Final Report Shailaja

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MUMIBS

2009

MARKET SURVILLANCE

OF STRONG KIT

SUBMITTED BY: SHAILAJA BHARATI

I N D C H E M I E H E A L T H S P E C I A L I T I E S P V T L T D .


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MARKET SURVILLANCE OF STRONG KIT

ii

IBS MUMBAI SUBMITTED BY: SHAILAJA BHARATI

A REPORT

ON


By

(SHAILAJA BHARATI - 08BS0003059)

Approved By

(Prof. S S NAYAK)

Submitted in partial fulfillment of the requirements

For the degree of MBA

ICFAI BUSINESS SCHOOL

MUMBAI

2009

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CERTIFICATE

Project Entitled : MARKET SURVILLANCE OF STRONG KIT

Submitted By : SHAILAJA BHARATI (08BS0003059)

This is to certify that the above mentioned student have successfully

completed the Project required in partial fulfillment of the requirement of

MBA Program of ICFAI BUSINESS SCHOOL during the academic year

2009.

Company Guide Faculty Guide

(Mr. Shishir Kumar Sinha) (Prof S S Nayak)

Date: ___________


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ACKNOWLEDGEMENT

Many people contributed in making my project a success. My Project is primarily the vision of

Mr. NANA RAO (Deputy General Manager of Indchemie Health Specialities Pvt. Ltd) who

initially defined the project, articulated its implementation as a resource, and determined its scale

and scope.

Thanks are also in line towards my Company Guide and MARKETING MANAGER of

Indchemie Health Specialities Pvt. Ltd, Mr. SHISHIR KUMAR SINHA. His untiring and able

guidance gave me the confidence and motivation to go forward with this daunting task.

I would also like to thank Mr. SUNIL KUMAR, Product Manager of Indchemie Health

Specialities Pvt. Ltd,for the exhaustive support provided and the confidence which he showed in

me.

My project would not have been a success without the help of Mr. AMIT A. JHADAV, Area

Sales Manager (Central Region), Mr. PANKAJ KUMAR MISHRA (Sales Representative),

Mr. ANUPAM KUMAR (Sales Representative), Mr. VINAY KUMAR MISHRA (Sales

Representative), Mr. PANKAJ KUMAR (Sales Representative), & Mr. SANJIV KUMAR

(Sales Representative),

A project of this enormity and complexity requires the dedication of a number of individuals.

OurFaculty Guide Prof S S NAYAKhas always been present as a guiding light whenever dead

ends were encountered.

I would also like to express my gratitude to our SIP Co-coordinator, Prof G.C. NAG for

providing us his valuable time and helping us in our study.

Finally, appreciation is expressed to all the Colleagues of Indchemie Health Specialities Pvt.Ltd for their continued support throughout.

Least but not the last a sincere thanks to all the Doctors, my Parents, my God, and my Friends.


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TABLE OF CONTENT

FRONTISPIECE ii

CERTIFICATE iii

ACKNOWLEDGEMENT

TABLE OF CONTENT v

LIST OF TABLES ix

LIST OF PICTURES vii

SUMMARY

A Short History of Medicine 1

1. ABOUT THE PHARMACEUTICAL INDUSTRY 2

1.1 History 2

1.2 Research and Development 4

1.2a Drug Discovery 4

1.2b Drug Development 4

1.2b Cost of Innovation 5

1.3 Product Approval in US 5

1.4 Pharmaceutical Industry and the Patent System 6


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1.4a what is Patent? 6

1.4b Global institution responsible for administering the Patent System 7

1.4c Special Problem of the Pharmaceutical Industry 7

1.4d In Future IPRs with Pharmaceutical Industry 7

1.5 Pharmaceutical Marketing 8

1.5a Direct and Indirect Marketing to Health Care Providers 8

1.5a1 Individual Research 9

1.5a2 Peer Influence 9

1.5a3 Direct Physician contact with pharmaceutical sales representative 9

1.5a4 Physician Targeting 10

1.5a5 Opinion Leader Influence Mapping 10

1.5a6 Sales Force Size and Structure 11

1.5a7 Private and Public Insurers 11

1.5b Direct Marketing to Patients 11

1.6 Majors Players of Pharmaceutical Industry 12

1.7 India Stand 13

1.7a Advantage India 14

1.7b Exports 15

1.7c Growth 16

1.7c1 New Business Model 16


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1.7c1a Contract Manufacturing 18

1.7d Enabling Framework Required 20

1.7d1 SWOT Analysis 20

1.8 Top Pharmaceutical Companies of India 22

1.9 Introduction about the Company 26

1.10 Introduction to the Project 28

1.10a Objective behind Launching the Strong Kit 29

1.10b What is Osteoporosis? 29

1.10b1 Diagnosis of Post Menopausal Osteoporosis 30

1.10b2 Incidence Osteoporosis in WO (Men) 30

1.10b3 Pathogenesis of Osteoporotic Fracture 31

1.10b4 Implications Postmenopausal Osteoporosis 32

1.10b5 Osteoporosis Treatment 33

1.11 Purpose Scope & Limitation 35

1.11a Purpose 35

1.11 b Scope

1.11c Limitations 36

1.12 Source & Method Adopted 37

1.21a Sources 37

1.21 b Methodology


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1.13 Report Organization 38

2 DISCUSSION OF THE PROJECT 39

2.1 Understanding the Project Literature 39

2.1a Strong Kit Dosage 39

2.1 b Pharmacology of each molecule 40

2.2 Market Research 42

2.2a Questionnaire Design 43

2.2b Analysis Method 43

3 ANALYSIS 46

3.1 Data Organization 46

3.2 Data Table 47

3.3 Pivot Table 49

3.4 Chi square analysis (Test of Independence) 51

3.5 Interpretation of the analysis done so far 55

3.6 Forecasting of sale of the Strong Kit 56

3.6a Correlation and Regression Analysis 56

3.6a1 Forecasting of sale of Strong Kit through Raloxifene 56

3.6a2 Forecasting of sale of Strong Kit through Risedronate 59

3.6a3 Forecasting of sale of Strong Kit through the usage of 62

Both molecules i.e. Raloxifene and Risedronate


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3.7 Gynecologist View 65

3.8 Orthopaedic View 68

3.9 Risedronate Vs other Bisphosphonate 71

3.9a under Gynecologist 71

3.9b under Orthopaedic 72

3.10 Preference for Menopause Clinic 73

3.11 Overall Result 74

4 CONCLUSION & RECOMMENDATION 75

4.1 Findings for Strong Kit 75

4.2 Recommendations 77

5 EXHIBITS, APPENDIX, REFERENCE 90


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LIST OF TABLES

Table 1.1: List of the Market leaders in terms of revenue

Table 1.2: Growth rate of export of pharmaceutical companies in India

Table 1.3: SWOT Analysis

Table1.4: Risk factors of Osteoporosis

Table 1.5: DEXA BMD Value

Table1.6: Strong Kit molecule information

Table1.7: Question and their Objective

Table1.8: List of Gynecologist who showed interest for Strong Kit

Table1.9: List of Orthopaedic who showed interest for Strong Kit

Table1.10: List of Gynecologist who asked for the Literature of Strong Kit

Table1.11: List of Orthopaedic who asked for the Literature of Strong Kit

Table1.12: List of Gynecologist who showed interest for opening Menopause Clinic.

LIST OF PICTURES

Figure1.1: India Pharma 2015 prescribed growth

Figure1.2: Emerging model to capture the outsourcing opportunity

Figure1.3: Contract Manufacturing (Comparison with other countries)


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Figure1.4: Contract manufacturing service providers across the service chain

Figure1.5: Incidence osteoporosis in women

Figure1.6: pathogenesis of osteoporosis fracture

Figure1.7: Implication Postmenopausal Osteoporosis

Figur1.8: Osteoporosis treatment

Figure1.8: Snapshot of Gynecologist Report

Figure1.9: Snapshot of Orthopaedic Report

Figure1.10: Snapshot of the Data Table

Figure1.11: Snapshot of the Pivot Table

Figure1.12: Snapshot of the actual Observation Table of the molecule Raloxifene

Figure1.13: Snapshot of the expected value of the molecule Raloxifene

Figure1.14: Snapshot of the actual Observation Table for the combination (Strong Kit)

Figure1.15: Snapshot of the expected value of the combination (Strong Kit)

Figure1.16: Snapshot of the data chart for the pivot table analysis

Figure1.17: Snapshot of the table of usage of Raloxifene and Strong Kit

Figure1.18: Snapshot of the correlation table between Writes Raloxifene & Writes Strong Kit

Figure1.19: Snapshot of the Summary Output of the Raloxifene molecule

Figure1.10: Snapshot of the table of usage of Risedronate and Strong Kit

Figure1.11: Snapshot of the correlation table between Writes Risedronate & Writes Strong Kit

Figure1.12: Snapshot of the summary output of the molecule Risedronate


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Figure1.13: Snapshot of the table of usage of both molecule together & Strong Kit

Figure1.14: Snapshot of the correlation table between Writes both & Writes Strong Kit

Figure1.10: Snapshot of the Summary Output of Writes both molecules

LIST OF GRAPHS

Graph1.1: Strong Kit acceptance

Graph1.2: Gynecologists Preference for Raloxifene

Graph1.3: Gynecologists Preference for Risedronate

Graph1.4: Gynecologist preference for Strong Kit

Graph1.5: Orthopaedic preference for Raloxifene

Graph1.6: Orthopaedic preference for Risedronate

Graph1

.7: Orthopaedic preference for Strong Kit

Graph1.8: Gynecologists preference for Risedronate Vs other Bisphosphonate

Graph1.9 Orthopaedics preference for Risedronate Vs other Bisphosphonate

Graph1.10: Gynecologist who showed interest for opening Menopause Clinic


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SUMMARY

The Summer Internship program (SIP) forms an important component of education

at IBS. It is an attempt to bridge the gap in the students perception between the

academic institution and the corporate world. Internship is a vehicle for

introducing students to real- life situations, which cannot be simulated in the

classroom. Therefore, Internship assignments must necessarily be those of direct

interest to the host organization.

Keeping these things in mind the project Market Surveillance of Strong KIT

which is allotted to me at Indchemie Health Specialities Pvt. Ltd has all the

ingredients of a great project. The core objective of the project is to find the

feasibitly of Strong Kit among the Doctors that is Gynecologists and Orthopaedics.

This project is of great importance to Indchemie Health Specialities Pvt. Ltd.

because it would help their company to

This project introduced me to real life business situations such as understanding

the companys product literatures and their strengths and weakness and then

communicating with the clients in such a way that they get impressed by the

companys products and profiles , which are hard to simulate in the classroom. It

has exposed us to the practical dimensions of the theoretical concepts that we have

learned so far and also to the art and craft of management which includes

maintaining good rapport with the boss, colleagues, juniors as well as the clients.

Through our interaction with the professionals in the industry, we have also

learned the necessary social/ interpersonal skills and undergone the rigor of

professional environment, both in form and substance.


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This report basically deals with how we have gone about implementing this project

and the learning that we have received. The report begins with a brief introduction

of the pharmaceutical industry followed by a brief introduction of the company ,

followed by the details of the project allotted to us which includes the objectives

and the goals, then I have described the methodology of implementation of this

project and finally ending with the conclusions and recommendations from my side

along with the learning from this project and company.


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A Short History of Medicine

2000 B.C. - "Here, eat this root."

1000 B.C. - "That root is heathen, say this prayer."

1850 A.D. - "That prayer is superstition, drink this

Potion."1940 A.D. - "That potion is snake oil, swallow this pill."

1985 A.D. - "That pill is ineffective, take this antibiotic."

2000 A.D. - "That antibiotic is artificial. Here, eat this

Root."

And this goes on..


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1. ABOUT THE PHARMACEUTICAL

INDUSTRY

The Pharmaceutical Industry develops, produces, and markets drugs licensed for use as

medications. Pharmaceutical companies can deal in generic and/or brand medication. They are

subject to a variety of laws and regulations regarding the patenting, testing and marketing of

drugs.

1.1 HISTORY:

The earliest drugstore dates back to middle ages. The first known drugstore was operated by

Arabian Pharmacists in Baghdad in 754, and many more soon began operating throughout the

medieval Islamic world and eventually medieval Europe. By the 19th century, many of the drug

stores in Europe and North America had eventually developed into larger pharmaceutical

companies.

Most of todays major pharmaceutical companies were founded in the late 19th and early 20th

centuries. Key discoveries of the 1920s and 1930s, such as insulin and penicillin, became mass

manufactured and distributed. Switzerland, Germany and Italy had particularly strong industries,

with the UK, US, Belgium and the Netherlands Following suit.

Legislation was enacted to test and approve drugs and to require appropriate labeling.

Prescription and nonprescription drugs became legally distinguished from one another as the

pharmaceutical industry matured. The industry gotunderway in earnest from the 1950s,due to

the development of systematic scientific approaches, understanding of human biology and

sophisticated manufacturing techniques.

Numerous new drugs were developed during the 1950s and mass-produced and marketed

through the 1960s. These included the first oral contraceptive, The Pill, Cortisone, blood-

pressure drugs and other heart medications.


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Attempts were made to increase regulation and to limit financial links between companies and

prescribing physicians, including by the relatively new US FDA. In 1964, the World Medical

Association issued its Declaration of Helsinki, which set standards for clinical research and

demanded that subjects give their informed consent before enrolling in an experiment.

Pharmaceutical companies became required to prove efficacy in clinical trials before marketing

drugs.

The industry remained relatively small scale until the 1970s when it began to expand at a greater

rate. Legislation allowing for strong patents, to cover both the process of manufacture and the

specific products came in to force in most countries. By the mid-1980s, small biotechnology

firms were struggling for survival, which led to the formation of mutually beneficial partnership

with large pharmaceutical companies and a host of corporate buyouts of smaller firms.

Pharmaceutical manufacturing became concentrated, with a few companies holding a dominant

position throughout the world and with a few companies producing medicines within each

country.

Managed care and health maintenance organizations (HMOs) spread during the 1980s as part of

an effort to contain rising medical costs, and the development of preventative and maintenance

medications became more important. A new business atmosphere became institutionalized in the

1990s, characterized by mergers and takeovers, and by a dramatic increase in the use of contract

research organizations for clinical development and even for basic R&D. The pharmaceutical

industry confronted a new business climate and new regulations, born in part from dealing with

world market forces and protests by activists in developing countries.

Marketing changed dramatically in the 1990s, partly because of a new consumerism. The

internet made possible the direct purchase of medicines by drugs consumers and of raw materials

by drug producers, transforming the nature of business. In the US, Direct-to-consumer

advertising proliferated on radio and TV because of new FDA regulations in 1997 that

liberalized requirements for the presentation of risks.

Drug development progressed from a hit-and miss approach to rational drug discovery in both

laboratory design and natural-product surveys. Demand for nutritional supplements and socalled

alternative medicines created new opportunities and increased competition in the industry.


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There are now more than 200 major pharmaceutical companies, jointly said to be more profitable

than almost any other industry, and employing more political lobbyists than any other industry.

Advances in biotechnology and the human genome project promise ever more sophisticated, and

possibly more individualized, medications.

1.2 RESEARCH AND DEVELOPMENT:

1.2a. Drug discovery is the process by which potential drug are discovered or designed. In

the past most drugs have been discovered either by isolating the active ingredient from

traditional remedies or by serendipitous discovery. Modern biotechnology often focuses on

understanding the metabolic pathways related to a disease state or pathogens, and manipulating

these pathways using molecular biology or Biochemistry. A great deal of early-stage drug

discovery has traditionally been carried out by universities and research institutions.

1.2b. Drug developmentrefers to activities undertaken after a compound is identified as a

potential drug in order to establish its suitability as a medication. Objectives of drug

development are to determine appropriate Formulation and Dosing, as well as to establish safety.

Research in these areas generally includes a combination of in vitro studies, in vivo studies, and

clinical trials. The amount of capital required for late stage development has made it a historical

strength of the larger pharmaceutical companies.

Often, large multinational corporations exhibit vertical integration, participating in a broad range

of drug discovery and development, manufacturing and quality control, marketing, sales, and

distribution. Smaller organizations, on the other hand, often focus on a specific aspect such as

discovering drug candidates or developing formulations. Often, collaborative agreements

between research organizations and large pharmaceutical companies are formed to explore the

potential of new drug substances.

1.2c. The Cost of Innovation: Drug discovery and development is very expensive; of all

compounds investigated for use in humans only a small fraction are eventually approved in most

nations by government appointed medical institutions or boards, who have to approvenew drugs

before they can be marketed in those countries. Each year, only about 25 truly novel drugs (New

Chemical entities) are approved for marketing. This approval comes only after heavyinvestment


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in pre-clinical development and clinical trials, as well as a commitment to ongoing safety

monitoring. Drugs which fail part-way through this process often incur large costs, while

generating no revenue in return. If the cost of these failed drugs is taken into account, the cost of

developing a successful new drug (New chemical entity or NCE), has been estimated at about 1

billion USD (not including marketing expenses).

These estimates also take into account the opportunity cost of investing capital many years

before revenues are realized. Because of the very long time needed for discovery, development,

and approval of pharmaceuticals, these costs can accumulate to nearly half the total expense.

Some approved drugs, such as those based on re-formulation of an existing active ingredient

(also referred to as Line-extensions) are much less expensive to develop. The consumer

advocacy group Public Citizen suggests on its web site that the actual cost is under $200 million,

about 29% of which is spent on FDA-required clinical trials. For me-too-drugs and for generics,

the cost are even less.

1.3 PRODUCT APPROVAL IN THE US:

In the United States, new pharmaceutical products must be approved by the FDA as being both

safe and effective. This process generally involves submission of an Investigational new drug

filing with sufficient pre-clinical data to support proceeding with human trials. Following IND

approval, three phases of progressively larger human clinical trials may be conducted.

Phase I generally studies toxicity using healthy volunteers.

Phase II can include Pharmacokinetics and Dosing in patients, and

Phase III is a very large study of efficacy in the intended patient population.

Phase 1V ofpost-approval surveillance is also often required due to the fact that even the largest

clinical trials cannot effectively predict the prevalence of rare side-effects.

Post-marketing surveillance ensures that after marketing the safety of a drug is monitored

closely. In certain instances, its indication may need to be limited to particular patient groups,

and in others the substance is withdrawn from the market completely. Questions continue tobe

raised regarding the standard of both the initial approval process, and subsequent changes to


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product labeling (it may take many months for a change identified in post-approval surveillance

to be reflected in product labeling) and this is an area where congress is active.

1.4 PHARMACEUTICAL INDUSTRY AND THE PATENT

SYSTEM:

1.4a. What is Patent It is a property right granted by a sovereign state to an inventor of a

novel, non-obvious and useful invention. The owner of a patent has the right to exclude others

from making, using, offering for sale, or selling his or her invention for a period of 20 years from

the filling of the patent application. The benefits of granting an inventor the exclusive property

right of a patent for the limited period of 20 years is that he or she is given a powerful incentive

to create. The inventor is assured that the inventors will be given the incentive to commit the

financial resources necessary to support the inventors research and to develop it to the point

where it can be manufactured and made available to market.

There are two kinds of patent: Product patent and Process patent

1.4b. Global Institutions responsible for administering the Patent System:

y National patent offices

y The world Intellectual Property Organization

y The World Trade Organization

1.4c. Special Problems of Pharmaceutical Patent: The pharmaceutical industry is one

of three technology based industries in which the patent virtually equals the product. The others

are chemical industry and the biotechnology industry, whose innovations span the spectrum from

the engineered plant varieties to human pharmaceutical therapies.

The pharmaceutical industry has an important characteristic that sets it apart from the other

industries that rely on patent protection. In many technology based industries it is possible to

keep invention a secret until the moment they are marketed. This allows inventors to delay patent

filings, until the last possible moment and, therefore, to maximize the effect of 20 year patent

term which runs from filing the patent application form. The culture of medical research,


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however, emphasizes very early disclosure of inventions, usually long before a resulting product

can be placed on the market. This is because the scientists working in the field of human

pathology have an obligation to share their findings as soon as possible with their peers so that

those peers will be able to benefit from the new knowledge in their own research. And, unlike

industries such as computers and software, the pharmaceutical industry is heavily regulated by

government agencies to assure the safety and efficacy of the products which will be sold to the

consumers. In US, the FDA performs this function. Much of the investment in new drugs is the

clinical trials which are necessary to satisfy safety and efficacy regulators. The tolerance to the

buyer beware philosophy in the pharmaceutical industry is extremely low compared to other

industries.

1.4d. In Future IPRs with Pharmaceutical Industry: Intellectual property rights

have been defined as ideas, inventions and creative expressions on which there is a public

willingness to bestow the status of property. IPRs provide certain exclusive rights to the creator

of IP, in order to enable them to reap certain commercial benefits from their creative efforts or

reputations.

y The pharmaceutical industry has relied to a considerable degree on contracting and

outsourcing, especially upstream in R&D through various licensing arrangement and

downstream through co-marketing arrangement.y Expanded sharing information including creation use of collaborative knowledge network

(CKN) can greatly enhance the companys performance.

y Flexible and pervasive communications systems that allow information to flow

effortlessly within and between contracting organizations will provide the key to success.

y More web-based approaches will provide the foundations for these systems.

y The greatest positive impact of IT is likely to be in R&D where systems can contribute to

faster approval and market introduction of products.

y To attain leading position in branded products, they must emulate their global

counterparts in initiating strategic alliance with smaller biotech company, which are

expected to key future source of innovation.


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Focusing on physicians as key decision-maker has long been a priority of the pharmaceutical

industry; physicians will contribute to be the most important gatekeeper to the market.

1.5 PHARMACEUTICAL MARKETING:

It is the business of advertising or otherwise promoting the sale of pharmaceuticals or drugs. The

marketing of medication has a long history. The sale of miracle cures, many with little real

potency, has always been common. Marketing of legitimate non-prescription medications, such

as pain relievers or allergy medicine, has also long been practiced. Mass marketing of

prescription medications was rare until recently, however. It was long believed that since doctors

made the selection of drugs, mass marketing was a waste of resources; specific ads targeting the

medical profession were thought to be cheaper and just as effective. This would involve ads in

professional journals and visits by sales staff to doctors offices and hospitals. An important part

of these efforts was marketing to medical students.

1.5a Direct and indirect marketing to health care providers

Physicians are perhaps the most important players in pharmaceutical sales. They write the

prescriptions that determine which drugs will be used by the patient. Influencing the physician is

the key to pharmaceutical sales. Historically, this was done by a large pharmaceutical sales force.

A medium-sized pharmaceutical company might have a sales force of1

000 representatives. Thelargest companies have tens of thousands of representatives around the world. Sales

representatives called upon physicians regularly, providing information and free drug samples to

the physicians. This is still the approach today; however, economic pressures on the industry are

causing pharmaceutical companies to rethink the traditional sales process to physicians.

Pharmaceutical companies are developing processes to influence the people who influence the

physicians. There are several channels by which a physician may be influenced, including self-

influence through research, peer influence, direct interaction with pharmaceutical companies,patients, and public or private insurance companies. There are also web based instruments that

can be used to determine the influencers and buying motives of physicians.

There are a number of firms that specialize in data and analytics for pharmaceutical marketing.


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1.5a1. Individual research:Physicians discover pharmaceutical information from such sources

as the Physicians Desk Reference and online sources such as PDR.net, as well as via PDAs with

application. They also rely upon pharmaceutical-branded e-detailing sites, pharmaceutical sales

and non-sales representatives, and scholarly literature. Scholarly literature can be in the form of

medical journal article reprints, often delivered by sales representatives at their place of

employment or at conference exhibitions.

1.5a2. Peer influence: Key opinion leaders

Key opinion leaders (KOL), or "thought leaders", are respected individuals, such as prominent

medical school faculty, who influence physicians through their professional status.

Pharmaceutical companies generally engage key opinion leaders early in the drug development

process to provide advocacy and key marketing feedback. Some pharmaceutical companies

identify key opinion leaders through direct inquiry of physicians (primary research).

y Colleagues

Physicians acquire information through informal contacts with their colleagues, including social

events, professional affiliations, common hospital affiliations, and common medical school

affiliations. Some pharmaceutical companies identify influential colleagues through

commercially available prescription writing and patient level data. Doctor dinner meetings are aneffective way for physicians to acquire educational information from respected peers. These

meetings are sponsored by some pharmaceutical companies.

1.5a3Direct physician contact with pharmaceutical sales representatives: Currently, there

are approximately 100,000 pharmaceutical sales reps in India pursuing some 830,000

pharmaceutical prescribers. A pharmaceutical representative will often try to see a given

physician every few weeks. Representatives often have a call list of about 200 physicians with

120 targets that should be visited in 1-2 week cycles. Because of the large size of the

pharmaceutical sales force, the organization, management, and measurement of effectiveness of

the sales force are significant business challenges. Management tasks are usually broken down

into the areas of physician targeting, sales force size and structure, sales force optimization, call

planning, and sales forces effectiveness. A few pharmaceutical companies have realized that


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training sales representatives on high science alone is not enough, especially when most products

are similar in quality. Thus, training sales representatives on relationship selling techniques in

addition to medical science and product knowledge, can make a difference in sales force

effectiveness. Specialist physicians are relying more and more on specialty sales reps for product

information, because they are more knowledgeable than primary care reps.

1.5a4. Physician targeting: Marketers attempt to identify the universe of physicians most likely

to prescribe a given drug. Historically, this was done by measuring the number of total

prescriptions (TRx) and new prescriptions (NRx) per week that each physician writes. This

information is collected by commercial vendors. The physicians are then "deciled" into ten

groups based on their writing patterns. Higher deciles are more aggressively targeted. Some

pharmaceutical companies use additional information such as:

y profitability of a prescription (script),

y accessibility of the physician,

y tendency of the physician to use the pharmaceutical company's drugs,

y effect of managed care formularies on the ability of the physician to prescribe a drug,

y the adoption sequence of the physician (that is, how readily the physician adopts new

drugs in place of older, established treatments), and

y the tendency of the physician to use a wide palette of drugs

y Influence that physicians have on their colleagues.

1.5a5. Opinion Leader InfluenceMapping: Alternatives to segmenting physicians purely on

the basis of prescribing do exist, and marketers can call upon strategic partners who specialize in

delineating which characteristics of true opinion leadership, a physician does or does not possess.

Such analyses can help guide marketers in how to optimize engagements as bona fide advisors to

a brand, and can help shape clinical development and clinical data publication plans for instance,

ultimately advancing patient care.

1.5a6. Sales force size and structure: Marketers must decide on the appropriate size of a sales

force needed to sell a particular portfolio of drugs to the target universe. Design the optimal

reach (how many physicians to see) and frequency (how often to see them) for each individual


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physician. Decide how many sales representatives to devote to office and group practice and how

many to devote to hospital accounts. Additionally, customers are broken down into different

classes; each class is differentiated by their prescription behavior and of course, their business

potential.

1.5a7. Private and public insurers: Public and private insurers affect the writing of

prescriptions by physicians through formularies that restrict the number and types of drugs that

the insurer will cover. Not only can the insurer affect drug sales by including or excluding a

particular drug from a formulary, they can affect sales by tiering, or placing bureaucratic hurdles

to prescribing certain drugs.

1.5bDirect marketing to patients

Since the late 1970s, direct-to-patient marketing of prescription drugs has become important.

Many patients will inquire about, or even demand to receive, a medication they have seen

advertised on television. In India, recent years have seen an increase in mass media

advertisements for pharmaceuticals. Expenditures on direct-to-consumer (DTC pharmaceutical

advertising) have more than quintupled in the last seven years since the FDA changed the

guidelines, from $700 million in 1997 to more than $4.2 billion in 2005.


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1.6 MAJOR PLAYERS OF THE PHARMA INDUSTRY:

Listed below are the market leaders in terms of revenue:

Revenue Rank

2008

Company Country Total Revenues(USD millions

1 Novartis Switzerland 53,324

2 Pfizer USA 48,371

3 Bayer Germany 44,200

4 GlaxoSmithKline United Kingdom 42,813

5 Johnson and Johnson USA 37,020

6 Sanofi-Aventis France 35,645

7 Hoffmann-La Roche Switzerland 33,547

8 Astra Zeneca UK/Sweden 26,475

9 Merck & Co. USA 22,636

10 Abbott Laboratories USA 22,476

11 Wyeth USA 20,351

12 Bristol-Myers Squibb USA 17,914

13 Eli Lilly and Company USA 15,691

14 Amgen USA 14,268

15 Boehringer Ingelheim Germany 13,284

16 Schering-Plough USA 10,59417 Baxter International USA 10,378

18 TakedaPharmaceutical Japan 10,284

19 Genentech USA 9,284

20 Procter & Gamble USA 8,964


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1.7 INDIAS STAND

The Indian pharmaceutical industry is the second-fastest growing industry sector in the country.

It has shown a revenue growth of 27.32 per cent (as per the latest data available) to touch Rs

25,196.48 crore (Rs 251.96 billion) in 2007-08. The industry also saw Indian drug companies

buying out many small firms the world over as they expand their reach, markets and muscle.

Figure1.1: India Pharma 2015 prescribed growth


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The Indian pharmaceutical industry currently tops the chart amongst India's science-based

industries with wide ranging capabilities in the complex field of drug manufacture and

technology. A highly organized sector, the Indian pharmaceutical industry is estimated to be

worth $ 4.5 billion, growing at about 8 to 9 percent annually. It ranks very high amongst all the

third world countries, in terms of technology, quality and the vast range of medicines that are

manufactured. Globally Indian Industry ranks 4th in terms of volume and 13th in terms of value. It

ranges from simple headache pills to sophisticated antibiotics and complex cardiac compounds;

almost every type of medicine is now made in the Indian pharmaceutical industry.

The Indian pharmaceutical sector is highly fragmented with more than 20,000 registered units. It

has expanded drastically in the last two decades. The Pharmaceutical and Chemical industry in

India is an extremely fragmented market with severe price competition and government price

control. The Pharmaceutical industry in India meets around 70% of the country's demand for

bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules,orals

and injectibles. There are approximately 250 large units and about 8000 Small Scale Units,

which form the core of the pharmaceutical industry in India (including 5 Central Public Sector

Units).

1.7a Advantage India:

1. Competent workforce: India posses a skillful work with high managerial and technical

competence.

2. Cost-effective chemical synthesis:Thetrack record for development, particularly in the area

of improved cost beneficial chemical synthesis for various drug molecules is excellent.

3. Legal & Financial Framework: India is a democratic country with a solid legal framework

and strong financial markets. There is already an established international industry and business

community.

4. Information & Technology: It has a good network of world-class educational institutions and

established strengths in Information Technology.


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5. Globalization:The country is committed to a free market economy and globalization. Above

all, it has a 70 million middle class market, which is constantly growing.

6. Consolidation: After many years, the international pharmaceutical industry has discovered

great opportunities in India. The process of consolidation, which has become a popular

phenomenon in the world pharmaceutical industry, has started taking place in the Indian

pharmaceutical industry as well. The Indian pharmaceutical industry which is worth US $ 3.1

billion is growing at the rate of14 percent per annum.

1.7b Exports:

2003-04 2004-05 2005-06 2006-07 2007-08

15.57% 20.73% 11.13% 21.2% 18.24%

Source DGCIS

Table 1.2: Growth rate of export of pharmaceutical companies in India

The export constitutes almost 40% of the total production of the pharmaceuticals in India. Indias

pharmaceuticals exports are to the tune of $3.5bn currently, of which formulations contribute

55% and the rest 45% comes from the bulk drugs.

According to the Quick Estimates of Directorate General of Commercial Intelligence and

Statistics (DGCIS), Pharmaceuticals exports (valued in US dollar terms) registered an impressive

growth rate at 30.7% terms during April-October,2008 compared to the corresponding period of

the last year. This growth further increases to 38.5% when valued in rupees terms. Exports on

account of Pharmaceuticals have been consistently outstripping the value of corresponding

imports during 1996-97 to 2007-08. The trade balance increased from Rs. 2157 corers in 1996-

97 to Rs. 13893 corers in 2007-08. Exports of pharmaceuticals registered a growth at the rate of

16.22% during 2007-08. The share of exports of Pharmaceuticals products to the total national

exports have been in excess of 2% during each of last 12 years ending 2007-08. It has exhibited a

long-term upward trend from 2.01% in 1996-97 to 2.55% in 2007-08.


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1.7c Growth:

India's pharmaceuticals market is expected to grow by about 12-13 per cent in 2009, says a study

by consulting firm IMS. During February 2009, India's drug retail industry continued its healthy

growth recording 13.3 per cent higher sales over the same month last year. A recent study by Yes

Bank estimates the domestic formulations market to touch US$ 21.5 billion by 2015. The Indian

vaccine market was worth US$ 665 million in 2007-08 and is growing at over 20 per cent.

Exports contribute over US$ 360 million, while the domestic market for vaccines is US$ 300

million.

By issuing a patent ordinance, India met the WTO commitment to reorganize foreign product

patent from January 1, 2005, the culmination of a 10 years process. In this scenario the Indian

pharmaceutical manufacturers wont be able to manufacture patented drugs.

To adapt to this business model the industry is exploring business model different from the

traditional ones.

1.7c1 New Business Model includes:

1. Contract Research (Drug discovery and clinical trials)

2. Contract manufacturing

3. Co-marketing alliances


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Figure1.2: Emerging model to capture the outsourcing opportunity


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Thefocus of Indian Pharmaceutical is also shifting from process improvisation to drug discovery

and R&D. The Indian companies are setting up their own R&D and setups and are also

collaborating with the research laboratories like CDRI, IICT etc.

1.7c1.a Contract Manufacturing:

Many global pharmaceutical majors are looking outsource manufacturing from Indian

Companies, which enjoy much lower costs (both capital and recurring) than their western

counterparts. The Pharmacy companies are going for the compliance with International

regulatory agencies like USFDA, MCC etc. for their manufacturing facilities.

Figure1.3: Contract Manufacturing (Comparison with other countries)


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Indian companies are proving to be better at developing APIs than their competitors from target

markets and that too with non infringing processes. Indian drugs are either entering in to strategic

alliances with large generic companies in the world of off patent molecules or entering into

contract manufacturing agreements with innovator companies for supplying complex under-

patent molecules.

Figure1.4: Contract manufacturing service providers across the service chain


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1.7d The Enabling Framework Required:

The Indian Pharmaceutical industry is highly regulated, essentially on three aspects:

Patent

Price

Product Quality

The various legislations that govern the Indian Pharmaceutical Industry are:

The Indian Patent Act 1970 (and the amendment thereafter)

Drug Price Control Order

The Drug and Cosmetics Acts 1940

The legal framework of the industry should be such so as to increase the strength of the industry,

mitigate the weakness, void off the threat and cash in opportunities.

1.7d1 SWOT Analysis:

Table 1.3: SWOT Analysis

Strength

1. Cost competitiveness

2. Well developed industry with strong

manufacturing base.

3. Access to pool of highly trained scientists,

both in India and Abroad.

4. Rich Biodiversity.

5. Competencies in chemistry and process

Weakness

1. Low investment in innovative R&D and lack

of resources to compete with MNCs for New

Drug Discovery Research and to

commercialize molecules on a world wise

basis.

2. Lack of strong Linkage between Industry

and Academia.

3. Low medical expenditure and healthcare


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development. spend in the country.

4. Production of spurious and low quality

drugs tarnishes the image of the industry at

home and abroad.

Opportunities

1. Significant export potential.

2. Licensing deals with MNCs for NCEs and

NDDS.

3. Marketing alliance to sell MNCs products in

domestic markets.

4. Contract manufacturing arrangements with

MNCs.

5. Potential for developing India as a centre

for International Clinical trials.

6. Niche player in global pharmaceutical R&D.

7. Supply of generic drugs to developed

markets.

Threats

1. Product patent regime poses serious

challenge to domestic industry unless it

invests in research and development.

2. R&D efforts of Indian PharmaceuticalCompanies hampered by lack of enabling

regulatory requirement. For instance,

restrictions on animal testing outdated patent

office.

3. Drug price control Order puts unrealistic

ceilings on product prices and profitability and

prevents pharmaceutical companies from

generating investible surplus.

4. Lowering of tariff potential.

5. The new MRP based excise duty regime

threatens the existence of many small scale

pharmacy units, especially in the states ofAndhra Pradesh and Maharashtra that were

involved in Contract manufacturing for larger

players.


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1.8 TOP PHARMA COMPANIES OF INDIA:

Ranbaxy Laboratories: Ranbaxy Laboratories Limited, India's largest pharmaceutical

company, is an integrated, research based, international pharmaceutical company,

producing a wide range of quality, affordable generic medicines, trusted by healthcare

professionals and patients across geographies. Ranked 8th amongst the global generic

Pharma companies, Ranbaxy today has a presence in 23 of the top 25 Pharma markets of

the world.

Dr. Reddys Laboratory: Headquartered in India, it is a global pharmaceutical company

with a presence in more than 100 countries. It has wholly-owned subsidiaries in the US,

UK, Russia, Germany and Brazil; joint ventures in China, South Africa and Australia;

representative offices in 16 countries; and third-party distribution set ups in 21 countries.

Dr. Reddys is the first pharmaceutical company in Asia outside of Japan to be listed on

the NYSE.

Cipla: Cipla products are bought by over170 countries located in USA, South America,

Africa, Europe, Middle East, Asia, and Australia. Cipla exports raw materials,

intermediates, prescription drugs, OTC products and veterinary products. Cipla

also offers technology for products and processes

Nicholas Piramal:Nicholas Piramal India Limited is one of India's largest companies

with an unmatched record of managing JVs/Alliances/Partnerships, and a proven

commitment to IPR. With strong brand management and sales capabilities, a US FDA

site-approved plant for on-and-off patent APIs and Intermediates, Basic Research,

Process Innovation, Custom Chemical Synthesis, Formulations R&D, NDDS, and a


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world-class, accredited Clinical Research Organization, NPIL is poised to emerge as

India's Pharma powerhouse.

Aurobindo Pharma: Aurobindo Pharma has identified international operations, catering

to over 100 countries, as a major engine of growth and expanding global network of

marketing and manufacturing operations across countries like China, Brazil, Japan,

Netherlands, South Africa, Thailand, UK, USA, Russia, Netherlands and many more

which will further expand its international reach.

GlaxoSmithKline: Established in the year 1924 in India GlaxoSmithKline

Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and

employs over 3500 people. Globally, it is a USD 42 billion, leading, research-based

healthcare and pharmaceutical company.

Lupin Laboratories: Lupin Limited, headquartered in Mumbai, India has successfully positioned itself as a Transnational Pharmaceutical Company, with a wide global

footprint. The Company develops and markets a wide range of quality, affordable generic

and branded formulations and APIs in multiple markets across the world.

Sun Pharmaceutical Industries: We are an international specialty Pharma company,

with a presence in 30 markets. We also make active pharmaceutical ingredients. In branded markets, our products are prescribed in chronic therapy areas like cardiology,

psychiatry, neurology, gastroenterology, and diabetology and respiratory.


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Cadila Health Care: One of Indias most reputed, Research based, Tech savvy

pharmaceutical companies focusing on areas Formulations (Human &

Veterinary), New Drug Discovery, Novel Drug Delivery, Active

Pharmaceutical Ingredients, Analytical Research, Phytochemistry,

Biotechnology, Plant Tissue Culture, Biosynthesis, Genetic Engineering,

Vaccines, Immunoglobulin the entire gamut of a True Life Science

Company.

Alkem Laboratories:

Alkem Laboratories Ltd. was founded in 1974 by one of India's respected entrepreneurs, Shri

Samprada Singh. In the last three and a half decades of its operations, Alkem has successfully

emerged as a leading domestic Pharma major in and is rapidly multiplying its international

footprint.

Alkem has carved out for itself, a special reputation in the field of sales and marketing. In India, the

strength of Alkem's sales and marketing, along with its expertise in brand buildings are recognized

widely and are considered as amongst the very best. Some of the biggest brands in the Indian

Pharma market are the Alkem brands. The Alkem product portfolio encompasses a wide spectrum

of therapeutic groups, ranging from Anti bacterial, NSAIDS, Gastro Enter logy products,

Gynecology products, CNS and CVS products along with an impressive oncology range. Alkem

has shown remarkable success with new products and converted several of them into market

leaders. For a company with patented new molecules, seeking sales and marketing partners in

India, Alkem emerges as the ideal Indian partner.

Alkem also has to its credit, world class manufacturing facilities approved by several regulatory

authorities. Alkem's formulation facilities for cephalosporin (oral & sterile), Penicillin (oral &

sterile) and General products have been approved by the regulatory authorities of US FDA, Europe,

South Africa and Australia. Thus, Alkem offers a plethora of product opportunities for companies


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interested in sourcing products from India.

Alkem is a financially secure company. Alkem has been conferred for two consecutive years (2007

and 2008) the P1+ RATING by CRISIL INDIA (SUBSIDIARY OF STANDARD AND POOR),

the best possible rating for a short term debt.

Research and development are its major focus areas and Alkem has undertaken several initiatives

and activities in order to continue a steady process of enhancement in these areas. Alkem possesses

its own CRO, Phoenix Bio Pharma Research Centre in Mumbai, an unit approved by ANVISA,

Brazil.

As an overall diversification strategy, Alkem has recently entered Nutritional and health foods

business, Alkem Health foods


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1.9 INTRODUCTION ABOUT THE COMPANY

Indchemie Health Specialities Pvt. Ltd., a Private Limited Company, was established in the year

1986 with the objective of serving human kind with highest quality drugs at competitive prices.

The company has grown in size and stature to occupy a premier position among Indias

pharmaceutical industry.

Headquartered in Mumbai, Indchemie is managed by an accomplished and experienced board of

directors, who are focused on maintaining Indchemie cherished reputation through adhering to

the highest quality levels in every activity. The Company is spread over 4000sq.ft.area, equipped

with the most advanced soft gel plant located at Daman. This dedicated manufacturing plant

ensures world-class products and every area of operation is under the supervision of experiencedpharmacists.

Indchemie also has an aggressive Research and Development approach, to ensure greater safety,

stability and effectiveness of products, as well as to develop new products.

Indchemie Quality philosophy focuses on guaranteeing that all products manufactured by the

company are consistent with respect to quality, purity, safety, efficacy and stability. The

companys ultra modem formulations manufacturing facility is environment friendly andconforming to c GMP standards as per the WHO guidelines, which comply with statutory

regulations, industry standards, and customer requirements.

In-house Quality Assurance implements stringent quality control measures in every stage, from

sourcing of raw materials till dispatch of finished products. The spectrum of quality control

activities covers self inspection/ internal audits, validations, vendor development and document

review.

Indchemie is committed to achieving recognition as a market leader in generic drugs spanning all

majors therapeutic areas. The company fosters an environment of scientific excellence with

innovation and strives to promote leadership, teamwork, productivity and customer satisfaction.


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Salient Features:

Prime Location: Headquartered in Mumbai, India commercial and financial capital, Indchemie

is well connected to national and global destinations, by road, rail, air and sea. Its state-of-the-art

manufacturing facility conveniently located in the union territory of Daman, close to Mumbai.

Outstanding People: Indchemie considers its highly qualified, dedicated people as its most

valuable resource. We work as a team to meet the company goals and objectives. To ensures that

this team to meet the company goals and objectives. To ensure that this work is maximized, the

company fosters an environment conducive to personal and professional growth.

Customer Satisfaction: Indchemie is committed to the highest standards of service, honesty and

integrity in all customer interaction, in order to deliver satisfaction levels that exceed

expectations.

On-time delivery: Aware of the critically important nature of our products, Indchemie is

committed to on-time deliveries, as per the most stringent of schedules.

Patient Focus: The health and quality of life of every patient using Indchemie products is an

abiding concern. To this extent the company places emphasis on staying up-to-date with global

advancements and breakthroughs to ensure a steady supply of the most effective, safe,

economical and high-quality products.

Scientific Orientation: Modern manufacturing facilities incorporate advanced tools and

equipment in order to deliver products that satisfy the most demanding of national and

international safety and quality requirements. To keep the experienced team ever competitive the

best training is imparted on an on-going basis.


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1.10 INTRODUCTION TO THE PROJECT:

The project allotted to me by the company Indchemie Health Specialities Pvt. Ltd is Market

Surveillance of Strong Kit.

The Company has launched a kit named as STRONG KIT, in India for the very first time.

STRONG KIT is a complete Kit for Post Menopausal Osteoporosis and I was asked to find its

feasibility among the Doctors that is Gynecologists and Orthopaedics.

1.10a Objective behind launching the STRONG KIT:

The motive behind launching this KIT can be very well explained by the following example:

$\HDUROGKHDOWK\SRVWPHQRSDXVDOZRPDQKDVD\HDUROGPRWKHUZKRUHFHQWO\IUDFWXUHGKHUIHPRUDOQHFNDIWHUIDOOLQJ7KHPRWKHUVSK\VLFLDQ

LQGLFDWHVWKDWWKHIUDFWXUHZDVFDXVHGE\SRVWPHQRSDXVDORVWHRSRURVLV

Now the following question arises:

y Is the woman at the risk of similar fractures?

y How can she determine how severe that risk is?

y If the risk is severe, what can she do to minimize it?

y What advise can the woman give to her 30 year old daughter such that she

will have a substantially lower risk of having an injury similar to her

grandmothers later in life?

Thinking in these lines, as the one mentioned above the company launched STRONG KIT,

which is the indication of the Postmenopausal Osteoporosis.

1.10bWhat is Osteoporosis?


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Osteoporosis is a disease of bone that leads to an increased risk of fracture. It is most common in

women after menopause, when it is called post menopausal osteoporosis. The presence of

osteoporosis can be suspected from an assessment of risk factors. Yet, evaluation of risk factors

alone can fail to identify a sizable number of individuals who are at risk of fracture. Only Bone

Mineral Density (BMD) measurements can accurately assess the risk for fractures.If the BMD of

the lady is 2.5 standard deviation below peak bone mass(20 year old healthy female average),as

measured by Dual Energy X-ray Absorptiometry(DEXA) then the lady is said to be suffering

from Postmenopausal Osteoporosis.

Risk Factors of Osteoporosis:

Highest Risk High Risk

y Hypogonadism (Postmenopausal)

y Female

y Previous fracture

y Thin posture

y Asian or Caucasian

y Smokingy Excess alcohol intake

y Sedentary Lifestyle

y Low Calcium intake

y Use of glucocorticoids.

Table1.4: Risk factors of Osteoporosis

Osteoporosis Path physiology

Osteoclastic activity Osteoblastic activity

Osteoclast (Greek word-Bone Broken) is a type of bone cell that removes bone tissue by

removing mineralized matrix and the process is called Bone resorption. This activity is required

to remove worn-out bone cells.


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Osteoblast (Greek Word-Bone Cell) is responsible for Bone formation, and its mineralization.

The Osteoblastic activity is required to provide fresh bone mass.

In case of healthy bones, both the cells activities are in a state of equilibrium, and both the

activities are required to maintain the required shape of the bone.

1.10b1 Diagnosis of Post Menopausal Osteoporosis: Through BMD (Bone Mineral

Densitometry) Test.

DEXA BMD VALUES DEFITION

T-Score between +1& -1 SD Normal

T-Score between -1& -2.5 SD Osteopenia

T-Score < -2.5 SD Osteoporosis

T-Score < -2.5 SD with Fragile Fracture Severe Osteoporosis

Table 1.5: DEXA BMD Value

1.10b2 Incidence Osteoporosis in WO (Men):

According to IOF,

1 in 3 Women & 1 in 5 Men

Over 50 years of age.

1.10b3 Pathogenesis of osteoporotic fracture:


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Figure1.5: Incidence osteoporosis in women

1.10b4 Implications Postmenopausal Osteoporosis


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Figure1.6: Osteoporotic Bones

More than 50% of the Women with Hip Fracture will have Dependence

Rest of them end with Mortality.

1.10b5 OSTEOPOROSIS Treatment


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Figure 1.7: Osteoporosis Treatment

Osteoporosis is considered to be major public health hazard because of

two main reasons:


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1.Osteoporotic fractures, most commonly observed in the vertebrae, the femur and the radius

can cause substantial morbidity and mortality. In the situation where femoral fractures occurs

patients are likely to require assistance for their activities of daily living or require

institutionalization in a chronic care facility after they leave the hospital.

Moreover, up to 20% of such patients can die as a result of post-operative complications.

2.Osteoporosis is a common disease among the elderly and with improvements in health care,

the lifetime expectancy in developed countries has increased. This means that as the fraction of

elderly individual increases in the population, osteoporosis is likely to become more prevalent.

As a result, the cost of osteoporosis-related health care expenses to our society is high and highly

likely to rise.

Osteoporosis can be fatal and more women die of hip fractures, than from cancer of ovaries,

cervix and uterus combined. It is a silent disease, because bone loss occurs without symptoms.

Osteoporosis ranks as one of the 5 costliest diseases of aging after diabetes, Hyperlipidaemia,

hypertension & heart disease.

According to World Bank report, the world wide population of PMO women which was 470 in

1990 is expected to increase to 1.2 billion by the year 2030 and 76% of these women will be

living in developing countries. In India, it is projected that by the year 2030, the population of

postmenopausal women will be 2nd highest in the world, 2nd to that in China. Thus the burden of

osteoporosis in the Indian scenario will also be immense.

So its important to take this disease as seriously as we take other disease and

awareness needs to be created for this. Taking these things into consideration,

the company launched STRONG KIT in the market.

1.11 PURPOSE, SCOPE & LIMITATION


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1.11a PURPOSE:

The main purpose of the project is to find the scope of the Strong Kit, which will also include

following:

y I have to do a post launch survey of the STRONG KIT and find its feasibility with the

Gynecologists and the Rheumatologists.

y As the KIT is already in the market, I need to find out why the Gynecologist does not

prescribe STRONG KIT in spite of it being preferred by most of the Orthopaedics.

y What are the limitations of STRONG KIT among Gynecologists?

y Do they need any scientific information on any of the ingredients in the STRONG

KIT?

The Project will help the Company in following ways:

Company will come to know about:

y The potential customers for Post menopausal Osteoporosis (PMO).

y Market Potential of STRONG KIT.

y Major hindrance for not prescribing STRONG KIT.

y Scope of PMO and treatment options available.

y Scope of Menopausal Clinics.

1.11b SCOPE:


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The Scope of the project is not only limited to the area of the marketing but also extends to

Human Resources. This is because although my project is Market Surveillance of Strong Kit,

which purely belongs to marketing field, but, in order to find out its scope among the Doctors

that is Gynecologists and Orthopaedics my HR skills will come into the picture as I will have to

handle their queries and complaints.

1.11c LIMITATION:

y Reach of respondents.

y Restricted only to Doctors of Mumbai.

y Length and complexity of the questionnaire.

y Getting information from the respondents is not easy and involves many problems.

y Respondents who are in hurry might respond carelessly leading to wrong information.

y Lower completion rates of questionnaire.

y Extent of non-response due to non-availability and ignorance.

y Unsafe areas, distance and lack of accessibility pose a hindrance in reaching the desired

sample.

y Respondents sometimes are too busy to entertain personal questions.

y Samples drawn may not be the representative of the population.


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1.12 SOURCES & METHOD ADOPTED:

1.12a SOURCES:

Primary Data: Primary data is the data which is collected by the researcher for a specific

research purpose. In my Research Survey data was largely collected by having face to face

interactions with the Doctors situated all over Mumbai and Telephonic Conversations are also

taken into consideration to collect valuable information required for the successful analysis of

the Research Survey.

1.12b METHODOLOGY:

The methodology used by me for the implementation of the project is as follows:

Keeping in mind the factors like time, cost and the kind of direct result which we wanted,

following methodology has been chosen:

y Questionnaire:A concise and precise questionnaire has been framed consisting of

11 tactful questions only, keeping in mind the busy schedule of the doctors.

The questionnaire consists of both close ended and open ended questions.

y Direct Meeting with the Doctors: this involves direct face to face interaction

reducing the chances of non-responses error.

y Analysis Methodology:

The tools which I have chosen for my analysis are:

CHITEST

PIVOT TABLE

CORRELATION & REGRESSION


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1.13 REPORT ORGANIZATION

The report is organized in such a way that the reader is able to understand each and every minute

detail of the project as follows;

The first chapter is the Introduction which contains an insight towards the Pharmaceutical

industry, purpose and scope of the report, limitation and scope of the study, method of collecting

data and their sources. In short it provides an outline of the work performed in the project.

The second part is divided into 3 chapters i.e., Discussion of the project, and the other works

undertaken. This section discusses or describes the main business of the report. It contains the

data collection, description of activities, results obtained, illustrations, the discussions and the

interpretations, etc.

The next chapter is the analysis or the findings part where the results of the research, project etc

are provided

Then finally there is the conclusions and the recommendations part which offer the reader to

base their decisions related to various issues involved in the project

Finally there are references and Bibliographies which gives us the list of all the websites that I

have visited and a list of all the books that I have used for making this project report a success.


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2. DISCUSSION OF THE PROJECT

As described earlier my project work consists of finding the scope of the Strong Kit among the

Gynecologists and Orthopaedics. For this I have to meet 100 Doctors, 50 Gynecologists and 50

Orthopaedics. Let us now take a look as to how exactly we went about achieving our objectives.

2.1 UNDERSTANDING THE PRODUCT LITERATURES

Each STRONG KIT blister Strip contains:

A) Calcitriol, Calcium Carbonate and Zinc Capsules, 6 Capsules.

B) Raloxifene Hydrochloride Tablets, 7 Capsules.

C) Risedronate Sodium Tablets,1 Capsule.

2.1a Strong Kit Dosage:

Risedronate; 1 tablet to be taken once a week on an empty stomach with a

glass of water first thing in the morning.

Calcitriol & calcium; 1 Capsule to be taken at night daily from 2nd

day

Raloxifene; 1 tablet to be taken daily with a glass of water with or without

meals.


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Molecules Calcitriol + Ca +Zn

Raloxifene Risedronate

Drugs Class Nutritional

supplements

SERM-Selective

Estrogen ReceptorsModulators

Bisphoshonate-

NitrogenContaining

Mode of Action Increases Intestinal

Ca Absorption

Anti-Resorptive Anti-Resorptive

Benefits Maintains SerumCa levels hencedecreases Boneloss

DecreasesOsteoclasticactivity, hencedecreases Boneloss

DecreasesOsteoclasticactivity, hencedecreases Boneloss

Dosage Once a day preferably in the

night from 2

nd

day

Once a day-preferable morning

after breakfast

Once a week early morning with

empty stomach

Table1.6: Strong Kit molecule information

2.1 b Pharmacology of each molecule:

Calcitriol:

1, 25-Dihydroxycholecalciferol, Calcitriol, is the product of liver and renal hydroxylation of

vitamin D3, and is the most active metabolite of Vitamin D. Production of this active form of

vitamin D is controlled by parathyroid hormone - PTH - and by serum phosphate concentration:

a rise in PTH or a fall in serum phosphate increases 1, 25-Dihydrocholecalciferol synthesis.


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Its site of action is intestine, bone and kidneys. It stimulates calcium uptake by the small intestine

and this indirectly promotes mineralization of new bone. 1, 25-Dihydroxycholecalciferol also

facilitates renal reabsorption of calcium, and increases Osteoclastic activity in bone. It has an

effect on bone quality not only via optimization of bone mineralization and inhibition of bone

resorption but also by promoting other important components such as micro callus formation.

This in turn improves deteriorated bone.

Calcium:

The bone of human skeleton contains 99.5% of total calcium in the body. It is the activity of

bone Osteoclast which absorbs the calcium in the bone and releases it into the blood stream.

Zinc:

It stimulates bone formation and inhibits bone loss in human body. It has a potent anabolic effect

on bone metabolism. It causes elevation of alkaline phosphatase activity. It synergistically

enhances Calcitriol stimulated bone metabolism.

Raloxifene: It is one of the molecules of the Selective Estrogen Receptor Modulator (SERM). It

selectively stimulates or inhibits the estrogen receptors of different target tissue. Raloxifene

appears to function like estrogen in bone, acting to maintain bone strength and increase bone

density. It also resembles estrogen in its ability to lower LDL cholesterol levels, thereby

decreasing the risk of heart disease.

Risedronate: It is a Bisphoshonate molecule.

Risedronate in Bone tissue Risedronate enters Osteoclast

Inhibits activation of Osteoclast Inhibits Biochemical reaction in

by preosteoblast Osteoclast

Prevention, Differentiation, - Detachment from bone

Released during resorption by Osteoclast


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Maturation and migration of - Loss of ruffled borders

Osteoclast - Inhibition of acid secretion

- Osteoclast Apoptosis

The very first task that was appointed to me was to go through the product literatures of the

company, understanding the strengths and limitations of our products and designing the

questionnaire.

2.2 MARKET RESEARCH

Marketing research, or market research, is a form of business research and is generally divided

into two categories: consumer market research and business-to-business (B2B) market research,

which was previously known as industrial marketing research. Consumer marketing research

studies the buying habits of individual people while business-to-business marketing research

investigates the markets for products sold by one business to another.

2.2a Questionnaire Design

The Questionnaire Designing was an interesting part of this Field Survey because of the large

presence of the topic on which I am working. The Questionnaire was designed keeping in mind

the GYNECOLOGISTS and ORTHOPAEDIC Doctors available all over Mumbai and divided

into two zones.

Zone 1: Central

Zone 2: Western

Central was again divided into 2

y Kanjurmarg to Dadary Kanjurmarg to Thane

Western Included regions from

y Dadar to Jogeshwari

PREVENT BONE RESORPTION


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Sample Size: 100 Doctors

50 Gynecologists & 50 Orthopaedic

The name of this Questionnaire wasMarket Surveillance for Strong Kit

2.2b Analysis Methodology:

The tools which I have chosen for my analysis are:

CHITEST

PIVOT TABLE

CORRELATION & REGRESSION

The questionnaire included total of 11 questions. Listed below are the questions and the

objective behind keeping these questions.

Question Objective

1. Do you treat PMO cases or do you refer

to your colleague?

Yes No

To find whether the Gynecologist treat

Postmenopausal Osteoporosis cases or not.

2. If yes, what molecules do you prefer?

a)

b)

c)

d)

To find out what were the molecules which theGynecologists and the Orthopaedics prefer prescribing to their PostmenopausalOsteoporosis patients.

3. Do you use them in a combination or do

you prefer to recommend monotherapy?

Comment:

To find the mode of treatment which the

Doctors prefer more. Whether they prefer

giving one molecule at a time or they combine

several molecules to treat.

4. For how long do you recommend this

therapy?

Keeping this question solved two purposes, 1st:let us know about the duration of the therapy


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18 months

with certain molecule which a Doctor follows.

2nd: let us know whether the patients follow

regularly or not.

5. What are the advantages of Raloxifene?

a)

b)

c)

d)

Again this question solved two purpose,

1st: Whether the Doctor prefer prescribing the

molecule Raloxifene to their PMO patients.

2nd: What are the positive points of the

Raloxifene which he/she encountered in his/her

patient?

6. What are the limitations of Raloxifene?

a)

b)

c)

d)

Why the Doctor, that is Gynecologist and

Orthopaedic do not prefer Raloxifene, and the

reason behind not suggesting it to their patient.

This question will help in understanding the

scope of Raloxifene in the Strong Kit, and the

Scope of Strong Kit as a whole.

7. Do you prefer to prescribe Risedronate?

Yes No

This question will let us know whether the

Doctors prefer Risedronate or not and if they

do what is the frequency of this molecule, that

is how often they recommend this molecule.

8. What are the merits of Risedronate?

a)

b)

c)

d)

1st: Whether the Doctor prefers prescribing the

molecule Risedronate to their PMO patients.

2nd: What are the positive points of the

Risedronate which he/she encountered in

his/her patient?

9. What are its demerits?

a)b)

c)

d)

What are the limitations of the molecule

Risedronate, and what is the reason behind not

prescribing the molecule? This question will

help in understanding the scope of Risedronate

in the Strong Kit, and the Scope of Strong Kit

as a whole.


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10. If you will get Raloxifene + Risedronate

+ Calcium together in one Kit, would you

like to prescribe it to your patients?

Comment:

This question will help in understanding the

scope of the Strong Kit.

1st: If the Doctor prefers this combination then

he may prefer Strong Kit which contains this

combination.

2nd

: It may also happen that the doctor prefer

this combination but would not like to give it

in a kit, so this question will also help in

knowing what is the reason behind not

prescribing a kit.

3rd

: It will also help in knowing the cost factor.

What importance do they give to the cost of the

molecule and what according to them should

be the cost of the kit so that they recommend it

to their patient.

11. Are you interested in opening a

menopause clinic?

Yes No

This question will help in letting know if the

Gynecologist is interested in opening a

Menopause Clinic then the company will help

in setting of the Menopause Clinic and willhelp generating the awareness for the

Postmenopausal Osteoporosis Cases.

Table1.7: Question and their Objective


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3. ANALYSIS:

After meeting the doctors, interviewing them, collecting the data and studying the project in

depth following conclusions about the Strong Kit has been made:The very first thing after collecting the data I did was, I organized the data under headings like

Dr. Name, Dr. Specialization, Dr. Mobile Number, Area, Date of Visit, Remark. I segregated the

data under Gynecologist and Orthopaedic Heading separately for my easy analysis. The data

after been organized looked like as under:

3.1 DATA ORGANIZATION

Figure 1.8: Snapshot of Gynecologist report


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Figure1.9: Snapshot of Orthopaedic report

3.2DATA TABLE:

After organizing the data as above I then prepared the data table. I took 3 headings as

Raloxifene, Risedronate and About Combination. Under these headings I then made subheadings

like for Raloxifene and Risedronate I segregated the data under subheading Yes, No, Very

Rare, Refer.

Yes means doctors those who have shown preference for the molecule Raloxifene and

Risedronate. No means doctors those who have not shown any liking for the molecule for the


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treatment of postmenopausal osteoporosis. Very rare mean doctors those who prefer

prescribing it to their patients but not very often. Refer column contains data of those doctors

who do not treat these postmenopausal osteoporosis cases.

Then for the heading About Combination I segregated the data under subheading Would

Try, No, Literature, Writes, Refer.

Would try means doctors those who have shown preference for the combination and said they

would like to try the combination in the kit. No mean doctors those who did not liked the

concept of the combination of the kit and refrained from using it. Literature means doctors

those who were not sure of the combination and needed more information and scientific proof

before prescribing it to their postmenopausal osteoporosis patients. Writes Column contains

doctors those who use this combination and writes Strong Kit also. Refer Column contains

doctors those who do not treat the postmenopausal osteoporosis cases and instead refer it to their

colleagues.

After segregating the data under the mentioned heading and subheading following Data Table

was obtained.

Figure1.10: Snapshot of the Data Table


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3.3 PIVOT TABLE:

With the help of the above Data Table, I then prepared the Pivot table. With the help of this pivot

table I did my further analysis. With the help of the Pivot Table the data which I wanted for my

analysis I filtered it in the report filter and then carried on with my analysis hence it made my work

easier and simpler.

The pivot table so obtained is shown below.

Figure1.11: Snapshot of the Pivot Table.


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Strong Kit Acceptance

Orthopaedic: 27.00%

Gynecologist: 42.00%

Graph1.1: Strong Kit acceptance

In thebeginning of my project my company had told me that as Strong kit contains Raloxifene

which is more famous among Gynecologist so acceptance of Strong Kit should have been more

among Gynecologist. But it was not so and I was asked to find the reason

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