A REVIEW ON PRESCRIPTION DRUG

PROMOTION STRATEGIES AND REGULATIONS

Project Report
Submitted in partial fulfillment of the requirements for the
degree of M.Sc. in Clinical Research (2008-2010)
To the
Institute of Clinical Research, India (ICRI)

Cranfield University, UK

Submitted By:
1. Dr. Priya Bhasin
2. Machut Zimik
3. Manoj Kumar Singh
4. Mariya Biswas
5. Mohd. Shahnawaz

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 6. Mohd. Rehmatullah Shah

DECLARATION

We hereby declare that the project work entitled “Drug Promotion Strategy and Regulations”,

submitted to the “Cranfield University”, is a record of an original work done by Learning Group

5 under guidance of Professor Phil Warner (Cranfield University) and Dr. Amit Kr. Verma

(Institute of Clinical Research India).

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 ACKNOWLEDGEMENT

We, the Learning Group 5 wish to thank our guide, Dr. Amit Kr.Verma for his invaluable
expertise and guidance. We would also like to thank Professor Phil Warner for providing us
some important pointers that helped us to reframe our project.

We, wish to thank DR. Reddy, Ranbaxy, and Panecea for their support and guidance and

allowing us to undertake the project in their companies.

Lastly, but most importantly, the Learning Group 5 would like to extend our gratitude to

everyone who responded to the survey questionnaire – Health Care Professional, Marketing

Representatives and the Marketing Heads of each companies. This project would never have

been completed, if not for their encouragement and support.

Background
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Many people are often unaware of the truth about pharmaceutical companies and prescription
drugs whilst they rely on them for improving the quality of life and health on a day to day basis.
The truth is that no drug is completely safe as side effects is a common phenomenon and doctors
generally know much less about the risks of those drugs because most of the times the source of
knowledge is the pharmaceutical company itself. Moreover, the new marketed drugs which are
considered as “breakthrough” drugs have only a slight fraction of improvement in contrast with
drugs that are already present in the market. The pharmaceutical companies made the impact in
the public mind for the high price of drugs are requisite to support the research and development
of drugs, however they actually spend nearly double the amount in marketing or promoting the
drug in the market rather than on research of the molecule and therefore it is considered as one of
the most profitable industry than any other. In 2002, the USA alone spent almost US$21 billion
on drug promotion. In developing countries particularly India, pharmaceutical sales
representatives are the only source of drug information. There are concerns about whether
commercial interest or consumer health should be given priority. Evidence showed that the
pharmaceutical industry remains guilty of inappropriately involving in unethical promotion that
will hinder with clinical-decision making by encouraging irrational use and over-prescription of
medicines. This approach remains a concern for the consumers because it not only increases the
cost of healthcare but also endanger consumer to unnecessary health risks.

This report is part of a group project on “Prescription drug promotion strategy and
regulations” being carried out by Learning Group 5. This phase of group project involved
surveying health care professionals, pharmaceutical representatives and marketing heads of the
pharmaceutical companies, collecting and analyzing of information on prescription drug
promotion and regulations. Research studies were conducted and compiled in a systematic
manner to form the basis of this project. This project will examine on drug promotion targeting
primarily on four audience; health care professional, sales representative, policies and practices
of companies on promotional activities and regulations.
This project will also provide a briefing on the recent activities regarding regulation and
promotion of medicines whilst providing overture about what we observed from our findings.
The major focus of this project therefore, is to understand the know-how about policies and
practices of 3 major pharmaceutical companies operating in India and specifically reviewing
their promotional activities with regards to self-regulatory code of the company, industrial
associations, and the national regulations. With conflict-of-interest apparent among the
pharmaceutical companies it is essential to pay attention to the regulatory framework of different
countries and justify the variations persisting in their promotional practices.
AIM:

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The aim of this project is to interpret the current scenario on promotion of prescription drugs and
to highlight the regulatory framework for promotional practices through an international
perspective.

OBJECTIVES:
This project primarily focuses on wide range of different topics on drug promotion
1) Determine the perception of health care professionals on prescription drug promotion.

2) Understand the roles and responsibilities of medical representatives on drug promotion.

3) Determine the promotional activities of pharmaceutical companies for prescription drugs

and identify the variations in promotional practices among the companies.

4) Highlight the regulatory frameworks on drug promotion through international

perspective.

5) Annotate on the control of drug promotion by identifying the right practice-both

regulations and pharmaceuticals promotional activities.

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SCOPE
The overall focus of our project can be summarized as below:

Health Care Professionals

Focus issues
 Views on medical representatives in particular and drug promotion in general
 Training of health care professionals to interact with medical representatives
 Information provided by medical representatives about pharmaceutical products
 Offers

Medical Representatives
Focus issues
 Roles and responsibilities
 Training requirement
 Attitude

Promotional activities of the pharmaceutical companies

Companies: Ranbaxy, Dr. Reddy, Panacea
Focus issues
 Prescription drug promotion strategy
 Channels of drug promotion
 Competition among the pharmaceutical companies
 Effectiveness of drug promotion
 Shortcomings
 Ethical Criteria

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Regulatory frameworks
Codes: WHO Ethical Criteria (1988), IFPMA 2006, OPPI 2007 (India), ABPI 2008 (UK),
EFPIA (EU) 2007, PhRMA (US) 2008
Focus issues
 Objectives of the codes
 Applicability of the codes
 Scope of the codes
 Definition of promotion in the codes
 Medical Representatives
 Gifts and hospitality
 Advertisement
 Distribution of free samples
 Product information

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 METHODOLOGY

This project report was carried out to analyze the marketing practices of drugs by pharmaceutical
companies and reviewing the regulatory codes on drug promotion of different countries.

Research Methods:

• Primary Research
• Secondary Research : through Websites and Literature

• Primary Research
Primary research methods were:
• Qualitative interviews with marketing heads of the pharmaceutical companies.
• Survey questionnaires for Health care professionals and Medical Representatives.

Sample Study:
A set of questions were asked to the Marheting Heads of three pharmaceutical companies:
 Dr. Reddy
 Ranbaxy and
 Panacea.

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These marketing heads provided the information regarding the promotional strategies and
regulations being followed for the promotion of prescription drugs.
Further, we were given permission to meet the medical representatives of the company so that
we could complete our survey.
Total Health care professionals targeted: 130 (to understand the prescribing behaviour of the
doctors.
Total Medical representatives: 15 (5 from each company).
It is uphill task to enter the enormous data received through the questionnaire which consist of

nearly 10 questions. The response to descriptive questions was very less but was valuable for the

purpose of study. Hence these were further structured in time with the system adopted for

compilation and data analysis.

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INTERACTION WITH THE MARKETING HEADS-
Regulations followed:

PANACEA –
Regulations followed: Member of IFPMA (International Federation of Pharmaceutical
Manufacturers and Associations)
Ranbaxy-
Regulations followed: OPPI, Member of IFPMA (International Federation of
Pharmaceutical Manufacturers and Associations) and company’s own regulations.
Dr. Reddy Lab

Regulations followed: Follows regulations by WHO and own company policy

Promotional policy:

PANACEA –
Promotional policy:
Research products-
The Company organizes a seminar and invites the doctors who are not private practioners
but are involved in research work and academics. A presentation is given to share the
information about the company product. Around 2000 doctors are provided with the
samples of the research drug. The doctors prescribe these drugs to their patients and If
80% of the doctors are satisfied with the results of the drug after prescribing to the
patients then these prescription drugs are being promoted through Medical
representatives.
Non-Research Products:

• Medical Representatives- The doctors are offered gifts from spoon to Honda City
according to their capability.

• Conferences: also a source of promotion of prescription drug among doctors.

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Dr. Reddy Lab

Common Promotional Strategies followed:

• Seminars

• Meeting the doctors through sales representatives

• Continued Medical Education

1. Seminars

In this programme, the company conducts a seminar about a particular disease in a

reputed hotel, where targeted doctors are invited.The Company chooses a senior doctor of
same speciality as a speaker and provides all the recent advanced information about their
product. The speaker explains the provided information about the drug to the invited
doctors.

The main aspect of the company is meeting the doctors regularly to maintain long-
termrelations with them.

2. Continuous Medical Education:

The company sponsors the doctors to attend important meetings and conferences which
are held regularly.

3. Medical Representatives:

The company has 8 departments in total:

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Aqura More known Drugs
Recura Gastro, Dental, Ortho
Ventura Pediatrics+ENT Each department has Medical
Xenura Cardiology+Diabetes representatives who are given training
Derma Skin on the specific products of the
Oncology Cancer
department with all relevant required
Futura Urology
Hospital Task force Hospital I.C.U. knowledge about those products so that
they can go to doctors and explain them
the products. The sales representatives are given training for a week. These sales representatives
have to meet a fixed target.

The company offers scientific and medical journals to the doctors like Journal of medicines,
magazines, medical dictionaries, gifts, and samples to the doctors.

Reporting of marketing work:

Professional Service Representative

Area Sales Manager

Regional Sales Manager

Sales Manager

Ranbaxy-
Promotional policy
• Medical representatives-
The company mainly offers pharmaceutical samples i.e. the drug samples to doctors. They target
different hospitals including government hospitals and provide the medical text and equipments
to the doctors.

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 • Conferences and Seminars are also held regularly to promote their drugs.But the
medical representatives are a common tool for the prescription drug promotion.

Training of Medical Representatives-

Panacea
Initially, an exam is conducted at the time of appointing the medical representatives in
which they are tested for the subject i.e., pharmacology, and their marketing skills.

The successful candidates who clear the exam are given training for 15 days according to the
information in the drug dossier.

Then the candidates are evaluated through exams so as to assess their knowledge about the
particular product.

After clearing the exam only, the medical representatives are sent to visit the doctors with all the
product informayion.

Dr. Reddy:
The medical representatives are given 7 day training and evaluated on the regular basis and are
provided opportunities to attend the seminars and meeting on their company products to update
their knowledge.
Ranbaxy
The medical representatives are provided complete knowledge about the products for 7 days and
no other information was provided about the training of the medical representatives.

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 LITERATURE REVIEW

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Promotion of Drugs:

According to WHO, Drug promotion is defined as “All informational and persuasive activities
by manufacturer and distributers to induce or to influence the sale and use of medicinal drugs”
(2). The rational use of drugs depends exclusively on the activities of drug promotion. The
methods applied in drug promotion takes a varying form with new product lines often plugging a
common place.

Types of Products-

1. Prescription (Rx) drug: is a licensed medicine that is regulated by legislation to require

a prescription before it can be obtained by healthcare professionals.
2. Over-the-counter (OTC) drugs, also called self-medication drugs, can be purchased
without a prescription.

These drugs can be sub-classified as following:

• Research product: The products which are under research, i.e., in phase 4 of clinical
trials.

• Non-Research Product: The products which have already cleared all phases of the
clinical trials.

Promotional Strategies:

The promotional strategies of the drug promotion:

• Medical representatives:

1. They are the key source of promotion of prescription drugs by

pharmaceutical companies. MRs approach health care professionals and
explain their product information to them so that they can prescribe

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 specific company products to the patients. Promotion through MRs
includes inducement to prescribe, supply, recommend, buy or sell
medicines by;

• Provision of Gifts or Samples (Gifts may vary from small to large

for eg- Stationery items, Beauty products etc. Samples are the
pharmaceutical medicines)

• Provision of Hospitality for promotional purposes

• Medical texts (Journals, Magazines etc.)

• Continuing Medical education

• Sponsorship of scientific meeting including payment of travelling

and accomodation expenses

• Participation in exhibitions

• Advertisements: Advertisement through journals and magazines etc.

• Sponsorship of educational events and conferences:

Pharmaceutical companies provide opportunities to the health care professionals to

attend conferences and medical seminars and in return expect them to prescribe their
drugs to the patients.

• Direct to consumer Advertisement:

DTCA usually refers to the marketing of pharmaceutical products which is directed

toward consumers, rather than healthcare professionals. The various forms of DTC
advertising are TV, print, radio etc. There are ethical and regulatory concerns regarding DTC
advertising, specifically the extent to which these ads may unduly influence the prescribing
of prescription drugs based on consumer demands when, in some cases, they may not be
medically necessary. At present only USA and New Zealand follows direct-to-consumer
(DTC) advertising of drugs and other regulatory authorities are considering whether or not to
follow USA pattern of drug promotion model. The truth is promotion tends to influence
doctors attitude more then they realize themselves as they report that promotion is the most
frequent source of information about new drugs.

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 Pharm
Perception of health care professional on drug promotion
Research studies have shown that the attitude of doctors on drug promotion vary to a large
extent. Some doctors suggest that they should be trained to interact with sales representatives
while others discard this idea. Many doctors believe that information on drugs from
pharmaceutical companies is useful while most doctors think they are biased. There is a mixed
opinion on doctors about direct-to-consumer (DTC) promotion of drugs.

The roles and powers of pharmaceutical representatives- or marketers

Pharmaceutical Representatives has a direct impact on the growth of a company whose main
attributes depends on the power to influence a Health Care Professional on prescribing a drug.
Therefore it is the responsibility of a company to provide a comprehensive training to the
pharmaceutical representaives about products which are in the phase of promotion. The roles and
responsibilities of pharmaceutical representatives should be clearly defined to enable health care
professionals for appropriate clinical-decision-making.

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Countering promotional activities of drugs-policies and practices
The main objective of drug promotion is to speed up the sales of products. Pharmaceuticals
Company adopts a drug promotion strategy that is aimed at both health care professionals and
the public. However, due to the competition in the market of drug promotion by different
companies there remains a concern regarding the ethical implementation of their practice. A
study has shown that two-third of the world has either no regulation on drug promotion or does
not implement the regulations they have (1). Pharmaceuticals Company should maintain a sense
of responsibilities towards drug promotion; directed not only in generating their sales but also
provide appropriate information that the consumer will need. Despite a regulatory system, it has
not shown any success of proper implementation.

Regulatory framework-an international perspective:

The primary objective of ethical criteria for the promotion of drugs is to encourage and support
the improvement of health through the implementation of rational use of pharmaceutical
products. Promotion of irrational prescription drugs are considered unethical in any form of
activities. Many countries have their own regulations for the promotion of prescription drugs in
which the strength of the regulations varies from one country to another. It is therefore important
to determine the ethical code of drug promotion so as to bring about changes to overcome the
unethical practices of pharmaceutical marketing. The following codes will be analyzed for this
study:

1. International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

2006, International
2. WHO Ethical Criteria, 1988
3. European Federation of Pharmaceutical Industries and Associations (EFPIA) 2007, EU
4. The Association of the British Pharmaceutical Industry (ABPI) 2008, UK
5. The Pharmaceutical Research and Manufacturers of America (PhRMA) 2008, US\
6. Organization of Pharmaceutical Producers of India (OPPI) 2007, India

REGULATIONS
The main sources for reviewing both the national and international industry codes and the WHO
ethical criteria were extracted from the websites of respective codes as given below:

Country Applicable codes Websites

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International WHO ethical criteria http://apps.who.int/medicinedocs/en/d/Js16520e/

International IFPMA http://www.ifpma.org/EthicalPromotion

EU EFPIA http://www.efpia.org/content/Default.asp?
PageID=615

UK ABPI http://www.pmcpa.org.uk/?q=getcopiesofcode

USA PhRMA http://www.phrma.org/code_on_interactions_with_h

ealthcare_professionals

India OPPI, IFPMA http://www.indiaoppi.com

http://www.ifpma.org/EthicalPromotion

OBJECTIVE OF THE CODES

1. IFPMA/OPPI

The international pharmaceutical industry is committed to the improvement of the

health of the mankind through research and development of new medicines and
production and marketing of pharmaceutical products of reliable quality, in accordance
with internationally defined standards of good practice.

2. WHO

Main objective of ethical criteria for medicinal drug promotion is to support and
encourage the improvement of health care through the rational use of medicinal drugs.

3. EFPIA

The objectives of EFPIA codes of practice are to ensure the highest possible
standards in the promotion and advertising of medicines.

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 4. ABPI

The objectives of ABPI codes of practice are to ensure that the promotion of
medicines to health professionals and to administrative staff is carried out within a robust
framework to support high quality patient care.

The objectives of each code specify different aspects of promotional practices which are
rarely put into practice. In the current scenario of pharmaceutical marketing many new
drugs are produced with little molecular manipulation to match with the competitive edge
of the industry and drugs with the same level of effect are sold at higher prices. The
ethical criteria of drug promotion also start from the validity of the medicine itself. The
existence of many codes also makes it difficult to follow internationally defined standards
of good practice as suggested in IFPMA.

5. PhRMA

PhRMA considers ethical relationship with healthcare professionals as their critical

mission to help patients by developing and marketing new medicines. They focus
primarily on the interaction with healthcare professionals that relate to the marketing of
products.

APPLICABILITY OF THE CODES

IFPMA confined mainly to its member organizations and affiliates in the industry: - America,
Asia Pacific (including India), Europe and Middle East and Africa

WHO expanded to people in all walks of life: governments; the pharmaceutical industry
(manufacturers and distributors); the promotion industry (advertising agencies; market research
organization’s and the like); health personnel involved in the prescription, dispensing, supply and
distribution of drugs; universities and other teaching institutions; professional associations;
patients and consumer groups; and the professional and general media (including publishers and
editors of medical journals and related publications).

EFPIA is the representative body of pharmaceutical industry in Europe and its code applies to its
members which consist of thirty pharmaceutical producing countries in Europe along with over
forty leading pharmaceutical companies.
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SCOPE OF THE CODES

The IFPMA code states that promotional activities within the scope of the code include direct to-
consumer advertising (DTCA), where this is permitted under local laws. However, in many
Third World countries there is no regulatory law for promotion of medicines through DTCA.
What will be the responsibility of the industry and who will monitor them? Such code becomes
ineffectual as evident in several clauses of the IFPMA code.

DEFINITIONS OF PROMOTION

The definition of 'promotion' is vital. In the context of WHO, ‘promotion refers to all
informational and persuasive activities by manufacturers and distributors, the effect of which is
to induce the prescription, supply, purchase and/or use of medicinal drugs.'

For some reason the IFPMA code did not feel the need to provide such a definition. It states:
'Promotional materials for pharmaceutical products should be accurate, fair and objective and
presented in such a way as to conform not only to legal requirements but also to high ethical
standards and to be in good taste.' This definition is not clearly understood.

OPPI guideline stated more specific terms of promotion, defining it as: 'Promotional material on
pharmaceutical products: printed literature (package inserts, data sheets, detail/visual aids, flip-
charts, leave-behinds, mailings and advertisements); audio-visuals; sponsored
symposia/conferences/guest lectures; gift items; information through medical representative
training.'

However, OPPI has ignored advertising through the electronic media, gifts, literature or display
materials given to wholesalers and chemists, the sponsoring of individuals to attend
meetings/conferences, etc.

“Promotion”, as used in the EFPIA Code, includes any activity undertaken, organized or
sponsored by a Member Company, or with its authority, which promotes the prescription,
supply, sale, administration, recommendation or consumption of its medicinal product(s).

ABPI also defined ‘promotion’ as any activity undertaken by a pharmaceutical company or with
its authority which promotes the prescription, supply, sale, or administration of its medicines.

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ADVERTISEMENTS
WHO has defined 11 specific criteria for advertisements, OPPI mentions four criteria,
and IFPMA mentions three criteria.
IFPMA categorizes advertisements as
• all advertisements
• full advertisements
IFPMA code states that contraindications, side-effects, and precautions must be mentioned only
in 'full advertisements. IFPMA code is more strictly followed in developed countries like USA
and UK for advertisements.

According to ABPI advertisement for prescription drugs must not appear anywhere where the
general public will see them; therefore drug advertisement can generally only be placed in
medical journals and magazines. There are also guidelines as to what constitutes an
advertisement, for example, a review article placed in a specialist nurse or physician magazine
may be rules as an advertorial if it is deemed too promotional. There are also limits on the
number of pages per publication that can be dedicated towards the promotion of one product.

PhRMA ensures that direct-to-consumer (DTC) advertisement comply with the regulations of the
Food and Drug Administration (FDA). In general, FDA requires all DTC information:
• To be accurate and not misleading
• To make claims only when supported by substantiated evidence
• To reflect balance between risks and benefits
• To be consistent with the FDA-approved labeling.

The table below shows the pharmaceutical advertising controls:

Examples Self regulatory Regulatory

Global IFPMA Code WHO ethical criteria 1988
Company Codes
Regional EFPIA Code EU Directive 2001/83 (as amended by
2004/27)
National • ABPI Code UK: Advertising Regulatory, MHRA
• PhRMA Code Activities, Medicines Act
• OPPI USA: FD&C Act, Lanham Act, DDMAC
Activities
India: Drugs and Magic Remedies Act

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MEDICAL REPRESENTATIVES
IFPMA mentions that medical representatives must be trained with sufficient medical and
technical knowledge. They should also collect information from professionals about the use of a
product.
WHO states that training should be:-
• Updated
• Continuous
• Training should include ethical codes.
MRs should not offer inducements to prescribers and dispensers, and prescribers and dispensers
should not solicit such inducements.

OPPI states that

• Adequate training should include information on basic medical sciences such as anatomy,
physiology, microbiology, and pharmacology.
• Sufficient medical knowledge should be given regarding aetiopathology and clinical
aspects of the disease for which the product is used.
• The representatives should be properly trained to impart information in an accurate and
scientific manner. There is no reference to the appropriate conduct of a medical
representative (MR)

PhRMA
• Representatives must be given adequate training and have sufficient scientific knowledge
to enable them to provide appropriate information about the medicines which they
promote.
• They must maintain a high standard of ethical conduct and comply with the Code at all
times. Companies must prepare briefing material for representatives on the technical
aspects of the medicine and how the product should be promoted.
• They must not use inducements or subterfuge to gain an appointment, and should ensure
that the frequency and duration of calls do not cause inconvenience.
• Payment of a fee for an appointment – even to a charity – is not permitted.

ABPI
Clause 15 of ABPI mentions that representatives must be given adequate training and have
sufficient scientific knowledge to enable them to provide full and accurate information about the
medicines they promote. Representatives must not make claims or comparisons which are in any
way inaccurate, misleading, disparaging, in poor taste etc, or which are outside the terms of
marketing authorization for the medicines or inconsistent with the summary of product
characteristics.

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GIFTS & HOSPITALITY
WHO Ethical Criteria states that “promotion in form of financial or material benefits should not
be offered to or sought by HCPs to influence them in the prescription of drugs”. This statement
does not explicitly prohibit the provision of gifts, however by not spelling this out specifically,
the WHO Code could be interpreted to mean that ‘nothing should be given’ as if all gifts are
inducement. OPPI and PhRMA also included similar statement that nothing should be offered as
an inducement to prescribe medicine.
Restriction on the nature/purpose of gifts is strictly followed in US law where as the IFPMA
Code remains quite weak in this issue. OPPI also fails to specify these cultural celebrations. The
IFPMA and the EFPIA leave it up to the national associations to define the specific value of gifts
that are permitted. However, PhRMA sets a maximum of $100 for educational items only.
Both codes and legislation are weak on the issues of ban on stand-alone entertainment. None of
the legislation bans all forms of entertainment. Even EFPIA Code seems unclear on this issue.
However, ABPI seems to be banning all entertainment as they considered such activities as
unprofessional.
Significant variation between the codes and the national regulations and industry codes were
observe in the categorization of gifts and hospitality.

DISTRIBUTION OF FREE SAMPLES

So far the OPPI remains silent with respect to the distribution of free samples. The IFPMA states
that samples may be given to prescribing professionals to familiarize them with the products,
enable them to gain experience with the products in their practice, or on request.
On the other hand WHO guidelines appear to be more lenient, considering that free samples may
be used by the weaker sections of society.
Depending on the national and community laws and regulations EFPIA allows a limited number
of samples of a particular medicinal product to be supplied to HCPs who are qualified to
prescribe that medicinal product. However, samples must not be given as an inducement to
recommend, prescribe, purchase, supply, sell, or administer specific medicinal products. ABPI

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also lays similar provisions on distribution of samples which may be provided only to HCPs
qualified to prescribe that particular medicines.

THE INDIAN SCENARIO OF REGULATING PHARMACEUTICAL

MARKETING
India has only one relevant clause of its own that relates to the promotion of prescription drugs;
Clause 4 of the Magic Remedies (Objectionable Advertisement) Act, 1954 on misleading of
advertisements. There has been a constant debate on the guidelines of pharmaceutical marketing
across the globe, more so in India. The drug industry sets their own standard of drug promotion
and interprets their own rules. Many issues are not clear and needs to be addressed and amended.
Due to certain reasons, fortunately no major cases of unethical promotion have been reported in
the Indian media as compared with the western countries. The reason though could be because
many such unethical promotional activities haven’t come to light.
At present prescription drug promotion in India is governed by three major documents:
 The Drugs and Cosmetics Act, 1940
It is defined as an act to regulate the import, manufacture, distribution, and sale of drugs
and cosmetics in India. It has last been amended in 1995.
 The Drugs and Cosmetics Rules, 1945
It describe the essential information to be provided regarding labeling of drugs. The
product monograph should comprise the full prescribing information necessary to enable a
physician to use the drug properly. It should include description, actions, indications, dosage
precaution, drug interactions, warnings, and adverse reactions.
 The OPPI Code of Conduct, 2007
This code sets out the guidelines to be followed for promotion of prescription drugs by
the pharmaceutical industry. It is based on the IFPMA code and incorporates local region (India)
specific guidelines. It sets out certain principles basic to the ethical promotion of pharmaceuticals
in the country. Though it is widely followed, it is not legally binding and the final responsibility
for implementation lies with the pharmaceutical marketing organizations themselves.
The Medical Council of India (MCI) started 2010 with a long awaited bang. On 1/1/10, MCI put
out a statement asking the country's doctors to stop receiving gifts or favors from any
pharmaceutical companies and said they must desist from endorsing products.
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As per the MCI, All medical practitioners shall not receive any gift, national/international travel
facility, paid vacations (for self or family), from any pharmaceutical or allied healthcare industry
and their sales people or representatives. The punishments range from censure (for accepting
gifts valued between Rs.1, 000 and Rs.5, 000) to removal from the Indian or State Medical
Registry for more than one year (for accepting gifts worth more than Rs.100, 000).

ANALYSIS

Do the medical representatives (MRs) approach you for

the Pharmaceutical products?

120%

100%
7%

80%

65%
60% NO
YES
93%
40%

20%
35%

0%
PRIVATE PRACTIONERS HOSPITALS

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 • 93 %( 52) Private Practitioners say Medical representatives approach them. 7
%( 8) say Medical Representatives donot approach them.

• 35 %( 21) doctors from hospitals says Medical Representatives approach

them while 65 %( 39) say no MRs don’t approach them.

InformationprovidedbyMRs

35%
48%
HELPFUL
NOT SURE
DON’T AGREE
17%

48 %( 58) doctors said that the information provided by the Medical

Representatives was helpful while 17 %( 19) were not sure and 35 %( 43) said that
they don’t agree with the information provided by MRs

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 Do MRs play an important Role in promotion of prescription
drugs?

60%

50%
54%
48%
40%
YES
30% 38% NO

30% Can't Say

20%
22%
10%
8%
0%
PRIVATE PRACTIONERS HOSPITALS

• 54% (32) Private practioners think that the Medical Representatives play an
important role in promotion of drugs while 38 %( 23) disagree.

• 30 %( 18) Doctors from hospitals say that the Medical reprsentatives play an
important role in promotion of drugs while 22 %( 13) disagree.

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 OFFERS MADE BY THE PHARMACEUTICAL COMPANIES TO THE
HEALTH-CARE PROFESSIONALS

PRIVATE HOSPITALS
PRACTIONERS

GIFTS 47 19

MEALS/DRINKS 5 2

ENTERTAINMENT/MOVIE 2 3
TICKETS

MEDICAL TEXTS 4 21

EQUIPMENTS 7 25

SAMPLES 51 16
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PERSONAL ITEMS 23 8

NEVER OFFERED 5 3

The Most common Source of information to update the knowledge about new
drugs

43% Private Practitioners and 38% doctors form the hospitals agree that the most
common source of information for them is medical representatives from the
pharmaceutical company.

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 Does MRs provide detailed information?

100%
90%
40%
80% 56%
70%
60%
NO
50%
YES
40%
60%
30% 44%
20%
10%
0%
PRIVATE PRACTIONERS HOSPITALS

• 60% (36) Praivete Practitioners and 44% doctors from hospitals agree that
MRs provide detailed information about the product.

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 Medical representatives need training to interact with the
doctors?

100%
90%
80%
46%
70%
60% NO
53%
50% YES
40%
54%
30%
47%
20%
10%
0% Hospitals Private
hospitals Practioners

47% of Private practioners say that MRs should be provided enough training to
interact with the doctors however, 54% physicians of hospitals say MRs should be
provided with training.

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Result:
Praivate practitioners

Through the survey of health care professionals, we found the following results:

• Medical representatives approach 93% of Private Practitioners.

• 48% of private practitioners find the information helpful which is provided by the
medical representatives and
• 54% of praivate practitioners agree to that MRs do play a very important role in the
promotion of drugs.
• Majority, almost 60% private practioners say that Medical representatives provide
detailed information about the product.
• Pharmaceutical samples and gifts are the major items offered by the pharmaceutical
companies to the private practioners.
• For the private practioners, MRs and internet are the major source of information about
the new drugs.
• 47% doctors think that the Medical Reps need training before interacting with the
physicians.

Doctors from Hospitals

• 35% Physicians from the hospitals are approached by MRs.

• 30% of them say that MRs do play a very important role in the promotion of drugs where
as 48% were not sure with the same.
• Equipments and medical texts are the major items offered by the pharmaceutical
companies to the doctors of hospitals.
• Half of the physicians do agree that the information given by the MRs is helpful.
• For them, MRs and conferences and seminars are the major source of getting information
of new drug.
• 56% doctors think that Medical representatives provide detailed information.
• 54% of them say that Medical representatives need training before interacting with the
physicians.

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 Medical Representatives

How do Medical Representatives approach health care

professionals?

80%
67%
70%

60%
57% 60%
50%
COMPANY's REFERENCE
40%
BY OWN
32%
30% OTHERS
20%
23% 20%
20%
10%
11% 10%
0%
RANBAXY PANACEA Dr. Reddy

Most of the medical representatives approach the doctors through company’s

reference.

Company’s Own Others

Source Reference

Ranbaxy 57% 32% 11%

Dr. Reddy 60% 20% 20%

Panacea 67% 23% 10%

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 DoHealth-Careproffessionalsneed
Training?

27%

YES
63% NO

Yes No

63% 27%

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 Items Offered by the Pharmaceutical Companies for the
promotion of drugs

50%
45%
48%
40% 42%
40%
35%
GIFTS
30%
SAMPLES
31% 29%
25%
MEDICAL TEXTS
20% EQUIPMENTS
15%
15% Conferencesand seminars
15%
17%
10% 12% 15%
10%
5% 8%
8% 10%
0%
0%
PANACEA RANBAXY Dr. Reddy

Company Gifts Samples Medical text Equipments Conferences/

Seminars

Panacea 42% 31% 12% 0% 15%

Ranbaxy 29% 40% 15% 8% 8%

Dr. Reddy 10% 17% 48% 15% 10%

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 Doyou think offersmadeto health care
professionalsinfluencethem?

20%
40%

YES
NO
40% can't say

• 40% of the MRs say that the promotional activities do not influence the doctors and only
20% say that the offers do influence the doctors.

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 Do es your companyprovidetrainingbefore
approachingthe doctors?

8%

YES
NO
92%

92% Medical representatives informed that companies provide training to them before
approaching the doctors.

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Conclusion:

• Medical representatives are the most common tool for the pharmaceutical companies to
approach doctors.
• The doctors find the information helpful provided by the medical representatives.
• However 50% of all the doctors think the medical representatives should be given
training.
• Gifts and samples are the most common items offered by the pharmaceutical companies
to the doctors in private practice while medical text is the most common source for
promotion in the hospitals.
• All the doctors depend on the information provided by the private practitioners.
• All the 3 companies provide References for the medical representatives to aproach the
health care professionals.
• However Ranbaxy and panacea offer gifts and samples more than Dr. Reddy.
• 63% Medical representatives think that the doctors should be given training to interact
with the medical representatives.
• 40% of the Medical Representatives say that the promotional activities do not influence
the doctors and only 20% say that the offers do influence the doctors.
• The medical representatives are given training before approaching doctors.
• Own company regulations- self industry regulations
• Gifts and samples are most commonly offered by the companies which are in the
compliance with the regulations. The Marketing head of Panacea said that the company
offers a spoon to Honda city to the doctor according to his potential. However, according
to Medical council of India, the doctors are not allowed to accept gifts more than
Rs.1000.
• Dr. Reddy sponsors the doctors for educational trips like conferences which has both
positive and negative sides. The positive side is that the company provides pportunities to
doctors to update their knowledge. But on the other hand, it can affect the prescribing
behaviour of the doctors.
39 | P a g e
 • Panacea keeps its Medical representatives updated with the current knowledge as they are
regularly evaluated which shows that the company’s pays attention to the information
which is being provided to the doctors throug MR’s.
• None of the company marketing heads were aware of the regulations being followed.
• Advertisements are not a tool for promotion by any of the company.

Loopholes in the guidelines:

• There is no Specific restriction on value of the gift being offered to the health care
professionals.No specific restriction on frequency of the gift being offered.
• There is no limit on the samples being given to the doctors unlike EFPIA guidelines
according to which only specific number of the samples should be offered to the doctors.
• There is no record-keeping of the gifts which are offered to the health care professionals.

WHO Ethical Criteria states that “promotion in form of financial or material benefits should not
be offered to or sought by HCPs to influence them in the prescription of drugs”. This statement
does not explicitly prohibit the provision of gifts, however by not spelling this out specifically,
the WHO Code could be interpreted to mean that ‘nothing should be given’ as if all gifts are
inducement. OPPI and PhRMA also included similar statement that nothing should be offered as
an inducement to prescribe medicine.
Restriction on the nature/purpose of gifts is strictly followed in US law where as the IFPMA
Code remains quite weak in this issue. OPPI also fails to specify these cultural celebrations. The
IFPMA and the EFPIA leave it up to the national associations to define the specific value of gifts
that are permitted. However, PhRMA sets a maximum of $100 for educational items only.
Both codes and legislation are weak on the issues of ban on stand-alone entertainment. None of
the legislation bans all forms of entertainment. Even EFPIA Code seems unclear on this issue.
However, ABPI seems to be banning all entertainment as they considered such activities as
unprofessional.

40 | P a g e
Indicators WHO IFPMA EFPIA ABPI (UK) PhRMA OPPI (IN)
Ethical (Internationa (EU) 2007 2008 (US) 2008 2007
Criteria l) 2006
1988

Ban Have basic Have basic Have basic Have basic No basic Have basic
inducement standard standard standard standard standard standard
to prescribe

Gifts

Ban all kinds No No No No No No

of gifts

Restriction No specific Weak Stringent Stringent Very No specific

on the guidance guidance guidance guidance stringent guidance
nature/purpos guidance
e of gifts

Specific Does not Does not set Does not Set value Set value Does not
restrictions set a a specific set a for only for only set a
on value specific value specific some kinds some kinds specific
value value of gifts of gifts value

Specific Occasionall Occasionally Occasionall Occasionall Occasionall Occasionall

restriction on y or or infrequent y or y or y or y or
frequency infrequent infrequent infrequent infrequent infrequent

Record- None None None Only All gifts None

keeping certain gifts that add up
(expensive more than
gifts) $100 per
year

Public None None None None All gifts None

disclosure that add up
to >$100
per year

Ban of all Strong Strong No If ban If ban Strong

41 | P a g e
entertainment limitations limitations clarification implicit explicit limitations
on types of on types of on types of
events events events
allowed allowed allowed

RECOMMENDATION
There is a strong need for a strong infrastructure and regulations for the pharmaceutical
companies.So, several key factors to control unethical promotion of prescription drugs can be
made effective through:
• Government regulation,
• Training of students (both before and after graduation)
• Independent monitoring bodies should be established.
• Government and national medicines agencies should take pro-active stances in
monitoring promotional activities since self-regulatory are often misleading or inaccurate
in their promotional practices.
• Attempts should be made to introduce a more effective general consumer’s awareness
program.
• Need improvement on current industry codes particularly the clause on gifts because it is
difficult to define different kinds of gifts. Gifts should be ban as the evidence has shown
that it influences the prescribing behavior of the doctors.
• Research and policy questions to be addressed include the development of effective
methods of educating doctors about drug promotion, the impact of guidelines on
promotional gifts, and the development of effective guidelines for managing conflicts of
interest in research.

LIMITATION:
• There was a gap in the information receivd as all companies were not transparent enough
to discuss all information about their company.

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 • The time duration was less.

REFERENCES

1. Rhein RW. Law enforcement and the Internet superhighwaymen. Scrip Magazine. 1996. Dec:
18-22

2. World Health Organization. Ethical criteria for medicinal drug promotion. Geneva, 1988:5.

3. Henry J. Kaiser Family Foundation, Prescription Drug Trends: A Chartbook, Menlo Park, CA,
July 2000.
4. Alperstein, N. and M. Peyrot, "Consumer Awareness of Prescription Drug Advertising,"
Journal of Advertising Research, July/August 1993, vol. 33, #4 pp. 50-
5. Prevention Magazine, "International Survey on Wellness and Consumer Reaction to DTC
Advertising of Prescription Drugs," Vol. 1, 2000/2001, Emmaus PA: Rodale, 2001.
6. Borzo, G., "Consumer Drug Ads Booming: FDA Reviews Restrictions," American Medical
News, 40(6):1, 37, February 10, 1997.
7. Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002. MCI
Notification dated the 11th March 2002. www.mohfw.nic.in accessed 27thNov.2002.
8. Wazana A. Physicians and the pharmaceutical industry - is a gift ever just a gift? JAMA 2000;
283: 373-380.
9. Curbing unethical drug promotion Thursday, December 01, 2005 08:00 IST
Avijit Chakraborty & Sukumar Ch. Das.
10. Direct-to-consumer advertising of prescription medicines: a review of international policy
and evidence: A report for the Royal Pharmaceutical Society of Great Britain by Colin Meek -
November 2001.
11. Directive 2001/83/ec of the European parliament and of the Council of 6 November 2001 on
the community code relating to Medicinal products for human use Official journal l – 311,
28/11/2004, p. 67 – 128\
12. World Health Organization. Global comparative pharmaceutical expenditures: with related
reference information (Health Economics and Drugs EDM Series No. 3). Geneva, 2000
(Document EDM/PAR/2000.2)
13. Efpia code on the promotion of prescription-only medicines to, and interactions with,
healthcare professionals.
14. IFPMA Code of Pharmaceutical Marketing Practices 2006 Revision
15. CODE OF PRACTICE for the PHARMACEUTICAL INDUSTRY 2008 Edition together
with the PRESCRIPTION MEDICINES CODE OF PRACTICE AUTHORITY

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 Questions for Marketing Heads

1. What are the existing channels for promotion of prescription drugs in India?

2. Which of the above channels has proved the most successful and why?

3. Does your company involve sales representatives in promotion of your

drug?

4. Are the medical repreentatives provided sufficient training?

5. For how much time do you provide training MR’s and what is the proced

6. What all information is provided to the MRs before they can contact health
care professionals?

7. Does your company carryout any evaluations to check for the effectiveness
of drug promotion strategies?

8. Which of the following issues are covered?

i) WHO Ethical criteria for medical drug promotion?

ii) Industry self-regulatory codes?

iii) National Government regulation of drug promotion

iv) IFPMA

v) Others please specify.

44 | P a g e
 QUESTIONARRIE FOR MEDICAL REPRESENTATIVES

All of your answers are strictly confidential and will be

used only for the purpose of this study.

Q.1. Does your company provide any training before approaching the doctors?

YES NO

Q.2.For how long does the training run before you approach the doctors?

Q.3. How do you approach the health care professionals?

a) Company reference

b) By own

45 | P a g e
 c) Others, please specify

Q.4.What all information do you share with the doctors?

Q.5. Do you think doctors are influenced by the promotional incentives?

YES NO

Q.6. Do you think giving incentives increases sales of your company products?

YES NO Can’t Say

Q.7. In your opinion what is the perception of HCPs about gifts or hospitality
offered by the company?

Q.8. Do you think HCP’s need training to interact with the medical
representatives?

YES NO

46 | P a g e
Q.9.Offers made to the doctors by your company.

a) Gifts

b) Samples

c) Medical Texts

d) Equipments

e) Conferences/ Seminars

f) Others

NAME-

PLACE-

COMPANY-

CONTACT NUMBER-

SIGNATURE-

DATE-

47 | P a g e
 QUESTIONNAIRE FOR HEALTH
CARE PROFESSIONALS

All your answers are strictly confidential and will be used only for the purpose
of this study.

Q1. What is your primary speciality?

Q2. Do you participate in clinical research?

YES NO

If YES, What percentage of your working time do you spend on research work?

Q3. Do the medical representatives (MRs) approach you for the Pharmaceutical
products?

YES NO

48 | P a g e
Q4. What is your opinion about the information that MRs provide you about a
pharmaceutical product?

Helpful Not sure Donot agree

Q5. Does MR provide all detailed information about the product including the
positive and negative aspects of the product?

YES NO

Q6. Do you think MRs who approach you are trained enough to provide the
required information regarding their products?

YES NO

Q7. Have you ever refused to meet the Medical Representatives?

YES NO

If Yes, What is your reason for refusal?

a) Too many calls

b) Negative experience with MR in the past

49 | P a g e
 c) Their main goal is marketing d) other

Q8. How often does a Medical Representative approach you?

a) Once every week

b) Once every two weeks

c) Once every 3 weeks

d) Other

Q9. Do you think MR plays an important role in promotion of drugs?

YES NO Can’t say

Q10. Promotion:
Please indicate which of the following have been offered to you by pharmaceutical
companies.

OFFERS

1. Gifts (i.e. pens, prescription pads, etc.)

2. Meals or drinks
3. Entertainment or sporting event tickets

4. Medical texts

5. Medical equipment

6. Equipment
7. Pharmaceutical samples for personal/family use ______________________

8. Other items for personal/family _______________________________________

50 | P a g e
9. Never Offered

Thank you for completing the survey. Please add additional comments, if any.

Comments:
Prescribing behaviour of the physicians is affected by the kind of gifts they are
offered.
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
____________________________________________________________

Place: _____________ Name:

Date: _____________ Signature:

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