Ethical Issues in Pharmaceutical Market In India

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SUMMER TRAINING REPORT

ON

“Ethical issues in Pharmaceutical Marketing in India”

AT

SK Pharma New Delhi

Submitted in partial fulfillment for the award of

Degree of

MASTER OF BUSINESS ADMINISTRATION

UNDER THE KIND SUPERVISION OF-

Mr. Ajay Sharma

(Proprietor SK Pharma)

Submitted by-Adil Khan (11-MBA-35)

Submitted on- August, 2012

DEPARTMENT OF BUSINESS ADMINISTRATION

FACULTY OF MANAGEMENT STUDIES AND RESEARCH

ALIGARH MUSLIM UNIVERSITY, ALIGARH

2011-2013

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Acknowledgement

Knowledge and Experience both are mutually dependent on each other for their

reinforcement. This project is an outcome of the learning acquired in our first year of

study at Faculty of Management Study and Research at Aligarh Muslim University

and experience and observations during summer training.

I am indebted and thankful for the assistance received from various people in making

of this project. I deeply express my gratitude towards those who were constantly

involved with this project. I would like to sincerely thank the entire faculty of FMSR,

AMU for imparting the relevant skill-set which proved to be precious during this

internship.

I am also very much thankful to Dr. Asif Akhtar for his valuable suggestion in writing

the report. I wish to express deep sense of reverence to Mr. Ajay Sharma Co-

proprietor and Managing director, S.K. Pharma, for providing such an opportunity to

enhance my skills.

Last but not least I would express my sincere gratitude to Mr. Kafeel Ahmad, a senior

Sales consultant for S.K. Pharma, with whom I became aware of the Intuitive and

ground realities of Market.

______________________

Adil Khan

Roll No. 11 MBA 35

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TABLE OF CONTENTS

I. CERTIFICATE

II. ACKNOWLEDGEMENT

III. EXECUTIVE SUMMARY

1 INTRODUCTION

1.1 Ethics in dealing with Pharma industry 1

1.2 Objectives of the study 1

1.3 Organization of report 2

2 ORGANIZATIONAL OVERVIEW 3

2.1 Introduction 3

2.2 How S.K. Pharma works 3

2.3 Major products owned by S.K. Pharma 4

3. AN OVERVIEW OF PHARMACEUTICAL INDUSTRY IN

INDIA

3.1 Evolution of Indian pharmaceutical industry 7

3.2 Stages of development 7

3.3 Present status of Indian pharmaceutical industry 9

3.4 DRIVING FORCES OF INDIAN PHARMACEUTICAL

INDUSTRY

10

3.5 Marketing in pharmaceutical industry 16

3.6 Regulatory environment 21

4. LITERATURE REVIEW: UNETHICAL PRACTICES IN PHARMA

INDUSTRY

4.1 Gifts and physician-representative relation 25

4.2 Why are gifts ethically problematic? 26

4.3 Medical interns‘ attitude towards gifts and Pharma reps 28

4.4 Conflicting views of physicians 28

4.5 Aggressive promotion accelerating irrational use of medicine 29

4.6 Promotion of hazardous and bannable drugs 34

4.7 DOCTORS AS KEY OPINION LEADERS 35

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4.8 PROMOTION OF DISEASE INSTEAD OF' ‘HEALTH’ 36

4.9 Direct to consumer advertising (DTCA) 37

4.10 Implications of unethical promotion and irrational use of drugs 37

5. RESEARCH METHODOLOGY 39

6. DATA ANALYSIS 42

7. CONCLUDING DISCUSSION 68

8. RECOMMENDATIONS AND LIMITATIONS OF THE STUDY. 70

9. BIBLIOGRAPHY 72

10. APPENDICES 73

Executive Summary

India has a huge market potential for Pharmaceuticals. It is highly celebrated in

international fraternity for making medicines at comparatively low-price. The Indian

industry is supplying around 20 percent of the world's drugs (by volume) and is

currently one of the largest Pharma industries in the world (by volume). At least 60

manufacturing plants in India have US Federal Drug Administration (FDA) approval,

second only to the United States. Currently a dozen of top Indian companies are major

suppliers to the US and European market as well as China. Nevertheless, the booming

Indian Pharma market coming to the rescue of generics world over, especially by

making low priced antiretrovirals, is a good part of the story.

The not so good part is that the Indian Pharma scenario, as far as the ordinary poor

consumer is concerned, is a failure of the market. As a result of this extreme market

failure and failure of regulation in the absence of well-functioning markets, the drug

(medicines) availability situation in India is one of poverty amidst adequacy - there is

inadequate access and supply of even essential drugs to the poor despite adequate

drug production. Adding to this misery is the poorly functioning public health system.

While the sales of Indian Pharma companies are increasing steadily (approximately

Rs 40,000 cr. during 2005, including exports), the total government expenditure by

both Central and State Governments would be of the order of a mere Rs 3000 cr., with

the Southern States spending 15 % on health of the total budget while Assam, Bihar,

UP and Orissa would spend around 5 percent!

More players in an uncontrolled market have meant only a wide range of prices for

the same drugs. On the other hand, you have the same drug being sold by different

companies (and sometimes by the same company) at vastly different prices. There is

not even a direct relation between top-selling drugs and the real need, as per the

disease and illness conditions prevalent.

These severe distortions are compounded by poor regulation, nexus between medical

profession and Pharma companies and their aggressive and often unethical marketing.

In this report these issues will be discussed. Further we will also try to explore views

and attitudes of doctors, patients, representatives and retailers regarding these issues

through our exploratory research.

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INTRODUCTION

1.1 Ethics in dealing with Pharma industry

Ethics in general is philosophical issue and is defined as philosophical study of

morality. The scientific study of morality is descriptive ethics and it is generally

concerned with explanation of moral views and its causal origin. However,

philosophical ethics involves normative ethics acknowledging what is morally right or

wrong in relation to human behavior. If we believe that medical ethics is applied

ethics then it is also prudent to consider that the ethics is also going to be influenced

by political, social and economic aspect and policies of our environment.

This report tries to understand various ethical issues in Pharma marketing in India.

Pharma companies are facing very tough competition and their middle managers, in

order to complete the assigned targets, are pushing their subordinate executives too

hard for sale. This may tempt sales executive for indulging in unethical practices.

Some companies also have propaganda of selling drugs unethically from top to

bottom of their management.

On the other hand when government is promoting private medical colleges, the

medical education became too costly. Doctors graduating from such institutes argue

how they will get return on their money!

Our regulatory machinery for pharmaceutical industry is very fragmented. And the

standard set for clinical trials, manufacturing, pricing, and marketing etc. are not as

stringent as that of other advanced countries. Neither they are in conformity with

WHO‘s standard guidelines

1.2 Objectives of the Study

In this report we will discuss the various issues surrounding Indian Pharma industry

with special focus towards unethical marketing practices. We will contrast the attitude

of Patients and Doctors towards certain ethical dimensions.

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1.3 Organization of Report

First we will have an overview of Indian Pharma industry, its evolution and growths

prospect. In middle part of the report we will discuss the various studies related to

unethical practices in pharmaceutical marketing. This will include gifts giving and

Medical Representative-Physician relationship and other related aspects.

In the later part primary research is discussed. The aim of the primary research is to

assess the difference of opinion between patients and Doctors, regarding certain issues

which consider the ethical dimension of pharmaceutical marketing in India. This

research is basically descriptive in nature and based on structured Interview and a

Questionnaire research instrument. Two transcripts (translated) of interview of a

Doctor and a Representative inserted.

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ORGANISATIONAL OVERVIEW

2.1 INTRODUCTION

S.K. Pharma is a Marketing and distribution firm with its major area of operation in

northern and north east part of the country. The registered office is located in

Janakpuri in Delhi and one branch office is in Mathura.

Today it is marketing around 2500 products of different Pharma manufactures

companies. It also manufacture more than 100 its own exclusive products.

2.2 HOW S.K. PHARMA WORKS

SK Pharma owns more than hundred generic drug formulations. It gets these drugs

manufactured through contract manufacturing. Majority of products it Market are

from established big Pharma Companies which is around 2500. It employs sales force

in two ways direct and indirect. There is a core team of six managers which deals with

Retailers Hospital dispensaries and super Stockist. This team is directly employed by

S.K. Pharma.

Sales consultants are channel member who are awarded monopoly rights for

marketing and selling drugs in a certain area. The fee for granting rights and the area

to be covered in contract is negotiable.

Figure : Channel Partners in S.K. Pharma

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2.3 Major products owned by S.K. Pharma

Table : List of Products

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Table : List of Products (continue….)

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Table : List of Products (continue….)

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An Overview of Pharmaceutical

Industry in India

3.1 EVOLUTION OF INDIAN PHARMACEUTICAL INDUSTRY

The Indian pharmaceutical industry has come a long way since the time of

independence when multinational corporations dominated the industry. The industry,

in addition to meeting domestic demand, is in a position to export significant volume

of pharmaceutical products to various destinations, including the developed markets

of USA, EU and Japan.

3.2 STAGES OF DEVELOPMENT

Evolution of Indian pharmaceutical industry can be classified into the following three

periods:

3.2.1 PRE-1970

Till 1970, the size of the Indian pharmaceutical industry was very small in terms of

number of firms as well as production capacities. Bengal Chemicals and

Pharmaceutical Works in Kolkot and Alembic Chemicals in Baroda, set up in around

1910 were the first two Indian firms to start pharmaceutical production. During this

period, the patent regime, based on The Indian Patents and Designs Act, 1911,

recognized both product and process patents.. Between 1947 and 1957, 99% of the

drugs and pharmaceutical patents in India were held by foreign MNCs. Naturally

prices of drugs were very high and to combat with such monopoly two public sector

company were set up. One of them was Hindustan Antibiotic Ltd. (HAL) established

in 1954, with the help of W.H.O. and UNICEF; and another The Indian Drugs and

Pharmaceutical Limited (IDPL), was in 1961.

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3.2.2 FROM 1970 TO 1995

Government of India introduced a new Patent Act, which came into effect in 1972,

recognizing only process patent and not product patent. The Act enabled Indian firms

to use ‗reverse engineering process‘, to manufacture drugs, without paying royalty to

the original patent holder. The Act, along with Drug Price Control 1995 to Present

Order, provided little incentive for MNCs to introduce new pharmaceutical products

in India. During this period, the number of domestic pharmaceutical firms increased

considerably, from around 2000 units in 1970 to 24,000 units in 1995. Production of

bulk drugs increased from Rs. 18 crores in 1965-66 to Rs. 1518 crores in 1995, while

that of formulations increased from Rs. 150 crores to Rs. 7935 crores during this

period. Share of exports as a percentage of total production has shown significant

increase from 3.22% in 1980-81 to 24% in 1994-95.

3.2.3 1995 ONWARDS

The year 1995 recorded another milestone for the Indian pharmaceutical industry.

One of the Agreements under the World Trade Organisation was complying with the

Trade Related Intellectual Property Rights (TRIPS) provisions. The TRIPS

Agreement reintroduced product patent in India. Further, during this period, tariff and

non-tariff measures have come down. Such developments have worked in favor of

Indian pharmaceutical industry to undertake activities such as clinical research and

new drug development. Indigenous producers dominated the market accounting for

more than 70% of the market share. Exports also continued to increase during this

period, due to strong R&D process and low manufacturing cost.

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Figure - Share of MNC’s and Indian companies

3.3 PRESENT STATUS OF INDIAN PHARMACEUTICAL INDUSTRY

The annual turnover of the Indian pharmaceutical industry is over US$ 12.2 billion.

Globally it ranks 4th

in terms of volume with a share of 8% in the world

pharmaceutical market. In terms of value, it ranks 14th. Key therapeutic segments of

Indian pharmaceutical industry include anti-infective, gastrointestinal and cardio-

vascular. Acute therapies make up about 60% of the market. However, it is expected

that with the changing lifestyle and aging population, sales of chronic therapies (i.e.

diabetes, cardiovascular) are growing rapidly. The pharmaceutical industry is also

showing good performance in terms of exports. It is one of the top export items from

India accounting for more than 4% of India‘s total exports in 2006-07. Exports, which

constitute around 50% of the industry‘s total production, have grown at a CAGR of

14% in the last decade.

Major export markets include USA, Germany, UK and Canada. Europe is the biggest

export destination for Indian pharmaceuticals accounting for more than 30% of the

total exports, followed by the Americas region (25%).

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Figure : Growth of Indian Pharmaceutical Industry

3.4 Driving Forces of Indian Pharmaceutical Industry

Indianan Pharma industry is growing at a very rapid pace almost double of India‘s

GDP at 14-15% CAGR. There are multifold factors for such a tremendous growth.

These forces are increasing disposable income, increasing accessibility to healthcare,

higher penetration in insurance coverage etc. Let‘s have a look at these Driving

Forces of Indian Pharmaceutical market.1

1 [snaps shots taken from India pharma2020, Mckinsey report ]

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

US $ bn 3.7 4.1 4.7 5.3 6.2 6.9 7.8 8.7 9.9 11.1 12.2 13.4 14.6 16

0

2

4

6

8

10

12

14

16

18

US $ bn

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1) Increase in Disposable income and poverty Eradication

2) Significant Growth in rural market

Figure- Figure : increase in disposable Income in India (source- The Bird of Gold: The rise

of India’s Consumer Market, May 2007, Mckinsey India

Figure : Growth in Rural Market, Source- Mckinsey India

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3) Expansion of Towns and Urbanization

4) Increase in Disposable income in rural India

Figure : Urbanization in India

Figure : Significant increase in Disposable income in India

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5) Increasing Governments spending on Healthcare

6) Growing affordability of and accessibility to Healthcare

Figure : Increasing Governments spending on Healthcare

Figure : Growing affordability of and accessibility to Healthcare

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7) Increase in Life style related and other chronic diseases

8) Health insurance level expected to touch around half of the

Figure : Increase in Life Style related Chronic Diseases

Figure : Trends in Health insurance Penetration India

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9) Expiry of Patents will create opportunity for Generic market

Table : List of Selected drugs going off- Patent 2008-2009 2

2 Source: INDIAN PHARMACEUTICAL INDUSTRY: SURGING GLOBALLY, OCCASIONAL

PAPER NO. 119 EXPORT-IMPORT BANK OF INDIA

Sl. No. Brand

Name

Generic Name Manufacturer Patent Expiration

date

1 Fosamax Alendronate Merck Feb. 6, 2008

2 Camptosar Irinotecan Pfizer Feb. 20, 2008

3 Effexor/XR Venlafaxine Wyeth June 13, 2008

4 Zymar Gatifloxacin Allergan June 29, 2008

5 Dovonex Calcipotriene Bristol-Myers

Squibb

June 25, 2009

6 Kytril Granisetron Roche July 29, 2008

7 Risperdal Risperidone Janssen June 29, 2009

8 Depakote Divalproex sodium Abbott Laboratories July 29, 2010

9 Advair Fluticasone and

salmeterol

GlaxoSmithKline Aug. 12, 2008

10 Serevent Salmeterol GlaxoSmithKline Aug. 12, 2008

11 Casodex Bicalutamide Bristol-Myers

Squibb

Oct. 1, 2008

12 Trusopt Dorzolamide Merck Oct. 28, 2008

13 Zerit

Stavudine

Bristol-Myers Squibb Dec. 24, 2008

14 Lamictal Lamotrigine GlaxoSmithKline Jan. 22, 2009

15 Vexol Rimexolone Alcon Labs Jan. 22, 2009

16 Avandia Rosiglitazone GlaxoSmithKline Feb. 28, 2009

17 Topamax Topiramate Johnson & Johnson March 26, 2009

18 Glyset Miglitol Pfizer July 27, 2009

19 Acular Ketorolac tromethamine Allergan Nov. 5, 2009

20 Xenical Orlistat Roche Dec. 18, 2009

21 Valtrex Valacyclovir GlaxoSmithKline Dec. 23, 2009

22 Avelox Moxifloxacin Bayer Dec. 30, 2009

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3.5 MARKETING IN PHARMACEUTICAL INDUSTRY

3.5.1 MARKET- SEGMENTS

Following list indicates the top Therapeutic Segments and their respective share. It

can also be divided into two broad segments Chronic and Anti Infective, where Anti-

Infective has the dominant share.

Table : Top Therapeutic segments in India3

Sl. No Category Value (Rs. Billion) Market Share (%)

1 Anti-infective 32.8 16.4

2 Gastrointestinal 21.8 10.9

3 Cardiac 20.7 10.3

4 Respiratory 20.4 1 0.2

5 Vitamins/ Minerals/Nutrients 19.3 9.6

6 Pain/analgesics 19.1 9.5

7 Dermatologicals 10.8 5.4

8 Gynecology 10.7 5.3

9 Neuro psychiatry 10.6 5.3

10 Antidiabetics 8.8 4.4

11 Opthologicals 3.5 1.7

3 SOURCE: ‘Pharmaceuticals’ A Report by Ernst & Young for IBEF

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3.5.2 Marketing Models

There are two broad models, super core model and core model. Super core model is

applied in Chronic-therapy segment and also called as Pull Approach Model, while

core model is applied in Acute-therapy segment and is called as Push approach

Model.

Super core model

Super Core Model involves the search for, and distribution of a small number of drugs

from Chronic Therapy Area that achieve substantial global sales. In this model

medical representatives are the key actors for example in a small cardiology unit

almost 40 sales representatives interacting with doctors, and most of them are coming

for a visit on a regular once-a-month basis as this is the restriction put by doctors of

meeting only once in a month

that to on a fix time only, in

order to stress the usefulness of

their products and push

clinicians towards the use of

their drugs. In this system,

doctors are the core customers

and the major thrust is given to

build and retain these customer

because they are pulling the

demand for products hence

companies also give main

emphasis in building and

retaining these customers. All

efforts are being put for

generating secondary sales i.e.

from Stockist to retailer.

Ensuring of auto demand with

limited availability and

maximum liquidation of the products is the main characteristic of this approach.

Figure : Super Core Model: The Pull Approach for chronic

segment

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Core Model

In this model a larger number of drugs from Acute Therapy Area are marketed to big

diversified markets. Here presenting a large number of products and taking the

advantage of opportunity cost is one of the important strategies. Other strategy

includes daily reminders to cross the perceptual filter and get the brand name in to the

sub-conscious state of mind.

For marketing of these types of products companies require more and more field force

to remind their products on daily basis to their direct customer (doctor). Also field

force is required to

have a good rapport

with retailers. Field

force also required to

ensure good

availability of their

products to convince

doctors and PUSH

their products i.e.

from to Stockist to

Retailer to Doctor. It

has been observed

that sometimes there

are more than fifteen

or sixteen

representatives in a

day are meeting with

their customer and

requesting for same

type of products. The relationship between clinicians and representatives has always

been good and pharmaceutical companies have provided, and still provide, the major

economic support for customers' continuous medical education. In this system,

doctors and retailers are the core customers and the major thrust is given to build and

Figure : Core Model: The Push Approach For Infective Segment

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retain these customers. Here retailers are also core customer as most of the times they

are substituting the products based on their own discretion. For retaining and

developing customers, the companies normally provide utility gifts to remind the

products on daily basis.

Integrated Model4

Marketing and Promotion in Pharmaceutical industry can also be explained with the

help of an integrated model.

4 Salma et al, SOCIALLY RESPONSIBLE PHARMACEUTICAL MARKETING PRACTICES: THE

CASE OF EGYPT, Cairo Egypt

Figure : Integrated model of Distribution in Pharmaceutical industry in India

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3.6 DISTRIBUTION AND SUPPLY CHAIN

Many a times drugs promoted through professional service representatives do not

appear on the shelves of the retailing chemist. This can be attributed to ineffective

distribution system. Although distribution is recognized in India as an important

function, many pharmaceutical marketers accord it a mere supportive role; so the

distribution system has remained traditional with little or no innovations. Super-

Stockist/Stockist, distributors and C& FA's (Carrying & Forwarding Agent) have

traditionally been very loyal to pharmaceutical marketers. As a result, strategic

changes in distribution arrangement were rarely recommended or carried out.

Problems, if any, were always sorted out amicably and changes, when at all, were

Figure : Pattern of Distribution of pharmaceuticals in India

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concerned only with adding or deleting Stockist in the distribution chain. Over time

when AIOCD (All India Organization of Chemist & Druggist) mobilized retailers in

every state, pharmaceutical companies found their freedom to appoint Stockist

restricted by retailer pressure.

There have been other changes too. One may view the distribution set up as a

concentric pattern with patients at the center with each ring representing a link in the

chain. It must be noted that some rings prefer by passing the next one. Some

companies, for instance, deal directly with Stockist, whereas some high end products

that require highly sensitive servicing are distributed directly to doctors. Some

innovative ideas have been coming from such companies like HoechstTM,

SarabhaiTM, Sandoz (NovaratisTM) and now Nicholas ParimalTM.

3.6 REGULATORY ENVIRONMENT

3.6.1 Regulatory Authorities

The Central Drug Standards and Control Organization (CDSCO), is located under the

aegis of the Ministry of Health and Family Welfare The CDSCO prescribes standards

and measures for ensuring the safety, efficacy and quality of drugs, cosmetics,

diagnostics and devices in the country; regulates the market authorization of new

drugs and clinical trials standards; supervises drug imports and approves licenses to

manufacture the above-mentioned products.

The National Pharmaceutical Pricing Authority (NPPA), which was instituted in 1997

under the Department of Chemicals and Petrochemicals, which fixes or revises the

prices of decontrolled bulk drugs and formulations at judicious intervals; periodically

updates the list under price control through inclusion and exclusion of drugs in

accordance with established guidelines; maintains data on production, exports and

imports and market share of pharmaceutical firms.

The Department of Chemicals and Petrochemicals also oversees policy, planning,

development and regulatory activities pertaining to the chemicals, petrochemicals and

pharmaceutical sector. The responsibilities assumed by this body are relatively

broader and varied in comparison to the other two bodies.

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State drug controllers have the authority to issue licenses for the manufacture of

approved drugs and monitor quality control, along with the Central Drug Standards

Control Organization (CDSCO).

3.6.2 Prevailing Mechanisms

In India, drug manufacturing, quality and marketing is regulated in accordance with

the Drugs and Cosmetics Act of 1940 and Rules 1945. The Drugs Controller General

of India (DCGI), who heads the Central Drugs Standards Control Organization

(CDSCO), assumes responsibility for the amendments to the Acts and Rules. Other

major related Acts and Rules include the Pharmacy Act of 1948, The Drugs and

Magic Remedies Act of 1954 and Drug Prices Control Order (DPCO).

Some of the important schedules of the Drugs and Cosmetic Acts include: Schedule

D: dealing with exemption in drug imports, Schedule M: which, deals with Good

Manufacturing Practices involving premises and plants and Schedule Y: which,

specifies guidelines for clinical trials, import and manufacture of new drugs

In accordance with the Act of 1940, there exists a system of dual regulatory control or

control at both Central and State government levels. The central regulatory authority

undertakes approval of new drugs, clinical trials, standards setting, control over

imported drugs and coordination of state bodies‘ activities. State authorities assume

responsibility for issuing licenses and monitoring manufacture, distribution and sale

of drugs and other related products.

3.6.4 Indian Regulations & Guidelines at a glance

CDSCO Central Drugs Standard Control Organization (CDSCO), Ministry

of Health & Family Welfare, Government of India provides

general information about drug regulatory requirements in India.

NPPA Drugs (Price Control) Order 1995 and other orders enforced by

National Pharmaceutical Pricing Authority (NPPA), Government

of India.

D & C Act, 1940 The Drugs & Cosmetics Act, 1940 regulates the import,

manufacture, distribution and sale of drugs in India.

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Schedule M Schedule M of the D&C Act specifies the general and specific

requirements for factory premises and materials, plant and

equipment and minimum recommended areas for basic installation

for certain categories of drugs.

Schedule T Schedule T of the D&C Act prescribes GMP specifications for

manufacture of Ayurvedic, Siddha and Unani medicines.

Schedule Y The clinical trials legislative requirements are guided by

specifications of Schedule Y of The D&C Act.

GCP guidelines The Ministry of Health, along with Drugs Controller General of

India (DCGI) and Indian Council for Medical Research (ICMR)

has come out with draft guidelines for research in human subjects.

These GCP guidelines are essentially based on Declaration of

Helsinki, WHO guidelines and ICH requirements for good clinical

practice.

The Pharmacy

Act,1948

The Pharmacy Act, 1948 is meant to regulate the profession of

Pharmacy in India.

The Drugs and

Magic Remedies

(Objectionable

Advertisement)

Act, 1954

The Drugs and Magic Remedies (Objectionable Advertisement)

Act, 1954 provides to control the advertisements regarding drugs;

it prohibits the advertising of remedies alleged to possess magic

qualities.

The Narcotic

Drugs and

Psychotropic

Substances

Act, 1985

The Narcotic Drugs and Psychotropic Substances Act, 1985 is an

act concerned with control and regulation of operations relating to

Narcotic Drugs and Psychotropic Substances.

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Figure : regulatory mechanism of Indian Pharma industry

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Literature Review

4.1 GIFTS AND PHYSICIAN-REPRESENTATIVE RELATION

Health care professionals who prescribe pharmaceutical products base their

prescription decisions on many factors including effectiveness, safety, and cost. In an

effort to influence practitioners‘ prescribing practices, the pharmaceutical industry

employs diverse marketing and promotional strategies, among them offers of free

drug samples, educational materials, meals, and other forms of gifts. These efforts are

both intensive and expensive. Some 80% of physicians admit that they have been

offered cash or gifts from pharmaceutical industry representatives. Many physicians

see medical representatives four or more times a month 5

The drug industry spent billion on visits to physicians‘ offices. In the last five years

the number of pharmaceutical company sales representatives in the India has

increased from around 65,000 in 2005 to 95,000 in 2009 and is expected to cross

300,000 in 2020.6

Serious ethical concerns have been raised about these contacts between the

pharmaceutical industry and individual health care professionals, especially when

gifts are involved.

4.1.1 WHAT IS A GIFT?

Webster defines a gift as: ―something bestowed voluntarily and without

compensation.‖ Although this definition captures our casual understanding of a gift as

something given with no expectation that the recipient will reciprocate, it misses

much of the social aspect of gifts that make gifts from pharmaceutical representatives

to health care professionals ethically challenging. Gifts have deep and sometimes

contradictory cultural meanings. Unlike contracts, in which parties set out clear,

5 [Gifts to Health Care Professionals from the Pharmaceutical Industry: A Report by the National Ethics

Committee of the Veterans Health Administration October 2003 USA] 6[India Pharma 2020, McKinsey and company]

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explicit expectations, gifts place people in binding personal relationships that generate

vague, open-ended moral obligations.

4.2 WHY ARE GIFTS ETHICALLY PROBLEMATIC?

The practice of accepting gifts from pharmaceutical industry representatives risks

compromising health care providers‘ professional objectivity and integrity, and

undermining their ethical commitment to putting the interests of patients first. Gifts

create relationships; health care professionals‘ acceptance of gifts from the

pharmaceutical industry can be ethically problematic in several ways.

Accepting gifts risks undermining trust. It may bias clinicians‘ judgments about the

relative merits of different medications. And it may affect prescribing patterns in

ways that increase costs and adversely affect access to care.

4.2.1 Undermining Patient & Public Trust

Health care professionals‘ fiduciary, or trust-based, relationship with patients requires

that practitioners explain the reasons for treatment decisions and disclose any

potential conflicts of interest, including the influence of gifts.

4.2.2 Effects on Professional Relationships

The ways in which gift are given from pharmaceutical representatives to health care

professionals may create a blurred relationship of mutual reciprocation. The process

of giving and receiving gifts affects the relationship between the two parties in

complex and subtle ways.

Anthropological literature explains that the recipient of a gift often feels three types of

obligation toward the giver: grateful conduct (i.e., acceptance of the gift and

expression of gratitude), grateful use (i.e., in accord with the giver‘s intention), and

reciprocation.

The felt obligation to reciprocate, to give or do something in exchange for the gift is

most troubling in the health care context. In the context of a gift to a health care

professional from a pharmaceutical industry representative, practitioners commonly

understand that the hoped for reciprocation involves the health care professional

writing more prescriptions for the drug(s) the representative is promoting.

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4.2.3 Prescription Patterns: Bias & Conflicts of Interest

One study, found that physicians who met with or accepted money from

representatives of pharmaceutical companies (e.g., for educational presentations) were

more likely to request that the companies‘ drugs be added to a hospital pharmacy than

were colleagues who did not interact with pharmaceutical companies. A review of

physicians‘ prescribing patterns found that usage of two drugs increased significantly

among physicians who attended ―all-expense-paid‖ symposia at resorts sponsored by

the manufacturer of the drugs compared to their practice before the symposia.

In one study, 86% of respondents to a nurse practitioner and physician assistant

survey regarding pharmaceutical industry promotions said ―it is appropriate to accept

gifts and that these gifts do not influence their prescription choices.‖

Pharmaceutical industry gifts to health care professionals create potential conflicts of

interest that can affect practitioners‘ judgment—without their knowledge and even

contrary to their intent—thereby placing professional objectivity at risk and possibly

compromising patient care.

4.2.4 Trap of CME (continuing medical education)

Pharma companies argue that they organize CME programs which helps healthcare

providers to up-to-date their Knowledge. But In fact gift incentives to participate in

continuing professional education programs are the wrong incentives for health care

professionals and trainees, who should be independently motivated to participate in

lifelong learning. And there are economic consequences when the costs of gifts are

passed along to patients, health care institutions, and third-party payers in the form of

higher prices for drugs. Escalating drug costs may ultimately result in limitations on

access to care.

4.2.5 Effects on Health Care Costs

Gifts from the pharmaceutical industry to health care professionals are not ―free.‖

while health care professionals are the beneficiaries of gifts; the cost of these

marketing tools is passed through to patients and increases the costs of pharmaceutical

products in two ways. First, expenditures for gifts are passed along to consumers in

the form of higher prices. Second, if gifts to professionals serve their purpose,

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28

practitioners will be influenced to prescribe heavily marketed drugs, which tend to

cost far more than less heavily marketed but often equally effective alternatives, such

as generic drugs.

4.3 MEDICAL INTERNS’ ATTITUDE TOWARDS GIFTS AND

PHARMA REPS

Trainees may be especially susceptible to conflicts of interest created by gifts. This

influence is also detectable among physicians in training and other prescribing

professionals. For example, more than half of psychiatric trainees responding to a

questionnaire about interactions with the pharmaceutical industry felt that receiving

gifts would not influence their prescribing practices.

According to a study 81% (of samples) of the medical students were of the opinion

that pharmaceutical companies should be allowed to interact with them at the college

level. About 95% believe that the information given by MRs is reliable and

confirmation of the claims is not required (75% students). Overall 68% students

believe that drug promotional offers never compromise the decision making of the

physicians. About 70% students think that physicians should be compensated with

gifts by medical representatives whenever their drugs are prescribed. The study

concludes that the medical students are generally not opposed to interact with MR at

some point of time or receive gifts from them.7

Another study reported that the more exposure trainees had to pharmaceutical

industry representatives, the higher they rated the general appropriateness of gift

acceptance. Yet other research reported that 90% of trainees surveyed acknowledged

that pharmaceutical industry representatives in fact were influencing their prescribing

practices.

4.4 CONFLICTING VIEWS OF PHYSICIANS

One study found that physicians at a single institution tended to hold fairly lenient

views on the ethical propriety of a wide range of gifts and activities sponsored by the

pharmaceutical industry. Many physicians did not seem troubled by gifts and

7 [Dr. Shahu Ingole et al. / International Journal of Pharma Sciences and Research (IJPSR) Vol.2 (2),

2011, 49-57]

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29

activities that are considered problematic by professional organizations. Nevertheless,

some physicians appeared to believe that even gifts of minimal monetary value might

pose ethical problems.8

4.5 AGGRESSIVE PROMOTION ACCELERATING IRRATIONAL

USE OF MEDICINE

Most doctors highly depend on MRs for updating their medical knowledge and their

prescription pattern is largely influenced by them. Unsuspecting doctors fail to

understand that the person coming to them has been hired by a drug company to

promote its sale and make profits. This is done by following three ways:

4.5.1 Prescription by brand name

In India there are 72 salts which come under drug price control order (DPCO). It

means that the selling price of these drugs is under control & decided by the NPPA

(National Pharmaceutical Pricing Authority). This also means that for all the

remaining drugs, the drug companies are free to decide the selling price (MRP).

A case of Amikacin

Amikacin Inj. 500 mg. is priced in range of Rs. 65-75 but costs retailers around

Rs. 7- Rs. 10. Let’s have a look on the following table:

If doctor has to treat a patient of blood cancer, he may advice the salt Imatinib by

various brand names. If he has prescribed brand Glivec a month‘s course will cost

Rs.1,14,400/- to the patient. Whereas, the same anti-cancer drug, but with a different

brand name Veenat costs just Rs.11,400/-. And Cipla supplies the generic equivalent

of this drug (@-imitib) at Rs. 8,000/- only, also Gelnmark supplies it for Rs. 5,720/-!

All these brands contain the same salt Imatinib, in the same quantity, conform to the

same quality standards and are equally effective.

See an example where the same company markets the same salt by different brand

names and use differential pricing policy

8 [Are Gifts From Pharmaceutical Companies Ethically Problematic? A Survey of Physicians, Allan S.

Brett, MD; Wayne Burr, MD; Jamaluddin Moloo, MD, MPH]

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30

Table2: Amikacin prices comparisons

Table3: Price comparison of Cetirizine Salt

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31

Cefixime is priced at Rs 65 by Mankind (brand name Mahacef) but at the other

hand it’s priced at Rs. 190 by Alkem (brand name Taxim).

Table4: Price comparison of Cefixime salt

Dose Brand

name

Company Salt Stockist

(1 strip of ten

tab)

(MRP)

200mg tab Mahacef Mankind(discovery) Cefixime Rs 45 Rs 65

200mg tab Zifi FDC Cefixime Rs 75 Rs 99.9

200mg tab Taxim O Alkem Cefixime Rs 165 Rs 190

200mg tab Biotax Biochem Cefixime Rs 75 Rs 99

BRAND MONOPOLY ELIMINATES PRICE COMPETITION

There are a number of reasons why the prices of drugs in India are so high. In many

developing countries, consumers buy the same drug marketed by several different

producers under different brand names, not realizing that they are all the same

product.

Paracetamol, for example, is the generic name, for a painkiller. It is available under

more than 20 brand names -Crocin, Calpol, Metacin, and Pyrin - all of which are

paracetamols. The consumer, however, is not aware of this. Drug companies and

doctors may swear that one particular drug is more effective than the other, although

this cannot be so as they all contain the same ingredient and conform to the same

quality control standards.

4.5.2 PROMOTION OF NON- ESSENTIAL DRUGS

There are a total of 354 drugs in the National List of Essential Medicines (NLEM),

which are adequate to take care of the majority of the health needs of the population.

But the sales of top 300 brands constitutes only 38% of brands are of the drugs

mentioned in the NLEM. The other 62% brands comprise drugs that are higher priced

alternatives without a clear therapeutic advantage and many are unnecessary,

irrational and even hazardous

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32

Top – Selling Drugs outside the NLEM include-

(i) Higher priced brand of either the same drug or a higher priced alternative to

a lower cost essential drug

Example: Cifran brand of ciprofloxacin is the largest selling antibiotic, whereas it is

the costliest among the ciprofloxacins. Other brands of ciprofloxacin (e.g. Zoxan)

although three times cheaper, sell five times lesser than Cifran.

(ii) Irrational combinations of drugs, which only add cost but are of no

therapeutic value, are touted as effective remedies and promoted aggressively.

In our country about 75 % of the children & 50 % of the women suffers from Anemia

and iron deficiency anemia is responsible for 1/3 of all maternal deaths. But the most

popular prescription is of fancy multivitamin formulations instead of iron and folic

acid preparations.

The sales figures reflect the fact that in India, drugs which are not considered essential

sell more than rational & essential drugs that costlier drugs most often sell more than

cheaper alternatives (even those made by well-known manufacturers). Brief analysis

of the top 300 brands suggests that the Indian doctors are prescribing drugs without

adequate concern for evidence of their efficacy, safety and cost. This is because of

poor access to unbiased information on drugs, aggressive and often misleading drug

promotion by the drug industry.

Table : Top brands In India

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33

Vitamins and Tonics

These are some of the most highly selling and highly priced products in India.

Vitamin and tonics are in many cases a mixture of Vitamin B-complex or vitamins in

solutions of sugar and alcohol. Among the top-selling 25 medicines in India are

Becosules, Neurobion and Dexorange; the first two are irrational and / or unnecessary

multivitamin preparations and the last is an irrational iron ―tonic‖. Vitamins

deficiency should be treated with specific vitamins in dry tablet form. Tonics are

hazardous when substances like caffeine, leptazol, are combined with vitamins

The table below shows that the sale of these rarely required tonics is in hundred crore

Rupees. It shows: According to the Pharmaceutical Industry, Most Common Public

Health Problem of India is Not Anemia, but B-Complex Deficiency!

Table : Top Brands and Their Business

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34

4.5.3 IRRATIONAL PRESCRIPTIONS

Ideally use of drugs should be only when there is an appropriate indication, but this is

not in the interest of the drug industry which is more interested in sales promotion.

Higher is the sales, higher is the profit. Therefore doctors under constant persuasion

of MRs sometimes follow what is being promoted by the brochures of drug

companies instead of prescribing what they have read in their standard medical text

books.

For example: A computer professional has low-backache because of long hours of

sitting at the desk in a faulty posture on a faulty chair. Should he receive long term

painkillers like indomethacin, valdecoxib, tramadol, etc. (all of which have well

known serious side effects) or advice on posture, exercise and a proper chair which

supports lower back?

A chronic smoker comes with cough off and on, especially in the morning. There is

no shortness of breath. The clinical examination is normal. Should he receive a cough

suppressant, an antibiotic or advice and support for stopping smoking?

4.6 PROMOTION OF HAZARDOUS AND BANNABLE DRUGS

Internationally, a whole group of "block-buster" drugs have been in serious trouble.

These include rofecoxib ("Vioxx"), valdecoxib ("Bextra"), celecoxib ("Celebrex"),

atoravastin ("Lipitor"), etc. as of writing there is enough evidence to doubt the safety

of a host of cyclooxygenase (COX) -2 inhibitors.

(i) Thalidomide (Tragedy): most women experience nausea during pregnancy which

is a physiological condition, but interestingly a drug was invented to cure it and

blindly propagated with the sole purpose of making money. It is another example

where a drug was pushed into the market without adequate evaluation of its safety.

Unfortunately above 8,000 mothers who unsuspectingly took the drug bore children

without arms and legs, the condition which is known among doctors as phocomelia

(seal like limbs).

(ii) Nimesulide was discovered by an American Company, 3M Pharmaceuticals, but

never got approval for use in the US, Canada, Britain, Australia, New Zealand and

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35

140 other countries around the world. It was banned in Spain and England in 2001 on

reports of its hepatotoxicity.

Despite of serious side effects and its indication for specific clinical conditions, there

is abundance of Nimesulide Formulations in our country. Pharmabiz.com reports that,

―...200 nimesulide formulations are marketed without the approval of Drug Controller

General of India. The nimesulide market is around Rs. 700 crores with profit

percentage over 1500%.‖

(iii) Depo Provera is an injectable contraceptive for use by women manufactured by

the American multinational, Upjohn. This drug is not allowed for use as contraceptive

in USA. Yet the drug is sold in the Third World for contraceptive use. The drug is

associated with breast and endometrial cancers and lowered resistance to infection.

The drug causes severe birth defects if a woman who is unaware of her pregnancy,

take the drug.

(iv) Dexorange: An outstanding example of a patently irrational drug is that of

Dexorange. This formulation is used for treatment of one of the most common and

serious health problems of people, anemia. It is one of the top selling preparations in

India with a Moving Annual total in retail sales of Rs. 57 crores. This particular

preparation still contains an iron salt, which is less efficiently absorbed, in a

concentration that is low, and is still marketed at a price that is extravagant. The cost

of treating iron deficiency anemia with this preparation can be up to Rs. 600 per

month, against the cost of a simple iron-folic acid preparation that should cost Rs. 9

per month.

4.7 DOCTORS AS KEY OPINION LEADERS

Key Opinion Leaders (KOLs) are influential specialists in their fields such as doctors

at teaching hospitals, senior consultants, authors etc.

1. Sun Pharmaceuticals sponsored over a dozen ―educational seminars‖ all over India

to advocate Letrozole‘s use in infertile young women. KOLs were paid up to Rs.

30,000 per lecture to endorse the new indication. It is illegal to promote any drug for

unapproved indications.

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36

2. Professional associations endorse products: Delhi branch of the Indian Medical

Association endorsed nimesulide and in its so-called survey for the purpose, the

sample of adults to children taken if extrapolated results in the number of children of

India being more than the population of India!

4.8 PROMOTION OF DISEASE INSTEAD OF' ‘HEALTH’

One of the important ways drug companies make money is by telling people they are

sick, even when they are passing through one of life‘s many normal transitions.

This ―Disease Mongering‖ suits the medical profession too, as it helps medicalising

problems.

1. In India, piractecam is being promoted for vague conditions like ―intellectual

decay‖, ―social maladjustment,‖ ―lack of alertness,‖ ―change of mood,‖ ―

deterioration in behavior‖ and ―learning disabilities in children associated with the

written word.‖ The recommended duration of treatment for the last indication is

―entire school year‖ in dose of ―3g per day‖ i.e. 7-8 capsules of 400mg daily. If the

drug is administered for the entire school year as recommended, it will mean parents

buying at least 2700 capsules at a cost of Rs. 12,775 year after year.

In Britain, piracetam (Nootropil) is permitted for use in just a single indication, a rare

disorder called cortical myoclonus, that too only as an adjunctive therapy. While in

India, the drug is being promoted for use in young children, in Britain its use is

contraindicated for adolescents under the age of 16 years.

2. Buclizine (brand Longifene in India) is being promoted as appetite stimulant while

the drug itself is not commercially available in the US and is restricted worldwide for

treatment of migraine in combination with analgesics. Internationally reported adverse

effects include: drowsiness, blurred vision, diarrhoea, and difficulty in passing urine,

dizziness, dryness, tachycardia, headache, nervousness, restlessness, hallucinations,

skin rash and upset stomach. Bottles of Longifene, the only brand of Buclizine being

sold in Indian do not contain either the package insert or the patient information

leaflet.

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37

3. Warner Lambert invented a condition called ―halitosis‖ which makes ordinary bad

smell in the breath sound serious. Sales of Listerine rose from US $ 100,000 to US $4

million in six years.

4. In the 1980s Glaxo needed to expand their market for ranitidine (brand Zantac).

They again created a condition called ―gastro-esophageal‖ reflux disease (GERD)‖

which is a serious sounding name for heartburn, an age-old complaint. Annual sales

of Zantac peaked at US $2 billion.

5. Manufactures of fluoxetine as a marketing strategy eulogized premenstrual

syndrome which is a routine physiological hormonal transition.

4.9 DIRECT TO CONSUMER ADVERTISING (DTCA)

Some products which should be taken under medical guidance are marketed through

advertisements using electronic & print media. Tall claims are made about the results

they will bring about but they are silent on the side effects which will occur. Thus

medicines are promoted like any other consumer item just to increase the sales.

For example: Oral emergency contraceptive pill: Unwanted 72 and i-Pill

Cough Syrups

Cough Syrups and expectorants are mixtures of drugs which stimulate coughing

(ammonium chloride, ipecac) as well as those which suppress coughing (codeine,

noscapine) and antihistamines that dry the secretions (some common brand names are

Benadryl Expectorant, Piriton Expectorant, and Avil Expectorant). Prolonged use of

cough syrup is habit-forming, it may cause stomach upsets, reduce food intake and

cause drowsiness. Coughing is a protective activity of the body. It should not be

Figure Pack of ‘Unwanted’, an Emergency

contraceptive Figure : i-pill, an

emergency contraceptive

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38

suppressed except in certain conditions. Simple steam inhalation is advised. If it is

necessary to use drugs, use only a single ingredient

Cough suppressants such as codeine, dextromethorphan. There is no scientific basis

for using cough suppressants and cough stimulants together. The WHO List of

Essential Drugs does not include cough syrups and lozenges. Bangladesh has banned

them on the grounds they are "of little or no therapeutic value and amounts to great

wastage of meager resources"

4.10 IMPLICATIONS OF UNETHICAL PROMOTION AND

IRRATIONAL USE OF DRUGS

1. MEDICINES BECOME UNAFFORDABLE

2. INAPPROPRIATE MEDICATION

3. CIRCULATION OF BANNED DRUGS

4. EXTRA BURDEN ON GOVT

5. DRAIN ON FOREIGN EXCHANGE

6. RISK OF ADVERSE EFFECTS

7. RISK OF TRANSMISSION OF DISEASES THROUGH UNSAFE INJECTIONS:

8. RISK OF ANTIMICROBIAL RESISTANCE

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5

Research Methodology

5.1 TITLE

The title of the study is ―Ethical issues in Pharmaceutical Marketing‖. This study is

conducted on Doctors, Pharma professionals and patients.

5.2 RESEARCH METHODOLOGY

Research methodology is the systematic way to solve the research problem. It gives

an idea about various steps adopted by the researcher in a systematic manner with an

objective to determine various manners.

5.3 RESEARCH DESIGN

A research design is considered as the framework or plan for a study that guides as

well as helps the data collection and analysis of data. The research design may be

exploratory, descriptive and experimental for the present study.

Descriptive research design has been adopted for this project.

5.4 RESEARCH APPROACH

The research worker contacted the respondents personally with well-prepared

sequentially arranged questions. The questionnaire is prepared on the basis of

objectives of the study. Direct contact is used for survey.

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40

5.5 SAMPLE SIZE AND METHOD OF SELECTING SAMPLE

The study sample constitutes 80 respondents among which 40 are doctors and

remaining 40 are patients.

5.6 SAMPLING DESIGN

Convenience sampling (non- probability) method was employed for the study.

5.6 COLLECTION OF DATA

Most of the data collected is primary data through personal interview, where there

was a face to face interaction with the respondents.

5.6 RESEARCH INSTRUMENT

A structured questionnaire, based on five point likert scale, is used as a research

instrument tool.

The questionnaire is consist of 10 questions out of which first 7 questions are

common for both Patients and Doctors and remaining 3 questions are only for

Doctors. Question no. 1 is based on ranking scale. Question no. 2 consists of 4

subparts. Question no. 4 consists of 5 subparts. Rest of the questions has only one

part.

Two structured formal interviews were conducted. Doctor‘s interview consists of 10

questions with sub parts in some question similarly Medical representative‘s interview

consist of six questions with subparts in some questions.

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41

5.8 STATISTICAL TOOLS

SPSS and excel software are used to analyze the data.

5.9 ANALYSIS OF DATA

The findings are tabulated and interpreted in order to make interpretations.

Research type- Descriptive

Data collected – Primary data

Instrument – Structured, non-disguised questionnaire

Analytical tool- SPSS software

Sample size –80

For all questions except 1, 8 and 9 test of hypotheses are conducted to check the

difference of opinion among the two groups.

For question no. 2 and 4 combined (overall view) tests are conducted and data is

assumed to be interval for 2 (combined) and 4 (combined). For rest of the question

data is considered as ordinal in nature.

Question no. 8 and 9 are only for Doctors.

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6

Data analysis

1. How important are following criterion for doctors while prescribing the medicine?

a) Company image

a) Percentage margin

b) Personal Relation with M.R.‘s

c) Self-evaluation of medicinal brand

Table : Sum of Responses, Q.no. 1

Company

image

Percentage

margin

Personal

Relation

Self-evaluation of

medicinal brand

Patients 80 81 126 103

Doctors 91 124 102 97

Total 171 305 228 200

Table : Ranking of preference, Q.no.1

Rank Patients Doctors Combined

1 Company image Company image

Company image

2 Self-evaluation of

medicinal brand

Self-evaluation of

medicinal brand

Self-evaluation of

medicinal brand

3 Percentage margin Personal Relation

Personal Relation

4 Personal Relation

With M.R.‘s

Percentage margin

Percentage margin

Rank them from 1-4

1=Most important

4=least important

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43

Here lower sum means the higher preference. For first two variables both doctors‘ and

patients‘ opinion is same i.e. company image and self-evaluation of medicinal brand

are top two criteria among four.

But for last two variables there is a difference of opinion, patients think that doctors

prefer percentage margin over personal relation with Medical Representative while

doctors‘ opinion is just opposite.

Q2 How appropriate is following gifts for physician to accept?

Stationary (Pen/pad etc.) / Samples/ Medical exhibition/ Conference fare/ Recreation tour9

Hypotheses for Question no.2

a) H0= There is no significant difference between the opinion of doctors and

patients for appropriateness of accepting ‗stationary‘ as a gift.

H1= There is a significant difference between the opinion of doctors and

patients for appropriateness of accepting ‗stationary‘ as a gift.

b) H0= There is no significant difference between the opinion of doctors and

patients for appropriateness of accepting ‗Samples‘ as a gift.


patients for appropriateness of accepting ‗Samples‘ as a gift.

c) H0= There is no significant difference between the opinion of doctors and

patients for appropriateness of organizing Medical Exhibition by Pharma

companies.

d) H1= There is a significant difference between the opinion of doctors and

patients for appropriateness of organizing Medical Exhibition by Pharma

companies.

9 Please refer to Questionnaire

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44

e) H0= There is no significant difference between the opinion of doctors and

patients for appropriateness of accepting ‗Conference fare‘ as a gift.


patients for appropriateness of accepting ‗Conference fare‘ as a gift.

Table : Mean Rank Table, Q.no. 2

Respondent

Category

N Mean

Rank

Sum of

Ranks

2(a)Stationary

Patient 40 35.95 1438.00

Doctor 40 45.05 1802.00

Total 80

2(b)Samples Patient 40 44.48 1779.00

Doctor 40 36.53 1461.00

Total 80

2(c) Medical

exhibition

40 31.20 1248.00

Doctor 40 49.80 1992.00

Total 80

2(d)Conference fare

Patient 40 29.69 1187.50

Doctor 40 51.31 2052.50

Total 80

2(e) Recreation tour

Patient 40 33.20 1328.00

Doctor 40 47.80 1912.00

Total 80

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Table : Test Statistics, Q.no.2

Stationary

Samples

Medical

exhibition

conference

fare

recreation

tour

Mann-Whitney U 618.000 641.000 428.000 367.500 508.000

Wilcoxon W 1438.000 1461.000 1248.000 1187.500 1328.000

Z -1.814 -1.617 -3.667 -4.305 -3.146

Asymp. Sig.

(2-tailed)

.070 .106 .000 .000 .002

In above cases Mann-Whitney U test is performed

In first two variables that are for Stationary and Samples significant difference is

more than .05(p> .05) hence null hypotheses cannot be rejected.

For next three variables (Medical exhibition, conference and recreation tour) null

hypothesis is rejected (p<.05)

This means that doctors and patients do not differ much on their opinion for

appropriateness for stationary and Samples while for other variables

Test of Hypothesis for overall view of Question no.2

H0= There is significant difference between the overall opinion of doctors and

patients for appropriateness of accepting a gift.

H1= There is no significant difference between the overall opinion of doctors

and patients for appropriateness of accepting gift.

For over all view of all gifts we assume data to be interval data. First normality test is

done.

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46

Table : One-Sample Kolmogorov-Smirnov Test, Q.no.2

Aggregate

1-5

N 80

Normal

Parameters(a,b)

Mean 15.81

Std. Deviation 3.019

Most Extreme

Differences

Absolute .128

Positive .081

Negative -.128

Kolmogorov-Smirnov Z 1.144

Asymp. Sig. (2-tailed) .146

.

The data distribution is found to be normal so t-test can be performed.

Table : Group Statistics, Q.no.2

Respondent Category N Mean Std. Deviation Std. Error Mean

Patient 40 14.38 2.880 .455

Doctor 40 17.25 2.436 .385

Table : T- test, Q.no.2

Levene's Test

for Equality of

Variances

Independent Samples Test

F Sig. t df Sig. (2-

tailed)

Mean

Difference

Std. Error

Difference

Equal variances

assumed

.867 .355 78 .000 -2.88 .596

Equal variances

not assumed

4.821 75.919 .000 -2.88 .596

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47

If sig>.05 then equal variance assumed row will be considered

Here sig. <.05, so we may interpret that there is a significant difference between the

opinion of two groups.

Question3: Giving receiving gift is close to bribery

Hypotheses for question 3

H0= There is no significant difference between overall opinion of doctors and patients

for considering gifts close to bribery.

H1= There is a significant difference between overall opinion of doctors and patients

for patients for considering gifts close to bribery.

Table : Mean Ranks, Q.no.3

Respondent

Category

N Mean

Rank

Sum of

Ranks

Patient 40 49.99 1999.50

Doctor 40 31.01 1240.50

Total 80

Table : Test Statistics, Q.no. 3

Mann-Whitney U 420.500

Wilcoxon W 1240.500

Z -3.750


In this case sig. <.05 (null hypothesis is rejected)

We can infer that opinion of doctors and patients differ on this issue. Patients think

that accepting gifts from Pharma companies is not appropriate and is quite close to

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48

bribery while doctors have mild attitude towards accepting gifts and don‘t consider

accepting gifts as close to bribery

Q.4: Who is/ are responsible for promoting unethical pharmaceutical

marketing?

Pharmaceutical companies/ Medical Representatives/ Chemists/Doctors10

Hypotheses for Question no.4

a) H0= There is no significant difference between the opinion of doctors and

patients for considering Pharmaceutical companies responsible for

promoting unethical marketing


patients for considering Pharmaceutical companies responsible for

promoting unethical marketing

b) H0= There is no significant difference between the opinion of doctors and

patients for considering Medical Representatives responsible for promoting

unethical marketing


patients for considering Medical Representatives responsible for promoting

unethical marketing

c) H0= There is no significant difference between the opinion of doctors and

patients for considering Chemists responsible for promoting unethical

marketing


patients for considering Chemists responsible for promoting unethical

marketing

10

Please refer to questionnaire

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49

d) H0= There is no significant difference between the opinion of doctors and

patients for considering Doctors responsible for promoting unethical

marketing


patients for considering Doctors responsible for promoting unethical

marketing

Table : Ranks Table, Q.no. 4

N Mean Rank Sum of Ranks

4(a)Pharmaceutical

companies

Doctor 40 41.83 1673.00

Total 40 39.17 1567.00

Patient 80

4(b)Medical

Representative

Doctor 40 42.61 1704.50

Total 40 38.39 1535.50

Patient 80

4(c) Chemists

Doctor 40 48.05 1922.00

Total 40 32.95 1318.00

Patient 80

4(d)Doctors

40 47.75 1910.00

Total 40 33.25 1330.00

Total 80

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50

Table : Test Statistics, Q.no. 4

Test Statistics, Q.no. 4

Pharmaceutical

companies

Medical

Representative

Chemists Doctors

Mann-Whitney U 747.000 715.500 498.000 510.000

Wilcoxon W 1567.000 1535.500 1318.000 1330.000

Z -.550 -.842 -3.084 -2.887

Asymp. Sig. (2 tailed) .582 .400 .002 .004

H0 is accepted for first two variables i.e.‘ pharmaceutical companies‘ and‘

Medical representative‘. It means that there is no significant difference

opinion both doctors and patients consider them equally responsible or in

promoting unethical promotion of pharmaceutical products.

H1 is accepted in case of last two variables i.e. ‗Chemists‘ and ‗Doctors‘.

There is a significant difference in opinion of Doctors and Patients.

Table : Frequency Tables (Q. No. 4) Patients’ View

4 In your opinion who is/are responsible in promoting unethical

marketing?

Pharmaceutical

companies

Medical

Representative

Chemists

Doctors

Count % Count % Count % Count %

ED 1 2.5% 2 5.0%

MD 5 12.5% 8 20.0% 4 10.0% 6 15.0%

ND 6 15.0% 10 25.0% 4 10.0% 11 27.5%

MA 7 17.5% 10 25.0% 8 20.0% 14 35.0%

EA 22 55.0% 11 27.5% 24 60.0% 7 17.5%

Total 40 100.0

%

40 100.0

%

40 100.0

%

40 100.0%

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51

Table : Frequency Tables (Q. No. 4) Doctors’ view

Doctors‘

View

Pharmaceutical

companies

Medical

Representative

chemists Doctors

Count % Coun

t

% Count % Count %

ED 1 2.5% 4 10.0% 8 20.0%

MD 5 12.5% 7 17.5% 10 25.0% 14 35.00

ND 3 7.5% 13 32.5% 7 17.5% 13 32.5%

MA 15 37.5% 15 37.5% 6 15.0% 5 12.5%

EA 17 42.5% 4 10.0% 13 32.5% 0 0

40 100.0

%

40 100.0

%

40 100.0% 40 100.0%

Analysis from Frequency Tables

i) From frequency tables we can see that 72% patients believe that

Pharmaceutical companies are responsible in unethical marketing, While

80% doctors also have same opinion.

ii) 52 % of patients think that medical representatives indulge in unethical

marketing practices. On the other hand only 47.5% of doctors have the

same opinion.

iii) 80% of Patients believe that Chemists are engaged in unethical

marketing/selling of drugs. Contrast to this only 47 % of Doctors have

similar opinion.

iv) 62 % patients believe that doctors are also engaged in unethical practices.

Doctors obviously are not agreeing to this allegation.

`

52

Q.4: Who is responsible for unethical Marketing of

pharmaceutical drugs in India?

`

53

For over all view of Question no.4 data is assumed to be interval and test for

normality is conducted

Table : One-Sample Kolmogorov-Smirnov Test, Q.no.4

4) Who is responsible for unethical

Pharma marketing?

Overall view

N 80

Normal Parameters(a,b) Mean 14.41

Std. Deviation 2.073

Most Extreme

Differences

Absolute .128

Positive .104

Negative -.128

Kolmogorov-Smirnov Z 1.146


Distribution is found to be normal so we can conduct t- test on this data.

Table : Group Statistics (T-Test), Q.no.4

Respondent

Category

N Mean Std.

Deviation

Std.

Error

Mean

Patient 40 15.45 1.616 .256

Doctor 40 13.38 1.970 .312

`

54

Table : Independent Samples Test, Q.no.4

4) Who is

responsible for

unethical Pharma

marketing?

Levene's Test

for Equality of

Variances

t-test for Equality of Means

F Sig. T df Sig. (2

tailed)

Mean

Difference

Std. Error

Difference

Equal variances

assumed

.717 .400 5.150 78 .000 2.07 .403

Equal variances

not assumed

5.150 75.133 .000 2.07 .403

For Levene‘s sig.>.05, so Equal variances assumed row will be considered. In this

row Sig. (2-tailed) <.05 which means that there is a significant difference of opinion

between Doctors and Patients

Q.5: It is Ok for professional bodies (MCI, DCI etc.) to endorse private

brands

Test of Hypotheses

H0= There is no significant difference between the opinion of doctors and

patients for above statement.



`

55

Mann-Whitney Test

Table : Ranks Table Q.no.5

Respondent Category N Mean

Rank

Sum of

Ranks

Patient 40 48.90 1956.00

Doctor 40 32.10 1284.00

Total 80

Table : Test Statistics Q.no.5


Wilcoxon W 1284.000

Z -3.332


H0 is rejected as there is a significant difference between the opinions of

Patients and Doctors.

Frequency Chart2: Q.no.5

ED MD ND MA EA

Patient 7.50% 20% 27.50% 32.50% 12.50%

Doctor 22.50% 35% 27.50% 15% 0

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

40.00%

It is Ok for professional bodies (MCI, DCI etc.) to

endorse private brands

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56

6: Doctors should write only generic name/ chemical name while prescribing

medicine.





Mann-Whitney Test

Table : Rank Table Q.no. 6

Respondent

Category

N Mean

Rank

Sum of

Ranks

Patient 40 40.59 1623.50

Doctor 40 40.41 1616.50

Total 80



Wilcoxon W 1616.500

Z -.035


Here sig>.972, H0 cannot be rejected.so we can say there is no significant

difference between the opinion of doctors and patients.

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57

Frequency Chart3: Q.no. .6

7: Do you agree that pharmaceutical companies inspire Doctors for unethical

promotion of their products?




patients for above statement

Mann-Whitney Test

Table : Mean Rank table Q.no.7

Respondent

Category

N Mean

Rank

Sum of

Ranks

Patient 40 43.35 1734.00

ED MD ND MA EA

Patient % 12.50% 27.50% 10.00% 20.00% 30.00%

Doctor % 15.00% 27.50% 15.00% 5.00% 37.50%

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

40.00%

Doctors should write only generic name/ chemical

name while prescribing medicine.

`

58

Doctor 40 37.65 1506.00

Total 80



Wilcoxon W 1506.000

Z -1.143


Here sig.>.05, H0 cannot be rejected.

So we may conclude that there is no significant difference in opinion of

doctors and Patients. We may assume that both patients and Doctors Believe

that Pharma companies try to influence doctors towards unethical marketing of

their products.

Frequency Chart4: Question no.7

ED MD ND MA EA

Patient 0.00% 5.00% 22.50% 37.50% 35.00%

Doctor 12.50% 22.50% 7.50% 17.50% 40.00%

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

40.00%

45.00%

Do you agree that pharmaceutical companies inspire Doctors for unethical promotion of their products?

`

59

Question Number 8 and 9 (questions only for Doctors)

Table : Statistic, Q.no. 8 and 9

8 Frequent samples help

you to determine quality

of medicine for

prescription.

9 Medical representatives

satisfy your queries about

new promotional drug.

N Valid 40 40

Missing 0 0

Mean 3.98 3.23

Median 4.00 4.00

Mode 4 4

Std. Deviation 1.000 1.250

Variance .999 1.563

Sum 159 129

Interpretation (Question No. 8)

1. 80% of Doctors maintains that frequent samples help in determining the Quality

of medicine for prescription.

2. Only 7.5 % of Doctors have opposite view.

3. 12.5 % choose not to be either agreeing or disagree.

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60

Frequency charts 5: Q.no 8

Frequency charts 6: Q.no 9

Interpretation (Question No. 9)

1. 55% are agreeing with above statement.

2. Only 27.5% are not agreeing.

3. 17.5 % could not give their opinion.

0.00% 10.00% 20.00% 30.00% 40.00% 50.00%

ED

MD

ND

MA

EA

ED MD ND MA EA

Q.9 15.00% 12.50% 17.50% 45.00% 10.00%

9) Medical representatives satisfy your queries about new promotional drug.

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61

Q.10: Mostly, doctors provide samples to their patients free of cost.

Frequency chart 7: Q.no. 10

Table : Frequency, Q.no. 10

Interpretation from frequency table (Question No. 10)

1. 92.5% of Doctors says that they provide samples free of cost to patients while

only 40 % of patients are agree with this.

2. 40% of Patients have not received any sample from any doctor or it may be just

their opinion.

Patients Doctors

Count % Count %

SD 4 10.0% 0 .0%

MD 12 30.0% 1 2.5%

ND 8 20.0% 2 5.0%

Ma 12 30.0% 24 60.0%

EA 4 10.0% 13 32.5%

10.00%

30.00%

20.00%

30.00%

10.00%

0.00% 2.50%

5.00%

60.00%

32.50%

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

SD MD ND Ma EA

Patients % Doctors %

`

62

This question was meant for both doctors and Patients so we will check the difference

of opinion between Doctor and Patients.

Test of Hypotheses Q.no.10

H0: There is no significant difference between the two groups about above statement

H1: There is a significant difference between the two groups about above statement.

Mann-Whitney Test

Table : Ranks Table Q. no.10

Respondent

Category

N Mean

Rank

Sum of

Ranks

Patients 40 28.90 1156.00

Doctors 40 52.10 2084.00

Total 80

Table : Test Statistics Q.no.10

Samples


Wilcoxon W 1156.000

Z -4.725


We have sig. <.05, H0 cannot be rejected

That is there is a significant difference between opinion of Doctors and Patients

`

63

Pharma Representative Interview

1. Tell me about your background, qualifications etc.

Representative: I am a B.Sc. (ZBC) graduate from B.R. Ambedkar University,

Agra. I am engaged in this sector for past 7 years.

2. What training have you received to be a pharmaceutical representative?

Representative: Our Company provides us training from time to time. Every

person who is selected as a Pharma representative is required to complete a

training program of around six to eight weeks. This program conducts classes

for Anatomy, Physiology, and Pharmacology. It also includes sessions on

Product knowledge and soft skills. There are also short trainings for new

product or any new research relating to efficacy of our product.

3. What methods do you use to contact customers?

Representative: Doctors and Retailers are our main customer .This is done

through two processes:

1. Retail Counter Prescription Audit (RCPA)

2. Detailing: Visiting to doctors

4. In what way your job as a representative you think is essential to the

pharmaceutical industry

Representative: We provide doctors the detail of our products. Doctors are

dependent on Pharma representative for knowledge of new product with

improved versions.

5. Do you think other methods of marketing are useful to the industry or they are

a threat to the representative‘s job?

Representative: Such methods may be useful for short term gain but may taint

the company‘s image. Our job is a very specialized and complex job other

`

64

method may be very attractive to our management but such methods are not a

replacement to a Pharma representative‘s job.

But I will confess that there are challenges. Companies are hiring people with

at low skill level. They may or may not have a proper background to work

effectively as a Pharma representative but are ready to work for lower salaries.

This may be a threat to the dignity of our profession.

6. Do you offer bonuses to your customers? Do you think they make a difference

to your sales?

Representative: few things we offer you may consider as bonus.

1. Continuing Medical Education (CME): average money spent on these is

around 30-35 thousand per event consisting of 20-25 doctors.

2. International seminars: Average money spent is around 60-70 thousand per

doctor.

In fact these activities should not be included as bonuses but the basic purpose

of attaining knowledge is not served. These activities are considered as just

some opportunities for recreation.

7. How we can tackle with such unethical challenges?

Representative: There is a lot of pressure on sales force to achieve the targets.

Management often assigns unreasonable targets to the representatives.

Preference is given to those representatives who have achieved or over

achieved their targets not on how they have done it. This encourages other to

follow suit.

Secondly our patients are not aware they purchase prescription drugs from

retail outlets. They have to purchase whatever doctor has prescribed them.

Knowledge may empower them to negotiate.

Other challenges are to be looked at government level like prices regulation

etc.

`

65

Doctor’s Interview

1. What did you study? What‘s your specialization?

Doctor: I have done B.D.S. from SZ Dental College AMU Aligarh

2. (a) When you are working, how often on average do you see a pharmaceutical

representative?

Doctor: On a given day I could see only 2-4 Pharmaceutical Representatives.

Often all representatives who visit clinic in a particular day may not get their

turn on same day.

On average Pharmaceutical representative visit 1-2 times a month. It depends

on different company‘s policies.

(b) How long would you see them for?

Doctor: Around five to fifteen minutes per representative. Area sales Manager

of Some big companies also visit ones in a month.

3. On a general visit from a representative, do you get the impression that the

information that is given is balanced?

Doctor: No, information is biased towards their product.

I cross question about products information. Ask Medical representative about

efficacy of drug, and also about Clinical trials, literature review etc. I also

compare prices of other competitive brands.

4. Have you had any guidance in relation to pharmaceutical marketing methods?

Doctor: We have Medical Ethics‘ guidelines. These are voluntary guidelines. One

can opt to study medical ethics‘ course in ones MBBS/BDS, but it is not

compulsory. All doctors swear for ―Hippocratic Oath‖ before starting their

practices.

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66

5. Do you go through the marketing material? What would be the main challenge for

you in reading all the marketing materials?

Doctor: Firstly I don‘t have much spare time to go through all the material

provided by Representatives. Secondly most of the materials are just fancy

pictures with attractive colors only little relevant information.

6. Do you think there has been any difference in marketing methods over the years

from pharmaceutical companies? Do you feel there‘s an increase in marketing

methods or it is just different?

Doctor: There are changes. Intensity of effort of Pharma companies has been

increased manifold. Secondly they are using different media for marketing. Earlier

more concentration was towards detailing.

7. How important to you is the information from pharmaceutical companies to your

practice?

Doctor: Medical representatives are good source of information for new

Formulations.

Pharma companies provide continuing education which helps in learning new

trends in medical practice.

8. (a) Have you had any patients/customers come to you because they saw a drug

advertised on the internet/television/newspaper?

Doctor: NO

(b) Do you think there should be more regulation about advertising drugs on the

internet/television/newspaper?

Doctor: I would like to change my answer to above question.

Yes there are many patients who have asked for ‗Sensodyne‘ toothpaste or

‗Coalgate sensitive‘ or other similar product. Such products claim instant relief

which is totally false.

`

67

Medicines are not magic. Effect of medicines start after using them for some time,

such advertisement may tempt patients to buy Medicines without proper

prescription and ultimately this may adversely affect them.

About regulation, there must be certain laws to curb such tactics of Pharma

companies which motivate patients for their self -treatment with these medicines

9. (a) Do you receive gifts?

Doctor: I never demand for gift. You can see my clinic. Some representative

leaves their letter pad or some stationary etc. but I could not use them all

Oh, yes I accept samples to check their quality. (While asking about samples)

(b) In general, would gifts influence or change the prescribing habits of doctors?

Doctor: May be, if gifts are expensive it may influence the prescribing towards

gift giving company‘s products

10. How do you think we can tackle with unethical practices in pharmaceutical

marketing?

Doctor: First there must be willingness for both Pharma companies and Medical

practitioners for promoting high ethical standard.

Second government should regulate prices of drugs so that there is no much

disparity in prices of drugs containing same formulations.

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68

7

Concluding discussions

As ethics for Pharma industry in India are questioned, it always boasts of Standards of Goods

and Manufacturing Practices (GMP) as their good behaviour. Though Food and Drug

Administrations (FDA),at state level, and Drug Controller General of India , at central level,

have laid down minimum GMP requirement to qualify for manufacturing license, the

standards prescribed in India are not as strict as that of recommended by World Health

Organization (WHO). Even then, the controlling authorities do not have adequate workforce

to monitor the practices followed by the licensed manufacturers and see that they conform to

GMP norms. Taking advantage of the situation manufacturers, both small and big, frequently

flout norms.

Pharmaceutical companies have a duty to uphold an ethical relationship within the

marketplace. There is a duty of care to the health and safety of all. Issues are raised that as

pharmaceutical companies have a large investment to protect and stakeholders to please, how

we ensure that an ethical standard is upheld.

Unethical marketing practices has become an essential part of the pharmaceutical industry in

India and it roots is so strong that it may not be possible to reverse the same.

The phenomenon of the unethical drug practices is common worldwide but its severity is

more deep rooted in developing countries. Unethical drug practices have two dimensions.

One is drug related, and other is drug promotion related. Extensive research on drug related

unethical practices has been carried out internationally. Pharma companies spent substantial

portion of its budget on market research but do not carry out the research on unethical drug

promotion practices. One of the reasons is that the industry itself is indulged in this practice

therefore it does not find any need to carry out the research on this issue.

Lack of research on the subject does not mean that unethical drug promotion practices do not

exist. The survey and interview discussions indicate that unethical pharmaceutical marketing

practices have become an acceptable norm of the pharmaceutical industry, and almost all the

pharmaceutical companies patronized these unethical practices in collaboration with doctors,

government and private hospitals, health related agencies and pharmacies at the cost of

patients‘ well-being. All the entities as discussed above appears to be corrupted, therefore, it

may not be fair to blame any one of them, including pharmaceutical industry.

`

69

Doctors and other entities as discussed have become greedy, therefore, are vulnerable to

Pharmaceutical industry unethical drug promotion practices. Most of the conferences and

academic activities of doctors are sponsored by the Pharmaceutical Industry; therefore, the

industry uses the forum to pursue its goals which at times may not be the same as the purpose

and objective of the conferences.

Unethical practices could be classified into two segments. One is related to the medical side

of the drug i.e. the trial of the drug both on animals and the human, and registration of

indications and patent period in different countries.

The contracting process for the purchase of drugs offers a lucrative source of returns for

corrupt officials and suppliers through kickbacks and over-invoicing. There are evidences for

the same in India from several public hospitals; however this needs to be assessed carefully

and its magnitude quantified. In a nutshell therefore, healthcare provision depends on a

system which efficiently combines financial and human resources and supplies to deliver

services; good governance and transparency are critical factors in making such a system

function. However on the other hand, both poor governance and corruption in the health

system are manifestations of a broader systems phenomenon in a country. Addressing these

issues requires mandates and prerogatives both within but also outside of the health sector,

which is why ideally, an anticorruption drive in health must ride a much larger wave.

`

70

8

Recommendations and Limitations

Recommendations

The discussions and survey findings suggest that strong legislation must be

developed, implemented and enforced by the government. However, the regulations

and legislation actually works when they are supported by the norms and values of the

society. In this particular case, these unethical practices are considered as the norms

of the pharmaceutical industry and the doctor‘s community; therefore, it could only be

addressed by educating both the segments for realizing their social responsibilities

with the focus on the patients‘ well-being.

Furthermore, there must be strong check and monitoring by the Ministry of Health

and other monitoring agencies both on pharmaceutical industry and the doctors. It is

also strongly recommended that there should be strong legislation by the healthcare

authorities and government agencies to stop or at least minimize these unethical

pharmaceutical marketing practices both by the doctor community and the

pharmaceutical industry. There must be strong enforcement of existing rules and

regulations by the relevant government departments and autonomous bodies who

responsible to implement and ensure these rules and regulations both on

pharmaceutical industry and the doctors‘ community.

We also recommend to the doctors‘ community that this is also their prime and ethical

responsibility to avoid getting unethical benefits from pharmaceutical companies

while they are prescribing their products.

The pharmaceutical industry should also restrict itself up to ethical marketing offers

and discourage healthcare professionals if they would ask any thing which is unethical

according to the ethical pharmaceutical practices guidelines.

Pharmaceutical companies must adopt the concepts of Corporate Social

Responsibility and Sustainable Development. Pharmaceutical organizations must not

only see how much profit is made but also how profit is made and must engaged in

Fair Trade practices with taking in view of People, Planet and Profit. It is required

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71

from the pharmaceutical companies to be engaged in the businesses only in which

they can be responsible ethically, economically and legally at the same platform.

The actions of the Pharmaceutical companies should be based on Value Based

Management System and the actions of the managers should be guided by the Ethical

Behaviour equations. The guiding frameworks of thinking according to Culture,

Context, Content and Time may help managers and decision makers to decide

ethically.

The Sales Representative should be able to provide accurate information, without

exaggeration of the capabilities, and be able to inform of the property compound or

the mode of action of the drug and possible side effects. The International Federation

of Pharmaceutical Manufacturers‘ Association code of pharmaceutical marketing

practice states that the detailers (medical representatives) must be adequately trained

and possess sufficient medical and technical knowledge to present information on

their company products in an accurate and responsible manner.

Limitations

Since the under taken study was a case study of Aligarh region only, therefore, it

could not be concluded that the result of the study if which would be conducted on

country-wide would be the same as, therefore, further research can be conducted on

Pan-India basis for more representative sample.

Some inherent limitations are present for example: Sample size is small. Sampling

method is of non-probability type. Most of the respondents were reluctant in giving

information. Data collection from doctors was a difficult task.

Some other improvement for example: segregate the specialties and then conducting

the study in order to analyze whether the results of different specialties are same or

different. Since in this study only promotional or the marketing aspect of

pharmaceutical industry is been covered, other areas of pharmaceutical industry like

medical, production and procurement could also be covered.

`

72

9

Bibliography

Abhijeet Kelkar, Eric S. Langer, Pharmaceutical distribution in India, Bio pharm

International.com

Allan S. Brett, MD; Wayne Burr, MD; Jamaluddin Moloo, MD, MPH, Are Gifts

From Pharmaceutical Companies Ethically Problematic? Arch Intern Med. 2003;

163:2213-2218

Deborah E. Simpson, PhD; Jesse L. Goodman, MD; Eugene C. Rich, MD, ‗Attitudes

of Internal Medicine Faculty and Residents toward Professional Interaction with

Pharmaceutical Sales Representatives‘

Jeffery et al, Pharmaceutical distribution systems in India, The Centre for

International Public Health Policy, University of Edinburg

India Pharma Inc.: Capitalising on India‘s Growth Potential, Price Water Cooper

house (PWC)

M. Ahmad, N. Akhtar1, M.H.A. Awan, G. Murtaza, Ethical Evaluation of

Pharmaceutical Marketing in Pakistan, Acta Bioethica 2011; 17 (2): 215-224

Salma Yehia El Guindy, Ehab Abou AishEl Guindy, Responsible marketing Practices:

The Case of Egypt, New Cairo City – Egypt.

Saurabh Kumar Saxena, ‗A Review of Marketing Strategies Work by Different

Pharmaceutical Companies‘.

Wazana A, Physicians and the pharmaceutical industry: Is a gift ever just a gift?

JAMA 2000; 283:373–80.

`

73

10

Appendices

Questionnaire for Doctors

1. How important are following criterion for doctors while prescribing the medicine.

Rank them from 1-4

1=Most important

4=least important

2. How appropriate are the following gifts for physicians to accept?

Highly appropriate Highly Inappropriate

5 4 3 2 1

Stationary

(Pen/pad etc.)

Samples

Medical exhibition

Conference fare

Recreation tour

Criteria Rank

Company image

Percentage margin

Personal Relation

Self-evaluation of medicinal brand

`

74

3. Giving/receiving gift is close to bribery

Extremely

agree

Moderately

agree

Neither

agree

nor

disagree

Moderately-

disagree

Extremely

disagree

4. In your opinion who is/are responsible in promoting unethical marketing?

Highly responsible------------------------------------------------------ not at all responsible

5 4 3 2 1

Pharmaceutical

companies

Medical Representative

Chemists

Doctors

5. It is Ok for professional bodies (MCI, DCI etc.) to endorse private brands

Extremely

agree

Moderately

agree

Neither

agree

nor

disagree

Moderately-

disagree

Extremely

disagree

`

75

6. Doctors should write only generic name/ chemical name while prescribing

medicine.

Extremely

agree

Moderately

agree

Neither

agree

nor

disagree

Moderately-

disagree

Extremely

disagree

7. Do you agree that pharmaceutical companies inspire you for unethical promotion of

their products?

Extremely

agree

Moderately

agree

Neither

agree

nor

disagree

Moderately-

disagree

Extremely

disagree

8. Frequent samples help you to determine quality of medicine for prescription.

Extremely

agree

Moderately

agree

Neither

agree

nor

disagree

Moderately-

disagree

Extremely

disagree

`

76

9. Medical representatives satisfy your queries about new promotional drug.

Extremely

agree

Moderately

agree

Neither

agree

nor

disagree

Moderately-

disagree

Extremely

disagree

10. Mostly, doctors provide samples to their patients free of cost.

Extremely

agree

Moderately

agree

Neither

agree

nor

disagree

Moderately-

disagree

Extremely

disagree

`

77

Questionnaire for Patients

1. How important are following criterion for doctors while prescribing the medicine.

Rank them from 1-4

1=Most important

4=least important

2. How appropriate are the following gifts for physicians to accept?

Highly appropriate Highly Un-appropriate

5 4 3 2 1

Stationary

(Pen/pad etc.)

Samples

Medical exhibition

Conference fare

Recreation tour

3. Giving/receiving gift is close to bribery

Extremely agree Moderately

agree

Neither agree

nor disagree

Moderately- disagree Extremely

disagree

Criteria Rank

Company image

Percentage margin

Personal Relation

Self-evaluation of medicinal brand

`

78

4. In your opinion who is/are responsible in promoting unethical marketing?

Highly responsible----------------------------------------------------------------- not at

all responsible

5 4 3 2 1

Pharmaceutical

companies

Medical Representative

Chemists

Doctors

5. It is Ok for professional bodies (MCI, DCI etc.) to endorse private brands

Extremely

agree

Moderately

agree

Neither

agree

nor disagree

Moderately-

disagree

Extremely

disagree

6. Doctors should write only generic name/ chemical name while prescribing medicine.

Extremely

agree

Moderately

agree

Neither

agree

nor disagree

Moderately-

disagree

Extremely

disagree

7. Do you agree that pharmaceutical companies inspire you for unethical promotion of their

products?

Extremely

agree

Moderately

agree

Neither

agree

nor disagree

Moderately-

disagree

Extremely

disagree

`

79

8. Blank

9. Blank

10. Mostly, doctors provide samples to their patients free of cost.

Extremely

agree

Moderately

agree

Neither

agree

nor disagree

Moderately-

disagree

Extremely

disagree

`

80

BIBLIOGRAPHY

Abhijeet Kelkar, Eric S. Langer, Pharmaceutical distribution in India, Bio pharm

International.com

Allan S. Brett, MD; Wayne Burr, MD; Jamaluddin Moloo, MD, MPH, Are Gifts

From Pharmaceutical Companies Ethically Problematic? Arch Intern Med. 2003;

163:2213-2218

Deborah E. Simpson, PhD; Jesse L. Goodman, MD; Eugene C. Rich, MD, ‗Attitudes

of Internal Medicine: Faculty and Residents toward Professional Interaction with

Pharmaceutical Sales Representatives‘.

Jeffery et al, Pharmaceutical distribution systems in India, The Centre for

International Public Health Policy, University of Edinburg

India Pharma Inc.: Capitalising on India‘s Growth Potential, Price Water Cooper

house (PWC)

M. Ahmad1, N. Akhtar1, M.H.A. Awan1, G. Murtaza2, Ethical Evaluation of

Pharmaceutical Marketing in Pakistan, Acta Bioethica 2011; 17 (2): 215-224

Salma Yehia El Guindy, Ehab Abou AishEl Guindy, Responsible marketing Practices:

The Case of Egypt, New Cairo City – Egypt.

Saurabh Kumar Saxena, ‗A Review of Marketing Strategies Work by Different

Pharmaceutical Companies‘.

Wazana A, Physicians and the pharmaceutical industry: Is a gift ever just a gift?

JAMA 2000; 283:373–80.

`

81

Ethical Issues in Pharmaceutical Market In India

Documents