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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 OFMr. 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

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 Coproprietor 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

TABLE OF CONTENTS
I. II. III. CERTIFICATE ACKNOWLEDGEMENT EXECUTIVE SUMMARY

1 INTRODUCTION 1.1 Ethics in dealing with Pharma industry 1.2 Objectives of the study 1.3 Organization of report 2 ORGANIZATIONAL OVERVIEW 2.1 Introduction 2.2 How S.K. Pharma works 2.3 Major products owned by S.K. Pharma 3. AN OVERVIEW OF PHARMACEUTICAL INDUSTRY IN INDIA 3.1 Evolution of Indian pharmaceutical industry 3.2 Stages of development 3.3 Present status of Indian pharmaceutical industry 3.4 DRIVING FORCES OF INDIAN PHARMACEUTICAL INDUSTRY 3.5 Marketing in pharmaceutical industry 3.6 Regulatory environment 4. LITERATURE REVIEW: UNETHICAL PRACTICES IN PHARMA INDUSTRY 4.1 Gifts and physician-representative relation 4.2 Why are gifts ethically problematic? 4.3 Medical interns attitude towards gifts and Pharma reps 4.4 Conflicting views of physicians 4.5 Aggressive promotion accelerating irrational use of medicine 4.6 Promotion of hazardous and bannable drugs 4.7 DOCTORS AS KEY OPINION LEADERS 25 26 28 28 29 34 35
3

1 1 2 3 3 3 4

7 7 9 10

16 21

4.8 PROMOTION OF DISEASE INSTEAD OF' HEALTH 4.9 Direct to consumer advertising (DTCA) 4.10 Implications of unethical promotion and irrational use of drugs 5. RESEARCH METHODOLOGY 6. DATA ANALYSIS 7. CONCLUDING DISCUSSION 8. RECOMMENDATIONS AND LIMITATIONS OF THE STUDY. 9. BIBLIOGRAPHY 10. APPENDICES

36 37 37 39 42 68 70 72 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.

1 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 WHOs 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.

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

2.3 Major products owned by S.K. Pharma

Table : List of Products

Table : List of Products (continue.)

Table : List of Products (continue.)

3 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.

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.

Figure - Share of MNCs 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 cardiovascular. 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 Indias total exports in 2006-07. Exports, which constitute around 50% of the industrys 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%).

US $ bn
18 16 14 12 10 8 6 4 2 0 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 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

US $ bn 3.7

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 Indias 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. Lets have a look at these Driving Forces of Indian Pharmaceutical market.1

[snaps shots taken from India pharma2020, Mckinsey report ]

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1) Increase in Disposable income and poverty Eradication

Figure : increase in disposable Income in India (source- The Bird of Gold: The rise Figureof Indias Consumer Market, May 2007, Mckinsey India

2) Significant Growth in rural market

Figure : Growth in Rural Market, Source- Mckinsey India

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3) Expansion of Towns and Urbanization

Figure : Urbanization in India

4) Increase in Disposable income in rural India

Figure : Significant increase in Disposable income in India

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5) Increasing Governments spending on Healthcare

Figure : Increasing Governments spending on Healthcare

6) Growing affordability of and accessibility to Healthcare

Figure : Growing affordability of and accessibility to Healthcare

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7) Increase in Life style related and other chronic diseases

Figure : Increase in Life Style related Chronic Diseases

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

Figure : Trends in Health insurance Penetration India

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9) Expiry of Patents will create opportunity for Generic market

Sl. No. Brand Name 1 Fosamax 2 Camptosar 3 Effexor/XR 4 Zymar 5 Dovonex

Generic Name

Manufacturer

Patent Expiration date

Alendronate Irinotecan Venlafaxine Gatifloxacin Calcipotriene

Merck Pfizer Wyeth Allergan Bristol-Myers Squibb

Feb. 6, 2008 Feb. 20, 2008 June 13, 2008 June 29, 2008 June 25, 2009

6 Kytril 7 Risperdal 8 Depakote 9 Advair

Granisetron Risperidone Divalproex sodium Fluticasone and salmeterol

Roche Janssen Abbott Laboratories GlaxoSmithKline

July 29, 2008 June 29, 2009 July 29, 2010 Aug. 12, 2008

10 Serevent 11 Casodex

Salmeterol Bicalutamide

GlaxoSmithKline Bristol-Myers Squibb

Aug. 12, 2008 Oct. 1, 2008

12 Trusopt 13 Zerit Stavudine 14 Lamictal 15 Vexol 16 Avandia 17 Topamax 18 Glyset 19 Acular 20 Xenical 21 Valtrex 22 Avelox

Dorzolamide Bristol-Myers

Merck Squibb Dec.

Oct. 28, 2008 24, 2008

Lamotrigine Rimexolone Rosiglitazone Topiramate Miglitol Ketorolac tromethamine Orlistat Valacyclovir Moxifloxacin

GlaxoSmithKline Alcon Labs GlaxoSmithKline Johnson & Johnson Pfizer Allergan Roche GlaxoSmithKline Bayer

Jan. 22, 2009 Jan. 22, 2009 Feb. 28, 2009 March 26, 2009 July 27, 2009 Nov. 5, 2009 Dec. 18, 2009 Dec. 23, 2009 Dec. 30, 2009

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

Source: INDIAN PHARMACEUTICAL INDUSTRY: SURGING GLOBALLY, OCCASIONAL PAPER NO. 119 EXPORT-IMPORT BANK OF INDIA

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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 AntiInfective has the dominant share.

Table : Top Therapeutic segments in India3

Sl. No 1 2 3 4 5 6 7 8 9 10 11

Category Anti-infective Gastrointestinal Cardiac Respiratory Vitamins/ Minerals/Nutrients Pain/analgesics Dermatologicals Gynecology Neuro psychiatry Antidiabetics Opthologicals

Value (Rs. Billion) 32.8 21.8 20.7 20.4 1 19.3 19.1 10.8 10.7 10.6 8.8 3.5

Market Share (%) 16.4 10.9 10.3 0.2 9.6 9.5 5.4 5.3 5.3 4.4 1.7

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 also in give building hence main and

companies emphasis

retaining these customers. All efforts are being put for

generating secondary sales i.e. from Stockist to retailer.

segment

Ensuring of auto demand with Figure : Super Core Model: The Pull Approach for chronic limited availability and maximum liquidation of the products is the main characteristic of this approach.

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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 their and PUSH i.e.

products

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

Figure : Core Model: The Push Approach For Infective Segment

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
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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.

Figure : Integrated model of Distribution in Pharmaceutical industry in India

Salma et al, SOCIALLY RESPONSIBLE PHARMACEUTICAL MARKETING PRACTICES: THE CASE OF EGYPT, Cairo Egypt 19

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

Figure : Pattern of Distribution of pharmaceuticals in India

distribution system has remained traditional with little or no innovations. SuperStockist/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
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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 The Pharmacy Act, 1948 is meant to regulate the profession of Pharmacy in India.

Act,1948

The

Drugs

and The Drugs and Magic Remedies (Objectionable Advertisement)

Magic Remedies Act, 1954 provides to control the advertisements regarding drugs; (Objectionable Advertisement) Act, 1954 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. it prohibits the advertising of remedies alleged to possess magic qualities.

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Figure : regulatory mechanism of Indian Pharma industry

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4 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,

[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 givers 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 judgmentwithout their knowledge and even contrary to their intentthereby 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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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 ATT ITUDE 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

[Dr. Shahu Ingole et al. / International Journal of Pharma Sciences and Research (IJPSR) Vol.2 (2), 2011, 49-57]

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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. Lets 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 months 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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Table2: Amikacin prices comparisons

Table3: Price comparison of Cetirizine Salt

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Cefixime is priced at Rs 65 by Mankind (brand name Mahacef) but at the other hand its 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) 200mg tab 200mg tab 200mg tab 200mg tab Mahacef Zifi Taxim O Biotax Mankind(discovery) FDC Alkem Biochem Cefixime Cefixime Cefixime Cefixime Rs 45 Rs 75 Rs 165 Rs 75 Rs 65 Rs 99.9 Rs 190 Rs 99 (MRP)

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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Table : Top brands In India

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.

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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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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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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 Letrozoles 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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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 lifes 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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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

Figure Pack of Unwanted, an Emergency contraceptive Figure : i-pill, an emergency contraceptive

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
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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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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. Doctors interview consists of 10 questions with sub parts in some question similarly Medical representatives interview consist of six questions with subparts in some questions.

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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 Rank them from 1-4 1=Most important 4=least important

Table : Sum of Responses, Q.no. 1

Company image
Patients Doctors Total 80 91 171

Percentage margin
81 124 305

Personal Relation
126 102 228

Self-evaluation of medicinal brand

103 97 200

Table : Ranking of preference, Q.no.1

Rank 1

Patients Company image

Doctors Company image

Combined Company image

Self-evaluation of medicinal brand

Self-evaluation of medicinal brand

Self-evaluation of medicinal brand

Percentage margin

Personal Relation

Personal Relation

Personal Relation With M.R.s

Percentage margin

Percentage margin

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

Please refer to Questionnaire

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e) H0= There is no significant difference between the opinion of doctors and patients for appropriateness of accepting Conference fare as a gift. H1= There is a significant difference between the opinion of doctors and patients for appropriateness of accepting Conference fare as a gift.

Table : Mean Rank Table, Q.no. 2

Respondent Category Patient 2(a)Stationary Doctor Total 2(b)Samples Patient Doctor Total

Mean Rank

Sum of Ranks 1438.00 1802.00

40 40 80 40 40 80 40

35.95 45.05

44.48 36.53

1779.00 1461.00

31.20 49.80

1248.00 1992.00

2(c) Medical exhibition

Doctor Total Patient

40 80 40 40 80 40 40 80

29.69 51.31

1187.50 2052.50

2(d)Conference fare

Doctor Total Patient

33.20 47.80

1328.00 1912.00

2(e) Recreation tour

Doctor Total

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` Table : Test Statistics, Q.no.2

Stationary

Samples

Medical exhibition

conference fare

recreation tour

Mann-Whitney U Wilcoxon W Z Asymp. Sig. (2-tailed)

618.000 1438.000 -1.814 .070

641.000 1461.000 -1.617 .106

428.000 1248.000 -3.667 .000

367.500 1187.500 -4.305 .000

508.000 1328.000 -3.146 .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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` Table : One-Sample Kolmogorov-Smirnov Test, Q.no.2

Aggregate 1-5 N Normal Parameters(a,b) Most Extreme Differences Mean Std. Deviation Absolute Positive Negative Kolmogorov-Smirnov Z Asymp. Sig. (2-tailed) . 80 15.81 3.019 .128 .081 -.128 1.144 .146

The data distribution is found to be normal so t-test can be performed. Table : Group Statistics, Q.no.2 Respondent Category Patient Doctor N 40 40 Mean 14.38 17.25 Std. Deviation 2.880 2.436 Std. Error Mean .455 .385

Table : T- test, Q.no.2 Levene's Test for Equality of Variances F Sig. t df Sig. (2tailed) Equal variances .867 assumed 4.821 Equal variances not assumed 75.919 .000 -2.88 .596 .355 78 .000 Mean Difference -2.88 Std. Error Difference .596 Independent Samples Test

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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 Patient Doctor Total

Mean Rank 40 40 80 49.99 31.01

Sum of Ranks 1999.50 1240.50

Table : Test Statistics, Q.no. 3

Mann-Whitney U Wilcoxon W Z Asymp. Sig. (2-tailed) In this case sig. <.05 (null hypothesis is rejected)

420.500 1240.500 -3.750 .000

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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bribery while doctors have mild attitude towards accepting gifts and dont 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 H1= There is a significant difference between the opinion of doctors and 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 H1= There is a significant difference between the opinion of doctors and 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 H1= There is a significant difference between the opinion of doctors and patients for considering Chemists responsible for promoting unethical marketing

10

Please refer to questionnaire

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d) H0= There is no significant difference between the opinion of doctors and patients for considering Doctors responsible for promoting unethical marketing H1= There is a significant difference between the opinion of doctors and patients for considering Doctors responsible for promoting unethical marketing

Table : Ranks Table, Q.no. 4 N Doctor 4(a)Pharmaceutical companies Patient Doctor 4(b)Medical Representative Total Patient 80 40 40 80 42.61 38.39 1704.50 1535.50 Total 40 40 Mean Rank 41.83 39.17 Sum of Ranks 1673.00 1567.00

Doctor 4(c) Chemists Total Patient

40 40 80

48.05 32.95

1922.00 1318.00

40 4(d)Doctors Total Total 40 80

47.75 33.25

1910.00 1330.00

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` Table : Test Statistics, Q.no. 4 Test Statistics, Q.no. 4

Pharmaceutical companies

Medical Representative 715.500 1535.500 -.842 .400

Chemists

Doctors

Mann-Whitney U Wilcoxon W Z Asymp. Sig. (2 tailed)

747.000 1567.000 -.550 .582

498.000 1318.000 -3.084 .002

510.000 1330.000 -2.887 .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 ED MD ND MA EA Total 5 6 7 22 40

Count 1

% 2.5% 20.0% 25.0% 25.0% 27.5% 100.0 %

Count

Count 2

% 5.0% 15.0% 27.5% 35.0% 17.5% 100.0%

12.5% 15.0% 17.5% 55.0% 100.0 %

8 10 10 11 40

4 4 8 24 40

10.0% 10.0% 20.0% 60.0% 100.0 %

6 11 14 7 40

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

Doctors View

Pharmaceutical companies Count %

Medical Representative Coun t %

chemists

Doctors

Count

Count

ED MD ND MA EA 5 3 15 17 40 12.5% 7.5% 37.5% 42.5% 100.0 %

1 7 13 15 4 40

2.5% 17.5% 32.5% 37.5% 10.0% 100.0 %

4 10 7 6 13 40

10.0% 25.0% 17.5% 15.0% 32.5% 100.0%

8 14 13 5 0 40

20.0% 35.00 32.5% 12.5% 0 100.0%

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.
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Q.4: Who is responsible for unethical Marketing of pharmaceutical drugs in India?

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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? N Normal Parameters(a,b) Mean Std. Deviation Most Extreme Differences Absolute Positive Negative Kolmogorov-Smirnov Z Asymp. Sig. (2-tailed)

Overall view

80 14.41 2.073 .128 .104 -.128 1.146 .145

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

Mean

Std. Deviation

Std. Error Mean

Patient Doctor

40 40

15.45 13.38

1.616 1.970

.256 .312

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Table : Independent Samples Test, Q.no.4

Levene's Test

t-test for Equality of Means

4) Who is responsible for unethical Pharma marketing?

Equal variances assumed Equal variances not assumed

for Equality of Variances F Sig. T df Sig. (2 tailed) .717 .400 5.150 78 .000 Mean Difference 2.07 Std. Error Difference .403

5.150

75.133

.000

2.07

.403

For Levenes 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. H1= There is a significant difference between the opinion of doctors and patients for above statement.

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Mann-Whitney Test
Table : Ranks Table Q.no.5

Respondent Category

Mean Rank

Sum of Ranks 1956.00 1284.00

Patient Doctor Total

40 40 80

48.90 32.10

Table : Test Statistics Q.no.5

Mann-Whitney U Wilcoxon W Z Asymp. Sig. (2-tailed)

464.000 1284.000 -3.332 .001

H0 is rejected as there is a significant difference between the opinions of Patients and Doctors.

Frequency Chart2: Q.no.5

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

40.00% 35.00% 30.00% 25.00% 20.00% 15.00% 10.00% 5.00% 0.00% Patient Doctor

ED 7.50% 22.50%

MD 20% 35%

ND 27.50% 27.50%

MA 32.50% 15%

EA 12.50% 0

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

H0= There is no significant difference between the opinion of doctors and patients for above statement. H1= There is a significant difference between the opinion of doctors and patients for above statement. Mann-Whitney Test
Table : Rank Table Q.no. 6

Respondent Category Patient Doctor Total

Mean Rank

Sum of Ranks 1623.50 1616.50

40 40 80

40.59 40.41

Table : Test Statistics, Q.no.6

Mann-Whitney U Wilcoxon W Z Asymp. Sig. (2-tailed)

796.500 1616.500 -.035 .972

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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Frequency Chart3: Q.no. .6

Doctors should write only generic name/ chemical name while prescribing medicine.
40.00% 35.00% 30.00% 25.00% 20.00% 15.00% 10.00% 5.00% 0.00% Patient % Doctor %

ED 12.50% 15.00%

MD 27.50% 27.50%

ND 10.00% 15.00%

MA 20.00% 5.00%

EA 30.00% 37.50%

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

H0= There is no significant difference between the opinion of doctors and patients for above statement. H1= There is a significant difference between the opinion of doctors and patients for above statement

Mann-Whitney Test
Table : Mean Rank table Q.no.7

Respondent Category Patient

Mean Rank

Sum of Ranks 1734.00

40

43.35

57

Doctor Total

40 80

37.65

1506.00

Table : Test Statistics, Q.no.7

Mann-Whitney U Wilcoxon W Z Asymp. Sig. (2-tailed)

686.000 1506.000 -1.143 .253

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 Do you agree that pharmaceutical companies inspire Doctors for unethical promotion of their products?
45.00% 40.00% 35.00% 30.00% 25.00% 20.00% 15.00% 10.00% 5.00% 0.00% Patient Doctor

ED 0.00% 12.50%

MD 5.00% 22.50%

ND 22.50% 7.50%

MA 37.50% 17.50%

EA 35.00% 40.00%

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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.

Valid Missing Mean Median Mode Std. Deviation Variance Sum

40 0 3.98 4.00 4 1.000 .999 159

40 0 3.23 4.00 4 1.250 1.563 129

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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Frequency charts 5: Q.no 8

Frequency charts 6: Q.no 9 9) Medical representatives satisfy your queries about new promotional drug.
EA MA ND MD ED 0.00% Q.9 10.00% ED 15.00% 20.00% MD 12.50% 30.00% ND 17.50% 40.00% MA 45.00% 50.00% EA 10.00%

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.

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

Frequency chart 7: Q.no. 10
70.00% 60.00% 60.00% 50.00% 40.00% 30.00% 30.00% 20.00% 20.00% 10.00% 10.00% 0.00% 0.00% SD MD Patients % ND Doctors % Ma EA 2.50% 5.00% 10.00% 30.00% 32.50%

Table : Frequency, Q.no. 10

Patients Count SD MD ND Ma EA 4 12 8 12 4 % 10.0% 30.0% 20.0% 30.0% 10.0% Count

Doctors % 0 1 2 24 13 .0% 2.5% 5.0% 60.0% 32.5%

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.

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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 Patients Doctors Total

Mean Rank 40 40 80 28.90 52.10

Sum of Ranks 1156.00 2084.00

Table : Test Statistics Q.no.10

Samples Mann-Whitney U Wilcoxon W Z Asymp. Sig. (2-tailed) 336.000 1156.000 -4.725 .000

We have sig. <.05, H0 cannot be rejected That is there is a significant difference between opinion of Doctors and Patients

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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 pharmaceutical industry

you think is essential to the

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 representatives job? Representative: Such methods may be useful for short term gain but may taint the companys image. Our job is a very specialized and complex job other
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method may be very attractive to our management but such methods are not a replacement to a Pharma representatives 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.

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Doctors Interview
1. What did you study? Whats 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 companys 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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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 dont 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 theres 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.

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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 companys 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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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. 68

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.

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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 doctors 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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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.

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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 Indias 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; 283:37380.

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Appendices
Questionnaire for Doctors 1. How important are following criterion for doctors while prescribing the medicine. Criteria Company image Percentage margin Personal Relation Self-evaluation of medicinal brand Rank them from 1-4 1=Most important 4=least important 2. How appropriate are the following gifts for physicians to accept? Rank

Highly appropriate 5 Stationary (Pen/pad etc.) Samples Medical exhibition Conference fare Recreation tour 4 3

Highly Inappropriate 2 1

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3. Giving/receiving gift is close to bribery Extremely agree Moderately agree Neither agree nor disagree Moderatelydisagree Extremely disagree

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

Highly responsible------------------------------------------------------ not at all responsible 5 Pharmaceutical companies Medical Representative Chemists Doctors 4 3 2 1

5. It is Ok for professional bodies (MCI, DCI etc.) to endorse private brands Extremely agree Moderately agree Neither agree nor disagree Moderatelydisagree Extremely disagree

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6. Doctors should write only generic name/ chemical name while prescribing medicine. Extremely agree Moderately agree Neither agree nor disagree Moderatelydisagree 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 Moderatelydisagree Extremely disagree

8. Frequent samples help you to determine quality of medicine for prescription. Extremely agree Moderately agree Neither agree nor disagree Moderatelydisagree Extremely disagree

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9. Medical representatives satisfy your queries about new promotional drug. Extremely agree Moderately agree Neither agree nor disagree Moderatelydisagree Extremely disagree

10. Mostly, doctors provide samples to their patients free of cost. Extremely agree Moderately agree Neither agree nor disagree Moderatelydisagree Extremely disagree

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

Criteria Company image Percentage margin Personal Relation Self-evaluation of medicinal brand Rank them from 1-4 1=Most important 4=least important

Rank

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

Highly appropriate 5 Stationary (Pen/pad etc.) Samples Medical exhibition Conference fare Recreation tour 4 3

Highly 2

Un-appropriate 1

3. Giving/receiving gift is close to bribery Extremely agree Moderately agree Neither agree nor disagree Moderately- disagree Extremely disagree

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` 4. In your opinion who is/are responsible in promoting unethical marketing? Highly responsible----------------------------------------------------------------- not at all responsible 5 Pharmaceutical companies Medical Representative Chemists Doctors 4 3 2 1

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

Extremely agree Moderately agree Neither agree nor disagree Moderatelydisagree Extremely disagree

6. Doctors should write only generic name/ chemical name while prescribing medicine. Extremely agree Moderately agree Neither agree nor disagree Moderatelydisagree 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 Moderatelydisagree Extremely disagree

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8. Blank 9. Blank

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

Extremely agree Moderately agree Neither agree nor disagree Moderatelydisagree Extremely disagree

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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 Indias 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; 283:37380.

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