delivery terms and conditions?<br />8,how would you describe the Company’s image?<br />9,if you had to give the Company a report grade, what would you give?<br />12345678910.<br />If you have any further comments or responses please feel free to share them here.<br />Further information (not compulsory)<br />Company<br />Name<br />Address<br />Postcode<br />City<br />Telephone number<br />Fax number <br />E mail address.<br />