generic drug industry

8/13/2019 Generic drug Industry

http://slidepdf.com/reader/full/generic-drug-industry 1/59



Dissertation project report

2

Coursework Header Sheet

209840-126

Course BUSI1359: Pathway Specialisation Project Course School/Level BU/PG

Coursework Dissertation (Sep 2012 starters) Assessment Weight 0.00%

Tutor AC Van Klyton Submission Deadline 30/09/2013

Coursework is receipted on the understanding that it is the student's own work and that it has not,in whole or part, been presented elsewhere for assessment. Where material has been used from

other sources it has been properly acknowledged in accordance with the University's Regulations

regarding Cheating and Plagiarism.

000738302 Ganesh Takale

Tutor 's comments

Grade Awarded___________ For Off ice Use Only__________ F inal Grade_________

Moderation requi red: yes/no Tutor______________________ Date _______________




3

TABLE OF CONTENTS-

SR. NO. CONTENTS PAGE NUMBERS

COVER PAGE 1

ACKNOWLEDGEMENT 2

LIST OF FIGURES AND DIAGRAMS 3

LIST OF ABBREVIATIONS 4

SUMMERY OF PROJECT 4

1 INTRODUCTION

1.1 INTRODUCTION/BACKGROUND 5

1.2 OBJECTIVES OF RESEARCH 5

1.3. IMP[ORTANCE OF THE RESEARCH 6

1.4 RESEARCH COMPLICATIONS 7

1.5 RESEARCH QUESTIONS 7

1.6 DRAWBACKS OF THE RESEARCH 7

1.7 OUTLINE OF INDIAN PHARMACEUTICAL

INDUSTRY

8

2 LITERATURE REVIEW 122.1 INTRODUCTION 12

2.2 STRATEGY OF LITERATURE REVIEW 12

2.2 INTRODUCTION TO TRADITIONAL MEDICINAL

SYSTEM

13

2.3.1 AYURVEDA 13

2.3.2 SIDDHA 14

2.3.3 UNANI 15

2.4 RELEVANCE OF TRADITIONAL MEDICINAL

SYSTEM TO MODERN MEDICINAL SYSTEM

16

2.5 GENERIC DRUG INDUCTION 17

2.6 GENERIC DRUG VS BRANDED DRUG 18




4

COMPETITION IN INDIA

2.7 PRICING OF DRUGS 19

2.8 DRUG REGULATORY AFFAIRS 20

2.8.1 INDIAN PATENT ACT,1970 212.8.2 DRUG PRICE CONTROL ACT (DPCO) 21

2.9 PFIZER PHARMACEUTICALS STRATEGIC

OVERVIEW

25

2.9.1 PRODUCT LIFE CYCLE 27

2.9.2 PFIZER PHARMACEUTICALS MARKET

SEGMENTATION

28

3 RESEARCH METHODOLOGY 29

3.1 INTRODUCTION OF RESEARCH

METHODOLOGY

29

3.2 RESEARCH PATHWAY 29

3.3 PHILOSOPHIES OF RESEARCH METHODOLOGY 30

3.4 STRATEGY FOR RESEARCH METHODOLOGY 31

3.5 METHODOLOGY OF SURVEY 32

3.6 COLLECTION OF DATA 32

3.7 ETHICAL CONFLICTS OF THE RESEARCH 34

4 DATA ANALYSIS AND INTERPRETATIONS 35

A) CHEMISTS QUESTIONNAIRE 36

B) DOCTORS QUESTIONNAIRE 43




5

5 RESEARCH FINDINGS, FUTURE WORK,

RECOMMENDATIONS

5.1 INTRODUCTION 53

5.2 FINDINGS 53

5.3 RECOMMENDATIONS 54

5.4 FUTURE WORK 54

CONCLUSION 55

BIBLIOGRAPHY/REFERENCES 56

APPENDIX

List of Tables

1. Table of Contents

2. India’s 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



9. Doctors Questionnaire Question.1






6


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

PA—Patent Act

SUMMARY OF THE PROJECT-

The 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 contempt’s critical

literature review carried over research issue. The various articles journals and official




7

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 Words-

Traditional 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 evolutions 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




8

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 toallopathic 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




9

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?




10

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)




11

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 17th

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

Figure.1 Indian Pharmaceutical Industry in US$ billion

According to different survey information 3

rd

biggest market in the world with respect tovolume 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

0

2

4

6

8

10

12

Formulations (Generic and

Patented) API and Intermediates

4.4

0.9

4.7

10.4 2007-2011

2001-2002




12

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

Figure.2 (Created by researcher, 2013)

Table.2

India’s pharmaceutical firms, by size, sales, function, exports, and R&D capabilities

Grouping Number of Firms Descriptions

Large Scale 100 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

0%

10%

20%

30%

40%

50%

60%

70%

80%

Bulk Drug

Formulations

Bulk Drug,

20%

Formulations,

80%




13

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 incontract 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 semi-

regulated pharmaceutical markets as they do not

comply with GMP standards of regulated market.

Source: (Padmashree Gehl Sampath, 2010-2011)




14

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 organization’s 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




15

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 re-

establish balance between the “Dosha”.




16

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

‘ panchamahabhutas’and ‘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.




17

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 oftreatments 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 ishighly 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 people’s

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:




18

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 SYSTEM-

Today, 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




19

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 plant’s 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.

http://en.wikipedia.org/wiki/Medication

http://en.wikipedia.org/wiki/Medication




20

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 Gleevic is most originative variantcompared 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 ofappeal 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 toproduce 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

http://en.wikipedia.org/wiki/Statutory_interpretation

http://en.wikipedia.org/wiki/Statutory_interpretation




21

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 DRUGS-

Interpretations 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 doesn’t 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.




22

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 product-

specific 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




23

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 non-

schedule 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)




24

(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 pricing-

- PL (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:




25

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).




26

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 Pfizer’s brand Becosules is targeted.




27

C) Positioning: Pfizer for their brand support implement Positioning strategies. Pfizer’s brand

ATIVAN drug taking care of sleep disorder is positioned as “Anti -anxiety” Becosules-A B-

complex 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 co-

branding 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 doctor’s

loyalty towards companies brand and organizations are concentrating on the same.

(www.pfizerindia.com, 2013)

2.9.1 PRODUCT LIFE CYCLE:




28

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 Pfizer’s 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 Pfizer’s 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

Introduction

Grwoth

Maturity

Saturation

Decline




29

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




30

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 PATHWAY-

The 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




31

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 usedto 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




32

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 DATA-

Obtaining 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 bedata 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




33

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 table-

Types of survey questions-

Table-3

OPEN END QUESTIONS CLOSE END QUESTIONS

- The associate’s alacrity to respond

positively to the question plays vital role in

such type of questions. The motivation

provided by the researcher towards the

respondent plays vital role in obtaining

focused information from associate

respondents.

- The source of the data is directly involved in

such research questions. Such questions

motivate the researcher as well as

respondents in favor of providing more

information over context of the research

question. These questions are very easy to

design and deliver.

- These questions are generally articulated

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

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

questions, Variance in dimensions, various

scales informative tables. This type of

question provides qualitative as well asquantitative data for the research.

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




34

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




35

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 information’s

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)




36

CHAPTER-4

DATA ANALYSIS AND INTERPRETASTIONS-

4.1 SURVEY PARTICIPANTS-

In 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 Schröder 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 table-

Table-4

PARTICIPANT IN THE SURVEY NUMBER OF PARTICIPANTS

DOCTORS 20

CHEMISTS 40


A) CHEMISTS QUESTIONNAIRE:

Que.1

What is the number of Pfizer Product prescriptions you receive per day on your counter?




37

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 drawn-

Table-5

No. of Pfizer Product Prescriptions No. of Pharmacists

0-4 12

4-8 8

8-12 10

More than 12 10

Total 40 Pharmacists


0%

5%

10%

15%

20%

25%

30%

35%

40%

0 to 44 to 8

8 to 12more than 12

40%

30%

20%

10%

Number of Prescriptions/Day

Sales




38


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




39

0-4 15

4-8 15

8-12 5

More than 12 5Total 40 Pharmacists



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.

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

40.00%

0 to 44 to 8

8 to 12more than 12

37.50%37.50%

12.50%12.50%

Lipitor Sales/Day

Sales




40

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 No. of Pharmacists

Yes 18

No 22






41


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, withrespect 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

0%

10%

20%

30%

40%

50%

60%

Yes

No

45% 55%

Awareness about Pfizer Product and

Strategies

Sales




42

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 follows-

Table-8

Effective Strategies by Pfizer No. of Pharmacists

Yes 18

No 22






43


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 anddevelopment in their firm.

0%

10%

20%

30%

40%

50%

60%

Yes

No

45% 55%

Effectiveness of Pfizer Products and Services

Sales




44

B) DOCTOR’S QUESTIONNAIRE -

The key backbone of any pharmaceutical business are doctor’s, 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 follows-

Que1.

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

company’s brand. This created intense competition in market. Thus data regarding doctor’s

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 doctor’s favour towards Pfizer Products against its generic drug product versions in

available in market.




45

Table-9

Doctors Response No. of Doctors responded

Yes 24

No 16




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.

0%

10%

20%

30%

40%

50%

60%

Yes

No

40%60%

Do you prescribe Pfizer Pharmaceuticals

Products every day?

Sales




46

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.




47

Que.2

What are the drug molecule prescription criteria you follow while prescribing particular

molecule or brands?

Table-10


Criteria’s for prescribing molecule or brand No. of doctors

responses

I. Scientific data provided based on

evidences

3

II. Own Practise experiences about

molecules effectively

2-3

III. Opinion and average use of

particular molecule by senior

doctors

5

IV. Promotion strategies used by

company or medical

representatives

5

V. Other 5

Total 20 General

Physicians




48


Interpretation-

Out 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.

0%

5%

10%

15%

20%

25%

IIII

IIIIv

v

15%15%

25%

20%

25% Sales




49

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 No. of Doctors Responded

Yes 8

No 12

Total 20 Doctors





50


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 Lipitormarket 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.

0%

10%

20%

30%

40%

50%

60%

Yes

No

40%60%

Awarennes about Pfizer Products and

Strategies

Sales




51

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 follows-

Table-12

Effective Strategies by Pfizer No. of doctors

Yes 11

No 9

Total 20 doctors





52


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 researchand 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.

0%

10%

20%

30%

40%

50%

60%

Yes

No

45% 55%

Effectiveness Of Pfizer Products and Services

Sales




53

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 byproviding 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 research-

1) 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, churn’s 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,




54

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 portfolio’s, 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.




55

5) Seminar, CME’s 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.




56

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.

REFERENCES-

1. 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 Cipla‟s generic is sold at

Rs.1500 per table.




57

3. Anonymous (2001). The Ayurvedic Pharmacopoeia of India. Part-I, Volume-III,

Ministry of Health and Family Welfare, Govt. of India, New Delhi.

4. 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.

5. (Reiffen, 2005) “Generic Drug Industry Dynamics,” Review of Economics and

Statistics 87(1):37-49.

6. 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 non-

bioequivalent molecules”. Journal homepage: www. elsevier.com/locate/ijresmar.

7. Drug expenditures have increased by over 8.5% per year during the period

2001-2011; whereas overall health expenditures have increased by

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.

8. Prasad, L.V. (2002). Indian System of Medicine and Homoeopathy Traditional

Medicine in Asia. Ranjit Roy Chaudhury and Uton Muchatar Rafei Eds. WHO-

Regional Office for South East Asia- New Delhi. PG-283-286.

9. DPCO ACT INDIA (http://pharmaceuticals.gov.in/DPCO2013.pdf).

10. The First Schedule, List of Price Controlled Drugs, Drug Prices Control Order

(1995).[Online] [Cited: 1 November 2010.]

http://nppaindia.nic.in/drug_price95/txt9.html;(http://www.pwc.in/assets/pd

fs/pharma/PwC-CII-pharma-Summit-Report 22Nov.pdf ).

11. Dubey J, Dubey R, 2010, “Pharmaceutical innovation and generic challenge: recent

trends and causal factors Institute of Public Enterprise”, Osmania University,Hyderabad, India, and Dr Reddy’s Laboratories Ltd, Hyderabad, India .

12. M. Mazumdar, Performance of Pharmaceutical Companies in India,

Contributions to Economics, DOI 10.1007/978-3-7908-2876-4_2, # Springer-

Verlag Berlin Heidelberg 2013.

http://pharmaceuticals.gov.in/DPCO2013.pdf

http://nppaindia.nic.in/drug_price95/txt9.html

http://www.pwc.in/assets/pdfs/pharma/PwC-CII-pharma-Summit-Report%2022Nov.pdf






http://nppaindia.nic.in/drug_price95/txt9.html





58

13. Indian Pharmaceutical Industry-Diagnostic Overview,

(http://ijppronline.in/journal/July_2013_Volume-4_Issue-1-articleNo-8.pdf).

14. INDIANPHARMACEUTICALINDUSTRY

(http://www.in.kpmg.com/pdf/indian%20pharma%20outlook.pdf).

15. http://planningcommission.gov.in/aboutus/committee/wrkgrp12/wg_pharma

2902.pdf

16. Jayachandran, S., Nevins, J.L., & Bearden, W.O. (2003), “Market share

retention after generic entry in a complex buying system: The case of

pharmaceutical brands,”working paper.

17. http://pharmaceuticals.gov.in/DPCO2013.pdf

18. Krishnankutty Varier, N. V., History of Ayurveda, Kottakkal Ayurveda Series: 56,

Arya Vaidya Sala, Kottakkal, 2005.

19. Gleckman, H. (2002, May 27). The backlash against big pharma. Business Week

Onlineaccessible at http://www.businessweek.com

20. (DUTTA S NARASIMHAN O RAJIV, 2004), conceptualizing and measuring

capabilities: methodology and empirical application, Strategic Management

Journal, V-26, 277-285.

21. Aronsson, T., Bergman, M. A., & Rudholm, N. (2001, December). The impact ofgeneric drug competition on brand name market shares — Evidence from

micro data. Review of Industrial Organization, 19(4), 425−435.

22. Reiffen, David and Michal R.Ward, 2005, Generic Industry Dynamics, review of

Economics and Statistics, 37-49.

23. www.pfizerindia.com, 2013.

24. Caraka Samhita, Sharira Sthāana, Chaukhamba Sanskrit Series Office, Varanasi,

India, 2001.25. Ashtanga Samgraha of Vagbhata, Sutra Sthānam, Chaukambha Orientalia,

Varanasi, India, 2005, Chapter 1, slokas 26 –28.

26. Ravishankar and Shukla Afr. J. Trad. CAM (2007), INDIAN SYSTEMS OF

MEDICINE: A BRIEF PROFILE, Pharmacology Laboratory, Institute of PG

http://ijppronline.in/journal/July_2013_Volume-4_Issue-1-articleNo-8.pdf

http://www.in.kpmg.com/pdf/indian%20pharma%20outlook.pdf

http://planningcommission.gov.in/aboutus/committee/wrkgrp12/wg_pharma2902.pdf








http://www.in.kpmg.com/pdf/indian%20pharma%20outlook.pdf

http://ijppronline.in/journal/July_2013_Volume-4_Issue-1-articleNo-8.pdf




Teaching and Research In Ayurveda IPGT and RA- Gujarat Ayurved University,

Jamnagar, India.

27. Government of India, 2013, Department of AYUSH

http://indianmedicine.nic.in/index2.asp?slid=117&sublinkid=59&lang=1.

28. Gönül, F., Carter, F., Petrova, E., & Srinivasan, K. (2001). Promotion of

prescription drugs and its impact on physicians’ choice behavior. Journal of

Marketing, 65, 79−90.

http://indianmedicine.nic.in/index2.asp?slid=117&sublinkid=59&lang=1

http://indianmedicine.nic.in/index2.asp?slid=117&sublinkid=59&lang=1

generic drug industry

Documents