Generic Drug Industry

Dissertation project report
A Dissertation Project Report Entitled As, To Investigate the Evolution of Indian Pharmacy Culture in India and the Impacts of Generic Drug Entry on Branded Drugs in Indian Pharmaceutical Market
AuthorGanesh Takale
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BUSI1359: Pathway Specialisation Project Dissertation (Sep 2012 starters) AC Van Klyton
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BU/PG 0.00% 30/09/2013
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Ganesh Takale
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Dissertation project report TABLE OF CONTENTSSR. NO. CONTENTS COVER PAGE ACKNOWLEDGEMENT LIST OF FIGURES AND DIAGRAMS LIST OF ABBREVIATIONS SUMMERY OF PROJECT 1 1.1 1.2 1.3. 1.4 1.5 1.6 1.7 INTRODUCTION INTRODUCTION/BACKGROUND OBJECTIVES OF RESEARCH IMP[ORTANCE OF THE RESEARCH RESEARCH COMPLICATIONS RESEARCH QUESTIONS DRAWBACKS OF THE RESEARCH OUTLINE INDUSTRY 2 2.1 2.2 2.2 LITERATURE REVIEW INTRODUCTION STRATEGY OF LITERATURE REVIEW 12 12 12 OF INDIAN 5 5 6 7 7 7 PAGE NUMBERS 1 2 3 4 4
PHARMACEUTICAL 8
INTRODUCTION TO TRADITIONAL MEDICINAL 13 SYSTEM
2.3.1 2.3.2 2.3.3 2.4
AYURVEDA SIDDHA UNANI
13 14 15
RELEVANCE OF TRADITIONAL MEDICINAL 16 SYSTEM TO MODERN MEDICINAL SYSTEM
2.5 2.6
GENERIC DRUG INDUCTION GENERIC DRUG VS BRANDED
17 DRUG 18
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Dissertation project report COMPETITION IN INDIA 2.7 2.8 2.8.1 2.8.2 2.9 PRICING OF DRUGS DRUG REGULATORY AFFAIRS INDIAN PATENT ACT,1970 DRUG PRICE CONTROL ACT (DPCO) PFIZER PHARMACEUTICALS 19 20 21 21 STRATEGIC 25
OVERVIEW 2.9.1 2.9.2 PRODUCT LIFE CYCLE PFIZER PHARMACEUTICALS 27 MARKET 28
SEGMENTATION 3 3.1 RESEARCH METHODOLOGY INTRODUCTION METHODOLOGY 3.2 3.3 3.4 3.5 3.6 3.7 4 A) RESEARCH PATHWAY PHILOSOPHIES OF RESEARCH METHODOLOGY STRATEGY FOR RESEARCH METHODOLOGY METHODOLOGY OF SURVEY COLLECTION OF DATA ETHICAL CONFLICTS OF THE RESEARCH DATA ANALYSIS AND INTERPRETATIONS CHEMISTS QUESTIONNAIRE 29 30 31 32 32 34 35 36 OF 29 RESEARCH 29
B)
DOCTORS QUESTIONNAIRE
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Dissertation project report 5 RESEARCH FINDINGS, FUTURE WORK,
RECOMMENDATIONS 5.1 5.2 5.3 5.4 INTRODUCTION FINDINGS RECOMMENDATIONS FUTURE WORK CONCLUSION BIBLIOGRAPHY/REFERENCES APPENDIX 53 53 54 54 55 56
List of Tables
1. Table of Contents 2. Indias Pharmaceutical Firms, By Size, Sales, Function, Exports, And R&D Capabilities 3. Close End Question and Open End Questions 4. Survey Participants 5. Chemist Questionnaire Question.1 6. Chemists Questionnaire Question.2 7. Chemists Questionnaire Question.3 8. Chemists Questionnaire Question.4 9. Doctors Questionnaire Question.1 10. Doctors Questionnaire Question.2 11. Doctors Questionnaire Question.3
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Dissertation project report 12. Doctors Questionnaire Question.4
List of figures
1. Indian Pharmaceutical Industry 2. Distinguishing Indian Pharmaceutical Industry 3. Product Life Cycle
Lists of abbreviation
NPPA- National Product Price Authority DPCO- Drug Price Control Order MAPE- Maximum Allowable Post Manufacturing Expenses PC Packaging Cost PL-Product Loss CC-Conversion Cost MRP-Maximum Retail Price PAPatent Act
SUMMARY OF THE PROJECTThe speculation of various sections of the research is done in this section of the study. The initial part of the research explains the issue of the project which created an opportunity to undertake this project. The changing scenario of pharmacy field has created an opportunity for the research to investigate evolution of pharmacy culture and generic drug entry in Indian pharmaceutical market is cited in this part of the research. The evolution in pharmacy created opportunity in development of Indian Patent Act in 1972, which revealed the patents of drug molecules, and allowed small scale industries to enter in business and create revolution in business to reach the level economic backbone of country economy, which is cited in overview of Indian Pharmaceutical market. The second section of the research contempts critical literature review carried over research issue. The various articles journals and official
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Dissertation project report publications, websites, magazines and newspapers are reviewed with the virtue of collecting secondary data for the research in order to form the base for the research methodology. The various ancient traditional medicinal systems like Ayurveda, siddha and Unani are explained in this part along with their co-relation to modern medicinal system and impacts generic drug entry on branded products is evaluated in this section. Also intense generic drugs competition in Indian market is highlighted in this section. In tertiary section of the research primary data is collected in the form of survey technique using interview methods by using sample interviews with chemists and doctors in key demographic. Next part of the research highlighted the questionnaire used and data interpretation over the data obtained from primary sources of information. The final part of research focus on findings from various research sections studded, future work to be carried and recommendation to individual organizations regarding obtaining benefits from research are considered. Key WordsTraditional Medicinal System, Modern Medicinal System, Generic Drugs, Branded Drugs, Drug Pricing
1.1 RESEARCH INTRODUCTION/ RESEARCH BACKGROUND:

The project aims to study various aspects of the Indian Pharmaceutical Industry in order to generate proper research over the evolution of pharmacy culture in India and entry prospects of generic drug products in Indian Pharmaceutical Market. The various attributes of traditional Indian Medicinal System are discussed in letter part of the research. The Indian Medicinal System was developed form Ayurveda. The base for Indian Medicinal system is Ayurveda which was later evolved to apothecaries theories and further pharmaceutical evolutio ns around the world and adopted to allopathic medication during British Empire. These attributes are discussed in this section of the study. After that focus is created on the generic drugs marketing, which had started in India in 2003, right from its beginning generic drugs are always an issue of controversy with respect to their quality, low price as well as availability in market. After the release of the patent over any molecule, numerous generic drug manufacturing
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Dissertation project report organizations enters in generic market with their own products with low prices with maximum availability in market and this affects the revenue generation of various generic as well as branded pharmaceutical organizations. The study is based on substantial data sets obtained from various official websites of generic pharmaceuticals as well as on documentary information provided by branded and generic drug manufacturing companies in response to information requests. This research presents various aspects of generic, branded and counterfeit drugs by considering the case of Pfizer Pharmaceuticals as baseline of the study that facing Patent Expiry issues over their top selling brand Lipitor in Indian Pharmaceutical market.
1.2 OBJECTIVES OF THE RESEARCH:

1. To investigate the evolution of Indian Pharmacy Culture from Ayurveda to Allopathic medicinal system. 2. To carryout market research regarding product life cycle of Pfizer Pharmaceutical Products in Indian Pharmaceutical Market. 3. To study the effects patent expiry and entry of generic drug products on branded drugs. 4. To study market segmentation and market share strategies used by Pfizer Pharmaceuticals.
5. To investigate the Pfizer Pharmaceutical customers atonement over their products and
services.
1.3 IMPORTANCE OF RESEARCH:

The project signifies to context to the research issue highlighted in research background by providing brief history of Pharmacy Culture evolved in India from traditional Ayurveda medicinal system to allopathic medicinal system. The entire scenario of medicinal growth in India and various traditional medicinal systems like Siddha, Unani and Ayurveda are explained in this research. The research also signifies by providing co-relation between modern medicinal system and traditional medicinal systems with examples. Further pharmaceutical revolution taken place in India, after Indian Patent Act, 1972, is also speculated in the research, by providing in depth analysis of Generic vs. Branded drug competition 8

issues in India. Research also signifies individual organization by providing market research on life cycle of their products and thus helping them to design or alter their strategies with respect to their product positions in market. It will also compensate the individual organization by providing various
amendments in acts, DPCO pricing strategy as well as various norms set by Ministry of commerce and industry upon drug patent as well as norms designed National Product Pricing Authority (NPPA) for product pricing.
1.4 RESEARCH COMPLICATION:

The research problem identified was impact of generic drug entry on sales of branded drugs in Indian Pharmaceutical Market. The case of Pfizer Pharmaceutical is studied in the research. The Pfizer pharmaceuticals is facing decline in their sales of most selling product Lipitor brand in Indian market after patent expiry of Atorvastatin Molecule discovered by them. This created an opportunity for researcher to investigate the evolution of Indian Medicinal System, right from Ayurveda to entry of Generic Drugs in Indian Pharmaceutical Market. The research problem states the need of studying relevance between Traditional Indian Medicinal System and modern medicinal system.
1.5 RESEARCH QUESTIONS:

1) How Pharmacy Culture evolved in India? 2) How traditional Indian medicinal System is relevant to Modern Medicinal System in India? 3) In what ways the generic drug entry affected branded drug product operations in India? 4) Which are the steps those will help branded drug product organizations restore the market position of their existing brands? 5) How strategies used Pfizer Pharmaceuticals will benefit them to attain the benefits from their existing product as well as new product launch?
1.6 DRAWBACKS OF THE RESEARCH:

The project raises many issues for further study of the evolution Indian Pharmacy Culture and generic drug entry in Indian pharmaceutical market. In comparison with large Pharmaceutical business sectors and industry sizes this research is restricted to small samples. Misinterpretations and usual pathway conflicts are prime disability of the survey technique used in the research. Research contributes to elaborate various aspects of growth of Pharmaceutical Business in India along with evolution of pharmacy Culture in India right from Ayurveda to modern medicinal system, though it has many drawbacks. More explanation of these factors with their corrective measures is required. In depth explanations of these medicinal systems are required which is not available due limited data recording sources in ancient times. Along with all above technical limitation, some most common limitations like time availability for research completion, limit of words and finance are can be speculated.
1.7 OUTLINE OF THE INDIAN PHARMACEUTICAL INDUSTRY:

In this sector compared to others in world, very tough guidelines were established by Pharmaceutical Industry of India for the purpose of development, research and production, marketing of drug product intended to be utilized for medication purpose. With the increased branded and generic drug product market Indian Pharmaceutical Industry experiencing high growth. Within the economic year 2011, Indian Pharmaceutical market appeals yearly growth of 15.7%. Bulk pharmaceutical products production is the key identity of the Pharmaceutical market. Glance towards this yearly growth rate of the year 2011 that is 15.5% of Indian Pharmaceutical industry emerges interest of the world. For the year 2010 it was just only 9.9% and is anticipated to increase effectively with 9.5% annual rate at the 2015 economic year. In anticipation of business of US$ 72 billion at end of 2020 economic year the business achieved by Indian Pharmaceutical market in the year 2012 is around US$ 11 billion as per the survey of (Dr. Geeta Gouri, 2009)
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Dissertation project report India exports to the countries are counting more than 200 along with major reputed markets like Australia, USA and Japan from India positions India t 17 th position in terms of export. The ambiguity is that Organization for Economic Cooperation and Development (OECD) considers India as source of simulated medicines while WHO proposed that due to high medical bills 3.2% Indians comes under poverty margin. Disturbed health forward 39 million Indians to financially poor condition every year. Due to weak financial position nearby 30% population of rural India is restricted to any treatment. High-out-of-pocket (OOP) expenditures by Indians for medicines contributes to the world health organization (W.H.O) increased concern. (ijppronline.in) Figure.1
12 10 8 4.7 6 4 2 0 Formulations (Generic and Patented) 4.4 10.4 2007-2011 2001-2002
0.9
API and Intermediates
Figure.1 Indian Pharmaceutical Industry in US$ billion
According to different survey information 3rd biggest market in the world with respect to volume of formulated product is Indian Pharmaceutical Market and it is established at 13 th position in terms of revenue generation within the time period of 2008-2013. With respect to
bulk drug manufacturer pharmaceutical industry around the world Indian industry is among top five as per the recent survey information by (Padmashree Gehl Sampath, 2010-2011). The Indian Pharmaceutical market distinguished depends upon directed manufacturing of the bulk drug and 11

formulations, experimentally it suggests that 20% market entertains production of bulk drugs with growth rate of 20% within Indian market and rest 80% market manufacturers are with annual growth rate of 15% as provided in year 2020-2011. (ijppronline.in) Figure.2
80% 70% 60% 50% 40% 30% 20% 10% 0% Bulk Drug Formulations Bulk Drug, 20% Formulations, 80%
Figure.2 (Created by researcher, 2013) Table.2 Indias pharmaceutical firms, by size, sales, function, exports, and R&D capabilities Grouping Large Scale Number of Firms 100 Descriptions The large scale pharmaceutical organizations in Indian Pharmaceutical organizations mainly
comprises of privately owned organizations and branches of multinational operators. These
organizations cited revenue of $650, 00 in each economic year. They have set their market with respect to R&D activities and market monopoly with the help of most recognized brands. In accordance to changes in regulatory framework of 12

cross border acquisitions allowed these
organizations to set up business with unregulated, regulated and semi-regulated pharmaceutical markets across the globe. Medium Scale 300 Medium scale pharmaceutical organizations
recorded US$ 210,410 annual turnover at each economic year. The prime motto of these
organizations is to serve for localities of India. They implicate reverse engineering in their business by manufacturing of off patent and patented drugs mainly Authorized Patent Drugs and Bulk drugs. These organizations also include corporations in contract research (CRAMS) and clinical trials in distributed market in order to gauge competitive opportunity organizations had set up business with unregulated, regulated and semi-regulated pharmaceutical markets across the globe Small Scale 8000 This category includes the small scale generic drug formulations manufacturers mainly having annual turnover less than US$ 210,410 each economic year. They operate their business on contract basis by forming manufacturing or packaging contracts with multinationals or large scale organizations. These organizations are always face threat of Good Manufacturing Practices (GMP) set under schedule M for Indian Drugs Producers and Indian Patent Act 1940. Organizations had set up business with unregulated, domestic and semiregulated pharmaceutical markets as they do not comply with GMP standards of regulated market.
Source: (Padmashree Gehl Sampath, 2010-2011)
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CHAPTER-2
CRITICAL LITERATURE REVIEW
2.1 INTRODUCTION
In connection of the research topic, related secondary data broadcasted through the different organisations website, various articles and literatures are revived and illuminated in this section. To understand various drug schedules and acts study targets to go through various literatures from internet, pharmaceutical journals, government drafts and different pharmacopoeias. For confirmation of data broadcasted related to revenue generation prior and after generics entry into market various financial reports of Pharmaceutical organizations also taken into account. Long lasting and acute effects of release of patent and pricing strategy by DPCO are critically analyzed with aid of different economic literatures forwarded in magazines, on electronic media and in newspapers. Initial section of the study is assembled with different theories proposed in accordance with drug pricing, generic drug entry. Furthermore these theories are detailed in direction of collecting data for the research issue. Introduction of acts like Drugs and Cosmetics Act 1942, Indian patent Act 1970 with its amendment in 1999, 2002 & 2005, Drug Price Control Act 2013 (DPCO) and influence of these acts on Indian pharmaceutical organizations patent issues, accordingly on prices of the generic drugs manufactured by them constructs next part of literature review.
2.1 STRATEGY FOR THE LITERATURE REVIEW

The internet browsing and library data review is used as base for the obtaining data for the literature. The conclusion of the research topic is drawn in accordance with generating vocabulary for the research by setting the particular parameters for the each different subject
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Dissertation project report or issue and accordingly internet browsing and library data is reviewed and extracted for the justification of the research topic. (Saunders Thornill M, 2009)
2.3 INTRODUCTION TO TRADITIONAL MEDICINAL SYSTEM OF INDIA-
2.3.1 AYURVEDA
Ayurveda is established medical system based upon confirmed theories and from generations to generations documented clinical recognitions with constant and strongly running clinical practice. This age-old medical science of India is boosting with increased interest in Ayurveda. Vedas generating various theories and philosophies and are aforethought as oldest written literature of the world forms the base for science of life known as Ayurveda. Word Veda represents knowledge and Vedas represents the bunch of knowledge in form of books including widespread knowledge. Ayurveda differs from biomedicine as it based upon the knowledge of human body functioning. Vata, Pitta and Kapha are the tridoshas which forms the base for Ayurveda. Tridoshas are the physico-chemical measures and are operative. Dryness, coldness, lightness parameters are the examples of vata. Bad smell is the example of pitta. Coldness, sluggish, heavy, firm/static is the well-known parameters of kapha. Ayurveda suggests that all doshas are in equilibrium and change in one area results in change in other activities of other Dosha parameters. Best example to explain is, increase in dryness parameters representing vata results in declines obsequious property of other doshas. Imbalance of these doshas results into disease and Ayurveda treatment takes measures to reestablish balance between the Dosha.
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Dissertation project report Ayurveda is time tested experienced practice putting various theories and therapies, practiced by large number of physicians on uncountable patients since long time compared to the biomedicine clinical trials, conducted on the few thousands of patients within very short time period of maximum 3 years. One thing to be noticed that, the system-wise classification preferred by western medicine resembles to the structural classification of body provided in Ayurveda on the basis of panchamahabhutasand dhatus means tissues and the classification explained in srotas. Importantly, Ayurveda had extremely advanced department of surgery. Susruta, the Ayurveda surgeon explained the vitality of many surgical procedures along with dissection is accepted as the father of surgery by the West. Rhinoplasty and Otoplasty are the examples of surgery methods adopted from Ayurveda and are continued with modern surgery. Ayurveda treatment is translation of written theory into successful and alive clinical practice with the aid of medicines, diet and lifestyle modification to restore the Dosha /functional balance. Ayurveda suggests that treatment should be without any side effect and same is implemented in Ayurveda practice. (GOVERNMENT OF INDIA, 2013)
2.3.2 SIDDHA
Siddha system of medicine is operated in the southern India. Siddha system maximally resembles to the Ayurveda and operated during same time period as that of the Ayurveda. Sanskrit word Siddhi gives birth to word siddha representing meaning perfection, or heavenly or goal to be attained. One definition of the word siddha medicine elaborates that it is conquest of death and measures for preventing mortality. Siddhars are the persons known for practicing siddha system. Siddha system explains that 72000 blood vessels, ten types of main arteries and 13000 nerves collectively form human body. Human body is subjected to affect from 4448 diseases.
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Dissertation project report Mercury and sulfur like metals used in siddha system targeted for the purpose of contributing to the everlasting body with primary aims like stoppage and alleviation of disease. Preference given to the metals for that purpose is due to the long lastingness of metals compared to plants and herbs which are short-lived. Siddha operates with very high necromancy and astrology, includes only 475 siddha drugs in contrast to 6000 drugs in Ayurveda. (GOVERNMENT OF INDIA, 2013)
2.3.3 UNANI
Greek community medicine forms base for Unani system of medicine. Various mechanisms of treatments of Unani system are like as diet modification, regimental therapy, surgery and pharmacotherapy are well explained in Urdu language. Unani system based upon the three approaches of human body including blood, bile and phlegm. These ideas or concepts are very similar to Ayurveda. Hakim is the term used to define the practitioners of Unani system. This system was prompted in India by Arabs. Postulates suggested by Hippocrates who organize disease as natural process and define its symptoms as body reaction towards the disease, forms the foundation for this system. In India, Unani sexual disorders and skin diseases treatment is highly operated under this system. Unani system of medicine has well developed pharmaceutical industry and own pharmacopoeia. Greek and Arab scholars like Galen, Raazes and Avicenna are the big contributors to the system considerably. Consumers of Unani system of medicine are present in huge number across India. Unani medicine system prefers to use drug in raw form either individually or in combinations compared to compound formulations. Terms like phlegmatic, sanguine, melancholic and choleric are utilized to denote peoples susceptibility with dominance of humors blood, phlegm, yellow bile and black bile, respectively. Pharmacotherapy, diet therapy and regimental therapy are the treatments types preferred in Unani system of medicine:
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Dissertation project report Diaphoresis, diuresis, massage purging, Turkishbath, emesis like treatments comes under Regimental therapy. Diet therapy concentrated to treat few disorders by utilizing specific diet strategy and maintaining quality and quantity of food. Herbal medicines are treatment strategy in the pharmacotherapy.
2.4 RELEVANCE OF TRADITIONAL INDIAN MEDICINAL SYSTEM WITH MODERN MEDICINAL SYSTEMToday, in India traditional medicinal systems are the backbones in the primary healthcare sector with utilization by 70% of the population. For the treatment of diseases the plants contributed in the Ayurveda and other literature are very useful for the generation of new leads. With the aid of provisions like herbal pharmacovigilance, clinical trials, herbal therapeutics, pharmacokinetics, standardization of finished products and raw materials, phytochemical profiling and screening, significance of these systems for healthcare purpose and maximum utilization of natural resources is analyzed as suggested by (Mukhergee PK Mukhergee K, 2005). The major relevance of Ayurveda with modern medicines is explained by the similarity of branches of Ayurveda to the modern medicines including shalya as surgery, kayachikitsa is the general medicine, shalakya has similarity to diseases related to the part of the body above the clavicle, example is ophthalmology, otorhinolaryngology, grahabadha means psychiatry,
kaumarabhritya resembles to obstetrics, gynecology and pediatrics, agadatantra is science similar to modern toxicology, rasayana is related to rejuvenation and vajikarana is similar to aphrodisiacs and treatment of sexual diseases. Like as the modern medicine especially in terms of clinical pharmacology, Ayurveda also suggest that treatment must be individualized. Almost all the traditional systems utilizes plants and their preparations for medicinal purpose and are giving birth to new molecule leads in the modern medicine. More than 80,000 plants
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Dissertation project report species are known for medicinal purpose among the 2, 50,000 higher plant species. In India, about 15000-20000 plants represents effective medicinal value. In contrast the traditional community utilizes only 7000-7500 species for healthcare segment. 70% of global population is dependent on plant and their extracts for health care. It is estimated that world market for plant derived drugs may account for about INR2, 00,000 cr. Presently; Indian contribution is less than INR2000 cr. Indian export of raw drugs has steadily grown at 26% to INR165cr in 1994-95 from INR130cr in 1991-92. The annual production of medicinal and aromatic plants raw material is worth about INR200cr. This is likely to touch US $1150 by the year 2000 and US $5 trillion by 2050. (GOVERNMENT OF INDIA, 2013)
2.5 GENERIC DRUGS INDUCTION:

According to Indian Drug Pharmacopoeia and Abbreviations in Drugs and Cosmetic acts 1942, the generic drug (generic drugs, short: generics) is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use." Generic drugs also can be referred as drugs which are marketed by their chemical name despite of using any brand name for their marketing and sale. The production and marketing of generic drug is entirely controlled by regulatory framework set by the particular government were it is intended to be manufactured and marketed. The generic drugs are dispensed with only chemical name of the therapeutic molecule in it and company name; they do not highlight any particular brand name or spurious name over their labels. The bioequivalent range is set by the U.S. Food and drug administration (FDA), with respect to the pharmacokinetic and pharmacodynamics properties of the generic drug. The generic drug is meant for the therapeutic activity, so it must contain therapeutic ingredient in it and its therapeutic index must be identical to that of branded version of same drug product.
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Dissertation project report The FDA's use of the word "identical" is very much a legal interpretation, and is not literal. With context to above statement FDA approves generic drugs equivalent in intended use, dose, efficacy, route of administration and safety to that of branded drugs.
2.6 GENERIC DRUGS VS BRANDED DRUGS COMPETITION:

Brief look of Indian Pharmaceutical market experiencing intensive competition focused by Indian media explains few examples of competition in Indian market as follows: The Indian media constantly highlighted the case filed by Novartis in this case Novartis bring action against the Indian patent Act section 3 (d) 3 in court, in privilege of their drug product Gleevic for treatment of Leukemia. Novartis appeals that Glee vic is most originative variant compared to currently patent expired older variant leukemia drug. Natco pharmaceutical one of the leading generic organizations in India objects this appeal of Novartis and gets the decision in their favor and able to produce generic variant of the drug Gleevic with grant. Make it available at very lesser price than actual branded drug. Explanation is from regular column of Jayati Ghosh in the year August 2009. (Ghosh, August 2009) Next case is referred from Financial Express Economic times, 2009 edition. This case is related to the dominant anticancer generic brand Nexavar belongs to Cipla.brand faces the protest of appeal by famous German Pharmaceutical organisation with respect to approvals of marketing granted by Drug Controller General of India (DCGOI). The appeal was refused by Delhi high court with forewarning that if Cipla founds at fault with any violation of Indian Patent Act, the patent violation damages has to pay to Bayer Healthcare by Cipla. (Financial Express Economic
times, 2009)
Financial Express Economic Times of the year 2009 reported the case of the company Cipla, organization appeals in Delhi Court claims to the patent for drug Tarceva and gets grant to produce Tarceva,s generic variant at half price that of the brand of Hoffman La Roche, a Swiss pharma company. (Financial Express Economic times, 2009)
Case represented by Federation of India, in the year 2005 of the Aurobindo pharma, huge Indian generic organisation. The company claims the formulation of risperidon on approvals
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Dissertation project report from US FDA and 50 ANDA against oral solution of Resperidon and produced the same at much reduced price utilized in the treatment of mental and emotional instances. (Federation of India, 2005)
2.7 PRICING OF DRUGSInterpretations of the study carried by Martini N, Addis A and Rocchi F in the year 2004 suggested that in direction of setting price competition within pharmaceutical markets, around the world 82% countries sets regulating standards for pricing operations, and rest 20% countries doesnt have any such provision. On deep understanding of the s ubject 36% among the nations having sets standard employed price regulation under the originator price to regulate generic drug products. Regulating price standards are set in India with respect to generic firms Gap within generics price and branded drug price is around 50%in few cases. In few states this difference is maintained at 20% and not allowed to decline down that level. Additional concentration of the author forwarded that 21% of the nations regulate average price towards generic products prior to its entry in the market. The 19% of the states established their pricing regulations with respect to Maximum Retail Price (MRP). After entry of generics in the market 12% of nations establish prices by assignable price. (Reiffen David and Michal R Ward, 2005)
2.8 DRUG REGULATORY AFFAIRS

This section of the research paper explains the Indian drug regulatory scheme. Licensing and pricing are the two pillars which contributes the Indian regulatory framework. Every state in India has State Drug Regulatory Commissions which looking after the licensing to the generic drug manufacturers within that state. Drugs and cosmetics act 1940 regulates the all provisions related to generic drug including Manufacturing, distribution, sale and import-export, in India. Authorities like Drug Controller General of India (DCGI) emerges under Drugs and Cosmetics Act, 1940 provide ground rules for conduction of clinical trials for different generic drugs with respect to granting license for manufacture and marketing of generic drugs in India.
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2.8.1 THE INDIAN PATENT ACT, 1970:

In the year of 1970 Government of India, constitute the Indian Patent Act to provide improved quality and declined price of drugs and to motivate the advancing of pharmaceutical industry in India. This act displaces the intellectual property rights which were established by British Colonial Era by rectifying the western style products patent protection for pharmaceuticals. This helps the local industry to generate required adequacy and legally provide inexpensive copycat generic variants in huge numbers throughout India with reduced price drugs from that of in the West. This act also suggests different production processes than that of employed by owner of the patent. For purpose of the evolution and examination of the new drug alternative to usual 15 years the act protects process patents for 7 years Indian Pharmaceutical manufacturers are able to utilize counter engineering patented drugs with no fees to be paid to the absolute product introducer with aid of this act. Government of India distributes productspecific patents through this act in affinity of manufacturing process patents. (Ministry of
Commerce and Industry)
2.8.2 DRUG PRICE CONTROL ORDER (DPCO)To regulate and fix drugs prices which are listed under regulations of central government the
Drug Price control Order (DPCO) comes into force. Currently, for sale of generic drugs in India, controls are established through National Pharmaceutical Pricing Authority (NPPA) and prices of the drugs are fixed.
DPCO was first comes into the act in the year 1970, following by the revisions in the year 1979, 1987 and 1995. Government prescribes pre-tax profit limits not to surplus beyond 15% of pharma sales including sales tax and excise duty. Profit more than 15% in any case, norms suggests that excess should be surrendered to government. Pricing strategy of pharmaceutical companies is thus controlled by criterions of DPCO though price of product is fixed by manufacturer with no interference. (NPPA, Government of India) Procedure for Pricing of Formulations
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Dissertation project report Following are the routes to fix prices of formulations based on scheduled bulk drugs. Based On Manufacturers application And On Suo-Motu Basis (Move on its own).
Drug (Prices Control) Order (DPCO) of 1995 para 8 (2) provides that a manufacturer using scheduled bulk drug in his formulation is required to apply for fixation of price of formulation within 30 days of fixation of price of such bulk drug (s). Application in Form III from manufacturers and in Form IV of DPCO by importers provided to NPPA is taken into account while fixing price. Para 8(4) of DPCO suggests that time period of 2 months are granted for formulations price approval from the date on which complete information was provided by company.
Procedure for Pricing Generic Drug Product:
A.
(a) Examination of Technical Parameters: In corresponds to label statement, quality of the product is assessed. The product is assessed on grounds of technical parameters of average claim set by the government bodies. (b) Examination of Prices of Bulk Drug: The product portfolio and information regarding price of bulk drug is speculated in case of nonschedule drugs. The price notified by government bodies is cited as notified price of drug. The average price claimed by applicant is considered against notified price in cases of non-schedule bulk drugs. (c) Examination of Excipient claims: Excipients claim guidelines for bulk formulations are set by national product price authority (NPPA)
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Dissertation project report (d) Examination of PL, CC, PC and PM cost: The NPPA provide guideline for the product material cost in accordance to price mentioned on invoice. In correspondent to Gazette vide S.O. 578(E) dated 13.07.99, following parameters are set for product pricingPL (Product Loss) CC (Conversion Cost) PC (Packing Charges)
(e) Application of MAPE: The 100% ex-factory cost is given to drug formulations, while that of 50% given to imported drug formulations, with respect to Maximum Allowable post Manufacturing Expenses (MAPE) (f) Working out the retail price: According to Para 7 of DPCO, 1995 viz., the prices for the retail sale of drugs are set in by using following formula"R.P. = [M.C. +C.C. +P.M. +P.C.] x [1+MAPE/100] +E.D.", Where, R.P., M.C., E.D. respectively denotes retail price, material cost, excise duty and the other symbols as explained above earlier. (g)Tax Treatments: DPCO awarded 16% of leeway to retailers selling bulk drug formulation, while regulations set by NPPA with 8% leeway to wholesalers. All this leeway is applicable with Actual and Net Modified Tax (MODVAT).
B.
Suo-Motu Cases:
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Dissertation project report The contract period of 30 days is provided to every manufacturer of bulk drug formulations to inculpate drug price revisions but if in any case he fails to do so, with correspondents to Para 8(2) of DPCO, 1995, manufacturer is prosecuted by government and he goes under suo-motu revision, were all the pricing elements required to be followed are moved by government itself and manufacturer is charged for same procedure by government. C. Notification of ceiling prices in the Gazette of India: The gazette of India (extra-ordinary) has amended the drug ceiling price notifications for large scale as well as small scale drug manufacturers, and this amendments are mandatory for them to follow. In corresponds to Para 9 of DPCO, 1995, the ceiling price for drugs are set in accordance to pack size of product marketed. D. Pro-rata price: The schedule as well as non-scheduled bulk drug manufacturers should lookout for amendments in notifications made under para 9 of DPCO act 19995, in order to verify their pack sizes as per the notification no. S.O.83 (E) set by NPPA on pro-rata ceiling prices issued. The ceiling prices for the tablets or capsules with same strengths packed in blister packaging or strips are set on the basis of pro-rata notification issued by NPPA. E. Non-ceiling Price Order The changes in pricing scenario of non-scheduled bulk drug is made with influence of Para 8 (1), (2) and (4) and Para 11 of the DPCO. The brand name under manufacturer is considered for such ceiling pricings. Such ceiling price notifications are made by NPPA, by inclusive of all local as well as other excise duties. (NPPA, Government of India).
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2.9 PFIZER PHARMACEUTICALS STRATEGIC OVERVIEW:

Management implemented in the Pfizer pharmaceuticals is important ingredient contributed to its success. To reduce burden on marketing function the management is eager to turn critical marketing activities into simple one by classifying them in different sectors of business. Few are explained below: A) Developing Marketing Strategies & Plans: Pfizer needed, according to different marketing strategies. The Promotion of fever and infection are done before Becosules. Pfizer implement varying strategies of promotion as per need. Promotion of Becosules in case of fever and infection is the well-known strategy. Best example to explain this Co-branding is promotion of Becosules with antibiotic brand trulimax in treatment of infections to fill-up the loss of vitamins occurred during infection. B) Brand Building: They follow the brand building strategy by focusing the strategies used by their competitors and accordingly they design their competitive strategy. Management analyses the measures taken by the competitor and in counter action they prepare more effective strategy to defend the competitor. For understanding any new activity carried by/for Cobadex competitor brand of Pfizers brand Becosules is targeted.
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Dissertation project report C) Positioning: Pfizer for their brand support implement Positioning strategies. Pfizers brand ATIVAN drug taking care of sleep disorder is positioned as Anti -anxiety Becosules-A Bcomplex is promoted under the tagline Everyone needs it. D) Co-Branding: In order to confirm cost effective marketing management Pfizer utilizes promotion of one product along with another. Becosules soften marketed with an antibiotic, also of Corex-T hand-by-hand Trulimax in disorders of reparatory tract are the examples of cobranding strategies. E) Umbrella Marketing: This strategy employed by Pfizer changes the names of their available brands in few instances. In the same Broncorex is replaced with name Corex-T and Becosules with Becosules-Z. F) Customer Loyalty: Prescribing Doctors are the customers for this pharmaceutical market as patients have to buy that which is prescribed by Doctor. So it is essential to have doctors loyalty towards companies brand and organizations are concentrating on the same. (www.pfizerindia.com, 2013)
2.9.1 PRODUCT LIFE CYCLE:
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Decline
Introduction
Saturation
Grwoth
Maturity
Figure 3. (Created by researcher, 2013)
Developing business and research based nature of Pfizer Pharmaceuticals forces them to knock the market with innovative molecule, as large numbers of their brands are at ripened stage and development period of molecule is more than 20 years involving lengthen procedure. No. 1 vitamin B complex brand is Becosules of Pfizers since from 20 years. With reference of MAT 2010 with trade of INR200cr Corex is the high selling pharmaceutical brand of India. Currently these two products are at maturity stage in Indian market. By defeat form the other new competitors brand product sales of few products of Pfizers are reduced like in antidepressant drug DAXID. Some of the products like BECOSULE-Z, a combination of Zinc and vitamin B gaining acceptance in the market. Becosules Z is at position 2 at current with respect to leader ZINCOVIT. Within upcoming few years Pfizer is thinking of introducing around 15-20 new products like as ABOVE-5 as antacid and in other segments. Large number of measures on sales and marketing are ongoing in anticipation of advancing these products. Pfizer has not released
its projected losses due to the patent expiration, but its company forecasts call for sales in 2012 of $63-63.5 billion, versus $67.8 billion in 2010. Lipitor global sales were over $10 billion last
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year, and Morningstar analyst Damien Conover estimates a sales figure of $3.8 billion in 2012 still among the top of drug sales. (www.pfizerindia.com, 2013)
2.9.2 PFIZER PHARMACEUTICALS MARKET SEGMENTATION:

Three main categories are separated in the Pfizer Pharmaceuticals like as human pharmaceuticals encoding allopathic, veterinary section and the Capsugel with Two-Pieced capsules intended in prescription production and OTC products, nutritive supplements purpose. CNS products, cardiovascular drugs intended in cure and mitigation and drugs used for the Diabetes, drugs for treatment of erectile dysfunction, eradication of infections and allergies and in arthritis treatment are the main proficiency of Pfizer in human Pharmaceuticals. Pfizer had sales of $1 billion (680,4 million) each with eight allopathic products including Lipitor, Norvasc, Zoloft, Neurontin, Celebrex, Zithromax, Viagra and Diflucan. For high lipids, cholesterol and triglycerides, in the bloodstream treatment Lipitor is the highest selling brand belongs to Pfizer. Another volume building brand of Pfizer is Norvasc for hypertension and angina treatment. Procardia XL, Cardura and Accupril/Accuretic brands are the major contributors of cardiac segment of Pfizer. Zithromax, Diflucan and Viracept products are the main leaders of company in treatment category of infections. To take care of diabetes Pfizer has the product Glucotrol XL, Zyrtec for the treatment of allergies. All these products of Pfizer and their contribution in terms of revenue generation detail the business improvement of Pfizer Pharmaceuticals. (www.pfizerindia.com, 2013)
CHAPTER-3
RESEARCH METHODOLOGY:
3.1 INTRODUCTION
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Dissertation project report The theoretical aspects of the research methodology are cited in this part of the research. The theoretical framework for obtaining the research data is created with the virtue of theoretical elaborations of the various terms like research pathways, research ethics, phenomenology of the research etc. The techniques used for obtaining the data for the research in order to generate the proper research, with the help of questionnaire method is elaborated theoretically in this research panorama. The methods implicated to obtain primary as well as secondary data are also highlighted in this research section. Section also focuses on techniques and theories used to design the research questionnaire in order to obtain the empirical data for the research significance. The evolutions of the pharmacy culture in Indian Pharmaceutical market is exploited in literature review part of the research, the generic drug evolution and its entry impacts on the prices, competition, market share, marketing strategies etc. of branded version drug product are required to be signified with the help of empirical data, and with the virtue of this statement the primary data regarding the impact of generic drug entry on branded drug products in Indian Pharmaceutical market required to be assessed with the help of empirical data obtained directly from the source i.e. pharmaceutical organization. This empirical data collection is obtained with the help of questionnaire techniques in by conducting workshop in organization facing patent expiry issues in India with deploying product position of their brand due to generic drug product entry of same molecule whose patent has been challenged or expired. The sales data with the virtue of various generic verses branded drugs as well as marketing strategies used by the various generic pharmaceuticals are studied by using the various statistical aspects and theories proposed by various theorist and researchers to reach the final outcome of the study.
3.2 RESEARCH PATHWAYThe sales as well as strategic data of choice organization that is Pfizer Pharmaceutical is evaluated by using inductive research pathway as primary data collection demands the direct
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Dissertation project report involvements of the data source is accordance to research methodology suggested by (Saunders, 2009).
3.3 PHILOSOPHY OF THE RESEARCH:

The following are the three Philosophies used for the research: Positivism: The official website of the Pfizer Pharmaceuticals is evaluated along with the articles, pharmaceutical journals and government drafts, published in various magazines, official websites regarding the issue of patent challenge or expiry and its impact on life cycle of Pfizer products are assessed in order to motivate the researcher for further research is future regarding the context of the issue with positive approach of delivering solution for the mentioned problem. (Saunders, 2009) Phenomenology: The reliability of the data obtained using primary and secondary source are evaluated for its authentication. In accordance to (Saunders, 2009) , the data interpretation techniques are used to evaluate the authentication of the data obtained. Realism: With prospect to motivate the researcher in favor of authentic and honest research, the approach of realism is used which according to (Saunders, 2009) states, whatever researcher predicts in the research is correct.
3.4 STRATEGY OF RESEARCH METHODOLOGY:

The strategy of experimental data collection is used in this research as the research context is entirely dependent on the data obtained directly from the source of data i.e. primary data. In order to implicate the authenticity of the data collected it is assessed directly from source of
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Dissertation project report data which is mainly employees and administrative staff of Pfizer Pharmaceuticals including sales managers, branch managers, territory managers, regional managers, zonal managers, area sales managers and general managers of marketing and sales department. The inductive pathway of data collection is implicated in research as direct involvement of sales team and operational management is mandatory for the research. (Hier J Page A Samouel P, 2007)
3.5 COLLECTION OF DATAObtaining of Primary Data: The primary data conflicts the data obtained directly from its source. In this research the issue of Pfizer Pharmaceuticals in Indian market is highlighted so the primary source of data will be data obtained directly from the employees from various departments of the Pfizer Pharmaceuticals. The electronic media is also used in such data collections by using emails, telephonic conversations, company portals or social media sites like Twitter, Google Hangouts, LinkedIn or Facebook. (Saunders, 2009) Obtaining of Secondary Data: The data obtained from internet indicates the secondary data. In this method survey is conducted by using electronic resources like TV, Internet to access the officially as well as un officially published articles, pharmaceutical journals, advertisements etc. on official company as well enormous other websites and channels of advertisement distribution. Along with it a print media is used which mainly involves magazines and newspapers. Data regarding Lipitor Sales before and after patent expiry is evaluated using the above sources mentioned in order to draw the interim conclusion of the project. (Saunders, 2009)
3.6 METHODLOGY OF SURVEY

Survey as a research approach
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Dissertation project report In survey as research methodology technique the questionnaire is formatted which mainly composed of close and open ended questions in accordance to the context of the research topic and this questionnaire is circulated using electronic source as well as by hand circulation of handouts in key demographics selected for the study (DUTTA S NARASIMHAN O RAJIV, 2004). The designing of open and closed end questions is speculated in following tableTypes of survey questionsTable-3 OPEN END QUESTIONS - The associates alacrity to respond CLOSE END QUESTIONS
positively to the question plays vital role in - These questions are generally articulated such type of questions. The motivation provided by the researcher towards the respondent plays vital role in obtaining focused information from associate for the respondents who provide very less time for research question-answers. Many recommendations and variable data can be provided to respondent while articulating such questions. When the sample size
respondents. - The source of the data is directly involved in such research questions. Such questions motivate the researcher as well as
selected is very large for the research, the close ended questions are used to save the time of the research. The close end questions can provide in variable types like, Yes/No questions, Multiple or list
respondents in favor of providing more information over context of the research question. These questions are very easy to design and deliver.
questions, Variance in dimensions, various scales informative tables. This type of question provides qualitative as well as quantitative data for the research.
(Hier J Page A Samouel P, 2007) (Saunders, 2009)
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Dissertation project report In some cases if the high quality research questions are used and source of data is not in favor to consulate the research questions, the close end questions are vary suitable is such cases as it only deals with Yes/No type of questions, while in other cases were associate respondents are in favor of delivering useful information open ended questions which requires fair amount of explanations are suitable. (DUTTA S NARASIMHAN O RAJIV, 2004) The various attributes of the questionnaire designed like applicability, architecture, acknowledgement of questions designed, are required to be validated from professional as in many cases associate respondents are do not show required co-operation during interviews due to importance of their time. The researcher interest about research is directly reflects in number respondents sampled in research and how many of them responded enthusiastically in favor of research. In such cases the response rate is recorded always high when in personnel distribution of research question handouts is made by researcher and responses are collected in personnel interviews with direct sources. In my choice of research the data regarding impacts of generic entry of branded drugs as well as pharmacy culture evaluating from Ayurveda to Allopathic medicines is studied by sampling the 20 general physicians and 40 Pharmacist who are direct source of information related to drug sales and drug evolutions in Indian Pharmaceutical Market. Merits Direct involvement of data source in order to ensure validness of data obtained. Activity of Market Research undertaken to understand market scenario about product. Authentic data collected direct from source. Academic skills like time management, running meetings, stress management are improved. Direct company or market exposure enables the researcher to motivate for further research
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Dissertation project report De-merits of surveys Loyalty of responses Time required to complete questionnaire Differentiation of the respondents viz. professional, workers, administrative etc.
Company secrecy law due to many of them unable to disclose private informations
regarding company.
3.7 ETHICAL CONFLICTS IN RESEARCH:

The prime ethical issue required to be highlighted in the research is loyalty of associate respondents, as in many cases respondents are not in favor of responding for the long term questions to due to unavailability of time for them and they sometimes do answer randomly which creates doubt about information provided. Another major ethical issue required to be highlighted is, authenticity of the data provided by respondents or collected from official websites, as many of the organizations implicate law of company secrecy in their panoramas, which provokes their professionals from disclosing the sensitive information regarding company under company secrecy law. In order to overcome these issues in my choice of research, the maximum focus is created to close end questions and assurance is given to employees that names of the associates responded will be kept confidential while submitting the project. (Saunders, 2009)
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CHAPTER-4
DATA ANALYSIS AND INTERPRETASTIONS-
4.1 SURVEY PARTICIPANTSIn my choice of research the data regarding impacts of generic entry of branded drugs as well as pharmacy culture evolution from Ayurveda to Allopathic medicines is studied by sampling the 20 general physicians and 40 Pharmacist who are direct source of information related to drug sales and drug evolutions in Indian Pharmaceutical Market. Number of administrative peoples, managers as well as skilled and non-skilled workers responded with enthusiasm in contrast to the statement made by (Kersten W Schrder M Singer C Feser M, 2011)as large scale industries respond devotion while small or medium scale shows deviation towards academic researches and are listed in following tableTable-4 PARTICIPANT IN THE SURVEY DOCTORS CHEMISTS NUMBER OF PARTICIPANTS 20 40
(Created by researcher, 2013)
A) CHEMISTS QUESTIONNAIRE:
Que.1 What is the number of Pfizer Product prescriptions you receive per day on your counter?
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Dissertation project report The sales of Pfizer Pharmaceutical products is depicted from key demographic selected by obtaining the response regarding Pfizer products sales per day with the help of distributing questionnaire to 40 pharmacists by implicating sales range from 0-4, 4-8, 8-12, more than 12 per day. This average sale per day is used to calculate monthly and annual sales data of most running Pfizer Pharmaceutical products in key demography viz. Maharashtra Subdivisions and following interpretations drawnTable-5 No. of Pfizer Product Prescriptions 0-4 4-8 8-12 More than 12 No. of Pharmacists 12 8 10 10 Total 40 Pharmacists
Number of Prescriptions/Day
40% 35% 30% 25% 20% 15% 10% 5% 0% 0 to 4 4 to 8 8 to 12 more than 12 40% 30% 20% 10% Sales
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Figure.5 (Created by researcher, 2013)
Interpretation: 40% of the associate chemists replied that 0-4 Pfizer Pharmaceutical product prescription come at their counter per day. The clear interpretation drawn from above survey that, most of the top selling brands of Pfizer like Becosules, Lipitor, Corex etc. are facing decline stage in India. Findings: 0-4 prescriptions of Pfizer products dispensed by greater number of chemists in the area. Que.2 What is the number of Lipitor Prescriptions received per day on your counter? As per stated in literature, Pfizer has cited huge market share about sales of their prime products like Corex, Becosules, Lipitor and Viagra. These products mainly counts for their average annual sales data superiorly. Due to generic brands entry of these products, their p[rime products have attended maturity state in Market and shows radicle decline in sales after patent expiry situations. In my choice of research focus has been dedicated to case of Lipitor patent expiry and impacts of its generic version entry in market on its sales. The clear focus has been created on competition of branded version of Lipitor and generic versions of Lipitor products. This created an opportunity to highlight on annual sales data of Lipitor in both of its generic as well as branded versions. In order to obtain such data regarding product life cycle of Lipitor, the questionnaire has been circulated to 40 chemists in key demographic viz. Maharashtra, India and associate responses conducted from chemists, which are interpreted as follows by selecting range of 0-4,4-8,8-12 and more than 12 products per day of Lipitor Prescriptions. Table-6 Sale of Pfizer products/day No. of Pharmacists
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Dissertation project report 0-4 4-8 8-12 More than 12 15 15 5 5 Total 40 Pharmacists
Lipitor Sales/Day
40.00% 35.00% 30.00% 25.00% 20.00% 15.00% 10.00% 5.00% 0.00% 0 to 4 4 to 8 8 to 12 more than 12 12.50% 12.50% 37.50% 37.50% Sales
Interpretation: 37.5% of the Pharmacist or the respondents have said that 0-4 and 0-8 Lipitor product sell at their counter per day, which clearly suggest that issues like patent expiry, generic drug entry as well as market saturation has created enormous impact on sales of Lipitor, which led the prime Pfizer Product in decline state in Market with respect to product life cycle. Findings: Lipitor facing decline stage in Indian Pharmaceutical market with most of 37.55 of chemists receiving only 0-4 prescriptions per day.
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Dissertation project report Que.3 Are you aware about Pfizer strategies after patent expiry or generic drug product entry upon their particular molecule viz. Atorvastatin (Lipitor)? As per the research demands, the market research activity is delivered in key demography selected, with the virtue of depicting the market acquaintance about Pfizer products and its marketing strategies they use after their molecule patent expiry or generic drug entry. As per previous discussion, focus has created to patent expiry of Atorvastatin molecule of Pfizer manufacturing Lipitor brand in India, the data is accumulated with the help of questionnaire circulated amongst 40 chemists representatives regarding their awareness about the strategies and product line of Atorvastatin molecule that Pfizer is promoting after patent expiry or generic drug product entry in same market. Table-7 Awareness about Lipitor Yes No No. of Pharmacists 18 22 Total 40 Pharmacists
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Awareness about Pfizer Product and Strategies

60% 50% 40% 30% 20% 10% 0% Yes No 45% 55% Sales
Interpretation: 55% of the associate respondents responded that they are not aware about promotions or strategies altered by Pfizer regarding their patent expired Atorvastatin Molecule product line viz. Lipitor after generic entry. While 45% of market is aware about strategies that Pfizer has designed to reconstruct its brand Lipitor market position by using lows cost strategy, product value adding strategy or customer oriented sales strategy (Discounts, offers etc.) Findings: Superiority of market is unaware about strategies that Pfizer Pharmaceutical adopts and promotes after patent expiry or generic drug product entry of their any drug molecule. Question-4 Is Pfizer Pharmaceutical Products and Services are cogent in key demographic selected, with respect to retain their existing customers and attract new group of customers? As per previous discussions made in research, Pfizer has adopted strategy of emphatic competition by research and development of new molecules in market in order to attain competitive advantage over their competitors by being first in market. They alter this strategy
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Dissertation project report to attract and retain their customers. Pfizer adopts strategy of lows cost products to their customers once they lose their patents, in order to stay competitive to generic drug product entries in market as market gets saturated as soon as patent of any molecule expires. They saturate the market by using product differentiation strategy, and thus produce many products n same market with different names in order to saturate market with their brands and also present themselves unique by providing excellent quality products and services at lower costs possible. With respect to above discussion, an opportunity has created to analyse the Pfizer market trends effectiveness in key demographics selected by sampling 40 chemists in market and distributing close end questionnaire amongst them in order to collect data regarding above question and interpretations are drawn as followsTable-8 Effective Strategies by Pfizer Yes No No. of Pharmacists 18 22 Total 40 Pharmacists
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Effectiveness of Pfizer Products and Services

60% 50% 40% 30% 20% 10% 0% Yes No 45% 55% Sales
Interpretation: Out of all associate responses 55% of the respondents are convinced that Pfizer products and services are not cogent in key demographic selected, with respect to retain their existing customers and attract new group of customers, still they are more effective in order to gain competitive advantage over their competitors by following strategy of research and development in their firm.
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B) DOCTORS QUESTIONNAIREThe key backbone of any pharmaceutical business are doctors, thus the data regarding sales of any pharmaceutical product is entirely revolves around brand image of any pharmaceutical organisations product as per Prescription system designed by government of India. The doctor prescribes the brand name or molecule name on his registered prescription and on the basis of that pharmacist dispense the medicine or molecule drug product prescribed, so the role of doctor in pharmaceutical business is very vital element of business. The revenue generation of any pharmaceutical firm revolves around what doctor pretends about their products. With the virtue of this discussion, the research requires the doctors opinion about the brand or organisation studied in this research i.e. Pfizer Pharmaceuticals and its products. In this research sample of 20 doctors selected from key demography and questionnaire is circulated amongst them and data is collected in interview format and results interpreted as followsQue1. Do you prescribe products of Pfizer Pharmaceuticals every day? As per previous discussion doctors are backbone of pharmaceutical business, thus image of Pfizer pharmaceuticals with respect to therapeutic use and quality of Pfizer products in their opinion plays vital role in business of Pfizer. Also due to patent expiry issue, market has saturated with numerous option are now available for the doctors while prescribing any companys brand. This created intense competition in market. Thus data regarding doctors everyday general practise is essential for this research. With the virtue of this above question is designed and circulated in key demography by selecting sample of 20 doctors in order to check loyalty and doctors favour towards Pfizer Products against its generic drug product versions in available in market.
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Dissertation project report Table-9 Doctors Response Yes No No. of Doctors responded 24 16 Total 40 Pharmacists
Do you prescribe Pfizer Pharmaceuticals Products every day?

60% 50% 40% 30% 20% 10% 0% Yes No 40% 60% Sales
Interpretation: Out of all responses 60% of the doctors in key demographic do not prescribe Pfizer Products every day due issue of patent expiry, higher costs and number of options available in its generic versions at lower costs in key demography, while 40% of the doctors do prescribe Pfizer Products due to GMP practises followed in Pfizer and Good Manufacturing Practises they use while manufacturing their products.
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Findings: The higher cost products due to research base nature and availability of number of low cost generic drug products in market, doctors do prefer generic drug product versions rather than higher costs products of Pfizer Pharmaceuticals, and this leads the Pfizer products to decline stage in market.
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Que.2 What are the drug molecule prescription criteria you follow while prescribing particular molecule or brands? Table-10
Criterias for prescribing molecule or brand
No.
of
doctors
responses I. Scientific data provided based on 3 evidences II. Own Practise experiences about 2-3 molecules effectively III. Opinion particular doctors IV. Promotion strategies used by company or medical representatives V. Other 5 Total 20 General Physicians
and
average by
use
of 5
molecule
senior
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25% 20% 15% 25% 10% 15% 5% 0% I III III 15% 20% 25% Sales
Iv
InterpretationOut of all responses obtained, 15% of the doctors prescribe any molecule or particular data on the basis of scientific data provided by the organisation regarding research and development of particular molecule or product, while 25% of the physicians do prescribe by taking in consideration their won practise as well as molecules or product brands suggested by the senior doctors. In case of such physicians there is no impact of product price or generic drug entry taken in considerations, while other 20% of the doctors do prescribe any particular product or molecule on the basis of various elements like product quality, GMP practises, cost effectiveness and pharmacokinetic as well as pharmacodynamics aspects of the molecule. In my choice of organisations, Pfizer follows GMP practises as well as they provide ample scientific data and evidences with their products in market. This made them top ranking organisation in India, but they are still lagging behind in issues like patent expiry or generic drug entry of their molecules which had led down their product sales in market.
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Dissertation project report Findings: Majority of doctors give consideration to cost effectiveness as well as brands suggested by senior doctors. Que.3 Que.3 Are you aware about Pfizer strategies after patent expiry or generic drug product entry upon their particular molecule viz. Atorvastatin (Lipitor)? As per the research demands, the market research activity is delivered in key demography selected, with the virtue of depicting the doctors acquaintance about Pfizer products and its marketing strategies they use after their molecule patent expiry or generic drug entry. As per previous discussion, focus has created to patent expiry of Atorvastatin molecule of Pfizer manufacturing Lipitor brand in India, the data is accumulated with the help of questionnaire circulated amongst 20 Doctors as representatives regarding their awareness about the strategies and product line of Atorvastatin molecule that Pfizer is promoting after patent expiry or generic drug product entry in same market. Table-11 Awareness about Lipitor Yes No No. of Doctors Responded 8 12 Total 20 Doctors
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Awarennes about Pfizer Products and Strategies

60% 50% 40% 30% 20% 10% 0% Yes No 40% 60% Sales
Interpretation: Out of all responses obtained 60% of the associate doctors responded that they are not aware about promotions or strategies altered by Pfizer after their patent expired on Atorvastatin molecule viz. Lipitor after generic drug products entry in market. While 40% of doctors are aware about strategies that Pfizer has designed to reconstruct its brand Lipitor market position by using low cost strategy, product value adding strategy or customer oriented sales strategy (Discounts, offers etc.) Findings: Superiority of market is not aware about strategies that Pfizer Pharmaceutical adopts and promotes after patent expiry or generic drug product entry of their any drug molecule.
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Dissertation project report Question-4 Is Pfizer Pharmaceutical Products and Services are cogent in key demographic selected, with respect to retain their existing customers and attract new group of customers? As per previous discussions made in research, Pfizer has adopted strategy of emphatic competition by research and development of new molecules in market in order to attain competitive advantage over their competitors by being first in market. They saturate the market by using product differentiation strategy, and thus produce many products n same market with different names in order to saturate market with their brands and also present themselves unique by providing excellent quality products and services at lower costs possible. With respect to above discussion, an opportunity has created to analyse the Pfizer market trends effectiveness in key demographics selected by sampling 20 doctors in market and distributing close end questionnaire amongst them in order to collect data regarding above question and interpretations are drawn as followsTable-12 Effective Strategies by Pfizer Yes No No. of doctors 11 9 Total 20 doctors
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Effectiveness Of Pfizer Products and Services

60% 50% 40% 30% 20% 10% 0% Yes No 45% 55% Sales
Interpretation: Out of all associate doctors responses 55% of the respondents are convinced that Pfizer products and services are not cogent in key demographic selected, with respect to retain their existing customers and attract new group of customers, still they are more effective in order to gain competitive advantage over their competitors by following strategy of research and development in their firm. Findings: Most of the chemists are not convinced with product and services of Pfizer Pharmaceuticals due to higher cost, research base operations and market saturation strategy with same product line.
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CHAPTER 5
FINDINGS AND RECOMMENDATIONS
5.1 INTRODUCTION
The entire scenario of the research is inspected in this research section. The section speculates the research outcomes with the virtue of citing the research findings and objectives achieved from the entire research and research methodology. This section of research depicts the future research which can further elaborates this study as well it will benefit individual organization by providing recommendations for improvement upon its market operations.
5.2 FINDINGS
With respect to study carried n various sections of the research, researcher came to find following aspect of the entire research scenario with respect to context of the research problem cited in this research1) The Indian Medicinal System has developed from Ancient Medicinal System used around the globe. 2) The base of the Indian Medicinal System is Ayurveda which further elaborated in various medicinal systems like Siddha, Unani, Homeopathy and allopathic medicinal system 3) The Allopathic medicinal system adopted by Indian Medicinal System from British Medicinal System, still resembles with traditional medicinal system Ayurveda which is operating India since many thousand years and entirely developed from natural drug resources like plants, herbs, churns and construct of mainly three elements vata, pitta, and doshas. 4) The various terms used in Allopathic Medicinal System shows relevance to traditional Indian Medicinal system Ayurveda, for example ophthalmology, otorhinolaryngology,
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Dissertation project report grahabadha means psychiatry, kaumarabhritya resembles to obstetrics, gynecology and pediatrics, agadatantra is science similar to modern toxicology, rasayana is related to rejuvenation and vajikarana is similar to aphrodisiacs and treatment of sexual diseases. 5) The Indian Patent Act, 1972, had created actual revolution in Indian Pharmaceutical Business and patent expiry or patent challenge period reduce to 15 years had allowed generic drug product enter in Indian Pharmaceutical market which has made Indian Pharmaceutical Business as prime base of Indian Economy in terms of domestic sales growth along with FDI growth in India. 6) The product life cycle of Pfizer Pharmaceutical products is facing decline stage due to patent expiry issues which led generic firms to enter the market with low generic versions of Pfizer products. 7) The number one selling brand of Pfizer that is Lipitor (Atorvastatin) is facing decline stage due to patent relief over Atorvastatin, and adopted market saturation due to low cost generic production of it.
5.3 RECOMMENDATIONS:
1) Awareness about the Pfizer products and services should be created amongst its prime customer identified i.e. doctor and chemists by using leaflets, internet media and electronic media. 2) Customer relationship should be followed in strongly by Pfizer Pharmaceuticals in order to stay connected with their customers during each new molecule research and development as they are research based organisations. 3) The Human resource should be added with respect to addition in trained medical representatives. 4) With the help of seminar and product, company portfolios, intense awareness must be speculated in senior doctors in order to set monopoly in market as most of the doctors do follow senior doctor practises and trusted brands prescribed by them.
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Dissertation project report 5) Seminar, CMEs as well as annual or monthly doctor meets must be increased with respect to stay sound in market while adopting new strategies or launching new products during patent issues or generic drug product entries in market. 6) In depth marketing and market research activities must be carried by company professionals in order to stay awake about latest market trends or designing to set new market trends.
5.4 FUTURE WORK:

The research carried had achieved all of its objectives set with the virtue of research problem speculated in earlier part of research. Despite of many limitations to the research, researcher had succeeded to deliver his best in the research, to conclude the interim conclusion of the research study. The researcher is looking further to elaborate the research more in depth if project deadline increased and further research study is funded. The more in depth study of Traditional Medicinal System used in around the world can be studied rather than just focusing on Indian Medicinal System. The researcher had created an opportunity for further research to study how pharmacy culture evolved around the world and what are the ancient medicinal systems used before evolution of allopathic medicinal system. Researcher is keen interested to focus on studying impact of generic drug entry on global pharmaceutical sector rather than just considering single case of Pfizer Pharmaceutical in India, if word limit and funds are made available for the research studies.
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Conclusion
In correspondent to all the research carried and interviews conducted, I came to conclude that Indian Pharmaceutical market is in extra=ordinary development state with respect to evolution and financial state. The various literatures studied in the research, clearly stated the evolution of Indian Medicinal System from Ayurveda to Allopath and further market revolution to generic drug entry after patent expiry. I came to conclude that, the medicinal system in India shows clear influence of Ayurveda over it, though it has adapted to allopath in recent era from British medicinal system. Ayurveda, Siddha and Unani are base for the development of Modern Indian Medicinal System. From various literatures and methodology of survey carried I came to conclude that generic drug entry has made the drug pricing very critical issue and they have impacts on revenue generation or both branded and their won drug manufacturers by proving intense market competition by saturating the market with molecule drug product whose patent is revealed. While studying case of Pfizer Pharmaceuticals with respect to patent release of Atorvastatin Molecule brand Lipitor, I came to conclude that Pfizer is facing decline stage in Indian pharmaceutical market and they must review their strategies regarding their product and services in Indian market. In the end I came to conclude their still lot of scope to study in deep of research context i.e. evolution of pharmacy culture in India right from Ayurveda to Generic drug entry in Indian Pharmaceutical Market and can be proved revolutionary study in Indian Pharmaceutical market if future if further studied.
REFERENCES1. Jayasundar R, April 2010, Current Science, Vol-98, Ayurveda: a distinctive approach to health and disease, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110 608, India. 2. Reported in Financial Express. 5th September,2009 and Economic Times.,19th August, 2009. The price difference for example, in the case of Cipla v/s Roche Roche sells Tarceva for Rs.4500 per tablet while Ciplas generic is sold at Rs.1500 per table.
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Anonymous (2001). The Ayurvedic Pharmacopoeia of India. Part-I, Volume-III, Ministry of Health and Family Welfare, Govt. of India, New Delhi.
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Magazzini L, Pammolli F, Riccaboni M (2004).Dynamic Competition in Pharmaceuticals: Patent Expiry, Generic Penetration, and Industry Structure." The European Journal of Health Economics, 5, 175{182.
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(Reiffen, 2005) Generic Drug Industry Dynamics, Review of Economics and Statistics 87(1):37-49.
Jorge Gonzalez, Catarina Sismeiro , Shantanu DuttA, Philip Stern,2007, Can branded drugs benefit from generic entry? The role of detailing and price in switching to nonbioequivalent molecules. Journal homepage: www. elsevier.com/locate/ijresmar. 7. Drug expenditures have increased by over 8.5% per year during the period
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2001-2011; whereas overall health expenditures have increased
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approximately 6.5% over the same period. Berndt, Ernst R. and Murray L. Aitken. 2011. Brand Loyalty, Generic Entry, and Price Competition in the Quarter Century after the 1984 Waxman-Hatch Legislation, International Journal of the Economics of Business 18(2):177-201.
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Generic Drug Industry

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Coursework Header Sheet 209840-126

Course Coursework Tutor

Course School/Level Assessment Weight Submission Deadline

BU/PG 0.00% 30/09/2013

Final Grade_________ Date _______________

INTRODUCTION TO TRADITIONAL MEDICINAL 13 SYSTEM

2.3.1 2.3.2 2.3.3 2.4

AYURVEDA SIDDHA UNANI

RELEVANCE OF TRADITIONAL MEDICINAL 16 SYSTEM TO MODERN MEDICINAL SYSTEM

GENERIC DRUG INDUCTION GENERIC DRUG VS BRANDED

OVERVIEW 2.9.1 2.9.2 PRODUCT LIFE CYCLE PFIZER PHARMACEUTICALS 27 MARKET 28

Dissertation project report 5 RESEARCH FINDINGS, FUTURE WORK,

Dissertation project report 12. Doctors Questionnaire Question.4

1.1 RESEARCH INTRODUCTION/ RESEARCH BACKGROUND:

1.2 OBJECTIVES OF THE RESEARCH:

1.3 IMPORTANCE OF RESEARCH:

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1.4 RESEARCH COMPLICATION:

1.5 RESEARCH QUESTIONS:

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1.6 DRAWBACKS OF THE RESEARCH:

1.7 OUTLINE OF THE INDIAN PHARMACEUTICAL INDUSTRY:

12 10 8 4.7 6 4 2 0 Formulations (Generic and Patented) 4.4 10.4 2007-2011 2001-2002

API and Intermediates

Figure.1 Indian Pharmaceutical Industry in US$ billion

Dissertation project report

comprises of privately owned organizations and branches of multinational operators. These

Dissertation project report

Source: (Padmashree Gehl Sampath, 2010-2011)

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CRITICAL LITERATURE REVIEW

2.1 STRATEGY FOR THE LITERATURE REVIEW

2.3 INTRODUCTION TO TRADITIONAL MEDICINAL SYSTEM OF INDIA-

2.5 GENERIC DRUGS INDUCTION:

2.6 GENERIC DRUGS VS BRANDED DRUGS COMPETITION:

2.8 DRUG REGULATORY AFFAIRS

Dissertation project report

2.8.1 THE INDIAN PATENT ACT, 1970:

Procedure for Pricing Generic Drug Product:

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2.9 PFIZER PHARMACEUTICALS STRATEGIC OVERVIEW:

2.9.1 PRODUCT LIFE CYCLE:

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Figure 3. (Created by researcher, 2013)

Dissertation project report

2.9.2 PFIZER PHARMACEUTICALS MARKET SEGMENTATION:

3.3 PHILOSOPHY OF THE RESEARCH:

3.4 STRATEGY OF RESEARCH METHODOLOGY:

3.6 METHODLOGY OF SURVEY

(Hier J Page A Samouel P, 2007) (Saunders, 2009)

3.7 ETHICAL CONFLICTS IN RESEARCH:

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DATA ANALYSIS AND INTERPRETASTIONS-

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Figure.6 (Created by researcher, 2013)

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Awareness about Pfizer Product and Strategies

Figure.7 (Created by researcher, 2013)

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Effectiveness of Pfizer Products and Services

Figure.8 (Created by researcher, 2013)

Final Grade_ Date _______