In partial fulfillment of the requirements for the degree

“MAKING A LAUNCH STRATEGY FOR A NEW BRAND OF AN EMERGING

COMPANY IN THE INTERNATIONAL AND DOMESTIC MARKET” by Diptarup Biswas

Dissertation submitted to the Rajiv Gandhi University Of Health Science, Karnataka, Bangalore In partial fulfillment of the requirements for the degree of MASTER OF PHARMACY IN PHARMACEUTICAL MARKETING AND MANAGEMENT Under the guidance of Dr.V Kusum Devi (H.O.D) Department of Pharmaceutical Marketing and Management Al – Ameen College of Pharmacy Bangalore – 560027 March 2010

COPYRIGHT

Declaration by the Candidate

I here by declare that the Rajiv Gandhi University of Health Sciences,

Karnataka shall have the rights to preserve, use and disseminate this

dissertation / thesis in print or electronic format for academic / research

purpose.

Date: March 2010

Place: Bangalore

DIPTARUP BISWAS

© Rajiv Gandhi University of Health Sciences, Karnataka

ii

Declaration by the Candidate

I hereby declare that this dissertation/ thesis entitled “Making a launch

strategy for a new brand of an emerging company in the international

and domestic market” is a bonafide work carried out by me under the kind

guidance of Dr. V Kusum Devi, (H.O.D) Department of Pharmaceutical

Marketing and Management, Al-Ameen College of Pharmacy, Bangalore

Date: March 2010

Place: Bangalore

DIPTARUP BISWAS

iii

CERTIFICATE BY THE GUIDE This is to certify that the dissertation entitled

“MAKING A LAUNCH STRATEGY FOR A NEW BRAND OF AN EMERGING COMPANY IN THE INTERNATIONAL AND DOMESTIC MARKET” is a bonafide research work done by

DIPTARUP BISWAS

In partial fulfillment of the requirement for the degree of

Master of Pharmacy in Pharmaceutical Marketing and Management

Date : March 2010 Place: Bangalore

Signature of the Guide

Dr. V Kusum Devi HOD

Dept. of Pharmaceutical Marketing and Management

iv

CERTIFICATE OF CO-GUIDE

This is to certify that the dissertation entitled “Making a launch strategy for a

new brand of an emerging company in the international and domestic

market” is a bonafide research work carried out by Diptarup Biswas under the

co-guidance of Dr. Anjan Roy.

Dr. Anjan Roy

Managing Director

R L FINE CHEM

v

ENDORSEMENT BY THE HOD, PRINCIPAL/HEAD OF THE INSTITUTION

This is to certify that the dissertation entitled Making a launch strategy for a

new brand of an emerging company in the international and domestic

market” is a bonafide research work carried out by Diptarup Biswas under the

guidance of Dr.V Kusum Devi (HOD)

Department of Pharmaceutical marketing and management, Al-Ameen College of Pharmacy, Bangalore Dr. V Kusum Devi HOD Dept. Pharmaceutical Marketing and Management Al-Ameen College of Pharmacy Bangalore 560027

Prof. B.G Shivananda Principal Al-Ameen College of Pharmacy Bangalore 560027

Date : March 2010 Place : Bangalore

Date : March 2010 Place : Bangalore

vi

ACKNOWLEDGEMENT

As I begin to reflect on to the magnitude of this project, I am reminded of the

kindness, support and affection rendered to me by selfless people to whom I am grateful.

I am indebted to my esteemed guide Dr. V Kusum Devi, HOD, Department of

Pharmaceutical marketing and management, for her valuable guidance, her advice and

constant encouragement, which saw me through the course of my research work.

I extended my sincere gratitude to Mr. Ashoke Bhattacharya (Vice President, R

L Fine Che)., Mr. Pawan K. Ghai (Marketing Head, RL Fine Chemicals), Mr Anjan

Ray (Managing Director, R L Fine Chem), Mr. P V Prasad (General manager, Centum

Pvt. Ltd), Dr. Asha N, Mr. Indu Sankar (Asst. Manager, International Procurement,

Manipal) for providing me valuable help and guidance through out my academic period

here.

I am thankful to “Almighty” and my “Guru-dev” for showering their grace and

blessing on me and helping me to overcome every obstacle I faced till now in my life.

I am blessed indeed to have such supportive, caring, and loving Parents, and it is

to them that I dedicate this thesis.

vii

I also want to thank my late Grand father, Choto pisi and Pisay-mosai, Mejo pisi

and Pisay mosai, Chanu pisi, Mala kakimuni, Jethu and Jemma for their support and

blessings.

I would be failing in my duty, if I do not express my heartfelt thanks to my

dearest friends, Gayatri, Siddharth, Rohit, Pasa, Chinmaya, Pankaj, Amitava, Trishna,

Snigdha, Sourab, Deena, Priyanka, Shruti, Suman, my juniors Pradipta, Saptarshi,

Soumoditta, Jaydeep, Chandana, Shubojit and seniors Aditya bhai, Viswas bhai, Sardul

bhai for their immense love, help, encouragement and support and without which I may

not have completed this work successfully.

I am also indebted to all the Cardiologists, MD Internal medicine, General

practitioners and Pharmacists/Chemists across Bangalore and Kolkata, who

participated in the primary market research and provided their comments and views that

laid the foundation of this work.

And lastly I would like to thank all those who have directly or indirectly helped

me getting through this project successfully.

Date: March 2010

Place: Bangalore Diptarup Biswas

viii

TABLE OF CONTENTS

ix

Sl. No.

CONTENTS PAGE NUMBER

1 Introduction 1

2 Need for study 4

3 Objectives 7

4 Review of Literature 8

5 Methodology 35

6 Results 45

7 Discussion 212

8 Conclusions 217

9 Summary 222

10 Bibliography 226

11 Annexure 230

LIST OF ABBREVEATIONS

x

ABBREVEATIONS

FULL FORMS

US United States

IMS Intercontinental Marketing Services

HCT Hydrochlorothiazide

BP Blood Pressure

CC Candesartan cilexetil

WHO World Health Organization

CO Cardiac Output

PVR Peripheral vascular resistance

ACTH Adrenocorticotropic hormone

IUPAC International Union of Pure and Applied Chemists

AUC Area Under Curve

RAAS Renin–Angiotensin–Aldosterone System

ARBs Angiotensin Receptor Blockers

ACEi Angiotensin-Converting Enzyme Inhibitor

CEO Chief Executive Officer

GDP Gross Domestic Product

USD United States Doller

CA Current Account

FDI Foreign Direct Investment

PT Partido dos Trabalhadores (portugese)

PAC Programade Aceleraçãodo Crescimento (portugese)

TRIPS Trade Related Intellectual Property Rights

ANVISA National Sanitary Vigilance Agency

IPR Intellectual Property Rights

HIV Human Immuno Virus

PTO Patent and Trademark Office

CMED Chamber for the Regulation of the Market of Medicines

xi

GNI Gross National Income

OECD Organization for Economic Cooperation and Development

RBI Reserve Bank of India

CNS Central Nervous System

CAGR Compounded Annual Growth Rate

CVS Cardio Vascular Disease

OPPI Organization of Pharmaceutical Producers of India

ORG Operational Research Group

R&D Research and Development

KPMG Klynveld Peat Marwick Goerdeler (accounting firm)

USFDA United States Food and Drug Administration

CRAMS Contract Research and Manufacturing services

JHW Jaipur Heart Watch

DOHA Declaration-Concession to developing nations

DCs Developed Countries

LDCs Less Developed Countries

WTO World Trade Organization

API Active Pharmaceutical Industry

BRIC Brazil, Russia, India and China

NCE New Chemical Entity

UKMCA United Kingdom Module Constructors Association

NDDS Novel Drug Delivery System

ANDA Abbreviated New Drug Application

TB Tuberculosis

AT Angiotensin Receptor

CCA Calcium Channel Antagonist

DPCO Drug Price Control Order

POD points of difference

POP points of parity

IBOPE Instituto Brasileiro de Opinião Pública e Estatística (portugese)

LIST OF TABLES

Table No.

Tables Page No.

4.1 Different brands of Candesartan available in Indian market 30

4.2 Different brands of Candesartan available in Brazilian market 31

6.1.1 Fact File Brazil 46

6.1.2 Economic Indicators 48

6.1.3 Major markets-2007 51

6.1.4 Prevalence of hypertension by age and sex in Brazil 53

6.1.5 Time and fees for registration of drug in Brazil 60

6.1.6 Procedure for Starting a Business in Brazil (Standardized Company)

63

6.1.7 Growth in Main Industry sectors ( in percentage) 69

6.1.8 Fact file India 69

6.1.9 Recent Indian hypertension prevalence studies in urban Indian subjects

78

6.2.1 Dynamic Risk – Index scores and categories 86

6.2.2 Structural Risk – Index scores and categories 87

6.2.3 Seven risk families 88

xii

LIST OF FIGURES

xiii

Figure No.

Figures Page No.

4.1 Anatomic sites of blood pressure control 8

4.2 Baro-reflexes arc 10

4.3 Amino terminal of human Angiotensinogen 11

4.4 Management of hypertension 18

4.5 Chemical Structure of Candesartan cilexetil 20

4.6 Chemical Structure of Hydrochlorothiazide 25

6.1.1 Age wise population distribution 70

6.1.2 Indian pharmaceutical market 71

6.1.3 Chronic segments 72

6.1.4 Retail sales of major companies 73

6.2.1 Dynamic Risk 86

6.2.2 Structural Risk 87

6.4.1 Number of prescriptions received per week for hypertension in Bangalore 104

6.4.2 Categories of doctors who prescribe anti-hypertensives for the treatment of hypertension 105

6.4.3 Trend of movement of the following brands of ACE inhibitors 107

6.4.4 Trend of movement of the following brands of ARBs 109

6.4.5 Comparison between top 5 brands of ACE inhibitor and ARB 111

6.4.6 Trend of movement of the following brands of ACE inhibitors + Diuretic 112

6.4.7 Trend of movement of the following brands of ARB + Diuretic 113

6.4.8 Trend of movement of the following brands of Calcium channel antagonist + Diuretic 114

6.4.9 Trend of movement of the following brands of Beta blocker + Diuretic 115

6.4.10 Comparison of 2 brands of four categories of antihypertensive combinations 116

xiv

6.4.11 Comparison between top 3 brands of ACE inhibitor and its combination and ARB and its combination 117

6.4.12 Trend of movement of the following brands of Candesartan and its combination 118

6.4.13 Number of prescriptions received per week for hypertension In Kolkata 119

6.4.14 Categories of doctors who prescribe anti-hypertensives for the treatment of hypertension 120








6.4.22 Comparison of 3 brands of four categories of antihypertensive combinations 131

6.4.23 Comparison between top 4 brands of ACE inhibitor and its combination and ARB and its combination 132

6.4.24 Trend of movement of the following brands of Candesartan and its combination 133

6.4.25 Number of patients treated per week in Bangalore 135

6.4.26 Age-group more prone to hypertension 136

6.4.27 Choice of drugs preferred by doctors to corresponding age group 138








6.4.35

Comparison between top 3 brands of ACE inhibitors + Diuretic ARB + Diuretic, Calcium channel antagonist + Diuretic and Beta blocker + Diuretic

150

6.4.36 Awareness of the molecule Candesartan among different specialities of doctors 151

6.4.37 Awareness of the molecule Candesartan cilexetil among different specialities of doctors 152

6.4.38 Awareness of the molecule Candesartan cilexetil with hydrochlorothiazide among different specialities of doctors 153

6.4.39 Single factor the doctors expect to support the brand 154

6.4.40 Number of patients treated per week in Kolkata 156

6.4.41 Age-group more prone to hypertension 157

6.4.42 Choice of drugs preferred by doctors to corresponding age group 158








6.4.50 Comparison between top 3 brands of ACE inhibitors + Diuretic ARB + Diuretic, Calcium channel antagonist + Diuretic and Beta blocker + Diuretic

170

6.4.51 Awareness of the molecule Candesartan among different specialities of doctors 171

6.4.52 Awareness of the molecule Candesartan cilexetil among different specialities of doctors 172

6.4.53 Awareness of the molecule Candesartan cilexetil with hydrochlorothiazide among different specialities of doctors 173

6.4.54 Single factor the doctors expect to support the brand 174

6.7.1 Components of marketing activities 190

xv

Introduction

DEPARTMENT OF PHARMAEUTICAL MARKETING AND MANAGEMENT Page 1

1. Introduction

Emerging from a highly protected economy and an insulated business environment,

many companies in India have come a long way in their quest to become global

players. Indian companies have started to venture into the global business arena by

acquisition, joint venturing and direct investment. Although the opportunities for

companies to enter and compete in foreign market are significant, the risks can also

be high.(1)

Among these companies, pharmaceutical organizations in India are also

competing in the global market. There are several factors which are responsible for

drawing more and more companies into the international arena:

• The company discovers that some foreign markets present higher profit

opportunities than the domestic market.

• The company needs a large customer base to achieve economies of scale

• The company wants to reduce its dependence on any one market

• Global firms offering better products can attack the company’s domestic

market.

• The company might want to counterattack these competitors in their home

markets.(1)

Introduction

DEPARTMENT OF PHARMAEUTICAL MARKETING AND MANAG

The Chartered Institute of Marketing Defines marketing as the “Management

process responsible for identifying, anticipating and satisfying customer

requirements profitably”. Thus marketing involves: n

Focusing on the needs and wants of customers

Identifying the best method of satisfying those needs a

Orienting the company towards the process of providin

Meeting organizational objectives(2)

Achieving product success is difficult. Projects like these

development for a number of reasons. Sometimes available

meet desired performance specifications or a desired price p

firm’s strategy changes, rendering the product on longer inte

beats the firm to the market or sometimes the development te

marketing or management in commercializing the product.

either strategic or development process factors or some com

most important aspects to manage effectively in the process

stages and the proficiencies of both the technological and ma

within them.( 3)

The key difference between domestic marketing and marke

scale is the multi-dimensionality and complexity of the many

a company may operate in.(4)

Introductio

EMENT Page 2

nd wants

g that satisfaction

are abandoned during

technology is unable to

oint. At other times, a

resting, or a competitor

am is unable to interest

Product can fail due to

bination of two. So the

are the predevelopment

rketing-related activities

ting on an international

foreign country markets

Introduction


Developing a new product and launching in the market is time and resource

consuming, as great care must be taken to ensure the best decisions are made before

the product reaches channel members and final consumers.

Therefore to launch a new product in the domestic and international market, some

important aspects such as analysis of targeted country, risks, cultural aspects,

competitors, company financial status should be extensively analyzed. The proposed

study involves the consideration of all the relevant aspects for the launch of a new

brand of a combination product that is Candesartan cilexetil with Hydrochlorothiazide

in domestic and international markets. It involves the development of tactics, plans

and strategies which helps to introduce the proposed new brand successfully.

Candesartan cilexetil with hydrochlorothiazide belonging to the therapeutic category

antihypertensives will be introduced in the market by formulating an effective launch

strategy.

• This project proposes to assist the company to develop a preliminary strategy

plan for introducing the new product into the market. The plan consists of

three part, such as

• The first part describes the target market’s size, structure and behavior; the

planned product positioning; and the sales, market share and profit goals

sought in the first few years

• The second part outlines the planned price, distribution strategy, and

marketing budget for the first year

Introduction


The third part of the marketing-strategy plan describes the long-run sales and profit

goals and marketing mix strategy over time.(1)

When launching new products in today’s competitive market, it is critical to develop

innovative launch strategies that differentiate a company’s new brand and position it

for maximum growth. Without aggressive tactics, a company risks in missing a

window of opportunity for achieving optimal results from the launch. The

development, evaluation and implementation of launch strategies are essential for a

successful product launch.

Thereby a launch strategy for a product includes the development of strategy that

is externally oriented, proactive, timely, implementable and appropriate for a long

time horizon.(5)

Introduction


Objectives

DEPARTMENT OF PHARMACEUTICAL MARKETING AND MANAGEMENT Page 8

3. OBJECTIVES

The study covers the following objectives:

1. To study the epidemiology of hypertension

2. Study of the anti-hypertensive drugs market with special reference to

Candesartan cilexetil with Hydrochlorthiazide

3. To find out the prescription trends for the treatment of Hypertension.

4. Preparation of the launch strategy for a new brand of Candesartan cilexetil

with Hydrochlorthiazide

Need for study


2. NEED FOR STUDY

The global pharmaceutical market was valued at US$ 712 billion in 2007. Major

markets can be broadly classified into mature markets and emerging markets

depending upon the nature of the market growth. The market growth accelerates in the

seven pharma emerging markets are China, Brazil, Mexico, South Korea, India,

Turkey and Russia. In these markets there is significantly greater access to both

generic and innovative medicines as primary care improves and becomes available in

rural areas. Ongoing economic growth in the developing world will continue to shift

the focus from infectious diseases to cardiovascular, diabetes and other chronic

illnesses.

From the source of IMS health audit 2007 world wide, Angiotensin-II antagonists

ranked 8th, amounting to a global sales of US$ 19.4 billion with a growth of 13.6%

within the top leading therapeutic segments.

The angiotensin II receptor blocker candesartan cilexetil and the diuretic

hydrochlorothiazide (HCT) is a combination introduced by Astrazeneca. It is used to

treat high blood pressure (hypertension) when one medicine (monotherapy) is not

sufficiently effective. The combination of two medicines that have different ways of

working (modes of action) and leads to a greater lowering of blood pressure in more

people than with either medicine used alone. The following studies supports the

greater efficacy and cost effectiveness of the product:

The clinical studies carried out by the company proved that the drug reduces

blood pressure and proportion of patients with normalized BP was greater with

Candesartan-HCT 16/12.5 mg than with Losartan-HCT 50/12.5 mg.(6)

Need for study


Another study which was carried out to compare the antihypertensive effect

and tolerability of a once-daily combination of candesartan cilexetil, and the

diuretic hydrochlorothiazide (HCT), with a combination of lisinopril and HCT

in patients with primary hypertension. The results proved that the

combinations of candesartan cilexetil/HCT once daily, and lisinopril/HCT,

once daily, had similar antihypertensive efficacy in patients, but candesartan

cilexetil/HCT was significantly better tolerated than lisinopril/HCT.(7)

The use of candesartan cilexetil as part of antihypertensive therapy in elderly

patients with elevated blood pressure was deemed to be cost effective in a

Swedish analysis, primarily resulting from a reduced risk of nonfatal stroke.(8)

The antihypertensive efficacy and tolerability of combination therapy with

candesartan cilexetil, 16 mg plus hydrochlorothiazide (CC/HCT), 12.5 mg was

compared with that of amlodipine , in a multicentre, double-blind, randomised,

parallel-group study in patients with mild-to-moderate essential hypertension

inadequately controlled by monotherapy.. In conclusion, CC/HCTZ and

amlodipine were equally effective in reducing BP in hypertensive patients not

controlled by monotherapy, but CC/HCT was much better tolerated.(9)

From the above mentioned data it is quite clear that the molecule Candesartan

cilexetil with Hydrochlorthiazide is a potent drug having superiority over other drug

in the same and different categories of antihypertensives and also economical and

safe.

Now developing a competitively advantaged product requires: input from customers

on unmet needs, input from marketing as to what the competition is doing to address

Need for study


the need, input from manufacturing about what the firm can currently build to satisfy

the need, input from R&D about new ways of potentially addressing the need and

input from finance about costs. Which finally leads to successful new product

development fulfilling the requirements of profit, market share and customer

satisfaction.(4)

Candesartan cilexetil with hydrochlorothiazide belongs to the therapeutic category of


strategy in the domestic and Brazilian market.

The apparent reasons for selecting Brazilian and Indian market is due to their market

growth of 13.4% and 13% respectively which is higher in comparison to other major

pharmaceutical markets, such as North America, Europe and Japan according to IMS

health report. The driving force behind the growth is the rising consumption levels in

both the countries.

This project proposes to assist the company to develop a preliminary strategy plan for

introducing the new product into the market.

Review of literature


4. REVIEW OF LITERATURE

The Concept of Hypertension (10)

According to WHO, Hypertension is the state of body in which systolic BP is 150

mmHg or more & diastolic BP is 95 mmHg or more.

Hypertension can be classified either essential (primary) or secondary.

Secondary hypertension indicates that the high blood pressure is a result of (i.e.,

secondary to) another condition, such as kidney disease or tumors

(pheochromocytoma and paraganglioma). Persistent hypertension is one of the risk

factors for strokes, heart attacks, heart failure and arterial aneurysm, and is a leading

cause of chronic renal failure.

Anatomic sites of blood pressure control (Figure No. 4.1)



According to the hydraulic equation, arterial blood pressure (BP) is directly

proportionate to the product of the blood flow (cardiac output, CO) and the resistance

to passage of blood through precapillary arterioles (peripheral vascular resistance,

PVR): Physiologically, in both normal and hypertensive individuals, blood pressure is

maintained by moment-to-moment regulation of cardiac output and peripheral

vascular resistance, exerted at three anatomic sites (Figure 4.1): arterioles,

postcapillary venules (capacitance vessels), and heart. A fourth anatomic control site,

the kidney, contributes to maintenance of blood pressure by regulating the volume of

intravascular fluid. Baroreflexes, mediated by autonomic nerves, act in combination

with humoral mechanisms, including the renin-angiotensin-aldosterone system, to

coordinate function at these four control sites and to maintain normal blood pressure.

Finally, local release of hormones from vascular endothelium may also be involved in

the regulation of vascular resistance

Blood pressure in a hypertensive patient is controlled by the same mechanisms that

are operative in normotensive subjects. Regulation of blood pressure in hypertensive

patients differs from healthy patients in that the baroreceptors and the renal blood

volume-pressure control systems appear to be "set" at a higher level of blood

pressure. All antihypertensive drugs act by interfering with these normal mechanisms.

Postural Baroreflex

Baroreflexes are responsible for rapid, moment-to-moment adjustments in blood

pressure, such as in transition from a reclining to an upright posture (Figure 4.2).

Central sympathetic neurons arising from the vasomotor area of the medulla are



tonically active. Carotid baroreceptors are stimulated by the stretch of the vessel walls

brought about by the internal pressure (blood pressure).

Baro-reflexes arc (Figure No. 4.2)

Baroreceptor activation inhibits central sympathetic discharge. Conversely, reduction

in stretch results in a reduction in baroreceptor activity. Thus, in the case of a

transition to upright posture, baroreceptors sense the reduction in arterial pressure that

results from pooling of blood in the veins below the level of the heart as reduced wall

stretch, and sympathetic discharge is disinhibited. The reflex increase in sympathetic

outflow acts through nerve endings to increase peripheral vascular resistance

(constriction of arterioles) and cardiac output (direct stimulation of the heart and

constriction of capacitance vessels, which increases venous return to the heart),

thereby restoring normal blood pressure. The same baroreflex acts in response to any

event that lowers arterial pressure, including a primary reduction in peripheral



vascular resistance (eg, caused by a vasodilating agent) or a reduction in intravascular

volume (e.g, due to hemorrhage or to loss of salt and water via the kidney).

Renal Response to Decreased Blood Pressure

By controlling blood volume, the kidney is primarily responsible for long-term blood

pressure control. A reduction in renal perfusion pressure causes intrarenal

redistribution of blood flow and increased reabsorption of salt and water. In addition,

decreased pressure in renal arterioles as well as sympathetic neural activity (via -

adrenoceptors) stimulates production of renin, which increases production of

angiotensin II (see Figure 11–1). Angiotensin II causes (1) direct constriction of

resistance vessels and (2) stimulation of aldosterone synthesis in the adrenal cortex,

which increases renal sodium absorption and intravascular blood volume. Vasopressin

released from the posterior pituitary gland also plays a role in maintenance of blood

pressure through its ability to regulate water reabsorption by the kidney.



Amino terminal of human Angiotensinogen (Figure No. 4.3)

The amino acid sequence of the amino terminal of human angiotensinogen is shown.

R denotes the remainder of the protein molecule.

By controlling blood volume, the kidney is primarily responsible for long-term blood

pressure control. A reduction in renal perfusion pressure causes intrarenal

redistribution of blood flow and increased reabsorption of salt and water. In addition,

decreased pressure in renal arterioles as well as sympathetic neural activity (via -

adrenoceptors) stimulates production of renin, which increases production of

angiotensin II ( Figure ). Angiotensin II causes (1) direct constriction of resistance

vessels and (2) stimulation of aldosterone synthesis in the adrenal cortex, which

increases renal sodium absorption and intravascular blood volume. Vasopressin



released from the posterior pituitary gland also plays a role in maintenance of blood

pressure through its ability to regulate water reabsorption by the kidney

Angiotensin

Angiotensin II inhibits renin secretion. The inhibition, which results from a direct

action of the peptide on the juxtaglomerular cells, forms the basis of a short-loop

negative feedback mechanism controlling renin secretion. Interruption of this

feedback with inhibitors of the renin-angiotensin system (see below) results in

stimulation of renin secretion.

Pharmacologic Alteration of Renin Release

The release of renin is altered by a wide variety of pharmacologic agents. Renin

release is stimulated by vasodilators (hydralazine, minoxidil, nitroprusside), β-

adrenoceptor agonists (isoproterenol), -adrenoceptor antagonists, phosphodiesterase

inhibitors (theophylline, milrinone,rolipram), and most diuretics and anesthetics. This

stimulation can be accounted for by the control mechanisms just described. Drugs that

inhibit renin release are discussed below in the section on inhibition of the renin-

angiotensin system.

Angiotensinogen

Angiotensinogen is the circulating protein substrate from which renin cleaves

angiotensin I. It is synthesized in the liver. Human angiotensinogen is a glycoprotein

with a molecular weight of approximately 57,000. The 14 amino acids at the amino

terminal of the molecule are shown in (Figure 4.3). In humans, the concentration of

angiotensinogen in the circulation is less than the Km of the renin-angiotensinogen

reaction and is therefore an important determinant of the rate of formation of



angiotensin. The production of angiotensinogen is increased by corticosteroids,

estrogens, thyroid hormones, and angiotensin II. It is also elevated during pregnancy

and in women taking estrogen-containing oral contraceptives. The increased plasma

angiotensinogen concentration is thought to contribute to the hypertension that may

occur in these situations. There is also evidence for a genetic linkage between the

angiotensinogen gene and essential hypertension..

Angiotensin I

Although angiotensin I contains the peptide sequences necessary for all of the actions

of the reninangiotensin system, it has little or no biologic activity. Instead, it must be

converted to angiotensin II by converting enzyme. Angiotensin I may also be acted on

by plasma or tissue aminopeptidases to form [des-Asp1]angiotensin I; this in turn is

converted to [des-Asp1]angiotensin II (commonly known as angiotensin III) by

converting enzyme.

Converting Enzyme (Peptidyl Dipeptidase , Kininase II)

Converting enzyme is a dipeptidyl carboxypeptidase that catalyzes the cleavage of

dipeptides from the carboxyl terminal of certain peptides. Its most important

substrates are angiotensin I, which it converts to angiotensin II, and bradykinin, which

it inactivates. It also cleaves enkephalins and substance P, but the physiologic

significance of these effects has not been established. The action of converting

enzyme is prevented by a penultimate prolyl residue, and angiotensin II is therefore

not hydrolyzed by converting enzyme. Converting enzyme is distributed widely in the

body. In most tissues, converting enzyme is located on the luminal surface of vascular

endothelial cells and is thus in close contact with the circulation.



Angiotensinase

Angiotensin II, which has a plasma half-life of 15–60 seconds, is removed rapidly

from the

circulation by a variety of peptidases collectively referred to as angiotensinase. It is

metabolized during passage through most vascular beds (a notable exception being

the lung). Most metabolites

of angiotensin II are biologically inactive, but the initial product of aminopeptidase

action—[des- Asp1]angiotensin II—retains considerable biologic activity.

Actions of Angiotensin II

Angiotensin II exerts important actions at several sites in the body, including vascular

smoothmuscle, adrenal cortex, kidney, and brain. Through these actions, the renin-

angiotensin system plays a key role in the regulation of fluid and electrolyte balance

and arterial blood pressure. Excessive activity of the renin-angiotensin system can

result in hypertension and disorders of fluid and electrolyte homeostasis.

Blood Pressure

Angiotensin II is a very potent pressor agent—on a molar basis, approximately 40

times more potent than norepinephrine. The pressor response to intravenous

angiotensin II is rapid in onset (10– 15 seconds) and sustained during long-term

infusions of the peptide. A large component of the pressor response to intravenous

angiotensin II is due to direct contraction



of vascular—especially arteriolar—smooth muscle. In addition, however, angiotensin

II can also increase blood pressure through actions on the brain and autonomic

nervous system. The pressor response to angiotensin is usually accompanied by little

or no reflex bradycardia because the peptide acts on the brain to reset the baroreceptor

reflex control of heart rate to a higher pressure. Angiotensin II also interacts with the

autonomic nervous system. It stimulates autonomic ganglia, increases the release of

epinephrine and norepinephrine from the adrenal medulla, and—what is most

important—facilitates sympathetic transmission by an action at adrenergic nerve

terminals. The latter effect involves both increased release and reduced reuptake of

norepinephrine. Angiotensin II also has a less important direct positive inotropic

action on the heart.

Adrenal Cortex

Angiotensin II acts directly on the zona glomerulosa of the adrenal cortex to stimulate

aldosterone biosynthesis. At higher concentrations, angiotensin II also stimulates

glucocorticoid biosynthesis.

Kidney

Angiotensin II acts on the kidney to cause renal vasoconstriction, increase proximal

tubular sodium reabsorption, and inhibit the secretion of renin.

Central Nervous System

In addition to its central effects on blood pressure, angiotensin II acts on the central

nervous system to stimulate drinking (dipsogenic effect) and increase the secretion of

vasopressin and adrenocorticotropic hormone (ACTH). The physiologic significance



of the effects of angiotensin II on drinking and pituitary hormone secretion is not

known

Primary hypertension(11)

The cause of essential hypertension is unknown but a number of factors are related to

its development. These are as under:

Genetic factors: The evidences in support are the familial aggregation,

occurrence of hypertension in twins, epidemiologic data, experimental animal

studies and identification of hypertension susceptibility gene (angiotensinogen

gene)

Racial and environmental factors: A number of environmental factor have

been implicated in the development of hypertension including salt intake,

obesity, skilled occupation, higher living standards and patients in high stress.

Risk factors modifying the course of essential hypertension : These are, age,

sex, atherosclerosis and others (smoking, excess alcohol intake, diabetes

mellitus etc).

The pathogenetic mechanism in essential hypertension is explained by many

theories…..

1. High plasma level of catecholamines

2. Increase in blood volume

3. Increased cardiac output



4. Low renin essential hypertension due to altered responsiveness to renin release

5. High renin essential hypertension due to decresed adrenal responsiveness to

angiotensin ll

Secondary hypertension(11)

Renal hypertension: Hypertension produced by renal diseases is called renal

hypertension, which can again be subdivided into 2 groups:

a) Renal vascular hypertension

b) Renal parenchymal hypertension can be due to activation of renin-

angiotensin system, sodium and water retension, or release of

vasodepressor materials

Endocrine hypertension: A number of hormonal secretions may produce

secondary hypertension. These are due to diseased condition in adrenal gland,

parathyroid gland and oral contraceptives

Coarctation of aorta can cause hypertension

Neurogenic: psychogenic, polyneuritis, increased intracranial pressure etc are

uncommon causes of secondary hypertension

Another way of classifying hypertension is as follows….

Normal – (Systolic 90-120, diastolic 60-80)

Pre-hypertension – (Systolic 120-139, diastolic 80-99)



Hypertension Mild, Stage 1 - (Systolic 140-159 or diastolic 90-99)

Hypertension Moderate, Stage 2 - (Systolic 160 - 179 diastolic 100 – 109)

Hypertension Severe, Stage 3 - (Systolic 180 - 209 or diastolic 110 – 119)

Hypertension Very Severe, Stage 4 - (Systolic > or = 210 or diastolic > or =

120)

Management Of Hypertension (10) (Figure No. 4.4)



All antihypertensive agents act at one or more of the four anatomic control sites

depicted in (Figure 4.4) and produce their effects by interfering with normal

mechanisms of blood pressure regulation.



A useful classification of these agents categorizes them according to the principal

regulatory site or mechanism on which they act (Figure4.4). Because of their common

mechanisms of action, drugs within each category tend to produce a similar spectrum

of toxicities. The categories include the following:

(1) Diuretics, which lower blood pressure by depleting the body of sodium and

reducing blood volume and perhaps by other mechanisms.

(2) Sympathoplegic agents, which lower blood pressure by reducing peripheral

vascular

resistance, inhibiting cardiac function, and increasing venous pooling in capacitance

vessels.

(The latter two effects reduce cardiac output.) These agents are further subdivided

according to their putative sites of action in the sympathetic reflex arc.

(3) Direct vasodilators, which reduce pressure by relaxing vascular smooth muscle,

thus

dilating resistance vessels and—to varying degrees—increasing capacitance as well.

(4) Agents that block production or action of angiotensin and thereby reduce

peripheral

vascular resistance and (potentially) blood volume.



CANDESARTAN CILEXETIL/ HYDROCHLOROTHIAZIDE (12)

Candesartan cilexetil:

Candesartan is a nonpeptide angiotensin II blocker used as an antihypertensive.

Commercially cilexetil (cyclohexyl 1-hydroxyethyl carbonate) ester form is available.

Candesartan cilexetil is the prodrug which is separated into the active candesartan and

ester by reacting with a molecule of water.

Chemical IUPAC Name: 2-Ethoxy-1-((2'-(1H-tetrazol-5-yl)(1,1'-biphenyl)-4-

yl)methyl)-1H-benzimidazole-7- carboxylic acid 1-

(((cyclohexyloxy)carbonyl)oxy)ethyl ester; 7-Carboxy-1-(2-

((cyclohexylcarbonyl)oxy)ethyl)-2-ethoxy-1-(2'-(1H-tetrazol-5-yl)(1,1'-biphenyl)-4-

yl) 1H- benzimidazolium hydroxide, inner salt; (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o-

1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate cyclohexyl carbonate

Chemical Formula: C33H34N6O6

Chemical Structure (Figure No.4.5):

Molecular Weight: 610.67

State: White to off-white crystalline powder

Water Solubility: Practically insoluble (soluble in methanol)



Half Life: Approximately 9 hours.

Melting point: 157 - 160 C

• Candesartan works by blocking the action of a hormone (a natural chemical

carried in the blood) called angiotensin II:

• It stops angiotensin II attaching itself (binding) to sites (called receptors)

found on cells in the body.

• In the body Angiotensin II causes blood vessels to become narrowed

(constricted) and in the kidney, it causes less urine to be produced so salt and

water are retained in the body. These actions may be part of the cause of high

blood pressure.

• If angiotensin II can’t bind to the receptors because of the action of

candesartan, the blood vessels relax and widen and blood pressure decreases.

Dose: The usual recommended starting dose of candesartan 16 mg once daily when it

is used as monotherapy in patients who are not volume depleted. Patients requiring

further reduction in blood pressure should be titrated to candesartan 32 mg. ( )

Pharmacokinetics: General

Candesartan cilexetil is rapidly and completely bioactivated by ester hydrolysis

during absorption from the gastrointestinal tract to candesartan, a selective AT1

subtype angiotensin II receptor antagonist. Candesartan is mainly excreted unchanged

in urine and feces (via bile). It undergoes minor hepatic metabolism by O-

demethylation to an inactive metabolite. The elimation half-life of candesartan is



approximately 9hours. After single and repeated administration, the pharmacokinetics

of candesartan are linier for oral doses upto 32 mg of candesartan cilexetil.

Candesartan and its inactive metabolite do not accumulate in serum upon repeated

once-daily dosing. Following administration of candesartan cilexetil, the absolute

bioavailability of candesartan was estimated to be 15%. After tablet ingestion, the

peak serum concentration (Cmax) is reached after 3 to 4 hours. Food with a high fat

content does not affect the bioavailability of candesartan after candesartan cilexetil

administration.

Metabolism and excretion:

Total plasma clearance of candesartan is 0.37 ml/min/kg, with a renal clearance of

0.19 ml/min/kg. when candesartan is administered orally, about 26% of the dose is

excreted unchanged in urine.

Distribution:

The volume of distribution of candesartan is 0.13L/kg. candesartan is highly bound to

plasma proteins (>99%) and does not penetrate red blood cells. The protein binding is

constant at candesartan plasma concentrations well above the range achieved with

recommended doses.

Special populations:

The pharmacokinetics of Candesartan have been studied in the elderly (≥65years).

The plasma concentration of Candesartan was higher in the elderly (Cmax was

approximately 50% higher, and AUC was approximately 80% higher) compared to

younger subjects administered the same dose. The pharmacokinetics of Candesartan

were linear in the elderly, and Candesartan and its inactive metabolite did not



accumulate in the serum of these subjects upon repeated, once-daily administration.

No initial dosage adjustment is necessary.

Gender:

There is no difference in the pharmacokinetics of Candesartan between male and

female subjects.

Pharmacodynamics:

Candesartan Cilexetil inhibits the pressor effects of angiotensin II infusion in a dose-

dependent manner. After 1 week of once-daily dosing with 8mg Candesartan cilexetil,

the pressor effect was inhibited by approximately 90% at peak with approximately

50% inhibition persisting for 24 hours.

Warnings:

Drug that act directly on the rennin-angiotensin system can cause fetal and neonatal

morbidity and death when administered to pregnant women. Post-marketing

experience has identified reports of fetal and neonatal toxicity in babies born to

women treated with Candesartan cilexetil during pregnancy. The use of drugs that act

directly on the rennin-angiotensisn system during the second and third trimesters of

pregnancy has been associated with fetal and neonatal injury, including hypotension,

neonatal skull hypoplasia, anuria, reversible or irreversible renal failure and death.

Oligohydramnios has been reported, presumably resulting from decreased fetal renal

functions.

Hypotension in volume and salt depleted patients:



Based on adverse events reported from all clinical trials, excessive reduction of blood

pressure was rarely seen in patients with uncomplicated hypertension treated with

candesartan cilexetil and hydrochlorothiazide. Initiation of antihypertensive therapy

amy cause symptomatic hypotension in patients with intravascular volume or sodium

depletion. These conditions should be corrected prior to administration of the drug.

Adverse reactions:

These include hypotension, hyperkalemia, and reduced renal function, including that

associated with bilateral renal artery stenosis and stenosis in the artery of a solitary

kidney. Hypotension is most likely to occur in patients in whom the blood pressure is

highly dependent on angiotensin II, including those with volume depletion (e.g., with

diuretics), renovascular hypertension, cardiac failure, and cirrhosis; in such patients

initiation of treatment with low doses and attention to blood volume is essential.

Hyperkalemia may occur in conjunction with other factors that alter K+ homeostasis,

such as renal insufficiency, ingestion of excess K+, and the use of drugs that promote

K+ retention.



HYDROCHLOROTHIAZIDE (12)

Chemical IUPAC name: 6-chloro-3,4-dihydro-2H1,2,4-benzothiadiazine-7-

sulfonamide 1,1-dioxide

Chemical formula: C7H8ClN3O4S2

Chemical structure (Figure No. 4.6):

Molecular weight: 297.72

Solubility: Slightly soluble in water, but freely soluble in sodium hydroxide solution

State: White crystalline powder

Hydrochlorothiazide is a diuretic:

o It works mainly by stopping the re-absorption of sodium (salt) and water from

the kidneys back into the blood stream.

Hydrochlorothiazide may open Ca2+-activated K+ channels, leading to

hyperpolarization of vascular smooth muscle cells, which leads in turn to closing of

L-type Ca2+ channels and lower probability of opening, resulting in decreased Ca2+

entry and reduced vasoconstriction Hydrochlorothiazide also inhibits vascular

carbonic anhydrase, which hypothetically may alter smooth-cell systolic pH and

thereby cause opening of Ca2+-activated K+ channels. The relevance of this intriguing



finding to the observed antihypertensive effects of thiazides is speculative. These

effects lower the blood pressure

Dose: It is effective in doses of 12.5 to 50 mg once daily.

Pharmacokinetics: General

When plasma levels have been followed for at least 24 hours, the plasma half-life has

been observed to vary between 5.6 and 14.8 hours

Metabolism and Excretion:

Hydrochlorothiazide is not metabolized but is eliminated rapidly by kidney. At least

61% of the oral dose is eliminated within 24 hours.

Distribution:

It crosses the placental barrier but not the blood brain barrier and is excreted in breast

milk.

Pharmacodynamics:

After oral administration of hydrochlorothiazide, dieresis begins within 2 hours, peak

in about 4 hours and last about 6 to 12 hours.

Warnings:

Thiazide diuretics should be used with caution in patients with impaired hepatic

function or progressive liver disease, since minor alterations of fluid and electrolyte

balance may precipitate hepatic coma. Hypersensitivity reactions to

hydrochlorthiazide may occur in patients with or without a history of allergy or

bronchial asthma, but are more likely in patients with such a history. Thiazide



diuretics have been reported to cause exacerbation or activation of systemic lupus

erythematous.

Adverse reactions:

Erectile dysfunction is a troublesome adverse effect of the thiazide-class diuretics,

and physicians should inquire specifically regarding its occurrence in conjunction

with treatment with these drugs. Gout may be a consequence of the hyperuricemia

induced by these diuretics. The occurrence of either of these adverse effects is a

reason for considering alternative approaches to therapy. However, precipitation of

acute gout is relatively uncommon with low doses of diuretics. Hydrochlorothiazide

may cause rapidly developing, severe hyponatremia in some patients. Thiazides

inhibit renal Ca2+ excretion, occasionally leading to hypercalcemia; although

generally mild, this can be more severe in patients subject to hypercalcemia, such as

those with primary hyperparathyroidism. The thiazide-induced decreased Ca2+

excretion may be used therapeutically in patients with osteoporosis or hypercalciuria.

Clinical trials (12)

Of 12 controlled clinical trials involving 4588 patients, 5 were double-blinded,

placebo controlled and evaluated the hypertensive effects of single entities vs the

combination. these 5 trials, of 8 to 12 weeks duration, randomized 3037 hypertensive

patients. does ranged from 2 to 32 mg Candesartan cilexetil and from 6.25 to 25 mg

Hydrochlorthiazide administered once daily in various combinations. the combination

of Candesartan cilexetil with Hydrochlorthiazide resulted in placebo-adjusted

decreases in sitting systolic and diastolic blood pressure of 14 – 18/8 – 11 mm Hg at

doses of 16 – 12.5 mg and 32 – 12.5 mg. The combination of Candesartan cilextil and



Hydrochlorthiazide 32 – 25 mg resulted in placebo adjusted decreases in sitting

systolic and diastolic blood pressure of 16- 19 /9 – 11 mm Hg. The placebo corrected

trough to peak ratio was evaluated in a study of Candesartan cilexetil

Hydrochlorthiazide 32 - 12.5 mg and was 88%.

Most of the antihypertensive effect of the combination was seen in 1 to 2 weeks with

the full effect observed within 4 weeks.in long term studies of upto 1 year, the blood

pressure lowering effect of the combination was maintained. the antihypertensive

effect was similar regardless of age or gender, and overall response to the

combination was similar in black and non-black patients.

Men and women, aged 20–80 years, during treatment with any kind of

antihypertensive monotherapy for at least 4 weeks were randomised to treatment with

Candesartan cilexetil (Candes)-Hydrochlorthiazide (HCT) or Los-HCT once daily for

12 weeks. Efficacy analysis was performed according to intention to treat. The

reduction in BP was independent of previous antihypertensive agent, gender and age

of the patient. It was concluded conclude that the combination Candes-HCT reduced

blood pressure effectively and was well tolerated. BP was normalised in 61% of these

patients who had insufficient response to previous monotherapy. The reduction in

blood pressure and proportion of patients with normalized BP was greater with

Candes-HCT 16/12.5 mg than with Los-HCT 50/12.5 mg.(13)

Monotherapy with an antihypertensive agent is likely to achieve a desirable lowering

of blood pressure in about 50% of patients. The aim of this study was to compare the



antihypertensive effect and tolerability of a once-daily combination of the angiotensin

II type 1 (AT1) receptor blocker candesartan cilexetil, and the diuretic

hydrochlorothiazide (HCT), with a combination of the angiotensin-converting

enzyme inhibitor, lisinopril and HCT in patients with primary hypertension. The

study included men and women, 20-80 years of age, with sitting diastolic blood

pressure of 95-114 mm Hg. After a run-in period of 2 weeks on any antihypertensive

monotherapy, 355 patients were randomized to double-blind treatment with either a

combination of candesartan cilexetil/HCT or a combination of lisinopril/HCT The

combinations of candesartan cilexetil/HCT once daily, and lisinopril/HCT, once daily,

had similar antihypertensive efficacy in patients with mild to moderate hypertension

during the 26-week treatment period, candesartan cilexetil/HCT was significantly

better tolerated than lisinopril/HCT.(6)

The primary objective of the study was to assess the bioequivalence of one

candesartan cilexetil/hydrochlorothiazide (HCT) 32/25 mg tablet and two candesartan

cilexetil/HCT 16/12.5 mg tablets after single dose administration. The secondary

objective of the study was to assess the pharmacokinetics of candesartan cilexetil 32

mg and HCT 25 mg after single dose administration of the fixed combination tablet

and after each monocomponent (ie one candesartan cilexetil tablet 32 mg tablet and

two HCT 12.5 mg tablets). According to the group-sequential design, 53 healthy male

and female subjects, aged between18 and 59 years, with female subjects comprising

at least 20% per treatment group, were enrolled in the first step, to ensure completion

by at least 48 subjects. A total of 48 subjects completed the study. Single dose

administration of candesartan cilexetil and hydrochlorothiazide was well tolerated,



and no new safety issues were identified during the study regardless of the

administration schedule. Headache and dizziness were the most frequently observed

adverse events (AE). No deaths, serious adverse events, or adverse events classified

as "other significant AEs" occurred during the study. No subject discontinued study

treatments due to an AE. There were no clinically relevant changes in laboratory

safety variables or physical examinations. An expected blood pressure lowering effect

was observed reaching mean minimum SBP and DBP values at around 8 hours after

dosing of 32 mg candesartan cilexetil, ie, after one candesartan cilexetil/HCT 32/25

mg tablet, after two candesartan cilexetil/HCT16/12.5 mg tablets or after one

candesartan cilexetil 32mg tablet. This blood pressure lowering effect was less

evident after treatment with two HCT 12.5 mg tablets.(10)

The angiotensin II receptor blocker candesartan cilexetil and the diuretic

hydrochlorothiazide is a combination introduced by Astrazeneca. It is used to treat

high blood pressure (hypertension) when one medicine (monotherapy) is not

sufficiently effective. The combination of two medicines that have different ways of

working (modes of action) and leads to a greater lowering of blood pressure in more

people than with either medicine used alone.(7)

Hypertension treatment and control is largely unsatisfactory when guideline-defined

blood pressure goal achievement and maintenance are considered. Patient- and

physician-related factors leading to non-adherence interfere in this respect with the

efficacy, tolerability, and convenient use of pharmacological treatment options.



Blockers of the renin–angiotensin system (RAS) are an important component of

antihypertensive combination therapy. Thiazide-type diuretics are usually added to

increase the blood pressure lowering efficacy. Fixed drug–drug combinations of both

principles like candesartan/hydrochlorothiazide (HCT) are highly effective in

lowering blood pressure while providing improved compliance, a good tolerability,

and largely neutral metabolic profile. Comparative studies with losartan/HCT have

consistently shown a higher clinical efficacy with the candesartan/HCT combination.

Data on the reduction of cardiovascular endpoints with fixed dose combinations of

antihypertensive drugs are however scarce, as are the data for candesartan/HCT. But

many trials have tested candesartan versus a non-RAS blocking comparator based on

a standard therapy including thiazide diuretics. The indications tested were heart

failure and stroke and particular emphasis was put on elderly patients or those with

diabetes. In patients with heart failure, for example, the fixed dose combination might

be applied in patients in whom individual titration resulted in a dose of 32 mg

candesartan and 25 mg HCT which can then be combined into one tablet to increase

compliance with treatment. Also in patients with stroke the fixed dose combination

might be used in patients in whom maintenance therapy with both components is

considered. Taken together candesartan/HCT assist both physicians and patients in

achieving long-term blood pressure goal achievement and maintenance. (13)

Therapeutic interventions that block the renin–angiotensin–aldosterone system

(RAAS) have an important role in slowing the progression of cardiovascular risk

factors to established cardiovascular diseases. In recent years, angiotensin receptor



blockers (ARBs) have emerged as effective and well-tolerated alternatives to an

angiotensin-converting enzyme inhibitor (ACEi) for RAAS blockade. The ARB

candesartan was initially established as an effective once-daily antihypertensive

treatment, providing 24 h blood pressure (BP) control with a trough:peak ratio close

to 100%.

Compared with other ARBs, candesartan demonstrates the strongest binding affinity

to the angiotensin II type 1 receptor. Clinical trials have demonstrated that

candesartan is well tolerated in combination with diuretics or calcium channel

blockers (CCBs), making it a suitable treatment option for patients whose

hypertension is not adequately controlled by monotherapy. Subsequently, candesartan

became the only ARB licensed in the UK to treat patients with CHF and left

ventricular ejection fraction ≤ 40% as add-on therapy to an ACEi or when an ACEi is

not tolerated. Studies in patients with symptomatic HF have indicated that candesartan

treatment was associated with significant relative risk reductions in cardiovascular

mortality and hospitalisation due to CHF. (14 )



Different brands available in market: (15) (Table No. 4.1)

India:

DRUG BRANDS COMPANY NAME

TYPE OF DOSAGE FORM

STRENGH COST

CANDESARTAN

CANDELONG®

Micro Cardicare

Tablet

4 mg x10's 8 mg x 10's 16 mg x 10's

IRP: rupee 26 IRP: rupee 45 IRP: rupee 70

CANDESAR®

Ranbaxy

Tablet

4 mg x 10's 8 mg x 10's

IRP: rupee 27 IRP: rupee 48

CANDESTAN®

Medley

Tablet

4 mg x 10's 8 mg x 10's


IPSITA®

Bal-Pharma (Servetus)

Tablet

4 mg x10's 8 mg x 10's 16 mg x 10's

IRP: rupee 24 IRP: rupee 38 IRP: rupee 56

DRUG BRANDS COMPANY

NAME TYPE OF DOSAGE FORM

STRENGH COST

CANDESARTAN CILEXETIL

CANTAR®

Dr. Reddy's

Tablet

4 mg x 10's 8 mg x 10's





TYPE OF DOSAGE FORM

STRENGH COST

CANDESARTAN CILEXETIL + HCT

CANDELONG-H ®

Micro Cardicare

Tablet

candesartan cilexetil 8 mg, hydrochlorothiazide 12.5 mg

10's (IRP: rupee 50)


TYPE OF DOSAGE FORM

STRENGH COST

CANDESARTAN + HCT

CANDESAR-H ®

Ranbaxy

Tablet

candesartan 16 mg, hydrochlorothiazide 12.5 mg

10's (IRP: rupee 90)

Brazil: (12) (Table No. 4.2)


TYPE OF DOSAGE FORM

STRENGH

CANDESARTAN CILEXETIL + HCT

ATACAND- HCT

Astra Zeneca

Tablet

Candesartan cilexetil 16mg, + hydrochlorothiazide 12.5 mg Candesartan cilexetil 32mg,+ hydrochlorothiazide 12.5 mg Candesartan cilexetil 32mg,+ hydrochlorothiazide 25 mg



Market potential:

According to World Health Organisation (WHO) the mortality from cardiovascular

disease by the year 2020 in low to middle income countries will exceed deaths from

infectious and parasitic disease in all regions except sub-Saharan Africa, where

hypertension is a major risk factor. (16) Where in India also high blood pressure is a

major risk factor and better control can lead to prevention of 300,000 of 1.5 million

annual deaths from cardiovascular disease. (17)

Thus the market potential (in terms of prevalence) is huge. Recently, the JNC 7 (the

Seventh report of the Joint National Committee on Prevention, detection, evaluation,

and treatment of High Blood pressure) has defined blood pressure 120/80 mmHg to

139/89 mmHg as "Pre-hypertension.“ Pre-hypertension is not a disease category;

rather, it is a designation chosen to identify individuals at high risk of developing

hypertension. Hence, strategies devised to increase awareness can help in gaining

footholds in the latent potential market also.

Methodology


5. METHODOLOGY

Source of Data:

The source for market research will include:

• Primary source: Primary data will be obtained from the identified respondents

by the administration of questionnaire following informed consent

Inclusion criteria:

a) Doctors who are cardiologist, general physician and general practitioners.

b) Registered pharmacists who are at retail outlets and hospitals

Exclusion criteria:

a) Doctors who do not belong to the specialties mentioned above and who

practice in Ayurvedic , Homeopathy, Unani etc are not included in the study

b) Pharmacist who are not registered and trainees are not included in the study

• Secondary source:

a) Journals

b) Trade and business journals

c) Internationals magazine

d) Textbook of pharmaceutical marketing and international marketing

Methodology


e) Internet

f) Pharma pulse

g) Pharma biz

Method of collection of data:

Preliminary communication with doctors and pharmacists through personal

interview to get consent to participate in the survey

Sample size:

1. Doctors:

a) 50 Cardiologists

b) 25 General physicians

c) 25 General practitioners

2. Pharmacist:

a) 100 registered pharmacists

Methodology


AL -AMEEN COLLEGE OF PHARMACY, BANGALORE-27

DEPARTMENT OF PHARMA MARKETING AND MANAGEMENT

QUESTIONNAIRE FOR DOCTOR

Q.1. How many patients with hypertension do you treat on average per week?

A. MALES:

a) Less than 10 (b) 11 to 15 (c) 16 to 20 (d) 21 to 30 (e) more than 30

B. FEMALES:

a) Less than 10 (b) 11 to 15 (c) 16 to 20 (d) 21 to 30 (e) more than 30

Q.2. Which age-group of patients are more prone to hypertension?

Sex of patient

Age group of patients in years

Female

Less than 35

36 to 45

46 to 55

More than 55

Methodology


Male

Less than 35

36 to 45

46 to 55

More than 55

Q.3. Does the age of patient play a role while deciding upon the drug of choice?

(a) Yes (b) No

If yes please select the appropriate drug of choice to the corresponding age group.

Age – group in years

Drug of choice

Less than35

36 to 45

46 to 55

More than 55

Beta blockers

Alfa blockers

Calcium channel antagonists

ACE inhibitors

Angiotensin II antagonist

Diuretics

Central and peripheral sympatholytics

Direct vasodilators

Calcium channel antagonists + Diuretic

Beta blockers + Calcium channel antagonists

Calcium channel antagonists +

Methodology


ACE inhibitors Diuretic + ACE inhibitors

Calcium channel antagonists + Angiotensin II antagonist

Angiotensin II antagonist + Diuretic

Alfa blockers + Diuretic

Angiotensin II antagonist + ACE inhibitors

Beta blockers + Diuretic

Q.4. Select the brand of your choice with respect to the following classes of drugs in

the treatment of hypertension

ACE inhibitors A B C D E F I L M ACETEN ACEBITOR ACINOPRIL

BQL BIOPRIL

CANVAS CIPRIL CARDACE CARDIOPRIL CORPRIL

DILVAS

ENACE ENAMATE ENAPRIL ENLACARD ENVAS ECATOR

FOSINACE FOVAS

INVORIL

LUPINACE LINVAS LIPRIL LISCARD LISITEC LISORIL LISOTEC LISTRIL

MINIPRIL MYOACE

P R S Z

PRILACE PREFACE

R-CORD RACE RAMACE RAMIHART RAMIL RAMIPRES RAMIRIL RAMISTAR

SCLERACE SERVACE

ZESTRIL ZIPRIL ZIRAM

Angiotensin II receptor antagonists

Methodology

Methodology


A C I L N T V Z ALSARTAN ACTILOP ARBITEL

CANDELONG CANDESAR CANTAR COSART COVANCE CZAR CRESAR

IROVEL

LOSACAR LOSAGARD LOSAKIND LOSARTAS LOSCARD LOSIUM LOZITAN

NUSAR

TOZAAR TELDAY TELI TELISTA TELMA TELMIKIND TETAN

VIDA

ZAART ZARGO ZILOS ZITELMI

Combinations


AMLOKIND-H AMLONG-H ESLO-D

ACE inhibitors + Diuretic

ACEZIDE-H CAPOTRIL-H CIPRIL-H LIPRIL-H LISORIL-5 HT LISTRIL PLUS CARDACE-H ECATOR-H HOPACE-H RACE-H5 RAMACE-H RAMIPRES-H RAMIRIL-H RAMISTAR-H TOPRIL H


CANDESAR-H ENACE-D ENAM-D ENAPRIL-HT ENARETIC ENVAS-H ENZIDE NORMACE-D IROVEL-H COSART-H COVANCE-D CZAR-H YSARTAS LARA-H LOSAKIND-H LOSARTAS-HT LOSIUM-H VIDA-H ZAART-H CRESAR TELDAY TELISTA TELI TELMA ZITELMI


ATEN-H ATENOVA-H BETACARD-H BETALOC H SELOPRES NEBEST-H NEBICARD-H NIAVAS-D NODON-H CIPLAR-H CORBIS-H


ARKAMIN-H

Q.5. Are you aware of Candesartan?

a) Yes b) No

Methodology


Please give opinion

………………………………………………………………………………………

Q.6. Are you aware of Candesartan Cilexetil?

a) Yes b) No

Please mention what you know about the molecule

………………………………………………………………………………………..

Q.7. Are you aware of Candesartan cilexetil with Hydrochlorthiazide?

a) Yes b) No

Please give your opinion

…………………………………………………………………………………………

Q.8. If a new brand of candesartan cilexetil with hydrochlorthiazide is launched in the

market, what is the single factor you expect in it to support the brand

a) Less costly

b) Reputation of the company

c) Better availability

d) Frequent visits by marketing people

e) Better and more technical information

f) Adequate physician samples to be tried on patients

g) Company sponsored CME programmes

Methodology


h) Sponsored medical camp

I may not prescribe because_________________________________________

Thanking you for spending your precious time Seal and Signature

(Doctor)

AL -AMEEN COLLEGE OF PHARMACY, BANGALORE-27

DEPARTMENT OF PHARMA MARKETING AND MANAGEMENT

CHEMIST QUESTIONNAIRE

Q.1. How many prescriptions for medications used in the treatment of hypertension

do you receive per week?

A) Less than10 B) 10-20 C) 20-30 D) More than 30

Q.2. Which categories of doctors prescribe the following drugs in the treatment of

hypertension?

Drugs Categories of doctors Drugs with combination

Beta blockers Calcium channel antagonists + Diuretic

Alfa blockers Beta blockers + Calcium channel antagonists

Calcium channel antagonists

Cardiologists

Calcium channel antagonists + ACE

Methodology


inhibitors

ACE inhibitors Diuretic + ACE inhibitors

Angiotensin II antagonis Calcium channel antagonists + Angiotensin II antagonist

Diuretics

General physicians


Central and peripheral sympatholytics


Angiotensin II antagonist + ACE inhibitors

Direct vasodilators

General practitioners


Q.3. What is the trend of movement of the following brands in the treatment of

hypertension?

ACE inhibitors A B C D E F I L M ACETEN ACEBITOR ACINOPRIL

BQL BIOPRIL

CANVAS CIPRIL CARDACE CARDIOPRIL CORPRIL

DILVAS

ENACE ENAMATE ENAPRIL ENLACARD ENVAS ECATOR

FOSINACE FOVAS

INVORIL

LUPINACE LINVAS LIPRIL LISCARD LISITEC LISORIL LISOTEC LISTRIL

MINIPRIL MYOACE

P R S Z

PRILACE PREFACE

R-CORD RACE

SCLERACE SERVACE

ZESTRIL ZIPRIL

Methodology


RAMACE RAMIHART RAMIL RAMIPRES RAMIRIL RAMISTAR

ZIRAM

Angiotensin II receptor antagonists A C I L N T V Z ALSARTAN ACTILOP ARBITEL

CANDELONG CANDESAR CANTAR COSART COVANCE CZAR CRESAR

IPSITA IROVEL

LOSACAR LOSAGARD LOSAKIND LOSARTAS LOSCARD LOSIUM LOZITAN

NUSAR

TOZAAR TELDAY TELI TELISTA TELMA TELMIKIND TETAN

VIDA

ZAART ZARGO ZILOS ZITELMI

Combinations


AMLOKIND-H AMLONG-H ESLO-D

ACE inhibitors + Diuretic

ACEZIDE-H CAPOTRIL-H CIPRIL-H LIPRIL-H LISORIL-5 HT LISTRIL PLUS CARDACE-H ECATOR-H HOPACE-H RACE-H5 RAMACE-H RAMIPRES-H RAMIRIL-H RAMISTAR-H TOPRIL H


CANDESAR-H ENACE-D ENAM-D ENAPRIL-HT ENARETIC ENVAS-H ENZIDE NORMACE-D IROVEL-H COSART-H COVANCE-D CZAR-H YSARTAS LARA-H LOSAKIND-H LOSARTAS-HT LOSIUM-H VIDA-H ZAART-H CRESAR TELDAY TELISTA TELI TELMA ZITELMI

Methodology



ATEN-H ATENOVA-H BETACARD-H BETALOC H SELOPRES NEBEST-H NEBICARD-H NIAVAS-D NODON-H CIPLAR-H CORBIS-H


ARKAMIN-H

Q.4. Which is/are the fastest moving brand(s) of candesartan and its combination?

Drug Drug + diuretic CANDELONG CANDESAR CANTAR IPSITA

CANDESAR-H

Date : Thank You

Place : Seal and Signature

Chemist/pharmacist

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6. RESULTS

6.1 Country analysis: (Secondary data)

Brazil (18)(19)(20)(23)

Brazil became an independent nation in 1822 after three centuries under the rule of

Portugal. It has pursued industrial and agricultural growth and development exploiting

vast natural resources and a large labor pool. Today, it is South America's leading

economic power and a regional leader. Being the largest and most populous country

in South America, Brazil continues to feel the pressure from highly unequal income

distribution. Brazil is located in the eastern part of South America, bordering the

Atlantic Ocean, spreading across 8,511,965 sq km. It shares common borders with

every South American country except Chile and Ecuador. Brazilian climate can be

described as tropical, but temperate in southern part. It is rich with natural resources

like bauxite, gold, iron ore, manganese, nickel, phosphates, platinum, tin, uranium,

petroleum, hydropower and timber.

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The country is having a total population is around 198,739,269 (July 2009 est.) with a

growth rate of 1.199% (2009 est.) While 66.8% per cent of population is in the age

group of 15-64years; 26.7% in 0-14 age group and leaving rest in the age group of

above 65 which is around 6.4%. Life expectancy at birth stands at 71.69 years while

total fertility stands at 1.93 children born/woman.

Fact File (Table No 6.1.1)

Population Growth Rate 1.199% (2009 est.)

Birthrate 18.72 births/1,000 population (2008 est.)

Death Rate 6.35 deaths/1,000 population (2008 est.)

Life Expectancy at Birth 71.99 years (2009 est.)

Total Fertility Rate 2.21 children born/woman (2009 est.)

GDP $1.99 trillion (2008 est.)

GDP-real growth rate 5.1% (2008 est.)

GDP- per capita $10,100 (2008 est.)

Stable economics and growing healthcare concerns make Brazil one of the top

emerging market. Many analysts argue that the future for Brazil, which has been

called for decades “the country of the future,” has finally arrived. With inflation under

control and economic growth above the world average (5.4% and 5.3% in 2007 and

2008, respectively) its considerable population of almost 200 million presents very

attractive prospects for pharmaceutical companies all over the world. The health

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sector as a whole represents 8% of the Brazilian GDP, around US$80 billion per year.

Government purchases represent 50% of the market for medical equipments, and

more than 90% of the vaccines and 25% of all drugs (Brazilian Ministry of Health).

On the foreign trade side, Brazilian products totaled more than US$961 million in

exports in 2008, a 29% increase from 2007. The main export markets are Venezuela

(14%), Argentina (13%) and the USA (12%). On the other hand, imports amounted to

US$ 4.28 billion, an increase of 21% year over year, coming mainly from the USA

(19%), Germany and Switzerland (13% each). For example, all 450 tons of

amoxicillin (antibiotics) consumed per year are imported.

External Sector:

The Lula administration has used the last few years of solid global demand, surging

commodity prices and elevated liquidity to lower external indebtedness, smooth its

debt maturity profile, and improve currency and interest rate dynamics. Massive

capital inflows have allowed foreign exchange reserves to grow to around USD

236.1bn (equivalent to more than a year worth of imports) and Brazil has become a

net international creditor for the first time in its history. On the downside, we expect

the Current Account will balance to end the year in negative territory. We estimate the

CA deficit will amount to around 1.8% of GDP this year, but it will continue to be

covered by FDI, even under the current tight global financial conditions.

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Outlook:

The outlook for the Brazilian economy is positive. Over the short-term, downside

risks are associated with a rapid deterioration in the current account balance that may

leave the country more exposed to adverse financial conditions. In the medium-term,

both private and public consumption will continue to grow faster than GDP, posing

pressures on domestic production capacity. More investment will be needed to keep

up with increasing domestic demand. In addition, with the goal of ensuring that the

country will grow at potential rates and not fall behind, some structural reforms need

to be addressed.

Economic Indicators (Table. No.6.1.2)

2007 2008 2009 2010

(Projected)

GDP (% growth, real) 3.9 5-1 -0.3 3.1

Inflation (% change, eop) 7.1 5.7 4.5 5.0

Fiscal Balance (% of GDP) -3.0 -1.5 -2.0 -2.0

Exports (% growth) 21.6 23.2 -25.4 8.3

Imports (% growth) 20.6 43.5 -25.7 10.7

Current Account (% of GDP) 1.1 -1.8 -1.8 -1.4

External Debt (% of GDP) 26.3 14.7 16.2 15.6

Debt Service/Current Account 42.7 19.9 23.2 20.6

Exchange rate (eop) 2.4 2.3 1.8 1.7

Source: EIU. EDC Economics

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Market Spotlight: The economy has gone out of recession in the second quarter.

• Both equity market and the currency are showing signs of recovery.

• The Central Bank is expected to hold rates for the rest of the year.

• The country has recently signed bilateral agreements with China for USD15bn

and is reviewing proposals for a new regulatory framework for the recently

discovered deepwater oil and gas reserves.

• The three rating agencies now rate the Brazil investment grade

• The government has announced a new 2% tax on foreign investment on equity

and bonds.

General Political Environment:

Brazilian politics are characterized by a fractiousness that mirrors the country’s

diverse socioeconomic make-up. Relations are generally difficult between the

executive and the legislature, as well as between federal and state governments. In

addition, a tradition of switching parties has made party politics and political strength

in Congress fluid. In 2007 the Supreme Court barred members of Congress from

party-hopping; this will likely forge stronger party loyalty over time.

For now political progress requires constant horse-trading that slows the passage of

reforms, including those widely considered necessary to maintain fiscal sustainability

and to accelerate growth to a level that will move Brazil forward. A difficult

balancing between promoting business and making progress on social issues

undermines the government’s ability to meet expectations on all fronts.

Populist president Luiz Inácio Lula da Silva (Lula) won a second term in October

2006 and has fashioned an 11-party Partido dos Trabalhadores (PT) -led coalition.

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Lula’s greatest challenge for 2009 and 2010 will be to construct an electoral coalition

out of the current government in preparation for elections in October 2010. He will

seek to ensure that Brazil’s next President is also from the PT and committed to his

policies. He has chosen to back a solid PT performer, Lula’s task is made more

difficult by the economic crisis and his administration’s priority is tackling the

negative effects of the global economic slowdown, including a slowing of important

flows of FDI and rising unemployment rates. Lula’s administration is focussing on its

expansionary "growth acceleration" programme of public investment (Programade

Aceleraçãodo Crescimento, or PAC).

Although Brazil’s ratings for control of corruption are improving, corruption is an

ongoing concern. It is more visible now than in the past because of increased

transparency and willingness to prosecute. Lula has skillfully remained at arm’s

length of the various corruption scandals that have touched many of his close allies as

well as his PT party.

Investment Environment:

Lula is a poster child for the moderate left in Latin America, promoting policies that

strengthen the investment environment. This said, Lula advocates for both

government participation in the economy and respect for investors’ contractual rights;

he actively promotes public-private partnerships, not privatizations, to attract private

capital. This approach functions as a moderate disincentive to investment. Despite

significant progress in the liberalization of the foreign exchange regime, important

residual controls remain. Foreign currency bank accounts (such as in USD) are not

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permitted in Brazil. Regulatory agencies are weak and the bureaucracy is

cumbersome. According to the World Bank’s 2008 Doing Business survey,

procedural requirements to start a business in Brazil take 152 days against a regional

average of 60.7 days. The judicial system is generally regarded as fair, but is

considered slow and complex.

Political Outlook:

A mix of moderate nationalism and neo-liberal economic policies will likely continue

to underpin Lula’s policy program, striking a balance between the interests of the

country’s various stakeholders. However, for the foreseeable future the

administration’s energies are expected to be directed to the management of oil policy

and the 2010 elections. On the international front, Lula will pursue his diplomatic

campaign to promote Brazil as the region’s leader and a key player on the world

stage.

Pharmaceutical market scenario:

Emerging pharmaceutical markets in Western Europe, the US and Japan are mature.

The top 10 key pharmaceutical markets accounts for majority of sales amounting to

US$529.5 billion. The seven emerging markets such as China, Brazil, Mexico, South

Korea, India, Turkey and Russia has a growth by 12-13% (US$ 85-90 billion) in

2008.

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Major markets-2007 (Table No. 6.1.3)

Region audited markets-

2007*

2007 Global

sales(US$)

%Global sales % Growth over

2006 (constant

US$)

North America 304.5 45.9 8.7

Europe 206.2 31.1 6.6

Japan 58.5 8.8 2.8

Asia, Africa and

Australia

62.2 9.4 11.3

Latin America 32 4.8 13.4

Total 663.4 100 7.4

Source: IMS Health *Excludes unaudited markets, and Russia, Ukraine and Belarus audited data and cover direct and indirect pharmaceutical channel, pharmaceutical wholesalers and manufacturers

Latin American markets continued their rapid expansion as the sales grew by 13.4%

to US$32 billion. The sales in Brazil grew by 9.7% to US$ 15.7 billion and in Mexico

by 7.5% to US$ 11.1 billion.

The market for generic drugs in Brazil was formally regulated in 1999 in a

government effort to reduce prices of medicines. Brazilian generics are normally

known as ‘similars’ or copies and have been the mainstay of the Brazilian

manufacturers and their production capabilities. In 2003, generics accounted for 6.49

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per cent of the total pharmaceutical market in Brazil at ex-manufacturers prices. The

generic market in year 2008 was around US$ 2.3 billion and use to cover 19.1% of the

total pharmaceutical market. Public awareness of generic alternatives is clearly

growing and the sector is also likely to remain attractive to foreign players.

Due to the depreciation of Brazil’s currency against the US dollar, the Brazilian

pharmaceutical market has fallen in dollar values in 2009. Controlled drug prices are

increasing below inflational levels and demand is contained by a falling economic

growth projected in 2009. For the industry, price controls are not directly linked to

consumption levels. In fact, between 1997 and 2008, the pharmaceutical market by

volume increased significantly only in 2004.

The pharmacy sector in dollar values performed exceptionally well in 2008, but the

sector is starting to register slower growth in the first quarter of 2009. Generic

medicines continue to grow at a higher rate than overall pharmacy sales, and are

expected to represent 20% of the sector by volume in 2010. Foreign participation in

the generic sector has increased.(10)

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Epidemiology of hypertension in Brazil (16 )(21)

Cardiovascular diseases are the leading cause of premature death in industrialized

countries and the World Health Organization (WHO) predicts that by the year 2020

the mortality from cardiovascular disease in low- to middle-income countries will

exceed deaths in all regions except sub-Saharan Africa. A study carried out in 2004

describes the prevalence of hypertension in an urban adult population in north east

Brazil and identifies the most common risk factors, and explores differences in

prevalence rates and risk factors in different socioeconomic areas within the urban

study area.

The prevalence of hypertension (31.8%) in this population is similar to reports from

other developing countries using similar diagnostic criteria. It has been reported that

hypertension affects up to 40% of the adult Brazilian population and is higher in the

urban areas. Most studies however come from the prosperous southern part of the

country. Catanduva (Sao Paulo state), for example (a municipality with high

socioeconomic profile), had a prevalence of 32%, Bambui reported 45% in adults and

Pelotas 20%. In contrast, a small study of the Xavante Indians in rural central Brazil

described a prevalence of 5% in males and 8% in females. Prevalence of hypertension

by age and sex was mentioned in the table below

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Table No. 6.1.4

Age band (years) Males (%) Females (%)

25–34 6/43 (14%) 5/88 (6%)

35–44 6/32 (19%) 15/87 (17%)

45–49 13/26 (50%) 19/34 (56%)

55–64 10/21 (48%) 21/28 (75%)

65–74 9/14 (64%) 13/15 (87%)

>75 2/4 (50%) 8/8 (100%)

Total 46/140 (33%) 81/260 (31%)

The study results says that there is an increasing recognition that dietary patterns and

lifestyles with increasing obesity are changing in developing countries, posing an

increase in the risks of developing hypertension. The study showed that waist-to-hip

ratio, a measure of central obesity was significantly associated with hypertension,

stressing the importance of diet and lifestyle modification as an effective preventative

measure against this disease.

Another study carried out in the year 2006 to estimate the prevalence of self-reported

diabetes and hypertension and their absolute numbers in Brazil. Data from 54,369

individuals aged >18 years, conducted in 27 Brazilian state capitals are analysed. The

result showed that the prevalence of self-reported diabetes and hypertension are high

in Brazil.

In 2009 an article published about the prevalence of hypertension and its associated

factors and to establish the impact of past (i.e. adolescence) and current physical

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activity on hypertension. The report says prevalence of hypertension is high among

Brazilians and markedly different among population subgroups. There was no robust

evidence of association between adolescence physical activity practice and

hypertension in later life.

The Pharmaceutical Intellectual Property (IP) Environment in Brazil:

Brazil's industrial property law (Law 9,279/1996) became effective in May 1997.

Concerns continue about a provision in Brazil’s industrial property law that disallows

importation as a means of satisfying the requirement that a patent be “worked” in

Brazil. Law 10,196 (2001) includes some problematic provisions, including a

requirement that Health Ministry approval be obtained prior to the issuance of a

pharmaceutical patent. This raises concerns with respect to Article 27 of the TRIPS

Agreement, and U.S. officials have raised this concern with their Brazilian

counterparts.

Brazil is one of the largest markets for pharmaceutical products in the world, with one

pharmacy for every 3,300 inhabitants, which is almost twice the number

recommended by the World Health Organization (WHO). The market has the

potential to double and reach more than $ 15 billion. This could be a dream scenario

for the pharmaceutical industry, but several hindrances stand in the way. The industry

is fighting battles against a few domestic laboratories and against ANVISA, (National

Sanitary Vigilance Agency), an agency of the Brazilian Ministry of Health.

Patent applications filed in Brazil on or after May 15, 1997, including PCT

applications having a later international filing date, fully benefit from the new law,

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particularly concerning the patentability of pharmaceutical products and processes

and the 20-year patent term. According to article. 68 of the new law, a patent is

subject to a compulsory license upon request by a third party if (i) the patentee

exercises patent rights in an abusive manner or (ii) by means of the patent the patentee

practices abuse of economic power that is proven under the terms of the law by an

administrative or court decision. A patent will also be subject to a compulsory license

if (iii) the invention is not effectively worked in Brazil or (iv) if commercialization

does not meet the needs of the market.

There still lot of flaws in the IPR issues which are contradictory in nature. Such as

,there has been an urgency to negotiate the prices of life-saving drugs with health

authorities from those countries rather than face the imminent granting of compulsory

licenses of their patents. The policies adopted by the Brazilian government in May

2007, that the government issued the first compulsory license on the grounds of public

interest after negotiations with patent owner Merck when price reduction of the HIV

drug Efavirenz fell through. This was without doubt the most severe penalty the

Brazilian government has applied.

The Brazilian government approved two laws (9,787) of February 10 1999, which

regulates provisions on generic drugs, and Law 10,603 of December 17 2002, which

protects confidential data and information submitted for obtaining approval of

agrochemical, veterinary and pharmaceutical products.

A further concern of the pharmaceutical companies is that Brazil’s Regulatory Law

10,603 of December 17 2002 exempts regulatory officers from responsibility in

granting sanitary registrations to third parties that cover patented drugs. In some

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countries, such as the US, the regulatory officer will check the Orange Book listing to

determine whether the granting of a registration on a drug to a third party will infringe

prior patent rights.(12)

It should be clear that the lack of a dynamic and modern IP system will block

substantial investment and divert it to other developing countries whose laws and

policies favor patent rights. Ironically, Brazil’s market potential as a net taker of

investments is widely acknowledged.

The backlog of patent applications pending substantive examination at the Brazilian

Patent and Trademark Office (PTO) is alarming. The simple reason is the inadequate

number of patent examiners – approximately 200 – responsible for examining all of

the technological areas. The result is a seven to eight year delay for a pharmaceutical

patent application to issue.

High tax rates and price control:

In addition to the high tax rate applied to pharmaceuticals in Brazil, which, at present,

amounts to 35% of the end price of the medicines, the pharmaceutical industry faces

another major problem with the pricing of its products. Since the enactment of Law

10,742/2003, the price of any medicine must be approved prior to its launch in the

market. After this readjustments are only granted on an annual basis by the Brazilian

Chamber for the Regulation of the Market of Medicines (CMED).

Influencing advertising:

Another concern of pharmaceutical companies doing business in Brazil relates to the

advertising of their products. For more than 24 years there was no official control

over advertising of pharmaceutical products. In November 2000 ANVISA

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implemented rigorous rules through Resolution RDC 102. A survey carried out by

IBOPE Monitor compared the first trimesters of the years 2000 through 2007, and

found that pharmaceutical industry investment in publicity had grown almost 70%

over the past three years, as opposed to 33,6% growth in publicity in general.(12)

Multiple trade marks:

Another concern for the pharmaceutical companies is ANVISA’s prohibition to the

effect that a given company cannot sell the same substance under two different marks.

This prohibition appeared in an internal ANVISA note issued in August 2004, and

was later confirmed by an ANVISA Committee. It states that the same pharmaceutical

company cannot own more than one registration covering the same product in the

same presentation identified by different trade marks. According to the internal

instruction, the legal basis for this prohibition is Article 124, Item XX, of Law

9,279/96, which happens to be the Brazilian Patent and Trade Mark Law.

It is clear to trade mark attorneys that ANVISA has misinterpreted the provision.

What the Patent and Trade Mark Law prohibits is the “duplication of trade marks in

the name of a single owner for the same product, unless they are displayed in a

sufficiently distinctive form”. As in foreign laws, the purpose of this provision is to

prevent trade mark owners from duplicating trade marks in an attempt to circumvent

cancellation proceedings on the grounds of non-use. ANVISA has not only

misinterpreted the provisions of the Trade Mark Law, but is also applying the Law

when it is not within its jurisdiction to do so.

Conflict between marks:

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Prior to 2005, whenever there was a conflict between two product names (marks),

ANVISA would give priority to that which identified the product that was first

submitted for registration before ANVISA, even over a previously applied-for or even

registered trade mark for a product which was submitted to ANVISA at a later date.

Surprisingly, however, since June 2005 ANVISA has been recognizing the rights of

trade mark owners and applicants over the rights of the companies which have merely

applied for a product registration, even when the product was registered with

ANVISA at a date earlier than that of the filing of the application or registration at the

Brazilian PTO.

The decision to empower ANVISA with the approval of pharmaceutical patents does

not make sense. It will serve to stimulate conflict between PTO examiners and

ANVISA’s authorities. In addition, the legitimacy of several of ANVISA’s actions

should be challenged on the basis of being unconstitutional.(12)

Drug registration in Brazil

Product registration in Brazil is a lengthy task. Only companies with local operations

have standing to apply for registration of medical products. Depending on the product,

the registration may be valid from two to five years and can be renewed continuously

for the same period. In the case of pharmaceutical drugs, one must inform the active

and inactive ingredients. Instructions, directions, cautions, labels, brochures, and

pertinent information about the products must be translated into Portuguese. The

product registration process often takes more than one year. If the process takes

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longer than three months, importers and producers are allowed to use a protocol

number provided by the Brazilian authorities to distribute their products in Brazil.

The only countries that offer incentives for the registration of generics/copies/similars

are Argentina, Brazil and Chile. These three countries discount the registration

application fee for generic drugs and in addition Brazil offers a shorter evaluation

time for generic and similar products. The cost of registering a product is $27,000 as

on March, 2005. According to the Brazilian legislation, the production,

manufacturing, imports, exports and sales of any medical, pharmaceuticals and

cosmetics products can only be handled by authorized companies, registered with the

ANVISA - National Sanitary Vigilance Agency, an agency of the Brazilian Ministry

of Health. Manufacturers have to disclose to the local authorities, through their agents

(local distributors), the quantitative and qualitative formula of their products, which

should be patented in Brazil before the product is introduced into the market, and at

the time of registration. This has to be described on the registration document.

Time & Fees

The length of time taken to approve drugs in each country is different. All countries in

Latin America, except Brazil, Chile and Cuba have shorter drug approval time than

more developed countries, such as Australia (17 months), countries in European

Union (14-30 months), Canada (17 months) and USA (14 months). The cost of

registering a product is low in Latin America. While Chile offer higher fees for the

registration of generics and similars than for the registration of a new product; Brazil

offer incentives for the registration of generics/copies/similars and discount the

registration application fee for generic drugs.

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(Table. No.6.1.5)

Country Number of Months Cost in US$ (2003)

Brazil Original = 12-14 months similar = 8-12 generic = 6-8

2700-27,000 for original drugs (the price depends on the size of the manufacturer) 7,000 for a similar drug 2,000 for a generic drug

Source: HNP Discussion Paper (World Bank)

Types of Product Registration

For registration purposes, ANVISA classifies products in the following categories

(Law 9.782/99):

1. Medicine Products (Drugs): for human use, their active substances and other inputs;

2. Pharmaceutical Raw Materials: drugs or raw materials to be used in medicines.

3. Health Product: Medical-hospital, Odontological and Hemotherapic equipment and

materials and those intended for laboratory and image diagnosis.

Documentation Needed for Registration

The followings are the basic documents required from the local agent of the foreign

company for the registration of products in Brazil.

Application form obtained from the Brazilian Ministry of Health.

Original copy of the machine stamped bank slip, which serves as proof of

registration fee payment.

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Trade Permit ("Alvará de Funcionamento") issued by the State authority to the

manufacturer's distributor.

Same type of document ("Autorização de Funcionamento"), issued by the

Federal authority to the manufacturer's distributor.

Document showing the technical responsibility of the distributor/

manufacturer, issued by the certification entity.

Technical Report on the product, informing the components of the formula,

instructions, directions, cautions, etc.

Label sample, brochures, pertinent information about the products, all

translated into Portuguese;

For products not clearly mentioned in the Brazilian law, it is mandatory to

provide information about their utilization in order to demonstrate its efficacy

and safety;

Copy of the registration granted to the products at the country of origin (or

copy of the Free Sale Certificate);

Copy of legal document, by which the manufacturer authorizes its distributor

to trade and distribute the products.

If a medical equipment, all documents showing product safety, country of

origin, detailed (exploded view) of the equipment’s inner parts and user

manual, have to be presented for registration.

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Registration of Company in Brazil

Setting up new companies is relatively easy and inexpensive in Brazil. There are four

steps to launch business viz. procedures required to establish a business, the

associated time and cost, and the minimum capital requirement. Entrepreneurs can

expect to go through 17 steps to launch a business over 152 days on average, at a cost

equal to 11.7 per cent of gross national income (GNI) per capita. There is no

minimum deposit requirement to obtain a business registration number, compared

with the regional average of 28.9 per cent of GNI and OECD average of 44.1 per cent

of GNI.

A company should go for registration if any of the following parameters exists:

It is a limited liability company

It operates in the country’s most populous city

The business is 100 per cent domestically owned and has five owners, none of

whom is a legal entity

It has a start-up capital of 10 times income per capita at the end of 2003, paid

in cash

It leases the commercial plant and offices and is not a proprietor of real estate

It does not qualify for investment incentives or any special benefits

The business has up to 50 employees one month after the commencement of

operations, all of them nationals

The turnover is at least 100 times income per capita, and

The business has a company deed 10 pages long.

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Registration Procedures

Following is the procedure for registering a company in Brazil:

Procedure for Starting a Business in Brazil (Standardized Company) (Table. No. 6.1.6)

Procedures Time to Complete

Cost (US$) Comment

Procedure 1 Check company name with State Commercial Registry Office

1 hour $9

Procedure 2 Pay registration fees

1 day

Procedure 3 Register with the Commercial Board of the state where the main office is located. ID number – NIRC

8 days $59.06 Depending on the activities performed by the company (business or civil), its corporate acts (Articles of Incorporations and Amendments) should be registered either with Board of Trade (“JuntaCommercial”) or with the Register of Civil Companies.

Procedure 4 Register for federal tax

10 days No charge

Procedure 5 Register with the Tax Authorities of State of Sao Paulo

10 days No charge It is necessary to fill out the forms available on the Internet with the company’s information.

Procedure 6 Get the authorization to Print receipts/invoices from the Secretaria da Fazenda Estadual

1 day No charge Once the company is registered at Secretaria da Fazenda Estadual, it is necessary to file a specific form (known as “AIDF”) and present the same to the authorities.

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Pocedure 7 Register with the Municipal Taxpayers’ Registry (Secretaria de Finançase Desenvolvimento Econômico ) of the City of Sao Paulo

5 days No charge

Procedure 8 Pay TFE to the Municipal Taxpayers’ Registry

1 day $300 (for retailing business), may vary in accordance with the company’s activities.

Procedure 9 Get the authorization to print receipts/invoices from the Secretaria de Finanças e Desenvolvimento Econômico

1 day No charge Once the company is registered at Secretaria de Fin anças e Desenvolvimento Econômico it is necessary to file a specific form (known as “AIDF”) and present it to the same authorities.

Procedure10 Order receipts/invoices (notas fiscais) with CNPJ numbers from authorized printing companies

3 days $600 ($0.6 per page, assume printing 1000)

Procedure11 Obtain Fire Brigade License from the State of Sao Paulo

120 days No charge In order to obtain the operational license, the company must first obtain the Fire.

Procedure12 Inspection from the Fire Brigade

1 day, included in the previous procedure

No charge

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Procedure13 Apply with the Municipality for an operations permit (Alvaráde Funcionamiento )

1 day, included in the previous procedure

No charge After registration with Secretaria de Finanças e Desenvolvimento Econômico , the company has 30 days to apply for the operations permit

Procedure14 Open a FGTS (special fund for unemployment) account in bank

1 day, simultaneous With Procedure - 13

No charge In order to open the account, the firm must go to any local branch of the Federal Savings Bank (Caixa Economica Federal ) with a copy of its tax number (CNPJ) and either an individual firm declaration or a partnership contract.

Procedure15 Register the employees in the social integration program (Programa de Integração Social, PIS)

1 day, simultaneous with Procedure

No charge The enrollment of a company’s employees with the Social Integration Program.

Procedure16 Notify the Ministry of Labor the employment of workers by sending a form

1 day (trivial), simultaneous with Procedure -

13

No charge Pursuant to applicable legislation, the employer is obliged to inform the hiring or dismissal of any employee to the local department of the Ministry of Labor (Delegacia Regional do Trabalho) until the 15th day of the month subsequent to the month of the event, upon delivery of writtennotice by post or via internet.

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Procedure17 Registration with the Patronal Union and with the Employees Union.

5 days, simultaneous With Procedure - 13

Annual fee to be paid depending on the Union

The registration with the Patronal Union and Employee’s Union is mandatory pursuant to Labor Legislation and ensures that the company is obeying employee labor rights. Each Municipality and State shall have their Unions as to the activity to be rendered by the company.

Regulatory Issues

In the early 1990s, the market for pharmaceuticals in Brazil was slackening. In the

mid-1990s, it was realized that drug prices had risen substantially and some control

was needed to be reintroduced. The failure of market forces in relation to

pharmaceuticals is attributable to the fact that pharmaceuticals are essential products

with inelastic demand and high technical complexity. A new regulatory body, CMED

was established in October 2003 to regulate prices and establish regulatory guidelines

for the pharmaceutical sector in Brazil. This development followed a change in the

law in June 2003, when the Ministry of Health and the Brazilian national healthcare

monitoring agency, ANVISA, took over full responsibility for drug pricing and

pharmaceutical industry regulation from the Ministry of Justice.

The new agency is responsible for overseeing pharmaceuticals, as well as medical

equipment, cosmetics and hospital services. The agency also has the additional

responsibility for authorizing products on the market, as well as the licensing of

manufacturers. TRIPS allow the government to grant licenses allowing the country to

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manufacture generic versions of patented drugs. Brazil's intellectual property law

allows the government to break patents in a health emergency or if it decides prices

are exorbitant.

In recent years, Brazil has repeatedly obtained price reductions from big

pharmaceutical companies by threatening to break patents on the drugs.

Regulatory and approval processes to enter the Brazilian Market

Imported products controlled by ANVISA – the National Sanitary Vigilance Agency,

including pharmaceuticals, vitamins and medical devices products, can be sold only

if:

A) The foreign company establishes a local Brazilian manufacturing unit or local

office, fully responsible for its products; or

B) The foreign company appoints a Brazilian distributor, who has the registration

with the ANVISA as an importer and distributor of the types of products being

offered.

The first step a foreign company must take is to decide whether it is going to

commercialize its products, through the Brazilian distributor or through its own

structure in Brazil. With either option, the distributor has to be duly registered at

ANVISA and authorized to operate by the sanitary agencies both municipal and

federal jurisdiction.

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India: (22)(23)(24)(25)

Industrial growth numbers for the months of May, June and July 2009 indicate that

the Indian industry is coming out of the distressed state. The upswing in the industrial

growth came as a result of upswing in the production of the manufacturing sector that

accounts for 80% of industrial output. Along with the manufacturing sector, mining

and electricity sectors were also seen to register high rates of growth. The average

growth numbers of the overall industry calculated for first four months of 09-10 was

4.6%. This was marginally lower the average growth posted in the corresponding

period of 2008-09. The improvement in industrial growth numbers came as a result of

measures taken by the government and Reserve Bank of India (RBI) to support

overall economic activity.

Latest figures show that FDI inflows in India for July 09 totaled US$ 3.4 billion.

Portfolio investments during the same month totaled US$ 2077 million. With the

Indian economy on the recovery path, it is expected that with time both portfolio

investments and foreign direct investments would go up further.

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Growth in Main Industry sectors ( in percentage) (Table

No. 6.1.7) July 2008 July2009

Food Products 4.7 2.2

Beverages, Tobacco and Related Products 13.7 2.5

Cotton Textiles -1.5 -0.4

Basic Chemicals & Chemical Products (except

products of Petroleum & Coal)

4.8 5.2

Rubber, Plastic, Petroleum and Coal Products -1.7 12.7

Non-Metallic Mineral Products 1.9 8.3

Other Manufacturing Industries 14.3 0.8

Rubber, Plastic, Petroleum and Coal Products -1.7 12.7

Source: Central Statistical Organization

Indian demography:

Fact file (Table No. 6.1.8)

Population: 1,166,079,217 (2009)

Growth rate: 1.548% (2009)

Birth rate: 22.22 births/1,000 population (2009)

Death rate: 6.4 deaths/1,000 population (2009)

Life expectancy: 69.89 years (2009)

GDP 1,164 billions (2009)

GDP real growth 6.2% (2009)

Source :CIA World Fact Book

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The demographics of India is remarkably diverse. India's population of approximately

1.17 billion people (estimate for July, 2009) consists of more than one-sixth of the

world's population.

The increase in aged population (see figure 3.3 below) is altering the healthcare

scenario in India. Furthermore, focus on preventive aspects such as vaccination and

immunization and shifting of disease patterns will create new opportunities and drive

healthy growth of pharmaceutical companies. People are looking forward to leading a

longer, healthier and more productive live.

This opens up new vistas of research into newer and better medicines. Nearly 64% of

the population was in the age group of 15-65 in 2005. As per Economic Survey, it will

increase to 68% of the total population in 2030. In addition, the age group under 65+

will increase from 5% in 2005 to 15% of the total population in the year 2050. With

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improvement in healthcare in terms of increase in life expectancy and decrease in

infant mortality, India has certainly made progress. Life expectancy during 1996-2008

increased from 60.6 to 69.2 years and has been the major contributor to the

pharmaceutical industry growth.

Lifestyle Drugs

The changing disease profile calls for more advanced and innovative therapies.

Lifestyle drugs have become the leading segment for the Indian pharmaceutical

industry. Fast-growing lifestyle segments such as Anti-diabetic segment, Cardio

Vascular segment and Central Nervous System are driving the demand for multi-

specialty and super-specialty healthcare services. Heart disease and diabetes are

growing at 10.7% and CNS is growing at 4.9%. Antiinfective (17.7%) was a major

contributor to the domestic sales in 2007-08. It was followed by gastro-intestinal at

11%. Diabetes is recognised as a major lifestyle disease in the India, with the country

having possibly the largest number of diabetics in the world. Ageing population,

sedentary lifestyles, high stress levels, improper sleep and deteriorating eating habits

are the factors contributing to India’s dubious distinction as the world's diabetic

capital.

The Indian pharmaceutical industry is among the front ranks of the country’s science

based industries with wide ranging capabilities in the complex field of drug

manufacture and technology. In 2006-2007, the Indian pharma market has grown to

US$ 8.16 billion and reached US$ 9.77 billion in 2007-2008.(see figure 6.1.2)

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The pharmaceutical market has grown at a compounded annual growth rate (CAGR)

of 13% during the year 2003-2007. According to a recent McKinsey report, Indian

pharmaceutical industry has the potential to touch US$ 25 billion by 2010.

Based upon the end usage/therapeutic application the pharmaceutical industry is

bifurcated into chronic and acute therapy area. In India, the chronic segment

constitutes only 28% of the market and is considered a high value segment and market

growth.

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Chronic diseases relate to long-term illnesses that require long term medical care.

Most of these diseases are caused by lifestyle changes, eating habits and rise in stress.

In recent years, the country has witnesses a rise in lifestyle related diseases such as

cardiovascular diseases and central nervous system diseases (CNS), as shown in the

figure 2. In 2015, CVS disorders would emerge as the biggest killers in India.

Pharmaceutical Market structure and Size

The pharmaceutical market components revolve round the structure the industry is

having which determines the number of players in the industry. These players can be

classified into bulk drugs and formulations manufacturers as per their role depending

upon the of drug components they manufacture.

Market Structure

Currently there are around 25,000 pharmaceutical registered units in India that

produce around 400 bulk drugs and more than 90,000 formulations (falling under 60

therapeutic categories) as per the Organization of Pharmaceutical Producers of India

(OPPI) estimates. Despite high fragmentation in the industry, a substantial portion of

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the industry’s turnover is contributed by few players. ORG-IMS (MAT June 2008)

data considered major 451 companies and the top 40 companies constitute around

76.6% of the retail sales of 451 companies and the remaining 411 companies have a

24 per cent share .The graphical presentation of the retail sales of the major

companies is depicted in the figure (6.1.4)

Generics are a bio-equivalent of a patented drug. Every year, a number of drugs come

out of the patent regime. A company, who does not have the R&D capabilities or

funds to invest in R&D, launches the generic version of the drug that is coming off

patent. The advantage is that the company need not invest large sums in R&D. The

Indian generic drug manufacturing has seen a substantial rise over the last few years

and is expected to be the main growth driver in future. According to KPMG and IMS

Health data, drugs with approximately US$ 20 billion in annual sales, has expired in

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2008. This market will be converted into generics market, which will provide an

opportunity of US$ 2-3 billion. Buying generic drugs is the only option for most of

the companies in India as the drug pipeline is very lean at present. Moreover, the

USFDA is getting more stringent in granting product approvals. India is capturing a

large portion of generic drugs by influencing its inherent strengths in technology,

R&D facilities and trained human capital.

Major growth drivers:

CRAMS

Contract Research and Manufacturing services (CRAMS) is the most talked about in

the Pharmaceutical industry in India as it turns out to be the biggest opportunity for

Indian Industry. The pressure on big Pharmaceutical companies to evolve a cost-

cautious operations model has resulted in the need to outsource.

Pressure to cut prices Pharmaceutical expenditure is only 7- 9% of total healthcare

cost. Inspite of this, very often the blame for rising healthcare costs is fixed on

pharma industry all over the world. The Pharmaceutical Industry is perceived to be

making high profits, ruthless in their approach & manipulative, with no regard for

patients and their problems. There is on going pressure on the Industry to cut prices.

Outsourcing production to low costs regions offers a way to lower prices without

cutting the margins.

Contract Manufacturing

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Majority of the global companies have started outsourcing the manufacture of

intermediates, APIs & generic drugs to countries like India and China. India has easy

availability of trained manpower. Manpower costs in India are 70% lower than USA.

Setting up FDA approved plant is 30% cheaper here. All these factors make the cost

of manufacture lower than the goods manufactured in the USA and Europe. Quality of

Indian Pharma. products is strictly regulated & accepted all over the globe.

Middle Class, Rural Market to Fuel Pharma Growth

According to the Confederation of Indian Industry (CII), the Indian pharma industry

is expected to touch the growth rate of 19% in 2015 from the growth rate of 13% in

2007. The incremental growth of 6.6% will be mainly supported by two factors:

middle class (2%) and untapped rural markets (2%). At present, the middle class

population, defined as households with an annual income in the range of Rs. 200,000-

Rs. 10,00,000, is estimated to be around 91 million in the country. The middle class

consists of around 8% of total population and is expected to grow four-fold by 2015

to reach 364 million. This will generate an additional demand for the existing and new

medical products.

Most of the rural markets in India, which were not feasible even a few years back,

have now become easily accessible for the companies. Hence, pharmaceutical

companies are thinking beyond larger cities and plugging into rural sectors, purely to

ramp up volumes. Although urban markets are still more lucrative and will continue

to be the focus for the industry, the untapped potential of Indian rural markets is now

seen as the next volume driver. With rising rural incomes and a strong distribution

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network, India's rural pharma market is also experiencing strong growth. Small towns

contribute 20% to the country's pharma market, whereas rural areas account for 21%.

Exports:

Before the patent regime, most Indian companies focused on exports. Exports

improved the valuation of companies owing to higher margin in overseas markets.

Indian companies built fortunes by making cheaper versions of blockbuster drugs and

selling them in domestic and export markets. They built strong position in

manufacture of bulk drugs. Out of the total phrama exports, formulations constitute

55% and the bulk drugs constitute 45%. Success in export market allowed some

Indian companies to build a strong position in the domestic market organically and

through acquisitions of brands and companies.

In the post-patents regime, exports will continue to be a priority for Indian companies.

Major blockbuster drugs will come off patent in the near future, creating a big generic

opportunity for Indian companies. Generic market is growing at a faster rate (20%)

than the pharma market. A growing demand for anti-AIDS drugs in Africa will keep

Indian companies busy.

Exports will provide Indian companies with the strength to withstand the onslaught of

multinationals in the domestic markets and is critical for bulk drug manufacturers. But

the costs of regulatory compliance will increase in domestic and export markets.

In the Indian pharmaceutical industry, drugs worth approximately US$ 20 billion in

annual sales has expired in 2008. Hence, this market will convert into generic market,

providing an opportunity of US$ 2-3 billion. With drug pipeline drying up and

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USFDA getting more stringent in granting product approvals, buying generic is only

option for most of the companies.

The US patent's expirations of branded products will substantially contribute to the

growth of Indian pharmaceutical industry, thereby pushing a great deal of its exports,

particularly in generic drugs markets. This is because low production costs give India

an edge over other countries. This will also provide adequate opportunities for the

Indian generic drug manufactures to capture the largest market share. The major part

of the Indian pharmaceutical industry is supported by exports. Hence, exports are a

must for the domestic market. Indian companies can initiate exports by forming

subsidiaries and joint ventures. It will generate more revenues for the industry.

Epidemiology study of hypertension: (17)

Cardiovascular diseases have emerged as an important health problem in India. High

blood pressure (BP) is a major risk factor and better control can lead to prevention of

300,000 of the 1.5 million annual deaths from cardiovascular diseases in India.

Epidemiological studies demonstrate that prevalence of hypertension is increasing

rapidly among Indian urban populations and using the current definitions more than

two-fifths of the Indian urban adult population has hypertension. The prevalence is

lower in rural populations, but is increasing. Jaipur Heart Watch (JHW) is an ongoing

cross-sectional epidemiological study in western India. Successive studies have been

performed in rural (JHW-R, 1992–93) and urban locations (JHW-1, 1993–94; JHW-2,

1999–2000; JHW-3, 2002–03, and JHW-4, 2004–05). The studies evaluated adults

≥20 years using standardized methodology and in the present analyses subjects aged

20–59 years from these JHW studies [4102 men (1700, 1294, 469, 179 and 413) and

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2872 women (1063, 655, 486, 195 and 433)] have been included. Prevalence of

various cardiovascular risk factors: smoking/tobacco use, sedentary habits,

overweight/obesity (body mass index ≥ 25 kg/m2), central obesity (waist : hip ratio

>0.95 men, >0.85 women), hypertension, dyslipidemias, metabolic syndrome and

diabetes was determined. Trends were analysed using least squares linear analyses.

Results show that mean systolic BP increased with age in all the study cohorts, while

there was no significant difference in diastolic BP. Age-adjusted prevalence of

hypertension in JHW-R, JHW-1, JHW-2, JHW-3 and JHW-4 studies in men was 21.6,

29.1, 29.6, 42.5 and 45.1% and in women it was 15.7, 21.7, 25.5, 35.2 and 38.2% (P

for trend <0.05). There was a significant association of escalating hypertension with

obesity and truncal obesity in both men (two-line regression analysis, unadjusted r2 =

0.91 and 0.50 respectively) and women (r2 = 0.88 and 0.57; P < 0.05). Increasing

hypertension in India is related to increasing adiposity levels. Population and

individual-based measures to prevent and control high BP should focus on measures

to prevent obesity.

Table 6.1.9 Recent Indian hypertension prevalence studies in urban Indian subjects (BP ≥140/90) Sample size Prevalence (%)

Year Age group (yrs)

Place Men Women Men Women

1995 20–75 Jaipur 1415 797 29.5 33.5

2000 20–89 Thiruvananthapuram 76 130 31.0 41.2

2000 30–60 Mumbai 1521 141 34.1*

2001 20–70 Chennai 518 657 21.1*

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2003 20–75 Jaipur 550 573 36.4 37.5

2004 18–60 Mumbai 40,067 59522 43.8 44.5

2006 20–70 National 11,829 8039 29.3 25.2

(*Gender-specific data not available) The study concludes that the prevalence is increasing exponentially in the country.

The studies demonstrate that increasing obesity and adiposity levels are driving this

epidemic. There is an urgent need to develop suitable strategies for prevention of

obesity in India using population-based approaches.

Intellectual Property Right Issues

In 1970, the Government of India had amended its IPR laws with a clear objective to

reduce

the price of medicines and to increase the access to the ailing population of the

country. As a result, drugs were made cheaper, but still a substantial percentage of

population does not have access to moderately-priced medicines and many children

go out without vaccination. Only 44% of infants are fully vaccinated against six major

diseases—tuberculosis, diphtheria, pertussis tetanus, polio and measles. The Patent

Law 2005 integrates India into global pharmaceutical market by bringing the

protected era to an end.

DOHA Declaration-Concession to developing nations: (26)

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The first significant achievement of the World Trade Organization's Doha ministerial

Conference came on the morning of 13 November 2000 when a compromise on the

'declaration on the TRIPS Agreement and Public Health' was reached. It was as a

result of staunch effort by India Brazil and about 55 other African nations. This is one

of the areas where there is an assurance that the restrictive clause under the TRIPS

agreement on drug patents will not over ride public health concerns. It is a positive

development that in TRIPS, a public health crisis has been included as an exception

for granting compulsory license (CL).

In the new Doha Declaration is that it recognizes the fact which was implicit under

Articles 7 and 8 of TRIPS, that considerations of Public Good which includes public

health could be the over riding factor while offering IPR protection for medicines for

specified diseases and 'epidemics' , particularly for DCs and LDCs . The one hundred

and forty two countries who came together at the 4th WTO Ministerial Conference at

Doha clearly affirmed that governments are free to take all necessary measures to

protect public health. The declaration gave primacy to public health over intellectual

property rights.

It is viewed that this declaration on public health is trophy for India since WTO had

accepted, unequivocally, that patents will not stand in way of Public health . This is a

very important aspect for India because, now national governments can decide if a

particular situation or crisis is an emergency and that whether it would warrant

sidelining of patents. How far this declaration would help India would be seen in

future.

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It is inevitable that the industry now has to face these challenges and the opportunities

that the new regime would throw open. To overcome the resource crunch the industry

may have to consider many options like mergers with other pharma firms,

collaborations with foreign companies, joining an R&D consortia etc. The industry

would learn to change its axis of expertise from re-engineering to innovation.

Aggressive marketing, good branding, better products, R&D and a patent protection

would be their tools of success. The past has shown that India appears to have the

technological and the commercial capability to adopt to more competitive

environment. It has often caught up with world technological frontiers in other

sectors. It can continue to do so again in future, if the industry wants to be an

important pharmaceutical development center on world map.

6.2 Risk analysis (1)(4)(28)(29)

If a company is to survive in the international marketplace, it is important that it searches for

methods to reduce, as far as possible, the risk of making wrong decision. Lack of knowledge

of foreign markets is one of the major barriers an international marketing manager has to

overcome.

Before making a decision to go abroad, the company must weigh several risks, such as

• the company might not understand foreign customer preferences,

• they might not understand the foreign country’s business culture or know how to deal

effectively with foreign nationals,

• the company might underestimate foreign regulations and incur unexpected costs,

• the company might realize that it lacks managers with international experience,

• the foreign country might change its commercial laws, devalue its currency or

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undergo a political revolution and expropriate foreign property.

Because of the conflicting advantages and risks, companies often do not act until

some event thrusts them into the international arena. In the markets where

opportunities have been identified, researchers need to make an assessment first as to

the type of risk.

Over recent years marketers have developed various indices to help assess the risk

factors in the evaluation of potential market opportunities. The four major categories

of risks identified are namely:

a) Macro-environmental risks arises from cataclysmic events such as wars, as

well as unstable political or economic conditions over which the firm has no

control.

b) Political risks arise from decisions by governments, such as tariffs, product

regulation, and restrictions on foreign investment which the firm can control

or influence to some extent

c) Competitive risks arise from the actions of competitors in domestic and

international markets, such entering a market, launching new products,

attacking or defending a position.

d) Operational risks are those associated with actions taken by the firm in

international markets, such as such as introducing products or services into

countries where there is no established market or they appear to run counter to

existing behavioral life-style patterns.

For any business, risks stemming from poor governance, political violence and an

unstable regulatory environment can significantly affect performance and reputation.

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For responsible business, considerations including a country’s human rights record,

such as the performance of its security forces or child labour, are also key to avoiding

accusations of complicity and maintaining brand equity. Managing risks well not only

improves profitability, but also enhances a company’s social license to operate, as

well as attractiveness to customers, clients, investors and other stakeholders.

Maplecroft’s Political Risk Report 2009 offers a distinct approach by dividing

political risk into two groupings. The first, dynamic risks, assesses ‘traditional’

political risk, such as regime stability, the rule of law, terrorism, expropriation and the

business environment. The second, structural risks, measures long-term trends and

intrinsic features of a country, such as its human rights record, its energy, food and

water security, its development status or its vulnerability to climate change.

This approach of differentiating between dynamic and structural risks more accurately

reflects new challenges in an increasingly interdependent world and supports

responsible business by:

• Examining the relationship between immediate political events and a

country’s resilience to long-term challenges

• Generating a point-specific, sub-national risk profile for terrorism, conflict

and political violence

• Forecasting potential instability and unrest

• Highlighting areas with greater supply-chain risks such as child labour and

forced labour

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• Assessing potential for reputational damage and complicity with human rights

violations

• Identifying areas for corporate social investment, philanthropy and

stakeholder engagement

Analysis of index results shows that despite current stability, a country may be highly

vulnerable to future challenges such as climate change or food scarcity. Conversely, a

country at apparent high risk due to factors such as terrorism may hold significant

appeal for business in long-term structural areas, such as infrastructure, levels of

education and energy security.

Among the BRICs (Brazil, Russia, India and China), there is a diverse pattern of risk

in the structural and dynamic risk indices.

Brazil comes out most favorable, scoring an overall medium risk for dynamic risks –

governance framework, political violence and business and macroeconomic

environment. It also has a medium risk profile for structural risks such as supply chain

risks, poverty, development, energy security and vulnerability to climate change.

However, Brazil performs badly in terms of its civil and political rights, its judicial

independence and its security forces’ respect for human rights.

India is high risk for both dynamic and structural risks. Its poorer score compared to

Brazil can be attributed to significantly higher levels of terrorism, poorer regime

stability and higher levels of corruption. India is also much more vulnerable to

climate change and natural hazards, has higher levels of poverty and significantly

lower water and food security. This will impact on future political risk.

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Interestingly, however, it scores better than Brazil in terms of corporate governance,

including its protection of investors, ethical behaviour of firms and strength of

auditing and reporting standards, making it an attractive place for investment in the

immediate term. However, for responsible business, India’s very poor score with

respect to child labour, forced labour and discrimination may overshadow these

positive trends. These areas will require companies to develop appropriate policy

interventions, monitoring systems and management frameworks.

The main value of subscribing to such indices is to give companies an appreciation of

the risk involved in opportunities identified.

(Table. No. 6.2.1) Dynamic Risk – Index scores and categories

Country Dynamic Risk Index Category

Brazil 6.2 Medium

China 5.4 Medium

India 3.9 High

Russia 2.5 Extreme

Source: Maplecroft | The Towers, St Stephen’s Road, Bath BA1 5JZ, United Kingdom, www.maplecroft.com

Dynamic Risk. Figure No.6.2.1

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Extreme risk (0-2.5) = (0-1.25) = (1.25-2.5)

High risk (2.5-5) = (2.5-3.75) = (3.75-5)

Medium risk (5-7.5) = (5-6.25) = (6.25-7.5)

Low risk (7.5-10) = (7.5-8.75) = (8.75-10) (Table. No. 6.2.2) Structural Risk – Index scores and categories

Country Structural Risk Index Category

Brazil 6.0 Medium

China 3.5 High

India 3.1 High

Russia 5.8 Medium

Source: Maplecroft | The Towers, St Stephen’s Road, Bath BA1 5JZ, United Kingdom, www.maplecroft.com

Structural Risk. Figure No.6.2.2

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Extreme risk (0-2.5) = (0-1.25) = (1.25-2.5)

High risk (2.5-5) = (2.5-3.75) = (3.75-5)

Medium risk (5-7.5) = (5-6.25) = (6.25-7.5)

Low risk (7.5-10) = (7.5-8.75) = (8.75-10)

The Country at rating assigned by Coface reflects the average level of short-term non-

payment risk associated with companies in a particular country.

Ratings are based on two fold expertise developed by Coface:

- macroeconomic expertise in assessing country risk based on a battery of

macroeconomic financial and political indicators

- microeconomic expertise that draws on Coface databases covering 44 million

companies worldwide and 50 years experience with payment in trade flows it

guarantees.

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7 families of risk are combined in order to determine an overall rating for each of the

154 countries monitored. Coface ranks country ratings on seven risk levels, A1, A2,

A3, A4, B, C and D, in the order of increasing risk.

The seven risk families are:

Table. No. 6.2.3

Growth vulnerability Banking sector's fragilities

Foreign currency liquidity crisis Geopolitical and Governance

vulnerabilities

External over indebtedness Companies' payment behaviour. Sovereign financial vulnerability

• A1 The steady political and economic environment has positive effects on an

already good payment record of companies. Very weak default probability

• A2 Default probability is still weak even in the case when one country's

political and economic environment or the payment record of companies is not

as good as in A1-rated countries.

• A3 Adverse political or economic circumstances may lead to a worsening

payment record that is already lower than the previous categories, although the

probability of a payment default is still low.

• A4 An already patchy payment record could be further worsened by a

deteriorating political and economic environment. Nevertheless, the

probability of a default is still acceptable

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• B An unsteady political and economic environment is likely to affect further

an already poor payment record.

• C An very unsteady political and economic environment could deteriorate an

already bad payment record.

• D The high risk profile of a country's economic and political environment will

further worsen a generally very bad payment record

The business climate rating is to assess overall business environment quality in a

country which comprises two modules ( )

1) The core of the new rating rests on the Coface experience with the quality of

information available on companies and the legal protection given to creditors.

The module was developed based on the responses by Coface entities

worldwide to a questionnaire covering:

the quality and availability of financial information (legal framework for

financial statement publication, availability, accessibility, and reliability of

corporate accounts, and so on)

creditor protection and debt collection efficiency (rating grids for summary

legal procedures, ordinary legal procedure, court costs, bankruptcy procedures,

for example)

The above ratings may be compared to other sources like the "institutional profiles"

database

maintained by the French Ministry of Finance and validated by an internal committee

to ensure homogeneous and consistent responses.

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2) The above ratings based on the Coface experience is supplemented by a

module on institutional framework quality. This module reflects the quality of

institutions whose strengths and weaknesses can affect companies.

The parameters considered include, for example, public service effectiveness

(government, education, health, infrastructures), regulatory quality, respect for

the law, and extent of corruption. The calculations are bases on data from

external sources notably including:

the government effectiveness indicator maintained by the World Bank

Institute based on the quality of public services provided and on civil service

efficiency

the HDI, or human development index, a composite statistical index created

by the United Nations to rank countries according to their qualitative

development based on the average of three quantitative indices reflecting

respectively health/life expectancy, knowledge or education level, and

standard of living

an infrastructure quality index (energy, transport, telecommunications)

published by the World Economic Forum in its "Global competitiveness

report"

a regulatory quality indicator (World Bank Institute) that reflects the possible

existence of policies contrary to the smooth running of a market economy (like

prices controls or poor bank oversight), and the apparent influence of local

regulations on foreign trade and the business climate.

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a rule of law indicator (World Bank Institute) reflecting the confidence of

economic a gents in their judicial system, legal system efficiency and

transparency.

an indicator of corruption (World Bank Institute) reflects the apparent extent

of corruption, defined as misappropriation of public property for private

purposes.

The above indicators and indices are generally based on information derived from

company surveys. • A1 The business environment is very good. Corporate financial information is

available and reliable. Debt collection is efficient. In stitutional quality is very

good. Intercompany transactions run smoothly in environments rated A1.

• A2 The business environment is good. When available, corporate financial

information is reliable. Debt collection is reasonably efficient. Institutions

generally perform efficiently. Intercompany transactions usually run smoothly

in the relatively stable environment rated A2.

• A3 The business environment is relatively good. Although not always

available, corporate financial information is usually reliable. Debt collection

and the institutional framework may have some shortcomings. Intercompany

transactions may run into occasional difficulties in the otherwise secure

environments rated A3.

• A4 The business environment is acceptable. Corporate financial information is

sometimes neither readily available nor sufficiently reliable. Debt collection is

not always efficient and the institutional framework has shortcomings.

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Intercompany transactions may thus run into appreciable difficulties in the

acceptable but occasionally unstable environments rated A4.

• B The business environment is mediocre. The availability and the reliability of

corporate financial information vary widely. Debt collection can sometimes be

difficult. The institutional framework has a few troublesome weaknesses.

Intercompany transactions run appreciable risks in the unstable, largely

inefficient environments rated B.

• C The business environment is difficult. Corporate financial information is

often unavailable and when available often unreliable. Debt collection is

unpredictable. The institutional framework has many troublesome weaknesses.

Intercompany transactions run major risks in the difficult environments rated

C.

• D The business environment is very difficult. Corporate financial information

is rarely available and when available usually unreliable. The legal system

makes debt collection very unpredictable. The institutional framework has

very serious weaknesses. Intercompany transactions can thus be very difficult

to manage in the highly risky environments rated D.

Brazil Country Rating: A4

A somewhat shaky political and economic outlook and a relatively volatile business

environment can affect corporate payment behaviour. Corporate default probability is

still acceptable on average.

India Country Rating : A3

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Adverse political or economic circumstances may lead to a worsening payment record

that is already lower than the previous categories, although the probability of a

payment default is still low.

Brazil and India Business Climate Rating : A4 (both)

The business environment is acceptable. Corporate financial information is sometimes

neither readily available nor sufficiently reliable. Debt collection is not always

efficient and the institutional framework has shortcomings. Intercompany transactions

may thus run into appreciable difficulties in the acceptable but occasionally unstable

environments rated A4.

6.3 Cultural aspects (2)(4)(30)

Markets in countries around the world are subject to many influences. The

development of successful international marketing strategies is based on a sound

understanding of the similarities and differences that exist in the countries around the

world. The differences between social and cultural factors in different parts of the

world can be a central consideration in developing and implementing international

marketing strategies. Differences in language can alter the intended meaning of a

promotional campaign and differences in the way a culture organizes itself socially

may affect the way a product is positioned in the market.

There are few components which does matters mainly when a organization is going

global. In pharmaceutical sector the market is focused and maximum promotional

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activities are targeted not for the end users, because drugs are prescribed by the

doctors and the end users has no other choice, but to buy the prescribed product. So

following are few things which are to be taken into consideration,

Education: the level of formal primary and secondary education in a foreign market

will have a direct impact upon the target customer or in business. The labeling of

products, especially which can cause fatal side effects, need to be taken seriously for a

market that has a very low literacy rate. Messages can be disseminated through

pictures or diagrams in low literacy sectors.

Law and politics: The legal and political environments in a foreign market are often

seen as consequences of the cultural traditions of that market

Aesthetics: This area covers the local culture perception of things. A firm needs to

ensure that their product and communications strategies is sympathetic and acceptable

to the local culture.

Values and attitudes: The values consumers from different countries place on things

such as time, achievement, work will effect seriously not only the products offered

but also the packaging, distribution and communication strategies.

Religion: It is a major cultural variable and has significant if not always apparent

effects on marketing strategy. No violation of religion by advertising and other

promotional practices no matter how significant, will go unnoticed or unpunished

either by the government or the consumer.

Language: It can be divided into two major elements. The spoken language is the

actual words spoken and the ways in which the words are pronounced and silent

language which is the communication through body language, silences and social

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distance. Silent languages are particularly important in sales negotiations and other

forms of business meetings for example time, friendship, agreements.

A study was carried out in Brazil by Department of Anthropology, the University of

Alabama, USA and departamento de Clínica Médica, Faculdade de Medicina de

Ribeirão Preto, Universidade de São Paulo, Brazil, to get an insight of the Social and

cultural dimensions of hypertension in Brazil.

Elevated arterial blood pressure varies substantially in relation to social and cultural

variables. Early work on acculturation, socioeconomic status, and blood pressure

documented this variation, which could not be explained entirely by conventional

factors such as diet, physical activity, or access to medical care. These findings

stimulated the development of a model of stress and disease. The stress model

emphasizes social and psychological factors that are perceived by individuals to be

stressful, as well as factors that help individuals to respond to those stressors.

Conventional stress models are, however, problematic because the primary emphasis

is on individual perception, with little consideration of the social and cultural context

in which stress occurs. Findings from research in Brazil indicate that the higher an

individual’s cultural consonance, the lower his or her blood pressure. These results

indicate the importance of linking different levels of analysis – the cultural, the

individual, and the biological – to understand disease risk.

In this paper it was examined, in the context of Brazil, theory and research on social

and cultural factors and cardiovascular disease risk. The earliest observations

regarding social and cultural factors and disease risk documented the mean

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differences in blood pressure (and rates of related cardiovascular diseases) between

societies with very different economic and social systems. Studies of isolated tribal

groups showed conclusively that certain kinds of associations – most prominently that

between age and blood pressure – that were thought to be “natural” based on research

in North American and Europe were actually not. Rather, the associations of age and

sex and blood pressure, and even adiposity and blood pressure, depended upon the

type of society studied. Explanations for this phenomenon included the low levels of

obesity, high activity levels, and low sodium intake observed in tribal societies, as

well as the possibility that individuals who might develop high blood pressure at a

later date had been selectively eliminated from the population by infectious or

parasitic disease. Detailed studies showed, however, that these explanations could not

account entirely for observed differences.

The association between societal type and blood pressure was further confirmed by

the study of two kinds of social change: the migration of groups from more traditional

to more modern communities, and social and cultural change occurring within a

single community. Results of these studies show that, as social and cultural change

occurs, mean blood pressure and rates of hypertension increase. Detailed studies show

that changes in physical activity and diet accompany culture change, but these

changes cannot account entirely for the magnitude of differences in mean blood

pressures and rates of hypertension between groups.

Cassel et al. (1960) were among the first investigators to suggest that social and

cultural processes might underlie these associations. Cassel acknowledged that

changes in diet, physical activity, adiposity, and health habits such as smoking

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certainly were occurring in contexts of culture change. But, he argued, other

fundamental changes were occurring. Individuals who had been socialized in one

culture were confronting another. Literally, individuals who had been raised with one

body of shared knowledge that guided their behavior and enabled them to understand

and interpret others’ behaviors were now in a situation in which they were attempting

to negotiate a social world governed by a different set of meanings. This, Cassel

argued, would lead to many situations of confusion and frustration in mundane social

interaction, a situation likely to be stressful and, repeated over years, conducive to

sustained disease.

This emphasis on the stressful nature of culture change led researchers to adopt the

stress model developed in research in industrialized societies as their theoretical

orientation, but with modifications introduced on the basis of ethnographic research in

developing societies. So, for example, concepts like lifestyle incongruity were based

on observations regarding the changing status value of lifestyles in developing

societies. Similarly, in studying buffers against social stressors, researchers adapted

existing concepts of social supports to knowledge of the importance of various kinds

of social relationships in specific cultural contexts. These efforts can be seen as

modifying somewhat the content of the stress model, but still working within that

tradition.

The emphasis on the stress model for studying culture change and health was also

consistent with socio epidemiological work on stress, which grew primarily out of the

observations linking social class or socioeconomic status differences and health. With

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conventional factors (such as obesity or diet) unable to explain social class differences

in health, researchers turned to the stress model.

More recent work on cultural consonance takes a different direction. Since the early

and pioneering work of Cassel, with its central importance of culture as a system of

knowledge and meaning, emphasis on culture per se has diminished in favor of the

specification of (culturally relevant) biobehavioral processes. The results of studying

cultural consonance, albeit tentative based on the results presented here from Brazil

and a replication study in the United States (Dressler et al., 1998), suggest that

Cassel’s original ideas may need to be reconsidered. The model of cultural

consonance provides theory and method for understanding how individuals are

distributed in cultural space, relative to prototypical shared cultural models of some

domain of life. Cassel suggested that individuals could find themselves in a state of

“cultural incongruity” because their own culture was not relevant in a particular

context. Similarly, we are suggesting that individuals can be low in cultural

consonance (or “culturally dissonant”) because they are, for whatever reason, unable

to act upon the widely shared ideas about how to live life appropriately. In either

respect, individuals (or groups of individuals) are prevented from effective

participation in their own society.

It would be straightforward to simply label this a stressful experience and leave it at

that. There is, however, a growing body of laboratory research to suggest that the

context of meaning surrounding social interaction can alter cardiovascular reactivity

to that interaction. For example, Lynch (1985) found that transitory blood pressure

elevations associated with social interaction can increase, and recovery to baseline

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lengthen, if the participants in the interaction are of unequal social status. Similarly,

cardiovascular reactivity to laboratory social stimuli can be diminished by the

presence of a supportive friend in the testing situation.

These laboratory studies suggest that when social interaction is more orderly and

meaningful, an individual’s cardiovascular system maintains a more stable state.

Individuals who attain and maintain a higher cultural consonance along several

dimensions are living a life that is, by definition, more meaningful. Their lived

experience of the world, not just in thought but in actual behavior, conforms to the

widely shared ideas about (or cultural models of) the world. Individuals low in

cultural consonance are literally not experiencing this stable and meaningful world.

Instead, their lives are a constant reminder, in very concrete ways, of this instability

and lack of meaning. It may be, then, that in response to mundane stimuli in the

world, including social interaction, they are more highly reactive physiologically, a

reactivity that in turn can lead to sustained changes in the vascular bed and higher

blood pressure. This interpretation is not entirely speculative. A recent study from the

West Indies has shown that males who do not conform to the local cultural ideal of

male behavior have higher circulating levels of cortisol, and show greater reactivity in

cortisol to mundane stimuli.

The model of cultural consonance can also account for our earlier findings in Brazil.

For example, careful examination of the measurement of lifestyle incongruity shows

that people are not really trying to live a lifestyle of conspicuous consumption in the

context of low income. Rather, a careful examination of this measure shows that it

actually measures individuals’ difficulty in maintaining a very conventional lifestyle.

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Instead of living beyond their means, they do not have the means to maintain a very

basic lifestyle. By isolating the elements of that lifestyle that are most highly

culturally salient, the measure of cultural consonance in lifestyle simplifies the

detection of that association. (This is analogous to isolating different fractions of

serum lipids and observing the different effects of those fractions.) Similarly, the

more careful assessment of cultural consonance in social support, based on the

cultural model of social support, clarifies the basis for different kinds of supports

having different effects on health.

This is not to say, however, that the model of cultural consonance can completely

replace models of stress. As here, in Brazilian sample, cultural consonance conditions

or moderates the effects of perceived stress. This review demonstrates the importance

of incorporating a cultural perspective into an understanding of psychological and

behavioral influences on blood pressure. The concept of cultural consonance links the

cultural level of analysis to individual behavior, and this dimension of behavior and

its effects on health cannot be reduced to psychological or behavioral influences.

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DEPARTMENT OF PHARMACEUTICAL MARKETING AND MANAGEMENT

6.4 Competitor analysis (1)(18)(22)

Competition is becoming intense with every passing year. Companies

their customer and competitor orientation in order to be success

changing environment. Competitive analysis is a program for gathering

information about competitor’s activities and general business tren

company’s own goal

There are five forces that determine the intrinsic long run attractiveness

market segment. They are as follows:

• Industry competitors - A segment is unattractive if it al

numerous, strong or aggressive competitors. There condition

frequent price wars and new product introductions and will ma

to compete. It is more even unattractive if it is stable or dec

costs are high etc.

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Page 97

need to balance

ful in the fast

and analyzing

ds to further a

of a market or

ready contains

s will lead to

ke it expensive

lining, if fixed

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• Potential entrants - A segment’s attractiveness varies with the height of its

entry and exit barriers. The most attractive segment is one in which entry

barriers are high and exit barriers are low. Few new firms can enter the

industry and poor performing firms can easily exit.

• Substitutes - A segment is unattractive when there are actual or potential

substitutes for the product. Substitutes place a limit on prices and on profit.

• Buyers - A segment is unattractive if buyers possess strong or growing

bargaining power. But in pharmaceutical market it is not applicable as the

drug to be bought, by the patient is decided by the doctor

• Suppliers - A segment is unattractive if company’s suppliers are able to raises

prices or reduce quantity supplied

Competition refers to rivalry among various firms operating in a particular market that

satisfy the same customer

Their action can spoil an attractive industry

Their weakness can be a target for exploitation

Their response to a firm’s marketing initiatives can have impact on a firm’s

success

Once a company identifies its primary competitors, it must ascertain their

strategies, objectives, strengths and weakness

Brazil plays a leading role in Latin America, being the main manufacturing center in

the region. The majority of the market volume is supplied by the domestic industry,

but in value terms, multinationals accounts for 70 per cent of market.

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The major part of pharmaceutical industry in Brazil includes Medley, EMS,

Biosintética and Eurofarma. Laboratórios Biosintética is one of the best

pharmaceutical companies in Brazil having major presence in cardiology,

dermatology, respiratory and oncology segments.

The other state-owned laboratory is Far-Manguinhos. International generic players

investing in the Brazilian pharmaceutical market are Hexal (Germany), Apotex

(Canada), Ranbaxy Farmaceutica Ltda (India), Teva (Israel), Ratiopharm (Germany),

Cinta (Spain) and Torrent Do Brasil (India).

The world’s largest generic drug maker, Teva entered into a joint venture with

Brazil’s leading generic company Biosintetica and formed BioTeva for distribution

and production of Teva generics. The latter also formed an agreement with Novartis

for marketing Valsartan (used as an anti-hypertensive). Teva invested between US$30

to 50 million towards production activities in Brazil. In another major event,

Denmark-based pharmaceutical major - Novo Nordisk acquired the Brazilian insulin

pharmaceutical company, Biobras. The wholly owned Brazilian subsidiary of India’s

Torrent Pharmaceuticals Ltd, Torrent Do Brasil, introduced ten products in Brazil.

Aurobindo Pharma Limited also targeted the Brazilian generic market for its

formulation business.

In Indian market the major players in cardiovascular segments are as follows:

I. Ranbaxy Laboratories Ltd is India’s largest pharmaceutical company,

manufacturing and marketing world class generics, branded generic

pharmaceuticals and active pharmaceutical ingredients. It is ranked amongst

the top ten generic companies worldwide. Ranbaxy has an expanding

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international portfolio of affiliates, joint ventures and representative offices

across the globe with a presence in 23 of the top 25 pharma markets of the

world. With respect to Candesartan, the company has 2 brands that is

Candesar and Candesar-H available in the market

II. Since its inception in 1984, Dr Reddy’s Laboratories (DRL) has chosen to

walk the path of discovery and innovation in health sciences. The company

operates in over 100 countries worldwide. It has more than 75 patents to its

name with its pharmaceutical value chain ranging from API and Intermediates,

Finished Dosages (Branded and Generic) and New Chemical Entity (NCE)

Research. The company is engaged in manufacturing and marketing

pharmaceutical products. Cantar is the only brand of Candesartan available in

the market.

III. Lupin Ltd is the merged entity of Lupin Chemicals and Lupin Laboratories.

Lupin limited is among the top six Indian pharma companies with an

increasing global presence. It is USFDA & UKMCA approved and has a

strong R&D which focuses on process chemistry, fermentation, ANDA,

NDDS and NCE. It is one of India's largest manufacturers of bulk actives and

formulations. Its major therapeutic focus areas are anti TB, Cephalosporin,

Ace-inhibitors, Statins and Prils. Telma is one of the leading brand currently in

the ARB category in the Indian market. It has also other brands such as Valent

which was a leading brand too few years ago.

IV. Cadila Healthcare Ltd, the flagship company of the Ahmedabad based Zydus

Group, is one of India's leading integrated pharmaceutical companies. The

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company is also a leading producer of niche and complex bulk drugs. Zydus

Research Centre (ZRC) is the research and development wing of Zydus

Cadila. The company plans to develop new markets in Latin America, Asia

and the Middle East.

V. Glenmark Pharmaceuticals is one of the leading Indian pharmaceutical

companies. It marketsits products to over 27 countries across the globe with

2000 employees, over 150 scientistsand 15 offices. It is a leading research &

development firm with a thrust on manufacturing &product marketing

globally. Glenmark follows a branded generic model in markets across Asia,

Africa, CIS countries, Russia and Latin America.

VI. Torrent Pharmaceuticals Ltd (TPL) is the flagship company of the Torrent

Group. Founded in 1972, it is based in Ahmedabad. It manufactures bulk

drugs and formulations. It also manufactures and markets medical diagnostic

instruments. In a major move to restructure, the company has carved out five

divisions: prima, psycan, vista, axon and neuron. Of its divisions, prima offer

mass products, psycan focus on cardiology, vista is a sub-speciality division

and axon and neuron focus on neuro psychiatry

VII. Aventis Pharma Limited is the second largest pharmaceutical multinational

company in India which has a commercial presence in 80 countries. Aventis

Pharma Limited previously known as Hoechst Marion Roussel deals in a

number of activities ranging form prescription drugs, vaccines, therapeutic

proteins and diagnostics. It has the distinction of being the only MNC to have

the most current product portfolio equivalent to its parent company. It

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provides high performance industrial facilities and is equipped with an

exceptional sales force

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Primary survey

Bangalore chemist’s survey:



A) Less than10 = 10% B) 10-20 = 42% C) 20-30 = 20% D) More than 30 = 28%

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Inference:

1. Majority of chemists ticked the option B (10 – 20) followed by the option D

(More than 30) in receiving prescriptions for hypertension per week.

2. Calculating in percentage around 42% of chemists received 10 – 20

prescriptions per week followed by < 30 whose percentage is 28%

Conclusion:

As nearly 50% of chemists receive around 20 prescriptions for hypertension it is

clearly seen that hypertension is fairly prevalent.

Q.2. Which categories of doctors prescribe anti-hypertensives in the treatment of

hypertension?

Results


Note: Respondents have opined more than one response

Inference:

1. In-between the three categories majority of chemist ticked general physician

followed by cardiologists.

2. Calculating in percentage, maximum number of antihypertensive drugs are

prescribed by general physician which is 76% followed by 66% of cardiologist

Conclusion:

• Not much of difference between the number of general physicians and

cardiologists prescribing antihypertensives

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• Not many general practitioners prescribe antihypertensives probably they refer

the patients to cardiologist or general physicians

General physicians are the maximum prescription givers for antihypertensive

drugs followed by Cardiologist. So the major target for the company should be the

general physicians and cardiologists

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Results


Inference:

1. The top 5 brands in the market which has the maximum presence in the market

are Cardace, Listril, Ramace, Envas and Ramistar, in which Cardace has the

highest number of preferences

2. Calculating the percentage 92% of chemist ticked Cardace, followed by Listril

86%, Ramace 84%, Envas 76%, and Ramistar 62%

3. The chemical entity in Cardace is Ramipril which is marketed by Sanofi

Aventis followed by Listril whose chemical entity is lisnopril marketed by

Torrent Pharma.

4. Captopril was the first agent to be developed for the treatment of hypertension.

Since then, enalapril, lisinopril, quinapril, ramipril, benazepril, moexipril are

also available in market, but from the above survey carried out in Bangalore,

Ramipril is the top molecule sold in market followed by Lisinopril as per 50

chemists.

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Results


Inference:

1. The top 5 brands in the market was found to be Telma followed by Losacar,

Telista, Tozaar and Convance.

2. Calculating in percentage, 84% of the chemist ticked Telma, followed by

Losacar 82%, Telista 66%, Tozaar 64% and Covance 56%

3. Telma whose chemical entity is Telmisartan is markeed by Glenmark followed

by Losacar whose chemical entity is Losartan potassium of Zydus Cadilla.

4. The importance of angiotensin II in regulating cardiovascular function has led

to the development of nonpeptide antagonists of the AT1 angiotensin II

receptor for clinical use. Losartan, candesartan, irbesartan, valsartan ,

telmisartan, and eprosartan have been approved for the treatment of

hypertension and are available in market.

The survey carried out in Bangalore for the 50 chemists showed that

Telmisartan is the top molecule sold in market followed by Losartan.

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Inference:

• The top 5 brands of ACE inhibitor and ARB respectively are Cardace, Listril,

Ramace, Envas, Ramistar and Telma Losacar, Telista, Tozaar and Convance.

• Comparing in between ACE inhibitors and ARB’s, ACE inhibitors still leads

the market with maximum number of respondants prefering the same.

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Drug combinations for hypertension

Inference:

1. The top 2 brands in the market which has the maximum priority are Ramistar-

H and Cardace-H

2. The chemical entity in CARDACE -H is Ramipril with hydrochlorthiazide

which is marketed by Sanofi Aventis followed by RAMISTAR-H whose

chemical entity is Ramipril with hydrochlorthiazide marketed by Lupin.

Conclusion: Ramipril with hydrochlorthiazide is the top selling combination in

Bangalore.

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Inference:

1. The top 2 brands in the market which has the maximum priority in the market

are Convance-H and Telma-H

2. COVANCE-H whose chemical entity is Losartan with Hydrochlorthiazide is

marketed by Ranbaxy followed by TELMA-H whose chemical entity is

Telmisartan with Hydrochlorthiazide of Glenmark.

3. No brands of Candesartan is being prescribed.

Conclusion: In Bangalore Losartan with hydrochlorothiazide is the top molecule

followed by telmisartan with hydrochlorothiazide

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Inference:

1. The top 2 brand in the market which has the maximum priority are

Amlong-H and Amlokind-H

2. The Amlong-H is marketed by Sun Pharmaceuticals, whose chemical

entity is Amlodipine with hydrochlorthiazide. Amlokind –H having the

same drug combination is marketed by Mankind

Conclusion: Amlodipine with hydrochlorothiazide is the maximum selling molecule

for Calcium channel antagonist with hydrochlorothiazide

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Inference:

1. The top 2 brand in the market which has the maximum priority are Betaloc-H

and Aten-H

2. Betaloc-H whose chemical entity is Metaprolol with hydrochlorthiazide is

marketed by Astra Zeneca and Aten-H is marketed by Ajanta Pharma whose

chemical entity is Atenolol with hydrochlorthiazide

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Conclusion: Metaprolol with hydrochlorothiazide is the maximum selling drug

followed by Atenolol with hydrochlorothiazide

(Note: The brands in the form of bar graph and in writings below are in ascending

order according to the number of respondents)

Inference:

1. The top 2 brands of ACE inhibitor+diuretic,ARB+diuretic,Beta

blocker+diuretic and Calcium channel blocker +diuretic respectively are,

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Ramistar-H and Cardace-H, Convance-H and Telma-H Amlong-H and

Amlokind-H, Betaloc-H and Aten-H

2. Comparing the top 2 brands of respective categories of antihypertensive

combinations the results shows that ARB+diuretic is leading the market

followed by ACE inhibitor+diuretic.



1. The top 3 brands of :

i) ACE inhibitor are Ramace, Listril and Cardace,

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ii) ACE inhibitor+diuretic are Ramce-H, Ramistar-h and Cardace-H

iii) ARB are Telista, Losacar and Telma,

iv) ARB+diuretic are Enace-D, Telma-H and Covance-D

2. From the above chart it is clear that single drug for the treatment of

hypertension is having the maximum presence in comparison to combination

therapy.

3. Possibly combination therapy is more preferred for ARB’s than ACE

inhibitors

Q.4. Which is/are the fastest moving brand(s) of Candesartan and its combination?

Results


1. The fastest moving brand is Candelong whose chemical entity is Candesartan

which is marketed by Micro Labs.

2. From the above data acquired, it is quite clear that the base molecule does not

yet have a good market share.

3. Some chemists are not even aware of the brands and in maximum number of

cases the chemists did not have a stock of the products containing

Candesartan.

Conclusion: Only 3 brands of Candesartan and 1 brand of Candesartan and its

combination are available among which Candelong is the moving brand.

Chemist survey Kolkata



A) Less than10 =16% B) 10-20 =30% C) 20-30 =14% D) More than 30 =40%

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Inference:

1. Majority of chemists ticked the option D (More than 30) followed by the

option C (10 to 20) with respect to receiving prescriptions for hypertension per

week.

2. Calculating in percentage around 40% of chemists received more than 30

prescriptions per week followed by 10 to 20 whose percentage is 30%

Conclusion: The number of prescriptions received by the chemists are more than 30

per week, which says that number of individuals are increasing who are diagnosed

hypertensive.Compared to Bangalore, Kolkata seems to have a higher prevalence of

hypertension.

Q.2. Which categories of doctors prescribe anti-hypertensives in the treatment of

hypertension?

Results


(Note: Respondents have opined more than one response)

Inference:

1. In-between the three categories (Cardiologists, General physicians and

General practitioners) majority of chemist ticked cardiologists followed by

general physician

2. Calculating in percentage maximum number of antihypertensive drugs are

prescribed by cardiologists which is 82% followed by 74% of general

physician.

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3. In Kolkata, General practitioners (58%) are also prescribing anti-

hypertensives, which is quite higher in percentage in comparison to Bangalore

(10%)

Conclusion:

Cardiologists are the maximum prescription givers for antihypertensive drugs

followed by General physicians. So the major target for the company should be the

Cardiologists. In Kolkata general practitioners are also prescribing antihypertensives

and this is higher than that in Bangalore

Results


Results


Inference:


are Cardace, Ramace, Envas, Ramistar,Lipril and Cardiopril in which

Cardace got the highest number of preferences

2. Calculating the percentage 94% of chemist ticked Cardace, followed by

Ramace 84%, Envas 72%, Ramistar 68%, Lipril 62% and Cardiopril 60%


Aventis followed by Ramace whose chemical entity is Ramipril marketed by

Astra Zeneca



also available in market, but from the above survey carried out in Kolkata,

Ramipril is the top molecule sold in market as per the study undertaken.

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Results


Inference:


Telday, Tozar, Losakind and Covance.

2. Calculating in percentage, 90% of the chemist ticked Telma, followed by

Losacar and Telday 84% which has the equal number of respondants, Tozaar

78%, Losakind 74% and Covance 62%.

3. Telma whose chemical entity is Telmisartan is marketed by Glenmark

followed by Losacar whose chemical entity is Losartan potassium of Zydus

Cadilla and Telday whose chemical entity is once again Telmisartan of

Torrent.

4. The survey carried out in Kolkata for the 50 chemists proved that Telmisartan

is the top molecule sold in market followed by Losartan.

5. In compare to Bangalore the preference to the molecule Telmisartan is higher

in Kolkata.

Results




Inference:

1. The top 6 brands of ACE inhibitor and ARB respectively are Cardace,

Ramace, Envas, Ramistar, Lipril Cardiopril and Telma Losacar, Telday,

Tozar, Losakind, Covance.

2. In comparison to ACE inhibitors, ARB’s leads the market with maximum

number of respondants but with marginal difference.

3. Comparing with Bangalore the preferred category of drug in the treatment of

Hypertension is ACE inhibitors but in Kolkata it is the ARB which have the

preference.

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Drug combinations for Hypertension

Inference:

1. The top 3 brands in the market which has the maximum priority are Cardace-

H, Ramistar-H and Enapril-HT

2. The chemical entity in Cardace -H is Ramipril with hydrochlorthiazide which

is marketed by Sanofi Aventis followed by Ramistar-H whose chemical entity

is Ramipril with hydrochlorthiazide marketed by Lupin and Enapril-HT whose

chemical entity is Enalapril with hydrochlorothiazide marketed by

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Conclusion: Ramipril with hydrochlorthiazide is the top selling combination in

Kolkata. In Bangalore also the combination Ramipril with hydrochlorthiazide got

the highest preference. Incidentally Ramipril is also the top selling molecule for

monotherapy

Inference:


are Telma-H, Covance-D and Enace -D

2. Telma-H whose chemical entity is Telmisartan with Hydrochlorthiazide is

marketed by Glenmark. Covance-H whose chemical entity is Losartan with

Hydrochlorthiazide is marketed by Ranbaxy and Enace-D is marketed by

NPIL.

Results


Conclusion: In Kolkata, Telmisartan with hydrochlorothiazide is the top

combination followed by Losartan with hydrochlorothiazide. With respect to

Bangalore chemist survey, the maximum selling combination in the above

category is Losartan with hydrochlorothiazide and Telmisartan with

hydrochlorothiazide has got the next highest preference.

Inference:

1. The top 2 brand in the market which has the maximum priority are

Amlokind-H and Amlong-H

2. The Amlokind –H having the same drug is marketed by Mankind.

Amlong-H is marketed by Sun Pharmaceuticals, whose chemical entity is

Amlodipine with hydrochlorthiazide.

Results


Conclusion: Amlodipine with hydrochlorothiazide is the maximum selling molecule

for Calcium channel antagonist with hydrochlorothiazide combination in Kolkata.

With respect to Bangalore chemist survey Amlong-H is found to be the maximum

selling brand

Inference:

1. The top 3 brand in the market which has the maximum priority are Nebicard-

H , Aten-H and Nodon-H

2. Nebicard-H whose chemical entity is Nebivolol with hydrochlorthiazide is

marketed by Torrent Pharma and Aten-H is marketed by Ajanta Pharma

Results


whose chemical entity is Atenolol with hydrochlorthiazide. Nodon-H is

marketed by Zydus Cadila have the chemical entity Nebivolol with

hydrochlorothiazide.

Conclusion: Nebivolol with hydrochlorothiazide is the maximum selling drug

followed by Atenolol with hydrochlorothiazide



Inference:

Results


1. The top 3 brands of ACE inhibitor+diuretic,ARB+diuretic,Beta

blocker+diuretic and Calcium channel blocker +diuretic respectively are,

Enapril-HT, Ramistar-H and Cardace-H, Enace-D, Convance-D and Telma-H

Amlokind-H, Amlong-H and Eslo-H andNodon-H, Aten-H and Nebicard-H

2. Comparing the top 3 brands of respective categories of antihypertensive

combinations the results shows that ARB+diuretic is leading the market

followed by ACE inhibitor+diuretic.

Results




1) The top 4 brands of :

i) ACE inhibitor are Ramistar,Envas, Ramace and Cardace,

ii) ACE inhibitor+diuretic are Ramce-H, Enapril-HT, Ramistar-H nd

Cardace-H

iii) ARB are Tozar, Telday, Losacar and Telma,

iv) ARB+diuretic are Enace-D, Telday-H, Covance-D and Telma-H

2) From the above chart it is clear that single drug in treatment of hypertension is

having the maximum priority in comparison to combination. Combinations are

mainly advised when mono-therapy with single drug is not sufficient to control

the blood pressure in individuals.

Q.4. Which is/are the fastest moving brand(s) of Candesartan and its combinations?

Results


Inference:

1. The fastest moving brand is Candesar whose chemical entity is Candesartan

which is marketed by Ranbaxy.

2. From the above data acquired, it is quite clear that the base molecule does not

yet have a good market share but in comparison to Bangalore data it has a

higher market.

3. Some chemists are not aware of the brands and in maximum cases the

chemists did not have a stock of the products such as Candelong, Candesar,

Cantar and Candesar-H.

Conclusion: Candesartan has a very low visibility in the market. Only 4 brands are

available in which Candesar is the top moving brand. In comparison to Bangalore’s

survey, Candesartan has a slightly higher market, which means the doctors are

prescribing the drug.

Results


Final conclusion of Kolkata and Bangalore chemists:

With respect to the first question of the chemist questionnaire in Kolkata and

Bangalore the results shows that, prevalence of hypertension is more in Kolkata with

respect to Bangalore. In Bangalore the particular disease condition is fairly prevalent

in individuals.

The results for the second question in the chemist’s questionnaire showed that in

Kolkata Cardiologists are the maximum prescriber of anti-hypertensive medicines

followed by General physicians. With respect to Bangalore General physicians are the

maximum prescriber of antihypertensive medicines followed by the Cardiologists. So

in Kolkata and Bangalore the company should target more General physicians and

Cardiologists respectively to increase its customer base. Among General practitioners,

the trend of prescribing antihypertensive drugs are very less in Bangalore in

comparison to Kolkata. So targeting general practitioners is another primary focus of

the company to increase its customer base.

The chemist survey with respect to single drug therapy, the results showed that ACE

inhibitors got higher priority in comparison to ARBs in Bangalore market. In Kolkata

ARBs are having maximum sales in comparison to ACE inhibitors. After asking the

chemists verbally about the other categories of drug which are having the major sale

in market, it was found that Calcium channel blockers got a good response in the

market. The reason behind this may be the cheaper cost of the products in this

category or doctors are not willing to shift in newer categories of drug for the

treatment of hypertension.

Results


With respect to combination drugs ARB with Diuretic got the maximum preference

followed by ACE inhibitor with Diuretic in Bangalore and Kolkata both.

The results with respect to Candesartan is poor in both the cities. In Kolkata, the

molecule still has a better market in comparison to Bangalore. In Bangalore maximum

chemists did not have a stock only for this particular molecule

Results


Bangalore doctors survey:

Q.1. How many patients with hypertension do you treat on average per week?

Male (in %):

a) <10 = 14 (b) 11 to 15 = 8 (c) 16 to 20 = 20 (d) 21 to 30 = 24 (e) > 30 = 34

Females (in %): :

a) < 10 = 20 (b) 11 to 15 = 14 (c) 16 to 20 = 14 (d) 21 to 30 = 24 (e) > 30 = 28

Inference:

1. In males, option E (More than 30) got the highest priority with a percentage

of 34% and in females option E (More than 30) with a percentage of 28%

2. From the above data it is clear that hypertension is more prevalent in males.

Conclusion: On comparing the first question in the chemist and doctor questionaire

for Bangalore, it was found that there is a growth in number of prescription received

Results


by the chemist and number of patient treated by the doctors. This denotes that the

prevalence of hypertension is increasing

Q.2 Which age-group of patients are more prone to hypertension?

Female (in %):

a) Less than 35= 8 b) 36 to 45= 22 c) 46 to 55= 52 d) More than 55= 64

Male (in %):

a) Less than 35= 6 b) 36 to 45= 32 c) 46 to 55= 56 d) More than 55= 70

Inference:

1. Individuals having age group more than 55 are more prone to hypertension as

per the doctors survey in Bangalore, followed closely by the age group 46 to

55 and 36 to 45

2. Individuals having age group more than 55 years, in males 70% of them

followed by females 64% are prone to hypertension. The next age group

Results


which is prone to hypertension is 46 to 55 years where males got 56%

followed by females 52% .

3. From the data it was found that males again have the higher tendency to have

hypertension

Conclusion: The 2nd question reflects the age group which is more prone to

hypertension. The survey reports says that the age group more than 55 are most prone

to hypertension followed by the age group 46 to 55 years.

According to literature survey, the prevalence of hypertension increases with age

proportionally.(31 ) As per the survey in the age group between 36 to 45 years the

prevalence of hypertension is also growing in Bangalore. From this we can predict

that as there is a change in lifestyle now a days, the tendency of developing

hypertension is there in both genders .

Results


Q.3. Does the age of patient play a role while deciding upon the drug of choice?

(a) Yes = 96% (b) No = 4%

If yes please select the appropriate drug of choice to the corresponding age group.

Inference:

Mono-therapy

Results


1. From the above data it was found that, for single drug therapy age group less

than 35 years ACE inhibitors followed by ARBs and diuretics are preferred.

2. For the age group 36 to 45 years, ARB’s got the highest preference followed

by ACE inhibitors and Calcium channel antagonist.

3. For the next age group that is 46 to 55 years, ARBs followed by Beta blockers

and Calcium channel antagonists got the higher preferences.

4. Coming to the last age group that is above 55 years Diuretics got the highest

preference followed by Calcium channel antagonist in Bangalore.

Combination therapy

5. With respect to the combination therapy, CCA with ACE inhibitors, CCA with

Diuretic, Beta blockers with CCA, ACE inhibitors with Diuretic, ARB with

CCA, ARB with Diuretic, ARBs with ACE inhibitors and Beta blockers with

Diuretics are being used in all corresponding age groups for treating

hypertension.

6. In age group less than 35 years, ACE inhibitors with Diuretics are preferred

followed by CCA and Diuretics are preferred.

7. For the age group 36 to 45 years, ACE inhibitors with Diuretic got the highest

preference followed by ARB with diuretic

8. For the age group 46 to 55 years, the same ACE inhibitors with Diuretic got

the highest preference followed by CCA with ARB and ACE inhibitor with

ARB.

9. The drug preferences for the last age group which is above 55 years is ARB

with Diuretic followed by Beta blocker with Diuretic

Results


Conclusion:

• Single drug therapy has got the first preference in the treatment of

hypertension. Combination therapy is used when single drug treatment is not

sufficient in maintaining the blood pressure in individuals.

• Within the categories of drugs such as beta blockers, Calcium channel

blockers, Alfa blockers, Calcium channel blockers still have major preferences

in the treatment of hypertension.

ACE inhibitors are preferred by the doctors as well. According to literature

survey the most commonly prescribed drug categories are Calcium channel

blockers and ACE inhibitors.(32)

• With respect to combination therapy, ACE inhibitor with Diuretic and ARB

with Diuretic has got major preferences.

• The preference of using ARB’s in the treatment of hypertension is also good

and is increasing. As per literature survey hypertension is directly responsible

for 57% of all stroke deaths and 42% of coronary heart disease death in

India.(31) So there will be a demand of drugs which serve both the conditions

such as hypertension and heart attacks. Candesartan cilexetil with

hydrochlorothiazide is the only ARB approved by US FDA for the treatment

of hypertension and heart attack.

• Comparing with the chemist survey report, ACE inhibitors are having higher

preference than ARB’s matches the report of doctor’s preference.

Results


Results


Inference:


are Cardace, Envas, Ramace, Ramistar and Rampres in which Cardace got

the highest number of preferences

2. Calculating the percentage 92% of doctors ticked Cardace, followed by Envas

62%, Ramace 58%, Ramistar 54%, and Ramipres 46%


Aventis followed by Envas whose chemical entity is enalapril maleate

marketed by Zydus cadilla.



also available in market.

5. From the survey carried out in Bangalore, Ramipril is the top molecule sold in

market followed by Enalapril as per the doctors.

6. As per the survey among both doctors and chemists, Cardace got 92% of

preference which made it a top moving brand of ACE inhibitor

Results


Results


Inference:


Tozaar, Convance and Arbitel.

2. Calculating in percentage, 60% of the doctors ticked Telma, followed by

Losacar 58%, Tozaar 54%, Covance 38% and Arbitel 34%.



Cadilla.



receptor for clinical use. Losartan, candesartan, irbesartan, valsartan ,

telmisartan, and eprosartan have been approved for the treatment of


5. The survey carried out in Bangalore for the doctors showed that Telmisartan is

the top molecule sold in market followed by Losartan.

6. As per the survey of doctors and chemists conducted, Telmisartan got 60%

and 84% of preference respectively which made it a top moving brand of

ARB.

Results


7. With respect to Candesartan, three brands are available in the market. They are

Candelong, Cantar and Candesar. The percentage preference of these brands

by the doctors are 4%, 4% and 12% respectively which is very low in respect

to other brands of different molecules that is Telmisartan, Losartan, Valsartan

and Irbesartan.



Inference:

1. The top 5 brands of:

a) ACE inhibitor are Cardace, Envas, Ramace, Ramistar and Ramipres

b) ARB are Telma, Losacar, Tozaar, Covance and Arbitel.

2. According to Bangalore survey ACE inhibitors got higher preference in mono-

therapy of hypertension according to doctors in respect to ARB’s.

Results


Drug combination for hypertension

Inference:


H, Ramistar-H and Ramipres–H

2. The chemical entity in CARDACE -H is Ramipril with hydrochlorthiazide

which is marketed by Sanofi Aventis followed by RAMISTAR-H and

Results


RAMIPRES-H whose chemical entity is Ramipril with hydrochlorthiazide

marketed by Lupin and Cipla pharmaceuticals respectively

Conclusion: Hence the most preferred combination among ACE inhibitor with

diuretic is Cardace-H

Inference:


are Covance-D, Telma-H and Envas-D

2. COVANCE-H whose chemical entity is Losartan with Hydrochlorthiazide is

marketed by Ranbaxy. TELMA-H whose chemical entity is Telmisartan with

Results


Hydrochlorthiazide is marketed by Glenmark followed by ENACE-D whose

chemical entity is Enalapril with Hydrochlorthiazide of NPIL.

3. No brands of Candesartan with hydrochlorothiazide is being preferred by the

doctors.

Conclusion: The most preferred brand of ARB with diuretic is Covance-D

Inference:

1. The top 2 brands in the market which has the maximum priority are


Results


2. Amlong-H is marketed by Sun Pharmaceuticals, whose chemical entity is

Amlodipine with hydrochlorthiazide. Amlokind-H having the same drug

combination is marketed by Mankind

So the preferred combination is Amlodipine with hydrochlorthiazide with

respect to combination of Calcium channel blocker with diuretic.

Conclusion: The most preferred brand of Calcium channel blocker is Amlong-H.

Inference:

Results


1. The top 3 brand in the market which has the maximum priority are Nebicard-

H, Aten-H, and Nodon-H

2. Nebivolol with hydrochlorthiazide is marketed by Torrent pharma and Aten-

H is marketed by Asjanta pharma whose chemical entity is Atenolol with

hydrochlorthiazide followed by Nodon-H which is marketed by Cadilla.

Conclusion: Nebicard-H has got the highest preference in doctors

Results




Inference:


a) ACE inhibitor + Diuretic are Cardace-H, Ramistar-H and Ramipres –H

b) ARB + Diuretic are, Covance-D, Telma-H and Enace -D

c) Calcium channel blocker + Diuretic are Amlong-H , Amlokind-H and

Elso -D

d) Beta blocker + Diuretic are Aten-H, Nebicard-H Aten-H and Nodon -H

From the above data it is clear that ACE Inhibitor + Diuretic have highest preference

among doctors of Bangalore.

Results


Q.5.Are you aware of the molecule Candesartan ?

The response from each category of doctors for the question 5 was that:

1. Cardiologist are aware of this particular molecule in greater number in

comparison to other 2 specialities

2. General physicians and General practitioners are reasonably aware of the

molecule

So awareness about the molecule has to be increased among General physicians and

practitioners. This will help the company to increase their customer base and increase

the market share.

Results


Q.6. Are you aware of the molecule Candesartan cilexetil?

The response from each category of doctors to the question 6 was:

1. Cardiologist are aware of this particular molecule Candesartan cilexetil in

greater number in comparison to other 2 specialities

2. General physicians are aware of the molecule but less in numbers.

General practitioners are not aware of the molecule in greater extent

Results


Q.7. Are you aware of the molecule Candesartan cilexetil with hydrochlorthiazide?


1. Cardiologist are aware of this particular molecule Candesartan cilexetil with

Hydrochlorothiazide in greater number in comparison to other 2 specialities

2. General physicians are aware of the combination but less in numbers. Only

few doctors are aware of it. And those who knew about it, hadn’t used it yet

3. General practitioners are not aware of the drug combination. Very few are

having knowledge about it.

Conclusion:

From the survey report of question 5, 6 and 7 it is quite clear that Cardiologist are

aware of the molecule Candesartan cilexetil with hydrochlorothiazide, but maximum

Results


nched in the

arket, what is the single factor you expect in it to support the brand?

number of them have not used it in the treatment of hypertension. But the doctors who

have used it for the treatment of hypertension have a good impression on the

molecule, which is same according to Kolkata doctor’s survey. General physicians are

not aware to that extent in comparison to the Cardiologists. Maximum times they have

not used it and some doctors have considered it a substitute for ACE inhibitors.

General practitioners are having the least knowledge about the molecule

Q.8. If a new brand of candesartan cilexetil with hydrochlorthiazide is lau

m

Inference:

he survey data points out 3 main aspects which the doctors of Bangalore preferred

f a new brand of Candesartan cilexetil with hydrochlorothiazide is launched

in the market. They are as follows:

T

the most, i

Results


.

Conclu

To the the questionaire for Bangalore doctors the results indicate the

me as for that in Kolkata. Doctors gave first preference to the cost of the drug which

w followed by better availability of the drug and better technical

1. The product should be less costly as maximum number of doctors ticked

option “a”. Calculating the percentage, 88% of doctors wants the brand to be

less costly.

2. The next highest preference goes to option “c”. Calculating the percentage

70% of doctors preferred it. So the doctors want that the drug to be available

in maximum

3. The third preference goes to option “e”. The doctors want more and better

technical information about the molecule. Around 60% of doctors gave their

opinion for it.

sion:

last question in

sa

should be lo

information should be provided by the company. Continuous Medical Education is

also a preferred option ticked by the doctors which the company has to consider and

develop the strategies.

Results


olkata Doctors survey:

on do you treat on average per week?

Male (in %):

16 (c) 16 to 20 = 32 (d) 21 to 30 = 22 (e) > 30 = 12

) 11 to 15 = 30 (c) 16 to 20 = 28 (d) 21 to 30 = 12 (e) > 30 = 8

K

Q.1. How many patients with hypertensi

a) <10 = 18 (b) 11 to 15 =

Females (in %):

a) < 10 = 22 (b

Inference:

1. In males, option C (16 to 20) got the highest preference with a percentage of

32% and in females option B (11 to 15) with a percentage of 30%

above data shows that hypertension is more prevalent in males.

Con

by the tor’s survey

rep

2. The

clusion: The survey analysis shows that in Kolkata the number of patient treated

doctors is not increasing. Comparing both the cities data of doc

ort, the prevalence of hypertension in Kolkata is less than Bangalore.

Results


5= 66

ess than35= 12 b) 36 to 45= 30 c) 46 to 55= 60 d) More than 55= 70

Q.2 Which age-group of patients are more prone to hypertension?

Male:

a) Less than35= 8 b)36 to 45= 32 c) 46 to 55= 50 d) More than 5

Female:

b) L

Inference:

1. Individuals having age group more than 55 are more prone to hypertension as

per the doctors survey in Kolkata, followed by the age group 46 to 55 and 36

5

is prone to hypertension is 46 to 55 years where males got 60%

followed by females 50% .

to 4

2. Individuals having age group more than 55 years, in males 70% of them

followed by females 66% are prone to hypertension. The next age group

which

Results


Conclu

hypertension. The survey reports say that the age group more than 55 are most prone

to

Bangalore doctors survey report with Kolkata the results are found to be same. In both

3. From the data it was found that males again have a higher tendency to have

hypertension

sion: The 2nd question reflects the age group which is more prone to

hypertension followed by the age group 46 to 55 years. Comparing with the

the places the prevalence of hypertension increases with age proportionally.

Results


.3. Does the age of patient play a role while deciding upon the drug of choice?

(a) Yes = 98% (b) No = 1%

yes please select the appropriate drug of choice to the corresponding age group.

Q

If

Inference:

Mono-therapy

1. In the selection of drugs for treating hypertension in corresponding age groups,

it was found that Calcium channel antagonists (CCA) have the highest

nce in treating hypertension in all age group except the last option ( more

here diuretics has the highest preference.

prefere

than 55 years) w

Results


2. itors, ACE inhibitors

ith Diuretic, ARB with CCA and ARB with Diuretic is being used in all

ifferent age groups for treating hypertension.

3. CA with ACE inhibitors are used in maximum in age group more than 55

with ARB.

uretic

Conc

Combination therapy:

Coming to the combination therapy, CCA with ACE inhib

w

d

C

years, followed by CCA

4. For the age group 46 to 55 years both ARB with Diuretic and ACE inhibitor

with Diuretic has the same preference followed by CCA with ACE inhibitors

and CCA with Diuretic.

5. In the age group of 35 to 45 years, CCA with ACE inhibitors has got the highest

preference followed by ARB with Di

6. Finally the age group less than 35 years, CCA with ACE inhibitors has got the

higher preference followed by ACE inhibitors with Diuretic.

lusion:

•

when single drug treatment is not

The doctors of Kolkata also preferred the single drug therapy for hypertension.

They use to shift to combination therapy

sufficient in maintaining the blood pressure. The same result is seen with

respect to Bangalore doctor’s survey.

• The major categories of drug in the treatment of hypertension in single drug

therapy are Calcium channel antagonist and Diuretic followed by ACE

inhibitors and ARBs. In combination therapy, Calcium channel antagonist

with ACE inhibitor, ACE inhibitor with Diuretic and ARB with Diuretic has

got the maximum preferences.

Results


With respect to Bangalore doctor’s survey report, Calcium channel antagonist

got the major preference in both the cities in single drug therapy. Diuretics are

mainly used for higher age groups according to literatures and it was found to

be the same according to primary survey in Kolkata and Bangalore.

Results


Results


ference:

1. The top 6 brands in the market which has the maximum presence in the market

are Cardace, Ramace, Ramistar, Envas, Cardiopril and Ramipres in which

Cardace got the highest number of preferences

2. Calculating the percentage 96% of doctors ticked Cardace, followed by

Ramace 80%, Ramistar 70%, Envas 66%, Cardiopril 60% and Ramipres 50%


Aventis followed by Ramace whose chemical entity is Ramipril marketed by

Astra Zeneca.

Captopril was the first agent to be developed for the treatment of hypertension.


also available in market. From the survey result obtained in Kolkata shows

that, Ramipril is the top molecule sold in market as per 50 doctors followed by

Enalapril

In

Results


Results


ference:


Telista, Covance, Tozaar and Telday

2. Calculating in percentage, 92% of the doctors ticked Telma, followed by

Losacar and Telista 80% which has the equal number of respondants, Covance

62%, Tozaar 66% and Telday 52%



Cadilla and Telista whose chemical entity is once again Telmisartan of Lupin



receptor blocker for clinical use. Losartan, Candesartan, Irbesartan, Valsartan ,

Velmisartan, and Eprosartan have been approved for the treatment of


The survey carried out in Kolkata for the 50 doctors indicated that Telmisartan

is the top molecule sold in market followed by Losartan.

In

Results




Inference:


c) ACE inhibitor are Cardace, Ramace, Ramistar, Envas, Cardiopril,

Ramipres

d) ARB are Telma Losacar, Telista, Covance, Tozar, Telday.

2. ARBs got higher preference in monotherapy of hypertension according to doctors

in Kolkata. With respect to Bangalore doctor’s survey report, where ACE

inhibitors got the higher preference than ARB’s. But with respect to the molecule

Candesartan Kolkata has got higher preference for it than in Bangalore.

Results


Drug combinations for Hypertension

Inference:


H, Ramistar-H and Ramace –H

2. The chemical entity in Cardace -H is Ramipril with hydrochlorthiazide which

is marketed by Sanofi Aventis followed by Ramistar-h and Ramace-H whose

ical entity is Ramipril with hydrochlorthiazide marketed by Lupin and

Conclusion: The doctors and the chemists both gave the maximum preferences to the

brand Cardace-H followed by Ram

chem

Asta Zeneca respectively.

istar-H

Results


Inference:


are Telma-H, Enace -D and Covance-D

2. Telma-H whose chemical entity is Telmisartan with Hydrochlorthiazide is

marketed by Glenmark is marketed by followed by Enace-D whose chemical

iazide of NPIL and Covance-H whose

3. w response from doctors of Kolkata.

entity is Enalapril with Hydrochlorth

chemical entity is Losartan with Hydrochlorthiazide marketed by Ranbaxy.

Candesartan combination got a very lo

Only 10 doctors out of 50 ticketed the brand of Candesartan with

hydrocglorothiazide which is Candesar-H

Results


Conclu

prefere 50

chem

sion: Among both the doctors and chemist the brand Telma-H got the highest

nces. With respect to chemist, Candesar-H was being ticked by 5 out of

ists.

Inference:

1. The top 2 brands in the market which has the maximum priority are


2. Amlong-H is marketed by Sun Pharmaceuticals, whose chemical entity is

Amlodipine with hydrochlorthiazide. Amlokind-H having the same drug

combination is marketed by Mankind

So the preferred combination is Amlodipine with hydrochlorthiazide.

Results


Conclu

with the c

market.

sion: With respect to doctors Amlong-H got the higher preference. Comparing

hemist data of Kolkata, Amlokind-H is the maximum selling brand in

Inference:

1. The top 3 brands in the market which has the maximum priority are Aten-H,

Nebicard-H and Corbis-H

2. Aten-H whose chemical entity is Atenolol with hydrochlorthiazide is marketed

by Zydus Cadila and Nebicard-H is marketed by Torrent Pharma whose

Results


chemical entity is Nebivolol with hydrochlorthiazide followed by Corbis-H

whose chemical entity is Bisoprolol , marketed by Neu Foreva

Con

survey

clusion: According to doctors Aten-H got the highest preference. But the chemist

reports shows that the maximum selling brand is Nebicard-H.



Inference:


Results


e) Calcium channel blocker + Diuretic are Amlong-H , Amlokind-H and

Elso -D

f) ACE inhibitor + Diuretic are Cardace-H, Ramistar-H and Ramace –H

g) ARB + Diuretic are Telma-H, Enace -D and Covance-D

h) ker + Diuretic are Aten-H, Nebicard-H and Corbis-H

2. ence

among doctors of Kolkata. With respect to chemist survey report where ARB

e doctor’s survey

Q.5

Beta bloc

From the above data it is clear that ARB + Diuretic have highest prefer

+ Diuretics have got highest preferences matches with th

report.

. Are you aware of the molecule Candesartan ?


Results


1. Cardiologist are aware of this particular molecule in greater number in

comparison to other 2 specialities

2. General physicians and General practitioners are aware of the molecule.

So awareness about the molecule has to be increased among General physicians and

practitioners. With that the company can also increase their customer base to increase

the market share.

Q.6.

Are you aware of the molecule Candesartan cilexetil ?

Results


6 was that:

1. Cardiologist are aware of this particular molecule Candesartan cilexetil in

greater number in comparison to other 2 types

2. General physicians are aware of the molecule but less in numbers.

3. General practitioners are not aware of the molecule in greater extent.

rthiazide?

The response from each category of doctors for the question

Q.7. Are you aware of the molecule Candesartan cilexetil with hydrochlo

Results



til with

2. G

3. G re

1. Cardiologist are aware of this particular molecule Candesartan cilexe

Hydrochlorothiazide in greater number in comparison to other 2 specialities.

eneral physicians are aware of the molecule but less in numbers. Only few

doctors are aware of it. And those who knew about it, they didn’t used yet

eneral practitioners are not aware of the drug combination. Very few a

having knowledge about it.

Results


Q.8. If a new brand of candesartan cilexetil with hydrochlorthiazide is launched in the

market, what is the single factor you expect in it to support the brand?

Inference:

The survey data point out 3 main aspects which the doctors of Kolkata preferred the

most, if a new brand of Candesartan with hydrochlorothiazide is launched in the

market. They are as follows:

1. The product should be less costly as maximum number of doctors ticked

option “a”. Calculating the percentage, 80% of doctors

2. Option “c” got the next highest preference. Calculating the percentage 60% of

doctors preferred it. So the doctors want that the drug to be available in

maximum.

3. The third preference goes to option “e”. The doctors want more and better

technical information about the molecule. Around 54% of doctors gave their

opinion for it.

Results


Final conclusion of Doctors in Kolkata and Bangalore:

After carrying out surveys in Bangalore and Kolkata for doctors and chemists, the

major competitors are found to be ACE inhibitors, Calcium channel blockers, ARBs

and Diuretics. With respect to combination therapy the above mentioned categories of

drugs with Diuretics are the competitors. Combinations other than the mentioned ones

above, includes Calcium channel antagonist with ACE inhibitors and ACE inhibitor

with ARB which will also be a competitor in Kolkata and Bangalore respectively.

May the combination of ACE inhibitor with ARB, did not enjoy a higher preferences

among the doctors presently but according to literature survey it was found that ARB

combined with ACE inhibitor reduces morbidity and mortality in patients with heart

failure.(33)

With respect to ACE inhibitors and ARBs, both of them are used in all different age

groups for treatment of hypertension. From the above conclusion it was quite clear

that if a new brand of ARB with diuretic is launched in market the major competitor

will be CCA and ACE inhibitors in mono-therapy as well as in combination therapy.

In both the cities the preferred molecule among ACE inhibitors are Ramipril followed

by Enalapril and with respect to ARBs, Telmisartan has the higher preference

followed by Losartan as per doctors preference and chemists sales experience.

With respect to Candesartan, the molecule has a very low preference in the market but

doctors specially the cardiologist has a good impression on this particular molecule

which is supported by the response gathered from the question 5, 6 and 7 of the

questionnier for the doctors. The preference of Candesartan by the doctors in Kolkata

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is higher than Bangalore which means the drug is being prescribed by the doctors in

Kolkata.

Although the molecule is a preferred one, it didn’t have a response to that extent in

comparison to Telmisartan and Losartan. The reason which can be the cause is less

number of quality brands in market or very less awareness about the molecule among

the doctors or less promotional awareness. The drug may not have higher plus points

in comparison to Telmisartan but it has some positive advantages in comparison to it

according to literature. Such as the maintenance dose of Candesartan is less than

Telmisartan(34) and it being the only drug licensed by US FDA for the treatment of

hypertension and heart failure. These can be used as a plus point to position the

product against Telmisartan. Candesartan is also the most cost effective ARB for the

treatment of hypertension and Heart failure. (33)

In comparison to Losartan, Candesartan has much higher superiority according to

literature survey. The plus points of candesartan over Losartan are greater

bioavailability, long duration of action, less side effects and better efficacy.(34) So if a

new brand of Candesartan is launched in the market, it can beat the second preferred

molecule in market if properly positioned.

In respect to the other category such as the ACE inhibitors and Calcium channel

antagonists, they are generally well tolerated.

The most preferred Calcium channel antagonist is Amlodipine as per the survey

carried out in both the above mentioned cities. Literature survey says that Candesartan

is better tolerated than Amlodipine.(9) So positioning the molecule Candesartan

against Amlodipine will have a plus point. However, ARBs unlike ACE inhibitors, do

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not block the synthesis of Kinins and are therefore less likely to be associated with the

adverse effects of cough and angioedema. So, ARBs are an appropriate alternative

when treatment with an ACE inhibitor is strongly indicated but poorly tolerated.

So finally we can conclude that, strategies which are to be made for the launch

program should focus on the gaps which the above categories of the drug could not

fulfill in respect to therapeutic aspects or promotional aspects or positioning aspects.

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6.5 Deciding how to enter the market (1)(18)

Once the company decides to target a particular country, it has to determine the best

mode of entry. Its broad choices are indirect exporting, direct exporting, licensing,

joint ventures and direct investment.

The normal way to get involved in an international market is through export. The

company produces its goods in the country and might or might not adapt them to

international markets. Companies typically start with indirect exporting that is they

work through independent intermediaries.

Domestic based export merchants buy the manufacturer’s products and then sell them

abroad. Domestic based export agents seek and negotiate foreign purchases and are

paid a commission. Cooperative organizations carry on exporting activities on behalf

of several producers and are partly under their administrative control. Export

management companies agree to manage a company’s export activities for a fee.

Indirect export has two advantages, first it involves less investment second it involves

less risk.

Company eventually may decide to handle their own exports. the investment and

risk are somewhat greater, but so is the potential return. A company can carry on

direct exporting in several ways:

1. domestic based export department or division

2. overseas sales branch or subsidiary

3. traveling export sales representatives

4. foreign based distributors or agents

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Licensing is a simple way to become involved in international marketing. The

licensor issues a license to a foreign company to use a manufacturing process,

trademark, patent, trade secret or other item of value for a fee or royalty. The licensor

gains entry at little risk. Licensing has potential disadvantages. The licensor has less

control over the licensee than it does over its own production and sales facilities.

Furthermore, if the licensee is very successful, the firm has given up profits and if and

when the contract ends, the company might find that it has created a competitor.

Foreign investors may join with local investors to create a joint venture company in

which they share ownership and control. A joint venture may be necessary or

desirable for economic or political reasons. It has certain drawbacks too. The partners

might disagree over investment, marketing or other policies. Joint ownership can also

prevent a multinational company from carrying out specific manufacturing and

marketing policies on a worldwide basis.

The ultimate form of foreign involvement is direct ownership of foreign based

assembly or manufacturing facilities. The foreign company can buy part or full

interest in a local company or build its own facilities. It has distinct advantages like

the firm secures cost economies in the form of cheaper labor or raw materials, foreign

government investment incentives and freight savings. The firm strengthens its image

in the host country because it creates jobs. The firm develops a deeper relationship

with government, customers, local suppliers and distributors enabling it to adapt its

products better to the local environment. The firm retains full control over its

investment and therefore develop manufacturing and marketing policies that serve its

long-term international objectives. The main disadvantage is that the firm exposes a

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large investment to risks such as blocked or devalued currencies, worsening markets

or expropriation. The firm will find it expensive to reduce or close down its

operations, because the host country might require substantial severance pay to the

employees.

To enter the Brazilian market products such as pharmaceuticals, vitamins and medical

devices products, can be sold only if:





offered.






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6.4 Deciding on the marketing program (1)(3)(35)

International companies must decide how much to adapt their marketing strategy to

local conditions. At one extreme are companies that use a globally standardized

marketing mix worldwide. Standardization of the product, communication and

distribution channels promises the lowest costs. At other extreme is an adapted

marketing mix, where the producer adjust the marketing program to each target

market.

Product:

Establishing Global Service Brands describes some of the special concerns for

marketing services globally. There are different strategies of product and

communication to a foreign market. Straight extension means introducing the product

in the foreign market without any change. Product adaptation involves altering the

product to meet local conditions or preferences

Communications:

Company can run the same marketing communications programs as used in the home

market or change them for local market, a process called communication adaptation.

Marketers must also adapt sales promotion techniques to different markets. As the

company is tapping in Brazilian market where the local languages are Spanish and

Portuguese, sales promotion should be done taking language into consideration, so

that accurate understanding takes place in-between the middle men and the company

as well as with customers

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Price:

Multinationals face several pricing problems when selling abroad. They must deal

with price escalations, transfer process, dumping charges and gray market.

Differences comes due to addition of costs such as cost of transportation, tariffs,

importer margin, wholesaler margin and retailer margin to its factory price. As there

are regulations in Brazil for pharmaceutical products the company has to follow those

and place a competitive price in the market for its product.

Basically, the following items have been agreed upon:

Price increases prior to March 1, 2003 cannot be implemented. After March 1, 2003,

companies will be allowed to increase the prices by 8.63 percent. CAMED--the

government medicines price control agency published a list of products and

therapeutic classes that was excluded from the price increases rules in the near future.

Once again, Inter-pharma supports free market and freedom of pricing.

Pharmaceutical companies are responsible for determining wholesale drug prices but

the prices which the consumer pays at the pharmacy also reflects other costs and

taxes. Prices for retail drugs also include a pharmacy mark-up, a federal tax and a

state tax.

Distribution:

“If your product is not there, your customer cannot buy it.” Distribution will be driven

by company’s product positioning and target market. In developing the launch

strategy, key distribution channels should be identified. A launch plan should be

developed specifically for each account based on factors such as their trading policy,

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promotional plans, customer profile and competitive set. This plan should then be

presented to each account within their necessary time frames. This presentation is the

first stage of securing distribution. Assuming a positive response, further negotiation

may take place alongside product sampling. Technical requirements for launch will

also need to be supplied e.g. New Product Listing forms which will provide key

technical information like barcode, case code, sizes, pallet configuration.

As the company is tapping in international market, it should take a whole channel

view of the problem of distributing products to final users. In the first link, seller’s

international marketing headquarters makes decisions on channels and other

marketing mix elements. The second link, channels between nations, gets the product

to the borders of the foreign nation. The decisions made in this link include the types

of intermediaries (agents, trading companies) that will be used, the type of

transportation (air, sea) and the financing and risk arrangements. The third link,

channels within foreign nations, gets the products from their point to final buyers.

When company first enter a foreign market, its better to work with local distributors

who have good local knowledge.

In Brazil a foreign company has to distribute its pharmaceutical products through

local distributors who are registered to ANVISA or set up its own subsidiary and built

its own marketing or sales team. The problem with local distributors are they do not

invest in business growth, do not follow company policy, do not share enough

information and may not promote the product due to less margin given in respect to

other companies. The positive side is the company Does not have to invest on

infrastructure and other things which need further investment. With that its own

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marketing team may fail to understand the market properly or the way the business is

being carried over there and the problem of language to interact with other people. So

the company should choose the right local distributors, invest in them and set up

performance goals to which they can agree. If the company is able to find an

exclusive distributor for its products then it’s most helpful.

After few years, when the company is able to understand its business dealings

properly in the foreign country, it can built its own distribution channels and invest in

the same.

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6.5 Business analysis(1)(36)

After management develops the product concept the next step is to conduct the

business analysis.

Sales volume potential: before making any estimates of expected sales it is important

to size up the opportunity. What is the size of the total market? Adding up the retail

sales volumes of all competitive products, the size of the total market can be found.

What is the extent of competition both direct and indirect? The indirect competition

includes all the products that can be used as substitutes for the same condition or

indication. Now as per the market survey the direct competitor of Candesartan

cilexetil is Telmisartan followed by Losartan with hydrochlorothiazide. The major

indirect competitor is found to be drugs under ACE inhibitors, such as Ramipril

followed by Enalapril. There is another category of drugs which are also competing as

a indirect competitior which is Calcium channel blockers specially Amlodipine.

The company also has to find out the growth trends of the market. From the

epidemiology study of hypertension it was found that hypertension is one of the major

risk factor for mortality and which is continuously increasing in both India and Brazil

as per WHO. So the potentiality to run a business in this particular sector is worth

while for an emerging company.

The company also has to estimate the extent of share the product entry could expect to

capture during the first and second year.

Estimating costs: Costs are estimated by R&D, manufacturing, marketing and finance

department. The company has to measure 5 years projection of sales costs and profits.

Factors such as sales revenue, cost of goods sold, gross margin, development costs,

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marketing costs and allocated overheads should be projected in cash flow statement of

the company.

Profit potential: The company should also assess or evaluate the profit potentials of

the new product. For that the following aspects have to be taken into considerations:

a) What will be the product’s gross margin? How are they comparable to the

existing products?

b) What levels of marketing expenditure are needed to achieve the projected

sales volumes in the first and the second year?

c) What is the break even point? By what time the company likely to achieve the

break-even point as per the projected sales volume?

d) Are the raw materials and packaging materials freely available and their costs

stable? Are there any shortage forecasts for these that might lead to cost

escalation?

e) Do the returns on investment projection for the product under consideration

offer the best alternative use of capital?

f) Considering that the product should be priced at par with competition and

since the trade margins are virtually the same for all competitors in India in a

given product category, (the retail margins are fixed by the DPCO and

wholesale margins by the industry and trade agreement) will the product

generate a gross margin equal to or in excess of current products?

Things will be different when the company wants to launch in international

market due to discrepant international laws.

g) What is the projected pay back period?

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h) Introductory marketing investment in terms of months after the product

introduction date?

So for a company to launch a new product in an international and domestic market

the financial status of the company should be strong. This will finally help the

company to meet up all the business steps and expectations, planned for the successful

launch for its new product.

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6.6 Operational plans (1)(4)( 35)

Once the firm has determined which markets to enter, the mode of entry and its goals

and objectives relative to international expansion, it next has to draw up operational

plans for marketing the product or service in the international market. These plans

will be guided by the firm’s competitive posture in international market and the nature

of its strategic thrust. All marketing strategy is built on STP-Segmentation, Targeting

and Positioning. A company discovers different market place, targets those needs and

groups that it can satisfy in a superior way, and then positions its offering so that the

target market recognizes the company’s distinctive offering and image.

Understanding product market structure:

In domestic markets, the firm must determine the place its product could occupy

within a given market, what benefits it will stress and what customers or market

segment it will target. In international markets, these positioning decisions are broader

in scope, and in some respects more crucial. A clear understanding of product market

structure is crucial to effective positioning decisions and for that the firm must first

establish the relevant set of competing products and identify relevant product market

boundaries.

Next management has to assess the dimensions of the product market in the

international market. Here management should consider the size, intensity and growth

rate of demand in the targeted foreign market. These factors impact, not only the

profit potential of a given market, but also the costs associated with market

development.

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Segmenting international and domestic market:

Next management has to determine how to segment markets. Markets usually fall into

natural segments, which contain customers who exhibit the same broad characteristic.

The discerning marketer is conscious of this fact and fine tunes his product, offering

specially to reach these segments effectively. The essential criteria for effective

segmentation is (36)

Measurability: the segment must be measurable or definable in some specific

way.

Accessibility: the segment must be reachable with proper communication

package in cost effective manner.

Desirability: the segment must be large enough to service profitably.

Homogeneity: there should be a proper match or fit between the need profile

of the members of the segment and the satisfaction qualities or attributes of the

product

Vulnerability: the market must not be excessively vulnerable to competition

The customer segmentation has been done on the basis of the various doctor

specialties that treat hypertensive patients. The results of the primary market research

indicate the presence of three major segments, these are:

1. Cardiologists

2. General physicians

3. General practitioners

The results of the primary market research conducted among chemists indicate that

the Cardiologists and General physicians treat the maximum number of hypertensive

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patients. This result is further augmented by the doctor’s survey that concluded that

the Cardiologists and General Physicians are the major prescribers for the categories

of drugs indicated for hypertension. Other than these two, General practitioners are

also prescribing ARB’s for hypertension but comparatively less than the above

mentioned two categories. From the market survey it was found that the general

practitioners are not so much aware about the efficacy of the ARB’s, or never used

them in the treatment of hypertension of their patients. So an effort from the

company’s scientific business development team is very much necessary to create an

awareness in doctors for their better effectiveness in hypertensive patients.

ARB’s also has additional effects. There are studies which proves that Candesartan,

in respect to other ARB’s such as Telmisartan and Losartan, improves arterial

stiffness independently of blood pressure lowering possibly by direct action resulting

from its potent affinity and binding capacity for the angiotensin II type 1 receptor, and

thus concludes that candesartan is a potentially useful therapy against arterial

stiffness in hypertensive patients with type 2 diabetes mellitus.(37)

In another study it was concluded that candesartan in type 2 diabetic patients with

mild to moderate retinopathy induced significant improvement in retinopathy over 4

years irrespective of hypertension status at baseline.(38)

So Diabetologist can also be targeted to treat patients with hypertension or other

complications mentioned above in type II diabetics, which will finally increase the

customer base.

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Branding of the product:

The American marketing association defines a brand as a name, term sign, symbol, or

design or a combination of them, intended to identify the product of one seller or

group of seller and to differentiate them from those of competitors. Brands identify

the source or marker of a product and allow consumers either individuals or

organizations to assign responsibility to a particular manufacturer or a distributor.

Branding is all about creating differences. To brand a product, it is necessary to teach

customers “who” the product is by giving it a name, as well as “what” the product

does and “why” customers should care.

For pharmaceutical products the brand name should be such that it should be easy to

remember, pronounce and write. The brand name should not resemble any other

pharmaceutical product, after the confirmation of the foresaid the product launch

should be undertaken. Since getting brand name registered takes a minimum of two to

three years, it is better to have ready in the category the company is entering.

The following is the proposed brand name for the product which will be available:

Proposed brand name is CANDEBEAT-HCT, the product contains (Candesartan

cilexetil 16mg + Hydrochlorothiazide 12.5mg) and (Candesartan cilexetil 32mg +

Hydrochlorothiazide 12.5mg) and (Candesartan cilexetil 32mg + Hydrochlorothiazide

25mg)

The brand name “CANDEBEAT-HCT” is coined from the parent molecule

Candesartan and Heartbeat. The part “CANDE” is taken from Candesartan and

“BEAT” from heart beat. Beat also means to defeat. So the brand name delivers a

message that the product can defeat hypertension if treated with it.

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Product positioning:

Once the competitive frame of reference for positioning has been fixed by defining

customer target market and nature of competition, the appropriate points of difference

(PODs) and points of parity (POPs) can be defined.

POD are attributes or benefits consumers strongly associate with a brand, positively

evaluate and believe that they could not find them to the same extent and nature in the

competitive brand. Creating strong, favorable and unique associations as POD is a

real challenge, but essential in terms of competitive brand positioning. In choosing

POD two important considerations are that customers find the POD desirable and that

the firm has the capabilities to deliver on the POD.

POP on the other hand are associations that are not necessarily unique to the brand but

may in fact be shared with other brands. These types of associations come in two

basic forms: category and competitive.

Category POP are associations customer view as essential to be a legitimate and

credible offering within a certain product.

Competitive POP are associations designed to negate competitors POD

There are three key consumer desirability criteria for PODs.

1. Relevance. Target customers must find the POD personally relevant and

important.

2. Distinctiveness. Target customers must find the POD distinctive and superior

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3. Believability. Target customers must find the POD believable and credible. A

brand must offer a compelling reason for choosing it over the other options.

There are three key deliverability criteria.

1. Feasibility. The firm must be able to actually create the POD. The product

design and marketing offering must support the desired association.

2. Communicability. It is very difficult to create an association that is not

consistent with existing customer knowledge or that customers, for whatever

reason, have trouble believing. Customer must be given a compelling reason

and understandable rationale as to why the brand can deliver the desired

benefit.

3. Sustainability. It will depend on internal commitment and use of resources as

well as external market forces

Candesartan cilexetil with Hydrochlorothiazide will be positioned for the treatment of

hypertension and heart failure.

Positioning statement for the above mentioned molecule: “A NEW HORIZON FOR

HEART PATIENT” Angiotensin II is formed from angiotensin I in a reaction

catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the

principal pressor agent of the rennin- angiotensin system, with effects that include

vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac

stimulation and renal reabsorption of sodium. Candesartan blocks the vasoconstrictor

and aldosterone secreating effects of angiotensin II by selectively blocking the

binding of angiotensin II to the AT1 receptor in many tissues, such as vascular

smooth muscle and the adrenal gland.

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Candesartan cilexetil is the only ARB currently licensed for the treatment of heart

failure.

Hydrochlorothiazide works mainly by stopping the re-absorption of sodium (salt) and

water from the kidneys back into the blood stream

Unlike ACE inhibitors Candesartan cilexetil does not inhibit the breakdown of

bradykinin and are therefore associated with a lower incidence of cough.

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6.7 Marketing strategy

A detailed tactical plan for marketing the new product has to be made for both

countries. The plan should cover all the details for the launch year and be based on the

core concept. Broad guidelines for follow up promotion in the second and third years

should be written. This is necessary to maintain continuity and consistency for

building a brand image.

(Figure No. 6.7.1) Components of marketing activities

Detailing by medical representatives will play a crucial role in introducing the new

product into the market and creating a favorable brand image among the target

doctors. It is proposed that for the launch of CANDEBEAT-HCT a special task force

will be constituted. The task force will specialize in knowledge dissemination and

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introducing the product in the market. The activities of the special task force will be to

identify the key opinion leaders, introduce the product among them and disseminate

the latest advances in the field of hypertension. The sales force will integrate the

marketing efforts for CANDEBEAT-HCT and promote the prescription strategy.

The detailing part for CANDEBEAT-HCT will focus upon the role of Candesartan

cilexetil in the treatment of hypertension as well as heart failure. Further, the detailing

story will involve the role of Hydrochlorothiazide in CANDEBEAT-HCT and how it

will enhance both doctors compliance. After that it will emphasize on the

improvement of blood pressure on long term treatment. The sales representative will

compare the efficacy of CABDEBEAT-HCT versus other brands of ARB’s in the

same and different categories and also the advantages of the molecule in respect to

other beneficial effects. The frequency of visits will depend upon the category of

doctors. In the initial phase focus will be upon the targeted doctor categories

(Cardiologists and General physicians) later general practitioners will also be

targeted. The frequency of visit will be calculated for 100 doctors. Each individual of

the special task force will cover 100 doctors in a month and on an average 10 calls

will be made per day.

Now in Brazil the promotional aspects will be different according to their country’s

promotional regulations. As the cost of investment in Brazil is very high for

promotion, the company has to invest very carefully. Company also has to decide

whether they will promote the product through local sales force in Brazil or should

teach their marketing people in its home ground and let it done by them. As the

promotional cost is high in Brazil, unless the company is not opening a subsidiary

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over their or an office setup in Brazil, its better to promote the product through local

distributors and their sales force.

Product training manual:

What is Hypertension?

According to WHO, Hypertension is the state of body in which systolic BP is 150

mmHg or more & diastolic BP is 95 mmHg or more.

Hypertension can be classified either essential (primary) or secondary. Secondary

hypertension indicates that the high blood pressure is a result of (i.e., secondary to)

another condition, such as kidney disease or tumors (pheochromocytoma and

paraganglioma).

What is Pre-hypertension?

Recently, the JNC 7 (the Seventh Report of the Joint National Committee on

Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) has

defined blood pressure 120/80 mmHg to 139/89 mmHg as "Pre-hypertension.“

Pre-hypertension is not a disease category rather, it is a designation chosen to identify

individuals at high risk of developing hypertension

Another way of classifying hypertension is as follows:

Normal – (Systolic 90-120, diastolic 60-80)

Pre-hypertension – (Systolic 120-139, diastolic 80-99)

Hypertension Mild, Stage 1 - (Systolic 140-159 or diastolic 90-99)

Hypertension Moderate, Stage 2 - (Systolic 160 - 179 diastolic 100 – 109)

Hypertension Severe, Stage 3 - (Systolic 180 - 209 or diastolic 110 – 119)

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Hypertension Very Severe, Stage 4 - (Systolic > or = 210 or diastolic > or =

120)

What are the Risk Factors involved in Hypertension?

Persistent hypertension is one of the risk factors for strokes, heart attacks, heart failure

and arterial aneurysm, and is a leading cause of chronic renal failure.

Hypertension is a significant public health problem in urban and rural areas of India.

It is directly responsible for 57% of all stroke deaths and 42% of coronary heart

disease death in India. It is also a leading cause of blindness, renal failure and

congestive heart failure.

Mortality as a consequence of morbidity has increased, with stroke being a leading

cause of death. 11.3% of total deaths, 10.1% of all deaths in the 20−59 year-old age

group, and 33.9% of cardiovascular deaths in Brazilian Capitals also and the reason

for this is elevated blood pressure level.

What is CANDEBEAT-HCT?

CANDEBEAT-HCT is a combination of two medicines used in the treatment of high

blood pressure (hypertension): the angiotensin II receptor blocker candesartan

cilexetil and the diuretic (water tablet) hydrochlorothiazide. Both medicines are

provided in one tablet.

What is CANDEBEAT-HCT used for?

The product contains (Candesartan cilexetil 16mg + Hydrochlorothiazide 12.5mg) and

(Candesartan cilexetil 32mg + Hydrochlorothiazide 12.5mg) and (Candesartan

cilexetil 32mg + Hydrochlorothiazide 25mg)

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CANDEBEAT-HCT is used to treat high blood pressure (hypertension) when one

medicine (monotherapy) is not sufficiently effective.

How does CANDEBEAT-HCT work?

CANDEBEAT-HCT combines two medicines that have different ways of working

(modes of action) and leads to a greater lowering of blood pressure in more people

than with either medicine used alone.

• Angiotensin II is formed from angiotensin I in a reaction catalyzed by

angiotensin- converting enzyme (ACE, kininase II). Angiotensin II is the

principal pressor agent of the renin-angiotensin system, with effects that

include vasoconstriction, stimulation of synthesis and release of aldosterone,

cardiac stimulation, and renal reabsorption of sodium. Candesartan blocks the

vasoconstrictor and aldosterone-secreting effects of angiotensin II by

selectively blocking the binding of angiotensin II to the AT1 receptor in many

tissues, such as vascular smooth muscle and the adrenal gland. Its action is,

therefore, independent of the pathways for angiotensin II synthesis.

There is also an AT2 receptor found in many tissues, but AT2 is not known to

be associated with cardiovascular homeostasis. Candesartan has much greater

affinity (>10,000-fold) for the AT1 receptor than for the AT2 receptor.

Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit

the biosynthesis of angiotensin II from angiotensin I, is widely used in the

treatment of hypertension. ACE inhibitors also inhibit the degradation of

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bradykinin, a reaction also catalyzed by ACE. Because candesartan does not

inhibit ACE (kininase II), it does not affect the response to bradykinin.

Whether this difference has clinical relevance is not yet known. Candesartan

does not bind to or block other hormone receptors or ion channels known to be

important in cardiovascular regulation.

Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of

angiotensin II on renin secretion, but the resulting increased plasma renin activity and

angiotensin II circulating levels do not overcome the effect of candesartan on blood

pressure.

• Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular

mechanisms of electrolyte reabsorption, directly increasing excretion of

sodium and chloride in approximately equivalent amounts. Indirectly, the

diuretic action of hydrochlorothiazide reduces plasma volume, with

consequent increases in plasma renin activity, increases in aldosterone

secretion, increases in urinary potassium loss, and decreases in serum

potassium. The renin-aldosterone link is mediated by angiotensin II, so

coadministration of an angiotensin II receptor antagonist tends to reverse the

potassium loss associated with these diuretics.

The mechanism of the antihypertensive effect of thiazides is unknown

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Pharmacokinetics of the combination:

Candesartan Cilexetil

Candesartan cilexetil is rapidly and completely bioactivated by ester hydrolysis during

absorption from the gastrointestinal tract to candesartan, a selective AT1 subtype

angiotensin II receptor antagonist. Candesartan is mainly excreted unchanged in urine

and feces (via bile). It undergoes minor hepatic metabolism by O-deethylation to an

inactive metabolite. The elimination half-life of candesartan is approximately 9 hours.

After single and repeated administration, the pharmacokinetics of candesartan are

linear for oral doses up to 32 mg of candesartan cilexetil. Candesartan and its inactive

metabolite do not accumulate in serum upon repeated once-daily dosing.

Following administration of Candesartan cilexetil, the absolute bioavailability of

candesartan was estimated to be 15%. After tablet ingestion, the peak serum

concentration (Cmax) is reached after 3 to 4 hours. Food with a high fat content does

not affect the bioavailability of Candesartan after candesartan cilexetil administration.

Hydrochlorothiazide

When plasma levels have been followed for at least 24 hours, the plasma half-life has

been observed to vary between 5.6 and 14.8 hours.

Distribution:


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The volume of distribution of Candesartan is 0.13 L/kg. Candesartan is highly bound

to plasma proteins (>99%) and does not penetrate red blood cells. The protein binding

is constant at Candesartan plasma concentrations well above the range achieved with

recommended doses. In rats, it has been demonstrated that Candesartan crosses the

blood-brain barrier poorly, if at all. It has also been demonstrated in rats that

Candesartan passes across the placental barrier and is distributed in the fetus.

Hydrochlorothiazide

Hydrochlorothiazide crosses the placental but not the blood-brain barrier and is

excreted in breast milk.

Metabolism and Excretion:


Total plasma clearance of candesartan is 0.37 mL/min/kg, with a renal clearance of

0.19 mL/min/kg. When candesartan is administered orally, about 26% of the dose is

excreted unchanged in urine. Following an oral dose of 14C-labeled candesartan

cilexetil, approximately 33% of radioactivity is recovered in urine and approximately

67% in feces. Following an intravenous dose of 14C-labeled candesartan,

approximately 59% of radioactivity is recovered in urine and approximately 36% in

feces. Biliary excretion contributes to the elimination of candesartan.

Hydrochlorothiazide

Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidney. At

least 61% of the oral dose is eliminated unchanged within 24 hours.

How is CANDEBEAT-HCT given?

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Candebeat-HCT supplied as tablets. It is very important to take medicines for high

blood pressure. This is because high blood pressure, if not treated, can get

progressively worse and can lead to number of other complications.

What are the contra-indications for usage of the brand?

CANDEBEAT-HCT is contraindicated in patients who are hypersensitive to any

component of this product. Because of the hydrochlorothiazide component, this

product is contraindicated in patients with anuria or hypersensitivity to other

sulfonamide-derived drugs.

What are the possible adverse reactions or side effects with CANDEBEAT-HCT?

Candesartan cilexetil:

These include hypotension, hyperkalemia, and reduced renal function, including that

associated with bilateral renal artery stenosis and stenosis in the artery of a solitary

kidney. Hypotension is most likely to occur in patients in whom the blood pressure is

highly dependent on angiotensin II, including those with volume depletion (e.g., with

diuretics), renovascular hypertension, cardiac failure, and cirrhosis; in such patients

initiation of treatment with low doses and attention to blood volume is essential.

Hyperkalemia may occur in conjunction with other factors that alter K+ homeostasis,

such as renal insufficiency, ingestion of excess K+, and the use of drugs that promote

K+ retention.

Hydrochlorothiazide:

Erectile dysfunction is a troublesome adverse effect of the thiazide-class diuretics,

and physicians should inquire specifically regarding its occurrence in conjunction

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with treatment with these drugs. Gout may be a consequence of the hyperuricemia

induced by these diuretics. The occurrence of either of these adverse effects is a

reason for considering alternative approaches to therapy. However, precipitation of

acute gout is relatively uncommon with low doses of diuretics. Hydrochlorothiazide

may cause rapidly developing, severe hyponatremia in some patients. Thiazides

inhibit renal Ca2+ excretion, occasionally leading to hypercalcemia; although

generally mild, this can be more severe in patients subject to hypercalcemia, such as

those with primary hyperparathyroidism. The thiazide-induced decreased Ca2+

excretion may be used therapeutically in patients with osteoporosis or hypercalciuria.

What are the possible drugs Interactions with this combination?


No significant drug interactions have been reported in studies of Candesartan cilexetil

given with other drugs such as glyburide, nifedipine, digoxin, warfarin,

hydrochlorothiazide, and oral contraceptives in healthy volunteers. Because

Candesartan is not significantly metabolized by the cytochrome P450 system and at

therapeutic concentrations has no effects on P450 enzymes, interactions with drugs

that inhibit or are metabolized by those enzymes would not be expected.

• Lithium− Reversible increases in serum lithium concentrations and toxicity

have been reported during concomitant administration of lithium with ACE

inhibitors, and with some angiotensin II receptor antagonists. An increase in

serum lithium concentration has been reported during concomitant

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administration of lithium with candesartan cilexetil, so careful monitoring of

serum lithium levels is recommended

during concomitant use.

Hydrochlorothiazide

When administered concurrently the following drugs may interact with thiazide

diuretics:

• Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension

may occur.

• Antidiabetic drugs (oral agents and insulin): Dosage adjustment of the

antidiabetic drug may be required.

• Other antihypertensive drugs− Additive effect or potentiation.

• Cholestyramine and colestipol resins− Absorption of hydrochlorothiazide is

impaired in the presence of anionic exchange resins. Single doses of either

cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its

absorption from the gastrointestinal tract by up to 85 and 43 percent,

respectively.

• Corticosteroids, ACTH− Intensified electrolyte depletion, particularly

hypokalemia.

• Pressor amines (eg, norepinephrine)− Possible decreased response to pressor

amines but not sufficient to preclude their use.

• Skeletal muscle relaxants, nondepolarizing (eg, tubocurarine)−Possible

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increased responsiveness to the muscle relaxant.

• Lithium−Generally should not be given with diuretics. Diuretic agents reduce

the renal clearance of lithium and add a high risk of lithium toxicity.

• Non-steroidal Anti-inflammatory Drugs− In some patients, the administration

of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic,

and antihypertensive effects of loop, potassium-sparing and thiazide diuretics.

Therefore, when CANDEBEAT HCT and non-steroidal anti-inflammatory

agents are used concomitantly, the patient should be observed closely to

determine if the desired effect of the diuretic is obtained

Warnings:

Drug that act directly on the rennin-angiotensin system can cause fetal and neonatal

morbidity and death when administered to pregnant women. Post-marketing

experience has identified reports of fetal and neonatal toxicity in babies born to

women treated with Candesartan cilexetil during pregnancy. The use of drugs that act

directly on the rennin-angiotensisn system during the second and third trimesters of

pregnancy has been associated with fetal and neonatal injury, including hypotension,

neonatal skull hypoplasia, anuria, reversible or irreversible renal failure and death.

Oligohydramnios has been reported, presumably resulting from decreased fetal renal

functions.

Hypotension in volume and salt depleted patients:

Based on adverse events reported from all clinical trials, excessive reduction of blood

pressure was rarely seen in patients with uncomplicated hypertension treated with

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candesartan cilexetil and hydrochlorothiazide. Initiation of antihypertensive therapy

may cause symptomatic hypotension in patients with intravascular volume or sodium

depletion. These conditions should be corrected prior to administration of the drug

What is the recommended dosage for CANDEBEAT-HCT?

The daily dose range for CANDEBEAT HCT tablets is Candesartan cilexetil 16 mg

combined with Hydrochlorothiazide 12.5 mg to Candesartan 32 mg combined with

Hydrochlorothiazide 25 mg to Candesartan cilexetil 32mg combined with

Hydrochlorothiazide 25mg.

To minimize dose-independent side effects, it is usually appropriate to begin

combination therapy only after a patient has failed to achieve the desired effect with

monotherapy.

Hypertension awareness campaign:

The hypertension awareness campaign will be designed nationally and delivered

locally to ensure dissemination not only to the mainstream population but also to the

diverse, underserved section of the population. The main campaign seeks to promote

awareness among all older men and women, their family and improve the

responsiveness of doctors.

In the international community, the campaign can only be launched after judging its

feasibility in respect to company’s strength and capability and constrains in the

foreign community.

Message to the communities:

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How can we help COMMUNITIES that don’t GO TO THE DOCTOR as often as

they should?

We see real health problems in our communities such as Asthma, diabetes, Heart

diseases. “And too many folks don’t see a doctor in time. So we are working with

community groups to offer free health screenings and connect local doctors with the

people that really need help. That does make our heart good, too.”

To find out more visit www.healthycommunities.com

Title of the campaign: “An important public issue”

Launch of the campaign: “WORLD HEART DAY ”

Our objectives:

To make the masses aware of hypertension.

To tell them about its prevalence.

To teach prevention and treatment of this “complication”.

To tell the measures to control it.

To encourage and boost the morale of those suffering from the same.

Target audiences:

Obese people

Geriatrics

Patients

Working women and housewives

People working in BPO’s

Working men

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Shopkeepers

Students

Planning of the campaign:

1. Identify the past and existing hypertension awareness campaign (sponsorships

by pharma companies) and ascertain their impact on national and local level

2. Ascertain the opportunities and barriers involved in implementing a national

hypertension awareness campaign

3. To identify and highlight the “best practices” which have laid an impact in

terms of efficacy, overall quality of life and cost effectiveness

4. To device strategies to fill the voids in awareness levels

5. Implement the approach that support the program and sustains the impact

6. Creating messages that are meaningful, culturally relevant and stimulating

7. To build the campaign on the existing health and community framework

8. To device and adapt strategies that cater to vast section of the population

Implementation of the campaign:

Built and mobilize a robust network for knowledge dissemination on

hypertension

Health care camps.

Reach the greatest number of men and women of age group starting from 45

years and above through a national campaign

Deliver the campaign locally, this will ensure greater likelihood of success

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To partner with trusted organization and key doctors

Call on helpline number provided by the campaign organizers..

Providing with a postal address.

Pamplets inserted in newspapers and health magazines.

Hoardings on road side especially at bus stops and public places.

Tactics used to ensure success of the campaign:

1) Information must be compelled by driving action: The information should

clearly covey the consequences of Hypertension if untreated and communicate

the ways to prevent it. Scare strategy should not be used as such tactics have a

short run and are effective. Focus should also be given to those who are

working in companies where work stress is more to create awareness for

future prevalence of hypertension. According to the JNC 7 (the Seventh Report

of the Joint National Committee on Prevention, Detection, Evaluation, and

Treatment of High Blood Pressure) has defined blood pressure 120/80 mmHg

to 139/89 mmHg as "Prehypertension.“ Prehypertension is not a disease

category; rather, it is a designation chosen to identify individuals at high risk

of developing hypertension. People can be motivated by messages that point

out the importance of taking care of themselves for their family.

2) Deploying nontraditional channels for communication such as ethenic media,

particularly multilingual news papers and television can be used for catering to

the mass.

The communication plan:

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Key promise statement: “By preventing and treating hypertension, I am avoiding the

silent killer to spoil my happiness and making me dependent on others. If I get

treated, I can enhance my quality of life and contribute more to my family and finally

to society”

sMessages and support statement:

Protect your vital part of your life “Heart” and it will support you for today

and tomorrow

Know your blood pressure. Take time to get tested

Weight Reduction, Increased Exercise, Salt Restriction, Relaxation & Stress

Management Supplementation of potassium, calcium, & magnesium, Use of

Fish oil and Cessation of smoking can control your blood pressure

Untreated Hypertension can lead to other Heart diseases and other complex

disorders.

Take the early first step to avoid happiness to run out from your life.

Evaluation of the campaign:

The purpose of evaluation will help in assessing the effectiveness of the awareness

campaign, reveal how well the campaign was implemented, the barriers encountered

and were the foresaid objectives attained. The following are the questions which need

to be answered for evaluation

Are the messages likely to be effective in increasing awareness and motivating

changes in the target audiences?

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Are the messages culturally sensitive and cater to the diverse group?

Did awareness of the campaign/messages increase?

Did awareness of the consequences of hypertension increase?

Did awareness of the blood pressure screening increase?

What actions did the target audience take

Constraints: the following are the constraints that can impact the launch of the

proposed products in the market:

Investments: this can be one of the leading factors that can impact the over all

framework of the strategy, adequate investments will be required at every level of the

implementation of the proposed launch strategy.

Strength of the sales force: the medical representatives will be forming the interface

between the various doctors’ categories and the company. The quality (which is the

function of the training program) and quantity (number of Medical representative’s

deployed by the company per territory) will play an important role at the time of

introduction of the product in the market

Image of the company: more than the proposed product, the image of the company

matters in recruiting the key opinion leaders. For a new product to make at impact on

the market a strong presence among the key opinion leaders is necessary.

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6.8 Product development (1)(36)

Up to now, the product has existed only as a word description, a drawing, or a

prototype. The next step involves a jump in investment that dwarfs the costs incurred

in the earlier stages. At this stage the company will determine whether the product

idea can be translated into a technically and commercially feasible product.

The R&D department will develop the physical versions of the product concept of

Candesartan cilexetil with hydrochlorothiazie. Its goal is to make the prototype which

performs safely with having key attributes described and within budgeted

manufacturing costs. The company has to make checklist, such as

I. The raw material specifications

II. The production specifications

III. Determining the shipper sizes

IV. Developing the packing including specifications of packaging materials.

As the company is also targeting a foreign market (Brazil) the

specifications should be according to the Brazilian regulations. The

company has to check whether your labeling is accordance with drug laws.

The language in brazil is Spanish, it better to label the product in local

language.

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V. Decision on the price: According to literature survey Candesartan is the

least expensive at maintenance doses for hypertension.(33)

VI. Fulfillment of all the licensing and other legal requirements.

After management is satisfied with functional and psychological performance, the

product is ready to be dressed up with a brand name and packaging and put into a

market test. The new product shall be introduced into an authentic setting to learn

how large the market is and how doctors and dealers react to handling and using the

product

Monitor performance: Elementary and fundamental as it may see, monitoring

performance of new products on a regular basis is an important task. Once the product

is commercialized, probably the newness and the consequent excitement are gone.

The common temptation is to revise the forecasts of new product for six months or

even longer instead of analyzing and finding out reasons. Monitoring the performance

of new products regularly against the original plan forecasts can provide significant

insights and leverages in the development of successful new product.

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6.9 Commercialization

To introduce a major new product into the national and international market, the

company may have to spend a huge amount of money in advertising, promotion and

other communications in the first year. A survey carried out by IBOPE Monitor

compared the first trimesters of the years 2000 through 2007, and found that

pharmaceutical industry investment in publicity had grown almost 70% over the past

three years, as opposed to 33,6% growth in publicity in general.( ) So for an emerging

company it’s a huge investment.

Most new-product campaigns rely on a sequenced mix of market communication

tools.

WHEN (timing): In commercializing a new product, market entry timing is critical.

WHERE (geographic strategy): The company must decide whether to launch the new

product in a single locality, a region, several regions in national and international

market. Company size is an important factor here. Small companies have to select an

attractive city and put a blitz campaign. They should enter other cities one at a time.

Now as per the survey carried out in domestic market such as Kolkata and

Bangalore the report says the awareness of the molecule Candesartan cilexetil with

hydrochlorothiazide in Kolkata is bit higher than Bangalore and ARB’s are also being

used in higher amount according to survey. So Kolkata is a target city for the

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company. As Bangalore is the home town of the company it can be the second choice.

The company may also target 3 other metros such as Mumbai, Delhi and Chennai.

This is because literature says that the prevalence of hypertension has increased by 30

times among the urban population over a period of 55 years and about 10 times

among the rural population over a period of 36 years. Dramatic changes in life style

from traditional to modern have lead to physical inactivity due to technological

advances. Rising affluence has modified the dietary pattern characterized by increased

consumption of diets rich in fat, sugar and calories.

Furthermore, increasing population growth at the current rate of about 2% in each

year and technological advances have shrunken the employment opportunities

particularly among young generation leading to stress and hypertension in young

persons, including students and laborers

As the company is also targeting a rollout market (Brazil), the major criteria are

market potential, the company’s local reputation, the cost of communication media

and competitive penetration.

HOW (introductory market strategy): The company must develop an action plan for

introducing the new product into the rollout markets. To coordinate the many

activities involved in launching a new product, management can use network planning

techniques. By estimating how much time each activity takes, the planners estimate

completion time for the entire project. Any delay in any activity on the critical path

will cause the project to be delayed. If the launch must be completed earlier, the

planner searches for ways to reduce time along the critical path.

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Discussion

DEPARTMENT OF PHARMCEUTICAL MARKETING AND MANAGEMENT Page 222

7. Discussion

The key difference between domestic marketing and marketing on an international

scale is the multi-dimensionality and complexity of the many foreign country markets

a company may operate in. Developing a new product and launching in the market is

time and resource consuming, as great care must be taken to ensure the best decisions

are made before the product reaches channel members and final consumers.

Once the company decides to target a particular country, it has to determine the best

mode of entry. Its broad choices are indirect exporting, direct exporting, licensing,

joint ventures and direct investment. The normal way to get involved in an

international market is through export. The company produces its goods in the

country and might or might not adapt them to international markets. Companies

typically start with indirect exporting that is they work through independent

intermediaries.


devices products, can be sold only if:





offered.




Discussion




After the company decides the way to enter the Brazilian market the company must

decide how much to adapt their marketing strategy to local conditions. Deciding on

the marketing program that is standardization of the product, communication and

distribution channels in the lowest costs is a challenging one. As the company is

tapping in Brazilian market where the local languages are Spanish and Portuguese,

sales promotion should be done taking language into consideration, so that accurate

understanding takes place in-between the middle men and the company as well as

with customers. For price structure there are regulations in Brazil for pharmaceutical

products which the company has to follow those and place a competitive price in the

market for its product. In Brazil a foreign company has to distribute its

pharmaceutical products through local distributors who are registered to ANVISA or

set up its own subsidiary and built its own marketing or sales team.

After management develops the product concept the next step is to conduct the

business analysis. Before making any estimates of expected sales it is important to

size up the opportunity. What is the size of the total market? Adding up the retail sales

volumes of all competitive products, the size of the total market can be found. What is

the extent of competition both direct and indirect? The indirect competition includes

all the products that can be used as substitutes for the same condition or indication.

From IMS health audit 2007 world wide. ARB ranked 8th amounting to a globle sales

of US$ 19.4 billion with a growth of 13.6% within the top therapeutic segment. Now

Discussion


as per the domestic market survey, the direct competitor of Candesartan cilexetil is

Telmisartan followed by Losartan with hydrochlorothiazide. The major indirect

competitor is found to be drugs under ACE inhibitors, such as Ramipril followed by

Enalapril. There is another category of drugs which are also competing as an indirect

competitior which is Calcium channel blockers specially Amlodipine. So the

company has to develop their strategies on the basis of primary data.

The company also has to find out the growth trends of the market. From the

epidemiology study of hypertension it was found that hypertension is one of the major

risk factor for mortality and which is continuously increasing in both India and Brazil

as per WHO. So the potentiality to run a business in this particular sector is worth

while for an emerging company.

Once the firm has determined which markets to enter, the mode of entry and its goals

and objectives relative to international expansion, it next has to draw up operational

plans for marketing the product or service in the international market. All marketing

strategy is built on STP-Segmentation, Targeting and Positioning. The customer

segmentation has been done on the basis of the various doctor specialties that treat

hypertensive patients. The results of the primary market research indicate the presence

of three major segments, these are:

1. Cardiologists

2. General physicians

3. General practitioners

Discussion


The results of the primary market research conducted among chemists indicate that

the Cardiologists and General physicians treat the maximum number of hypertensive

patients. This result is further augmented by the doctor’s survey that concluded that

the Cardiologists and General Physicians are the major prescribers for the categories

of drugs indicated for hypertension. Other than these two, General practitioners are

also prescribing ARB’s for hypertension but comparatively less than the above

mentioned two categories.

So an effort from the company’s scientific business development team is very much

necessary to create an awareness in doctors for their better effectiveness in

hypertensive patients.

Branding is an important aspect before positioning the product in customers mind.

The following is the proposed brand name for the product which will be available.

The brand name “CANDEBEAT-HCT” is coined from the parent molecule

Candesartan and Heartbeat. The part “CANDE” is taken from Candesartan and

“BEAT” from heart beat. Beat also means to defeat. So the brand name delivers a

message that the product can defeat hypertension if treated with it.

Once the competitive frame of reference for positioning has been fixed by defining

customer target market and nature of competition, the appropriate points of difference

(PODs) and points of parity (POPs) can be defined.

Candesartan cilexetil with Hydrochlorothiazide will be positioned for the treatment of

hypertension. Candesartan cilexetil is the only ARB currently licensed for the

treatment of heart failure which is an additional advantage of the molecule and will

help to develop more confidence in the doctors about the product. Unlike ACE

Discussion


inhibitors Candesartan cilexetil does not inhibit the breakdown of bradykinin and are

therefore associated with a lower incidence of cough

Coming to the marketing strategies, a detailed tactical plan for marketing the new

product has to be made for both countries. The plan should cover all the details for the

launch year and be based on the core concept. For the proposed project development

of promotional materials, detailing by medical representatives and frequency of visits

and sampling pattern, training manual/product literature for the sales team, awarness

campaign for hypertension are the major components of marketing activities. The

detailing part for CANDEBEAT-HCT will focus upon the role of Candesartan

cilexetil in the treatment of hypertension as well as heart failure. Further, the detailing

story will involve the role of Hydrochlorothiazide in CANDEBEAT-HCT and how it

will enhance both doctors compliance.

In Brazil the promotional aspects will be different according to their country’s

promotional regulations. As the cost of investment in Brazil is very high for

promotion, the company has to invest very carefully. Company also has to decide

whether they will promote the product through local sales force in Brazil or should

teach their marketing people in its home ground and let it done by them.

The next step involves a jump in investment that dwarfs the costs incurred in the

earlier stages. At this stage the company will determine whether the product idea can

be translated into a technically and commercially feasible product.

The R&D department will develop the physical versions of the product concept of

Candesartan cilexetil with hydrochlorothiazie.

Discussion


To introduce a major new product into the national and international market, the

company may have to spend a huge amount of money in advertising, promotion and

other communications in the first year. As per the survey carried out in domestic

market such as Kolkata and Bangalore the report says the awareness of the molecule

Candesartan cilexetil with hydrochlorothiazide in Kolkata is bit higher than Bangalore

and ARB’s are also being used in higher amount according to survey. So Kolkata is a

target city for the company. As Bangalore is the home town of the company it can be

the second choice. The company may also target 3 other metros such as Mumbai,

Delhi and Chennai. As the company is also targeting a rollout market (Brazil), the

major criteria are market potential, the company’s local reputation, the cost of

communication media and competitive penetration.

Conclusion


8. Conclusion

A strategy is like a route or road the company wants to take to reach its objectives. A

decision on strategy, therefore involves all aspects like the target audience, key

product attributes, allocation of resource-mix and the segment the company will

attack.

Market penetration and development strategies:

Market penetration and development suggests how the company will increase the

market share and profits of its new product in its own existing markets. Before

offering a new product in the market, the company must define its market. It is the

process by which products select the market in which they propose to operate.

Candesartan cilexetil with hydrochlorothiazide will be launched in the anti-

hypertensive drugs market. CANDEBEAT-HCT will be positioned for treatment of

hypertension and heart failure. The combination of hydrochlorothiazide with the

parent molecule will increase the synergy of the brand and will provide better market

penetration and enhance the market share in antihypertensive market.

CANDEBEAT-HCT will adopt market penetration strategy in the existing product

market, this will be achieved by deploying the following:

Hypertension is a highly prevalent risk factor for cardiovascular deaths and disability

worldwide. A study carried out in Brazil which reveled that cardiovascular diseases

are a leading cause of mortality, and systemic hypertension is a major risk factor. In

India it is directly responsible for 57% of all stroke deaths and 42% of coronary heart

Conclusion


disease deaths. It is also a leading cause of blindness, renal failure and congestive

heart failure. So, the cardiologists will be made aware to start therapy with

CANDEBEAT-HCT for better management of high blood pressure. The brand

CANDEBEAT-HCT have been specifically formulated for the patients who are not

tolerant to ACE inhibitors and are admitted for heart failure. But according to

literature the effects of ARBs in hypertension is probably a class effect. As the

molecule is the only licensed ARB for the treatment of heart failure and the condition

is one of the major causes of death in India as well as in Brazil, proper positioning

will help the company to attract customers from competitors and also will help the

product to penetrate in the market. As per the survey it is clear that doctors who

prescribed Candesartan for the treatment of hypertension showed a positive response.

But maximum of them have not used it, specially the general practitioners followed

by the general physicians. With respect to this aspect the company has to increase the

awareness of the molecule to the maximum extent which will help to develop its

market by changing the prescription habit.

So among the general physicians and general practitioners, the initial tactic will be to

promote the cumulative action of the brand CANDEBEAT-HCT. This will be done by

providing the latest scientific knowledge about the combination effect of the

molecule.

Operational strategies:

The operational strategy has been devised across product differentiation, product

positioning, targeting and segmentation strategy.

Conclusion


The product positioning will be done with respect to the product by explaining how

CANDEBEAT-HCT is different from other products in its and other categories.

After doing the primary survey in Kolkata and Bangalore, the results shows that the

molecule is a preferred one, but didn’t have a response to that extent in comparison to

Telmisartan and Losartan which are the top selling molecule in the ARB category.

The drug may not have higher plus points in comparison to Telmisartan but it has

some positive advantages in compared to it according to literature. Such as the

maintenance dose of Candesartan is less than Telmisartan and it is the only drug

licensed by US FDA for the treatment of hypertension and heart failure.

In comparison to Losartan, Candesartan has much higher superiority according to

literature survey. The plus points of Candesartan over Losartan are greater

bioavailability, long duration of action, less side effects and better efficacy.

The most preferred Calcium channel antagonist is Amlodipine as per the survey

carried out in both the above mentioned cities. Literature survey says that Candesartan

is better tolerated than Amlodipine

Focusing on the above aspects will help the brand for its better positioning in the

customers mind.

The customer segmentation has been done on the basis of the various doctor

specialties that treat hypertensive patients. The results of the primary market research

indicate the presence of three major segments, these are cardiologists, general

physicians and general practitioners

Conclusion


Promotional strategies:

Before the actual launch, a special task force will be created that will help to increase

the knowledge regarding the product among the various category of doctors

(especially targeting the cardiologists and the general practitioners). The initial

promotion of the products will be handled by the special task force which will help to

reinforce the credibility of the firm and the product among the doctors’ mind.

Continuing Medical Education (CME) programmes shall be conducted

simultaneously in the targeted states of India as a future strategy for product recalling.

The availability of the product will be ensured at chemist outlets and hospital

pharmacies before the actual prescription generation starts. The distribution channel

will be streamlined from the carrying and forwarding agent (C&F Agent) to the

distributors/ super-stockists and the retailer in India and in Brazil. Product handling

guidelines will be provided to all the elements across the distribution channel.

As part of new commercial model the company can focus on more targeted

communication to doctors through its representatives (if any in Brazil), e-detailing

and video detailing which can be useful for promoting the product in Brazilian

market. Extensive use of new media such as the internet can be implemented.

By identifying the sales promotion strategy, company will be able to align its plan

with the short-term incentives used to encourage prescription sales. If the company is

going to run a special campaign in the first three months of the launch, then the sales

team should be given some type of incentive to push that particular promotion (i.e.

discounts, rebates, samples), such as rewarding the reps with a specific dollar amount

Conclusion


for each prescription filled. If it is only being offered in a particular region, than that

also needs to be considered when devising national incentive compensation plan.

In order to measure the actual effectiveness of the strategy, the company must first

define success. Is it based on the number of samples distributed, coupons used or total

prescriptions sold? The strategy needs to incorporate different scenarios. By using

effective ways to model and forecast launch product performance they can optimize

the compensation plans and predict compensation expenses.

Awareness among the patients will be generated by providing scientific information

in layman language in the leading magazines which target the aged individuals and

young professionals. The campaign conducted by the company will also help to create

awareness in individuals which will help to recognize the initial symptoms of

hypertension and also make aware of pre-hypertension which is not a disease

category; rather it is a designation chosen to identify individuals at high risk of

developing hypertension and urge the patients to consult a doctor.

Investment strategies:

The investment option for the product will be; to enter and grow in the Brazilian and

Indian market for the treatment of Hypertension. There should be aggressive

promotion of the product and try and differentiate product from competitors, for

which substantial amount of cash inflow for the product will be needed. A product's

success during the first six months of a launch has a significant impact on sales over

the entire product life cycle. Therefore, it is critical to know the budget in order to

determine how much the sales team can be compensated for attaining certain goals.

Conclusion


Emphasis will also be laid on generating awareness programs among elderly

population and promoting diagnosis in the high risk population.

Launch program:

Before launching the products in the domestic market, test marketing can be an

option, but to make an impact in the market CABDEBEAT-HCT will be launched

countrywide at the same day (the preferred day will be World Heart Day). The launch

can also be integrated with the proposed Hypertension Awareness Conference; this

will further help to live up to the product hype created before the product launch.

The launch program shall include-details of the launch including the ambience setting,

the invitees, public relations arrangements, the guests of honor and any specific doctor

(specifically a key opinion leader). Before, the actual launch event it is always viable

to do dummy rounds of the whole launch program which will involve both the

scientific and the marketing activities.

The review of the launch strategy will be done on a constant basis and it will be a

function of the sales achieved for the products in a given time frame.

Finally taking every aspects concluded above, we can come to an idea that before

launching a product in the international and domestic market by the company, it has

to decide extensively in proper budgeting of the overall project for launching a new

product and come out with answers which are not covered in this proposed such as

how the company will do an cost effective branding and maintaining brand equity and

reasons behind competitors not promoting the molecule which are operating in

present market even though the molecule is having potential for the treatment of

hypertension.

Summary


9. Summary

Emerging from a highly protected economy and an insulated business environment,

many companies in India have come a long way in their quest to become global

players. To develop a new product and launching in the market is time and resource

consuming, as great care must be taken to ensure the best decisions are made before

the product reaches channel members and final consumers.

Therefore to launch a new product in the domestic and international market, some

important aspects such as analysis of targeted country, risks, cultural aspects,

competitors, deciding how to enter the market, deciding on the marketing programme,

development of the product and its commercialization, company financial status

should be extensively analyzed. The proposed study involves the consideration of all

the relevant aspects for the launch of a new brand of a combination product that is

Candesartan cilexetil with Hydrochlorothiazide in domestic and international markets.

It involves the development of tactics, plans and strategies which helps to introduce

the proposed new brand successfully. The apparent reasons for selecting Brazilian and

Indian market is due to their market growth of 13.4% and 13% respectively which is

higher in comparison to other major pharmaceutical markets, such as North America,

Europe and Japan according to IMS health report. The driving force behind the

growth is the rising consumption levels in both the countries.

The top 10 key pharmaceutical markets accounts for majority of sales amounting to

US$529.5 billion. The seven emerging markets such as China, Brazil, Mexico, South

Korea, India, Turkey and Russia has a growth by 12-13% (US$ 85-90 billion) in

2008.

Summary


Generic medicines continue to grow at a higher rate than overall pharmacy sales, and

are expected to represent 20% of the sector by volume in 2010.

Lifestyle drugs have become the leading segment for the Indian pharmaceutical

industry. Heart disease and diabetes are growing at 10.7% and CNS is growing at

4.9%. According to a recent McKinsey report, Indian pharmaceutical industry has the

potential to touch US$ 25 billion by 2010.

According to risk analysis Brazil comes out most favorable, scoring an overall

medium risk for dynamic risks – governance framework, political violence and

business and macroeconomic environment. It also has a medium risk profile for

structural risks such as supply chain risks, poverty, development, energy security and

vulnerability to climate change.

India is high risk for both dynamic and structural risks. Its poorer score compared to

Brazil can be attributed to significantly higher levels of terrorism, poorer regime

stability and higher levels of corruption. This will impact on future political risk.

The differences between social and cultural factors in different parts of the world can

be a central consideration in developing and implementing international marketing

strategies.


devices products, the company has to establishes a local Brazilian manufacturing unit

or local office, fully responsible for its products; or the foreign company appoints a

Brazilian distributor, who has the registration with the ANVISA as an importer and

distributor of the types of products being offered.

Summary


Candesartan cilexetil with hydrochlorothiazide belonging to the therapeutic category


strategy. .

The objectives of the study was to find out the prevalence of hypertension in Brazil

and India. To study the anti-hypertensive drugs market in the above mentioned

countries with special reference to Candesartan cilexetil with Hydrochlorothiazide

followed by the prescription trends for the treatment of Hypertension. And finally

preparing an effective launch strategy for a new brand of Candesartan cilexetil with

Hydrochlorothiazide in international and domestic market.

This open prospective and comparative study was conducted in Bangalore and

Kolkata. The survey was conducted amongst the doctors and chemists to explore the

anti-hypertensive drugs market with special reference to Candesartan cilexetil with

Hydrochlorothiazide and to find out the prescription trends for the treatment of

hypertension. The secondary data was obtained from Journals and internet. The

method of data collection was preliminary communication and personal interview

with doctors and chemists to get their consent to participate in the survey.

The sampling technique adopted was convenience sampling and the sample size was

100 doctors and 100 chemists in total from the cities. The data obtained was tabulated

and compared.

The results of the primary market research showed that the major competitors are

found to be ACE inhibitors where Ramipril followed by Enalapril is the top molecule

and with respect to ARBs, Telmisartan has the higher preference followed by

Summary


Losartan as per doctors preference and chemists sales experience. Amlodipine is the

preferred molecule among Calcium channel blockers. Diuretics are mainly have

preference for higher age groups. With respect to combination therapy the above

mentioned categories of drugs with Diuretics are the competitors. Combinations other

than the mentioned ones above, includes Calcium channel antagonist with ACE

inhibitors and ACE inhibitor with ARB which will also be a competitor in Kolkata

and Bangalore respectively.

With respect to Candesartan, the molecule has a very low preference in the market but

doctors specially the cardiologist has a good impression on this particular molecule.

But maximum doctors have not prescribed this molecule and also within them the

awareness of the molecule is not there. As per chemists over view about the molecule,

in Bangalore the molecule has very low market but Kolkata do have higher market

with respect to Bangalore.

The market analyses identified the following key competency areas required for

success of the product such as:

1. Recognizing the right segment, that is the anti-hypertensive market and

targeting the doctors specially the Cardiologists, General physicians and

General practitioners who will generate the maximum number of

prescriptions.

2. Customizing the product according to the requirement of segment and needs

of the customer.

Summary


3. Promotion strategy should emphasize on contrasting the efficacy and benefits

of the proposed product. In this proposed project the promotional strategy

followed here are, visual aid preparation, making an awareness campaign for

hypertension.

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sortspec=relevance&resourcetype=HWCIT,HWELTR

Annexure


11. ANNEXURES

Annexure


List of Doctors Surveyed in Bangalore

Sl. No. Name (CARDIOLOGISTS) Location 1. Dr. A Gopi Apollo Hospital

2. Dr. Balram Sri Jayadeva Institute of Cardiology

3. Dr. B G Baliga Cardiac Care Centre, Jayanagar

4. Dr. B Kumar K R Hospital

5. Dr. B Ramesh Sri Jayadeva Institute of Cardiology

6. Dr. B Srinivas Sri Jayadeva Institute of Cardiology

7. Dr. Jaya Prakash Jaya Prakash Clinic, Bansankari

8. Dr. Joshwa Sri Jayadeva Institute of Cardiology

9. Dr. Harsha Jeevan Sri Jayadeva Institute of Cardiology

10. Dr. H. R Jagdish Sri Jayadeva Institute of Cardiology

11. Dr. K B Prasad Apollo Hospital

12. Dr. K R Samsundar Sagar Hospital

13. Dr. M. R Prasad Sri Jayadeva Institute of Cardiology

14. Dr. Mahesh B. V Vinayaka Hospital

15. Dr. N. G Shivaswamy Sri Jayadeva Institute of Cardiology

16. Dr. Narendra Kori Sri Jayadeva Institute of Cardiology

17. Dr. Nagesh Sri Jayadeva Institute of Cardiology

18. Dr. Nagesh Vinayaka Hospital

19. Dr. N Sridhar Wockhard Hospital

20. Dr. N M Prasad Sri Jayadeva Institute of Cardiology

21. Dr. Prabhabati Sri Jayadeva Institute of Cardiology

22. Dr. Santosh Sri Jayadeva Institute of Cardiology

23. Dr. Satish Sri Jayadeva Institute of Cardiology

24. Dr. S Venkatesh Wockhard Hospital

25. Dr. T R Raghu Sri Jayadeva Institute of Cardiology

Annexure


Sl. No. Name (GENERAL PHYSICIANS)

Location

1 Dr. Addis Jayanagar General Hospital

2 Dr. B P Allan Hari Pandu Hospital

3 Dr. Chandrasheker Chiranjeevi Clinic

4 Dr. Mahesh P Shiva Specialist Clinic

5 Dr. Prasanna Kumar Apollo Clinic Bangalore, Koramangala

6 Dr. Ravindra Victoria Hospital

7 Dr. Saroja Jayanagar General Hospital

8 Dr. S N Mohan K R Hospital

9 Dr Susma Nagesh Poly Clinic

10 Dr.K.Sukumar Shetty Bangalore Hospital

11 Dr.Sandip Malli Bangalore Hospital

12 Dr. Vijaya Vardhan Apollo Clinic Bangalore, Koramangala

Sl. No. Name

(GENERAL PRACTITIONERS) Location

1 Dr. Amarnath Victoria Hospital

2 Dr. Anitha KIMS

3 Dr. Deepti KIMS

4 Dr. Kesava Sri Srinivas Nursing Home

5 Dr. Murthy Pandu Hospital

6 Dr. Satish Kumar Jain Padmashree Clinic

7 Dr. Santosh Jeevana Deepa Hospital

8 Dr. S Sridhar Sri Srinivas Nursing Home

9 Dr. Srinivas Sri Srinivas Nursing Home

10 Dr. Sowmya Shree KIMS

11 Dr Eshwari Prasad Ashwin Family Health Clinic

12 Dr. Manjunath Cubbonpet

13 Dr.Ganesh Prasad Kamath Rajarajeswari Hospital

Annexure


List of chemists surveyed in Bangalore

Sl. No. Name Location

1. Santhosh Medicals Hanumathanagar

2. Med Plus Ramamurthynagar

3. Sri Gurudev Medical Centre Ramamurthynagar

4. B K Medicals Ramamurthynagar

5. Murthy Medicals V V Puram

6. Ram Medicals Nagartpost

7. Apple Pharma Jayanagar

8. Shree Lakshmi Pharma Basavanagudi

9. Venus Medicals Doddamavalli

10. Divine Medicals BTM Layout

11. Manjunatha Medicals Lalbagh Fort Road

12. Jagannath Medicals SBM Colony

13. Prime Pharma V V Puram

14. Sree Balaji Medicals Corporation, Market

15. Gupta Medicals Bansankari

16. Sree Manjunatha Medicals V V Puram

17. Medplus SBM Colony

18. Sapthagiri Medicals Lalbagh Road

19. Nataraj Medicals Vijayanagar

20. Manoj Medicals Cox Town

21. Apollo Pharma Jayanagar

22. Eshwar Medicals R T Nagar

23. Apollo Pharma Bansankari

24. Maruthi Medicals J P Nagar

25. Chetak Pharma Residency Road

Annexure



26 Om Medicals BTM II Stage

27 Trust Cmemist and Druggists BTM II Stage

28 Anand Medicals Jayanagar

29 Lifetime Health Care Hanumanthanagar

30 Trust Cmemist and Druggists Mabanahalli

31 Balaji Medicals J C Nagar

32 Sahay Chemists and Druggists Bellandur

33 The Consumer’s Pharma Basavanagudi

34 Medplus Basavanagudi

35 Essar Pharma R T Nagar

36 Yash Pharma Residency Road

37 Medplus Hanumanthanagar

38 Mamta Medicals Srinagar

39 Sagar Pharma Srinagar

40 Balaji Pharma Residency Road

41 Vasavi Medicals Kengeri

42 Maruthi Medicals Vijayanagar

43 Shreya Medicals K S Town

44 Shreaa Medicals BTM Layout

45 Sri Naresh Pharma Srinagar

46 Master Medicals Srinagar

47 Durga Medicals J P Nagar

48 Medplus J P Nagar

49 Apollo Pharma Shivajinagar

50 Apollo Pharma Yelanka

Annexure


List of Doctors Surveyed in Kolkata

Sl. No. Name (CARDIOLOGISTS) Location

1 Dr. Asit Kumar Satpati Cittaranjan National Medical Hospital

2 Dr. Asis Kumar Mondal Cittaranjan National Medical Hospital

3 Dr. A.K. AgarwaL Peerless Diagnostic

4 Dr. A.K Bardhan Woodlands Hospital

5 Dr. A.K. Mahapatra Aram Clinic (Boubazar)

6 Dr. Anjan Lal Dutta Nightingale Diagnostic Centre

7 Dr. B Halder N R S Medical Hospital

8 Dr. Bhabotosh Biswas Peerless Hospital

9 Dr. C.C. Kar A.G. Hospital & Research Centre

10 Dr. Debal Sen Woodlands Hospital

11 Dr Dhiman Kahali Kolkata Medical Hospital

12 Dr. J. Maitra Kolkata Medical Hospital

13 Dr. K Ganguly N R S Medical Hospital

14 Dr. K.K. Mitra Kolkata Medical Hospital

15 Dr. Sunil Sarkar R.N. Tagore Medical Research Institute

16 Dr. Mrinal Kanti Das Lala Lajpat Rai Sarani

17 Dr. P K Biswas Burdwaman Medical Hospital

18 Dr. R K Sharma Cittaranjan National Medical Hospital

19 Dr. Sadhan Roy B.M. Birla Heart Research Centre

20 Dr. S Mandal Cittaranjan National Medical Hospital

21 Dr. Suchet Mukherjee N R S Medical Hospital

22 Dr. Subhanan Roy Apollo Hospital

23 Dr. Sibananda Dutta N R S Medical Hospital

24 Dr. Suvro Banerjee Kolkata Medical Hospital

25 Dr. Tapas Roychowdhury B.M. Birla Heart Research Centre

Annexure


Sl.No.

Name (GENERAL PHYSICICANS)

Location

1 Dr. A. K Bera Cittaranjan National Medical Hospital

2 Dr. A. K Kundu Cittaranjan National Medical Hospital

3 Dr. Amitava Chatterjee Kolkata Medical Hospital

4 Dr. M.Banerjee N R S Medical Hospital

5 Dr. Mani Chetri A.M.R.I.(Near Dhakuria Bridge)

6 Dr. N.Karmakar N R S Medical Hospital

7 Dr. Sanjay Banerjee N R S Medical Hospital

8 Dr. S Banerjee N R S Medical Hospital

9 Dr.Samar Banerjee N R S Medical Hospital

10 Dr. Subhashish Ganguly Venus Diagnostic

11 Dr. Salil Pal N R S Medical Hospital

12 Dr. U S Ghosh N R S Medical Hospital

Sl.No.

Name (GENERAL PRACTITIONER)

Location

1 Dr. Amlan Banerjee K.D. Cure Nursing Home

2 Dr. Anraj Singh Asia Rescue & Medical Services

3 Dr. B Chatterjee Cittaranjan National Medical Hospital

4 Dr. B Sarkar Cittaranjan National Medical Hospital

5 Dr. Debasis Das Cittaranjan National Medical Hospital

6 Dr. Debobroto Nandi N R S Medical Hospital

7 Dr. Manjul Kr. Roy Kolkata Medical Hospital

8 Dr. Mousumi Dutta Matrimoyee Medicals

9 Dr. Ranjit Das Cittaranjan National Medical Hospital

10 Dr. Sayantan Banerjee Kolkata Medical Hospital

11 Dr. Santi Saha Kalindi, CESC staff Quarter

12 Dr. Shashwata Tuhi Annada Neogi Lane

13 Dr. Vijay Mehta Apsara Building,

Annexure


List of chemists surveyed in Kolkata Sl. No. Name Location

1. Roy Clinic Behala

2. Blue Print Esplanade

3. Apollo Pharmacy Bagha Jatin

4. Drug Point Pharmacy Shyambazar

5. Dey's Medical Hall Shobhabazar

6. Bengal Medical Hall Salkia

7. Frank Ross Pharmacy New Alipore

8. Central Medical Stores Beadon Street

9. Chowranghee Blue Print New Market,

10. Kothari Medical Centre Alipur

11. Dhanwantary Medical Shop Hazra Road

12. Astha Bangur Avenue

13. Rejuv Pharmacy Bidhan Nagar (Salt Lake)

14. The Relife Pharmacy New Alipore

15. Gemini Pharmacy Barobazar

16. Health Pharmacy Dhakuria

17. Medica Pharmacy Regent Park

18. Medina Pharmacy Jodhpur Park

19. Deys Clinic Pharmacy Jadavpur

20. Samcon Pharmacy Bow Bazar

21. Seetal Pharmacy Kankurgachi

22. Wardex Aarogya Pharmacy Dhakuria

23. Adeline Pharmacy Joka, Kolkata

24. Medi-aid Pharmacy Shreebhumi

25. Medicon Pharmacy Baguihati

26. Medicos Pharmacy Bhawanipur

Annexure



26 Medicus Pharmacy Dum Dum, Kolkata

27 Vintage Pharmacy Park Street

28 Blue Sky Pharmacy Dum Dum, Kolkata

29 Deepneel Pharmacy Belgachia

30 Gadadhar Pharmacy Hati Bagan

31 Apollo Pharmacy Barahanagar

32 Apollo Pharmacy Barasat

33 Apollo Pharmacy Barrackpore

34 Apollo Pharmacy E.M Bypass

35 Medicino Pharmacy New Alipore

36 G D Enterprise Park Circus

37 Sarada Medical Jessore Road

38 Sarkar Medicine Park Circus

39 Blue Print Sealdah

40 Ma Sarada Pharmacy Jessore Road

41 Chandra Prova Medicals Jessore Road

42 Roy Medicals Jessore Road

43 Deepali Drugs Park Circus

44 Ramkrishna Medicals Shyambazar

45 Dey’s Medical Shyambazar

46 Nirmal Medical Nagendra Nath Road

47 Apollo Pharmacy Nagerbazar

48 Jibandeep Pharmacy Nagerbazar

49 GM Stores Pharmacy Dalhousie

50 Jibandeep Pharmacy Kalighat

Page 217

* ABC Journal of Hypertension Page 218

Rx

Candesartan cilexetil 16mg + Hydrochlorothiazide 12.5mg TabletsCandesartan celexitil 32mg + Hydrochlorothiazide 12.5 mg TabletsCandesartan cilexetil 32mg + Hydrochlorothiazide 25 mg Tablets

Candesartan celexitil works by blocking the action of a hormone called angiotensin II

with Hydrochlorothiazide

New combination

IndicationsHypertensionHeart failure

1. (www.patienthealthinternational.com)

®

1

Page 219

**Barreras Amy, Turner Gurk Cheryle. Angiotensin II receptor blockers. 2003 Jan ;16:123126.*Drug update angiotensin II receptor antagonists. http://www.nyrdtc.nhs.uk/docs/dud/DU_42_Angiotensin_II_a.pdf Page 220

Rx

Better tolarated than LISINOPRIL-HCT and AMLODIPINE

Effective and well tolerated in patients with essential hypertension, including elderly patients

2. Blood Pressure, Volume 9, Supplement 1, 15 May 2000 , pp. 61-61(1)3. Journal of the renin-angiotensin aldosterones syatemISSN 1470- 3203 Source / Source, 2007)4. Journal of human hypertension, Volume 13, Supplement 1, Pages S27S31

®

2 34

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Documents

In partial fulfillment of the requirements for the degree