Assignment On

Pharmacist's Code of Ethics & Pharmaceutical Marketing

Course Title : Pharmaceutical Regulatory Affairs and Ethics

Course Code : PHARM 5204

Submitted To -

Halima Akter

Lecturer
D Department of Pharmacy
C Comilla University

Submitted By-

Tanvir Ahmed
ID-11515025
Department of Pharmacy
Comilla University

Date of Submission- 17/0

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 INDEX

Serial No Topics Page No

01 Introduction 01

02 Pharmacist's Code of Ethics 01-07

03 Code of Ethics for Pharmaceutical Marketing-

3.1, Pharmaceutical Marketing practice in INDIA 07-24

3.2, Pharmaceutical Marketing practice in USA
3.3, Pharmaceutical Marketing practice in UK
3.4, Pharmaceutical Marketing practice in Canada
3.5, Pharmaceutical Marketing practice in Bangladesh

04 Ways to Improve the Pharmaceutical Marketing 24-25

Practice in Bangladesh

05 Conclusion 25

06 References 26

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 Pharmacist's Code of Ethics & Pharmaceutical
Marketing

1. Introduction:

Pharmacists are an essential part of the healthcare multidisciplinary team. They help to ensure that
medicines are used in the safest and most effective manner. The pharmacists working in various
areas need to maintain or comply with some guidelines or code of ethics. This introduces a
number of ethical complications and a strong need for guidelines to base decisions on that are
centered on moral obligations and virtues.

The pharmaceutical industry is one of the most technologically advanced sectors currently in
existence in Bangladesh. It has grown in the last two decades at a considerable rate in spite of
having many challenges. In order to explore in International market, they also need to follow of
marketing practice or ethics to obtain a balance goal

2. Pharmacist's Code of Ethics

This is a guide to the pharmacists in their relationship with the patients, fellow practitioners and
other health professionals and the public. A pharmacist should realize that ultimate success of the
heal the profession largely depends how effectively the pharmacist has been able to make, store
and dispense the drug to the public.

(1) Pharmacist's prime concern shall be for the welfare of both patients and public.

(a) Safety - (i) The pharmacists should take all reasonable steps to ensure that working
conditions are so arranged that the safety of the public and the people working in the premises
1s protected.
(ii) Dispensing procedures should be adopted which will aim at preventing dispensing errors.
(iii) The pharmacists should not purchase, sell or supply any medicinal product where there is
reason to doubt the safety or quality.
(iv)The pharmacists should excerc1se his professional judgment in controlling the purchase of
unnecessary and excessive quantities of medicines.

(b) Environment - The pharmacists should com ply with the guidelines which are appropriate
to field of work.
All premises where medicinal products are manufactured, stored, sold or supplied should be
maintained in a good state and precaution should be taken against the entrance and harbor of
animals, birds and insects. The premises should be maintained in a clean and tidy condition

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(c) Efficacy of Medical Products - The pharmacists should not give impression to a purchaser
that a medical product is efficacious when he has reason to believe it is not.

(d) Efficient Service to the Community - (i) When providing service • to the community the
pharmacists should ensure that the service is efficient and meets the reasonable needs of those
whom he serves.

(ii) The pharmacists should not substitute any other product for specifically named product even if
he believes that the therapeutic effect and the quality of other products are identical.

(iii) The pharmacists should do everything reasonable within his power to assist a person in need of
emergency medical treatment.

(iv) The pharmacists should not deviate from the practitioners instructions when dispensing the
prescription except when necessa1 y to protect the patient.

(e) The Sale of Medical Products Liable to Abuse - The pharmacists should apply additional
control over• sale 01 medicinal products known to be likely to cause abuse of such products.
(2) The pharmacists shall uphold the honour and dignity of the profession and not engage in
activity which may bring the profession into disrepute.

(a) Honour and Dignity of the Profession - The pharmacists should not bring to the
profession disrepute by acting unlawfully or disregarding the reasonably accepted
standards of behaviour both within and outside his professional practice

(b) Use of Name, Title or Qualification - The pharmacists should not use or permit to use of
his qualifications or his position as a pharmacist to mislead or defraud. He should not
allow others to use his name, qualifications, address or photograph in connection with
the distribution to the public of any medicinal product or the provision of his professional
services.

(3.) The pharmacists shall at all times have regard to the laws and regulations applicable
to pharmaceutical practice and maintain a high standard of professional conduct. The pharmacist
shall avoid any act or omission which would impair confidence in • the pharmaceutical profession.
When a pharmaceutical service 1s provided a pharmacist shall ensure that it is efficient.

(a) Code of Practice - The pharmacists should be aware of and comply with accepted code
of practice relevant to his field of practice.

(b) Professional Responsibility - As an independent practitioner a pharmacist should act

within his professional competence and be personally responsible for his decision.

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 (4) The pharmacists shall respect confidentiality of information relating to patients and
their families. Such information shall not be disclosed to anyone without the patient's or
appropriate guardian's consent except where it is in the patient's interest to do so.

(5) The pharmacists shall keep abreast of the progress of pharmaceutical knowledge in
order to maintain a high standard of professional competence related to his sphere of activity.

(6) The pharmacists shall neither agree to practice under any condition of service which
prevent his professional independence nor impose such conditions on other pharmacists.

(7) Publicity for promotional service is permitted provided such publicity does not create
discrimination between pharmacists and does not bring the profession into disrepute.

(8) Pharmacists at• all times shall endeavor to cooperate with professional colleagues and
members of other health profession so that the patients and public may benefit.

(9) Quality Assurance and Manufacturing

(i) Because of close integration between assurance and manufacturing both activities have
been included in this section. There are however separate rules for pharmacists in quality control
and manufacturing to be carried out independently but in cooperation.

(ii) There should be comprehensive system so designed, documented and implemented and
so furnished with personnel and equipment as to provide assurance that the products will be of
quality appropriate to their intended use. The attainment of that quality objective requires s the
involvement and commitment of pharmacists responsible for both quality control and
manufacturing.

(iii) The objective of quality assurance is achieved when the process has been defined
which when followed will yield a product which complies with its specification, and when the
finished product:

a) Contains the correct ingredients in correct preparations.

b) is of purity required.
c) has been correctly processed according to the defined procedures.
d) is enclosed in the proper container.
e) bears the correct label, stored and distributed so that quality is maintained.

(iv) Quality control pharmacist should achieve effective control of quality by ensuring
that :

a) Adequate facilities and staff are available for sampling for inspection and testing of raw
materials, packaging materials, intermediate bulk and finished products and for the quality of the
environment.
b) Samples of raw materials, packaging materials, finished products• and intermediate
products are taken by personnel using methods approved under the direction .of Quality Controller.

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 c) Result of inspection and testing of materials and intermediate bulk or finished products
are formally assessed against specifications by the quality control before the materials are released
lor use or products are released for further processing, sale or supply; product assessment should
include a review and evaluation of relevant manufacturing documentation.
. d) Sufficient reference samples of products are retained (where possible in final pack) to
permit future examination if necessary,

(v) The pharmacists responsible for manufacturing should implement the basic
requirements of good manufacturing practices by ensuring that:

a) The manufacturing process is designed before commencing of any activity.

b) Necessary facilities and resources are provided including

i. appropriate trained personnel.
ii. adequate premises and space.
iii. suitable equipment.
iv. approved procedures.
v. correct materials.
vi. suitable storage and transport.
vii. store of representative samples of each batch produced.

c) Procedures are written in instructional form in clear and unambiguous language.

d) Operators a e trained to carry out procedures correctly.
e) Records are made during manufacture including packaging to demonstrate that all
steps required by the defined procedures were in fact taken and the quality and the quantity
produced were those expected.
t) Records of manufacture and distribution which enable the history of a batch to be traced
and retained in legible and acceptable form. •
g) A system is available to recall any batch of product should that be necessary.

LAW AND ETHICS COMMITTEE

Its 38th General Meeting, Pharmacy Council of Bangladesh has constituted a committee
entitled Law and Ethics committee to exercise the statutory powers of the Council.

Law and Ethics committee consists of the following members:

1. Dr. A. M. M. Khan: Chairman Ex-officio Vice President, Pharmacy Council of

Bangladesh
2. Dr. Md. Jahangir: Member Ex-officio Director, Directorate of Drugs
administration.
3. Mr. M. K. Choudhury: Member, Pharmacist.
4. [Link] Shahrear Zahedee: Member, Pharmacist.
5. Mr. Fakharuddin Chowdhury: Member, Manufacturing Pharmacist .

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. The responsibilities laid on the Law and Ethics Committee are:

1. To set guidelines for practicing the ethical norms of Pharmacy profession and to
take necessary measures for its implementation.
2. To interpret the aforesaid guidelines and settle differences, if any, pertaining to the
legal and ethical aspects of practicing Pharmacy.
3. To recommend to the regulatory authorities or to Pharmacy Council of
Bangladesh for taking action against establishment or individual as appropriate, at
the event _ of necessity. PMC. (2013, May 13)

3. Code of Ethics for Pharmaceutical Marketing

3.1, Pharmaceutical Marketing practice in INDIA

India does not have a specific law at present that regulates promotion and marketing of drugs and
medical devices by companies before health care practitioners (“hcps”). Advertisement of drugs
and medical devices to end consumers, on the other hand, is heavily regulated.

The Central Government had published a set of guidelines in December 2014 called “Uniform
Code of Pharmaceutical Marketing Practices” (“UCPMP”) as guidance to the industry for
promotion and marketing of drugs and medical devices. However, these guidelines are voluntary
and do not have the force of law, at present.

The government is contemplating a separate code for promotion of medical devices called
Uniform Code for Medical Device Marketing Practices (“UCMDMP”). However, the code has
not yet been finalized. Until UCMDMP is officially published, the UCPMP should be treated as
the official guidance for promotion of medical devices by medical devices companies.

Accordingly, in the paragraphs below, the reference to the word “drug” should be considered as
a reference to “medical device” as well.

In India, the import, manufacture, distribution and sale of drugs and cosmetics are regulated by
the Drugs and Cosmetics Act of 1940 (DCA) and the Drugs and Cosmetics Rules of 1945
(DCR)1.

Advertising and promotion for a certain category of drugs is controlled by the Drugs and Magic
Remedies

(Objectionable Advertisements) Act of 1954 and Rules of 1955. These aim to prevent people
from medication due to misleading or exaggerated advertisements. There are 54 ailments

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covered under this action, including fever. Over-the-counter (OTC) and direct-to-consumer
(DTC) have no legal recognition in India, consequently regulations apply to all drugs that are not
included in the list of prescription-only drugs.

Drugs in the system of traditional medicine, such as Ayurveda, Siddha, Unani and Homeopathy,
are also controlled by the DCA of 1940 and the DCR (1).

Very recently, the Department of Pharmaceuticals formulated a voluntary Code of Marketing

Practice for the Indian Pharmaceutical Industry. The code states that all promotional material
issued by a product authorisation holder must be consistent with the requirements of this Code.
UCPMP, (2017, November)

3.2, Pharmaceutical Marketing practice in USA

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents research-

based pharmaceutical and biotechnology companies. It develops and market new medicines to
enable patients to live longer and healthier lives.

Ethical relationships with healthcare professionals are critical to the mission of helping patients
by developing and marketing new medicines. An important part of achieving this mission is
ensuring that healthcare professionals have the latest, most accurate information available
regarding prescription medicines, which play an ever-increasing role in patient health care. This
document focuses on interactions with health care professionals that relate to the marketing of
products.

Appropriate marketing of medicines ensures that patients have access to the products they need
and that the products are used correctly for maximum patient benefit. Our relationships with
healthcare professionals are critical to achieving these goals because they enable us to:

 inform healthcare professionals about the benefits and risks of our products to help
advance appropriate patient use,
 provide scientific and educational information,
 support medical research and education, and
 obtain feedback and advice about our products through consultation with medical experts.

In interacting with the medical community, they are committed to following the highest ethical
standards as well as all legal requirements. They are also concerned that interactions with health
care professionals not be perceived as inappropriate by patients or the public at large. This Code
is to reinforce our intention that our interactions with health care professionals are professional
exchanges designed to benefit patients and to enhance the practice of medicine. The Code is
based on the principle that a healthcare professional’s care of patients should be based, and
should be perceived as being based, solely on each patient’s medical needs and the healthcare
professional’s medical knowledge and experience.

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Therefore, PhRMA adopted this updated and enhanced voluntary code on relationships with U.S.
health care professionals. PhRMA member companies’ relationships with clinical investigators
and other individuals and entities as they relate to the clinical research process are addressed in
the PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial
Results.

As a proud member of the International Federation of Pharmaceutical Manufacturers and

Associations (IFPMA), the PhRMA Code on Interactions with Health Care Professionals
embodies the principles of the IFPMA Code and we strongly endorse the Ethos of trust that
serves as the foundation for the IFPMA Code and industry’s interactions with the health care
community. . PhRMA Org. (2021, August 6).

3.3, Pharmaceutical Marketing practice in -UK

The ethics of pharmacy practice is an empirical and philosophical study. The empirical research
provides evidence that ethics is present throughout the daily work of pharmacists and paints a
picture of the kinds of ethical problems these are, how frequently they occur, how pharmacists
handle them, and what pharmacists understand ethics to be. These data are useful for
acknowledging that ethics has a significant presence in that pharmacists tend to take a
commonsense approach to ethics in their work.

There is general agreement across community and hospital sectors about which ethically
problematic situations occur most often, except in cases which are sector specific (for example a
community pharmacist would not come across a hospital based situation at work). On the whole
there was agreement across the profession about how ethical problems should be handled. Such a
consensus implies certain attitudes and ethical values are embedded in the culture of pharmacy
practice.

The data in this report provide useful indications of possible trends among pharmacists, but the
quantitative data should not be regarded as statistically representative of the population of UK
pharmacists. Similarly, the qualitative data are useful for gaining insight into pharmacists’
attitudes and beliefs but are not intended to be representative.

The results show that pharmacists currently understand ethics as being a mixture of personal
opinion, peer consensus, cultural influence and institutional rules. Pharmacists take a
‘patchwork’ approach to ethics, relying on a combination of common sense, official guidance,
strict rules, professional obligations, and professional autonomy. One of the strongest themes
emerging from the data was the prominence of institutional rules, and a concern for the interests
of the patient. Pharmacists tend to be dutiful in regard to institutional rules, but are sometimes
willing to break them when the interests of the patient are considered to outweigh the possible
negative consequences of breaking the law. In fact, the majority of pharmacists across the sectors
reported the patient’s health interests as the most important factor to consider when making
ethical decisions.

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It is perhaps not surprising that ethics is a prominent feature in pharmacy practice given the
change in the professional role of pharmacists and the corresponding shift towards being more
patient-centred over the past forty years.2 The important questions to follow will be about how
ethics should be taught to pharmacists, how well pharmacists are dealing with the ethical
problems of their work, and what impact this may have on the services the pharmacy profession
delivers. [Link]. (n.d)

3.4, Pharmaceutical Marketing practice in CANADA

Pharmaceutical promotion in Canada is controlled by two codes: a voluntary one developed by

the Pharmaceutical Advertising Advisory Hoard dealing mostly With printed promotional
material, and Onc from the Pharmaceutical Manufacturers Association of Canada covering other
forms of promotion. This article kooks at enforcement of the provisions of these codes and at
areas in which they are deficient One of the major weaknesses in both codes is their lack of
effective sanctions for companies that violate their provisions. Strong codes are necessary
because many physicians rely heavily on promotional material for their source of prescribing
information. However, involuntary codes or codes developed by the industry are inherently weak
and lack effective enforcement mechanisms. Although the US. Food and Drug

Administration is currently very active in curtmling promotional excesses, govemment control is

not the solution since regulatory action will depend on the ideological position of the head of the
regulatory body and/or the party inpwer. An independent body backed by legislative authority is
preferable.

Although the Food and Drugs Act gives the Canadian federal government the theoretical right to
control the promotion of prescription drugs, in practice, that control has been ceded to the drug
industry and others. Elsewhere (1) I have argued that effective industry control over its own
promotional practices reflects a government—industry relationship termed "clientele pluralism."
This tyEE of relationship occurs under circumstances where the state has a high degree of
concentration of power in one agency (the Health Protection Branch), but a low degree of
autonomy. On the other hand, the association representing all the multinational companies
operating in Canada, the Pharmaceutical Manufacturers

Association of Canada (PMAC), is highly mobilized 10 assume a role in the making and
implementing of drug policy through an elaborate committee structure, the ability to act for its
members, and the capacity to bind member firms to agreements. Lexchin, J. (1994).

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3.5, Pharmaceutical Marketing practice in Bangladesh

Code of Pharmaceutical Marketing Practices (CPMP) is an essential instrument to ensure

the rational use of medicines. Formulation of this Code for Bangladesh will accord a new
dimension to our continued efforts to develop the pharmaceutical services of our country.

1. INTRODUCTION

1.1 The formulation of this Code of Pharmaceutical Marketing Practices has been consequent
upon the initiative of the Pharmacy professionals and realization by the Ministry of Health and
Family Welfare and the Directorate of Drugs Administration to promote and support continuous
development of and strict adherence to the ethical principles and practices with respect to
marketing of pharmaceutical products.

1.2 This Code of Pharmaceutical Marketing Practices has been drawn up by a committee with
the Director of Drugs Administration as the Chairman and the representatives of the following
bodies as the members:

– Pharmacy Council of Bangladesh

– Bangladesh Medical Association

– Bangladesh Pharmaceutical Society

– Bangladesh Pharmaceutical Manufacturers Association

1.3 This Code has been formulated with due consideration to the socio – economic, cultural and
health care context of Bangladesh. The following documents have been considered as references
for the formulation of the Code:

– Ethical Criteria for Medicinal Drug Promotion, WHO, Geneva.

– IFPMA Code of Pharmaceutical Marketing Practices.

– Code of Practice for the Pharmaceutical Industry, Association of British Pharmaceutical

Industries, London.

2. DEFINITION OF CERTAIN TERMS

2.1 “Pharmaceutical Product” means any pharmaceutical or biological product intended for use
either in the cure, mitigation, treatment, prevention or in vivo diagnosis disease in humans, or to
affect the structure or any function of the human body.

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2.2 “Promotion” means those informational and marketing activities, undertaken by a
Pharmaceutical company or with its authority, the purpose of which is to induce the prescribing,
sales, or use.

It includes the activities of representatives and all other aspects of sales promotion in whatever
form, such as journal and direct mail advertising; participation in exhibitions; the use of audio-
cassettes, films, records, tapes and video recordings; the use of view data systems and data
storage devices such as memory discs accessed and reproduced on television apparatus, visual
display units and the like; the provision of samples, gifts and hospitality.

The term “Promotion” does not include to:

i. Replies made in response to enquiries from particular doctors or to replies in response to a

specific communication

ii. Announcements of pack changes, adverse reaction, warnings or recall of products provided
they contain no product claims.

iii. Scientific/clinical papers presented in seminars, scientific films on diseases and their
management shown to the doctors.

iv. “Trade Advertisements” such as catalogues, price lists or other documents issued with a view
to the trade but not containing any reference to product usage other than a generic name and
therapeutic classification.

2.3 The terms “Medical Profession”, “Practice of Medicine”, Practitioner” and “Doctor” should
be interpreted to include health-care professionals duly registered by relevant statutory authority.

2.4 The terms “Medical Representative” means a person whose duties comprise or include
calling upon member of the medical profession for the purpose of promotion of pharmaceutical
products.

OBJECTIVES

3.1 The main objective of the Code of Pharmaceutical Marketing Practices it to support and
encourage the improvement of health care through the rational use of medicinal substances.

3.2 The Code accepts the principle that such information should be presented in a form and by
ways and means which conform not only to legal requirements but also a ethical standards and to
standards of goods taste.

3.3 The Code, therefore, represents an act of self -discipline and appeal to pharmaceutical
manufacturers and distrib utors, the promotion industry, health personnel involved in the
prescription, dispensing, supply and distribution of drugs, universities and other teaching
institutions, professional associations, patient and consumer groups, the professional and general

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media (including publishers and editors of medical journals and related publications), and the
public.

4. PRODUCT LICENSE

4.1 A pharmaceutical product must not be promoted prior to the grant of the product license
authorizing its sale or supply.

4.2 Pre-registration feasibility studies, awareness campaigns or promotional activities of any

other form, may be conducted with prior approval of the licensing authority of the relevant
authorities and that should be confined to a reasonable extent.

5. NATURE L AVAILABILITY OF INFORMATION

5.1 The company concerned shall on request, promptly provide the health professionals with
accurate and relevant information about the pharmaceutical product which the company markets.

5.2 Information about pharmaceutical products should accurately reflect current knowledge or
other responsible opinion and should be based on an up-to-date evaluation of available scientific
evidence and should reflect this evidence clearly..

5.3 Information on pharmaceutical products must be accurate and balanced and must not mislead
either directly or by implication.

5.4 Information must be capable of substantiation, such substantiation being provided without
delay at the request of the relevant person or authority.

5.5 No public communication shall be made with the intent of promoting a pharmaceutical
product as safe and effective for any use before the required approval of the pharmaceutical
product for marketing of such use is obtained

5.6 Particular care should be taken that essential information as to pharmaceutical products’
safety, contra -indications and side effects or toxic hazards in appropriately and consistently
communicated, subject to the legal, regulatory and medical practices of Bangladesh.

5.7 Promotional communications should have medical clearance by the qualified person of the
company as provided for at clause 15.

6. CLAIMS & COMPARISONS

6.1 Claims for a medical product must be based on an up-to-date evaluation of available
evidence and must reflect this evidence accurately and clearly.

6.2 Exaggerated or all-embracing claims must not be made and superlatives must not be used.

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6.3 Any statement about side-effects should be specific and based on data submitted with the
license application or notified to the licensing authority, or on published data to which references
are given. It should not be stated that a product has no side effects, toxic hazards or risks of
addiction.

6.4 The word “safe” must not be used without rational qualification.

6.5 The word ‘new’ should not be used to describe any product or presentation, which has been
generally available for more than twelve months in Bangladesh.

6.6 Comparisons of products must be factual, fair, and capable of substantiation.

6.7 ‘Hanging’ comparatives, which without having any appreciable reason, merely claim that the
product is ‘be tter1, ‘stronger’ etc. must not be used.

6.8 Brand names of products of other companies must not be used unless the prior consent of the
proprietors has been obtained. The ownership of the trade -mark shall be acknowledged.

7. DISPARAGING REFERENCES

7.1 The products or services of other companies should not be disparaged either directly or by
implication.

7.2 The clinical and scientific opinion of members of the medical and allied professions should
not be disparaged either directly or by implication.

8. PRINTED PROMOTIONAL MATERIALS

8.1 A pharmaceutical company should provide the member of the health profession with a data
sheet while promoting the product to him. The content of such data sheet should be approved by
the licensing authority.

8.2 All other printed materials which is issued by the product license holder or with his authority
should comply to the content of the data sheet and must include certain information specified
hereunder in this code.

8.3 (i) Except for “abbreviated advertisements”, as defined in clause 8.4 of this code, the
following information must be given clearly and concisely on printed promotional material:

a. The name and address of the holder of the license, or the name and address of the part of his
business, responsible for the promotion of the product.

b. A quantitative list of the active ingredients, using approved names where such exist, or other
non-proprietary names; alternatively, the non-proprietary name of the product if it is the subject
of an accepted monograph.

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c. At least one authorized indication for use consistent with the data sheet.

d. A succinct statement of the information in the data sheet relating to the dosage and method of
use relevant to the indications quoted in the advertisement and, where not otherwise obvious, the
route of administration.

e. A succinct statement of the side -effects, precautions and contra indications relevant to the
indications in the advertisement; the substance of the relevant information in the data sheet being
given in a concise form.

f. Any warning issued by the Licensing Authority which is required to be included in

advertisements.

8.3 (ii) The information required by Clause 8.3 (i) (d), (e) and (f) must be printed in such type
and in such a position that its relationship to the claims and indications is readily appreciated by
the reader.

8.4 (i) The requirements of Clause 8.3 do not apply in the case of an “abbreviated
advertisement”. An “abbreviated advertisement” is one, the text of which contains in relation to
the product no more than:

a. The brand name of the product.

b. The approved names of the active ingredients, where such names exist, or other non-
proprietary names; alternatively, the non – proprietary name of the product if it is the subject of
an accepted monograph.

c. The name and address of the product license holder, or the name and address of the part of his
business responsible for the promotion of the product.

d. One indication for use, or more than one indication provided that these are in accordance with
the data sheet.

e. A concise statement, consistent with the data sheet, giving the reason why the product is
recommended for such indication or indications.

f. A form of words which indicates clearly that further information is available on request from
the license holder or is to be found in the data sheet relating to the product.

 8.4 (ii) An abbreviated advertisement must always contain the information required by Clause
8.4 (i) (a), (b), (c) a nd (f). The information required by Clause 8.4 (i) (d) and (e) is optional. An
abbreviated advertisement must not include any illustration which is likely to convey any
information about the product or imply claims which are additional to those provided in
accordance with Clause 8.4 (i) (a) to (e) inclusive.

15
8.4 (iii) an abbreviated advertisements directed towards a doctor is permissible only when it
constitutes ad advertisement appearing in a publication sent or delivered wholly or mainly to
doctors..

8.4 iv) An abbreviated advertisement cannot appear as part of another promotional item, such as
in a brochure consisting of a full advertisement for another of a company’s products.

8.4 (v) An abbreviated advertisement is not permissible where the licensing authority has
required a warning to be included in any advertisement relating to the medical product, and/or
the licensing authority has issued a direction that abbreviated advertisements should not be
issued.

8.5 Promotional materials, such as mailings and journal advertisements, must not be designed in
a manner which may obviously defeat its purpose.

8.6 Promotional material should conform, both in text and illustration, to the standards of good
taste and should recognise the professional standing of the recipients

8.7 Doctors’ names, photographs or a prominent portrait must not be used in a promotional
material or in any other way by which any individual doctor may be identified or the ethical code
of the medical profession is contradicted.

8.8 Promotional materials should not imitate the devices, copy slogans or general layout adopted
by other companies in a way that is likely to mislead or confuse.

8.9 Where appropriate, for example e, in technical and other informative material, the date of
printing or the last review should be stated.

8.10 No advertisement included in a journal may consist of more than two consecutive pages.

 8.11 Postcards, other exposed mailings, envelopes or wrappers should not carry matter which
might be regarded as advertising to the lay public or which could be considered unsuitable for
public view.

8.12 Telephone and Telex messages must not be used for promotional purposes.

8.13 In a two page journal advertisement only one page need include the information required by
Clause 8.3 of the Code provided that the other page (except where it faces the page on which the
information is printed) includes a reference, on an outer edge, in at least 8 point type, indicating
where that information appears. Where the two pages of the advertisement are not facing, neither
must be false or misleading when read in isolation.

8. 14 In a multi-page advertisement, the information required by Clause 8.3 of the Code must
appear on one or more continuous pages and where such an advertisement consists of more than
four pages, the advertisement must include a clear indication as to the location of this
information.

16
8.15 Promotional materials should be used within two years of its approval by the licensing
authority. However, fresh approval may be obtained for further use.

REFERENCES TO OFFIC IAL BODIES

Promotional material should not include any reference to the Committees formed by the
government or to the licensing authority, unless this is specifically required by the licensing
authority.

10. ART WORK, GRAPHS, ILLUSTRATIONS ETC.

10.1 Illustrations must not mislead as to the nature of the claims neither comparisons being
made, nor as to the purposes for which the product is used; nor should illustrations distract from
warnings or contra-indications.

10.2 Art work illustrations must conform t o the letter and the spirit of the Code. Graphs and
tables should be presented in such a way as to give a clear, fair, balanced view of the matters
with which they deal, and should only be included if they are relevant to the claims or
comparisons being made.

10.3 Graphs and tables must not be used in any way which might mislead; for example, by their
incompleteness or by the use of suppressed zeros or unusual scales.

11. REPRINT, ABSTRACTS AND QUOTATIONS

11.1 It is only permissible to include in promotional material reasonably brief abstracts of, or
quotations from, articles by members of the medical profession and to include in such materials
reference to doctors names in a bibliography of published works. In no case, however, should
doctors names be used in a prominent manner in promotional material.

11.2 Quotations from medical literature, or from personal communications received from
doctors, must accurately reflect the meaning of the author and the significance of the study.

11.3 Quotations relating to medical products taken from public broadcasts (e.g. audio and
television) and from private occasions, such as medical conferences or symposia, should not be
used without the written permission of the speaker.

11.4 The utmost care must be taken to avoid ascribing claims or views relating to medical
products to authors when such claims or views no longer represent or may not represent the
current views of the authors concerned.

12. DISTRIBUTION OF PRINTED PROMOTIONAL MATERIAL

12.1 Promotional material should only be sent or distributed to those categories of health-care
professionals whose need for; or interest in, the particular information can reasonably be
assumed.

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12.2 Any information designed to encourage the use of medical products in clinics, industrial
concerns, clubs or schools must be addressed to the medical staff only.

12.3 Mailing lists only include those healths -care professionals as defined in this code. Requests
from doctors to be removed from promotional mailing lists must be complied with promptly and
no name may be restored except at the doctor’s request or with his permission.

13. AUDIO -VISUAL MATERIAL

13.1 Audio-visual material qualifying as promotional material must comply with all relevant
requirements of the Code, with the exception of Clause 8.3.

13.2 When audio-visual material is used to promote a product, the information required by
Clause 8.3 (i) of the Code must be provided either by way of a document made available to all
persons to whom the material is played or shown, or to whom it is sent or except in the case of
material which consists of sound only, by way of inclusion as part of the audiovisual material.

13.3 Wherein the information required by Clause 8.3 (i) is provided as part of the audio-visual
material, it must appear visually in or with the advertisement and be of sufficient clarity and
duration that it can be read easily.

13.4 Audio-visual promotional material is subject to the certification requirements of Clause

14. MATERIAL REPRODUCED ON TELEVISION, APPARATUS, VISUAL DISPLAY

UNITS AND THE LIKE

14. (i) Promotional material which is made available to hospitals, doctors, pharmacists etc., by
systems which enable the material to be accessed and reproduced on to television apparatus,
visual display units arid the like, must comply with all relevant requirements of the Code, with
the exception of Clauses 8.3 and 8.14. Such material includes view data systems, memory discs
and the like, but not video-tapes, which come within the scope of Clause 14.

14. (ii) The obligatory information required by Clause 8.3 (i) (a) – (f) must be available through
the system conveying the promotional material and instructions for accessing that information
must be displayed with the promotional material.

14.(iii) Promotional material made available in this way is subject to the certification
requirements of Clause 15.

15. CERTIFICATION OF PRINTED PROMOTIONAL MATERIAL

15.1 No promotional material shall be issued unless the final text and layout have been certified
on behalf of the company by an authorized person in the manner provided by this clause. The
authorized person shall be a pharmacy graduate or a medical graduate. The authorized person
may be a full time employee of the company or retained by the company. The retainer ship of an
individual by more than one company is not allowed.

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15.2 The names of authorized persons, together with their qualifications, shall be notified in
advance to the licensing authority. Changes in the names of the authorized persons must be
promptly notified to the Licensing Authority.

15.3 The certificate shall certify that the signatories have examined the material in its final form
that in their belief it is in accordance with the requirements of the relevant advertising
regulations and this Code of Practice, is consistent with the product license and the data sheet,
and is a fair and truthful presentation of the facts about the product.

15.4 Companies shall preserve all certificates, together with the material in the form certified, for
not less than three years and produce them upon request from the Licensing Authority or the
appropriate committee formed by the government.

15.5 The foregoing procedure shall apply, with the necessary variation, to audio-visual material
prepared by or on behalf of companies in accordance with Clause 13, to promotional material
provided by or with the authority of companies for reproduction on television apparatus, visual
display units and the like in accordance with Clause 14.

16. SUSPENSION OF ADVERTISEMENTS OR PRACTICES

In the event of the Code of Pharmaceutical Marketing Practices Committee (CPMPC) requiring a
company to suspend a practice or the use of an advertisement pending its decision on a complaint
relevant to the safe or proper use of the product; the company shall comply forthwith.

17. MEDICAL REPRESENTATIVES

17.1 Medical Representatives must be adequately trained and possess sufficient medical and
technical knowledge to present information on the company’s products in an accurate and
responsible manner.

17.2 Medical Representatives should at all time maintain a high standard of ethical conduct in
the discharge of their duties.

17.3 The requirements of the Code which aim at accuracy, fairness, balance, and good taste
apply to oral representations as well as printed material.

17.4 Unfair or misleading comparisons must be avoided by Medical Representatives.

17.5 Claims made for products by medical representatives must be limited to the indications
permitted by the product license.

17.6 Medical representatives must not employ any inducement or subterfuge to gain an
interview. No payment of a fee should be made for the grant of an interview.

17.7 Medical representatives must ensure that the frequency, timing and duration of calls on
doctors, or on hospitals, together with the manner in which they are made, do not cause

19
inconvenience. The wishes of an individual doctor, or the arrangements in force at any particular
establishment, must be observed by medical representatives.

17.8 Medical Representatives must take adequate precautions to ensure the security of medical
products in their possession.

17.9 Medical Representatives must not use the telephone to promote products to the medical
profession unless prior arrangement has been made with individual doctors.

17.10 Medical representatives compensation should be such so as not to encourage unethical

practices.

[Link] When discussion about a product is initiated by a medical representative, he should be able
to place before the doctor for reference, on request by the doctor, the approved data sheet of the
product.

17.12 Companies should prepare detailed briefing material for medical representatives on the
technical aspects of any product which the medical representative is to promote. Briefing
material must comply with the relevant requirements of the Code and, in particular, is subject to
the certification requirements of Clause 15.

17.13 Medical representatives should not make a claim for a product based on the regulatory
management of that product, or of competing products, or based on any warnings issued in
relation to other products, unless in accordance with a specific requirement. However, a medical
representative may refer to such matters in answer t o a specific question.

17.14 A company may only employ as medical representatives persons who are graduates in
science and have undergone at least 4 weeks training on the relevant fields.

18. SAMPLE

18.1 Where the company so desires samples of pharmaceutical products may be supplied to the
medical and allied professions to familiarize them with the products, to enable them to gain
experience with the product in their practice, or upon request.

18.2 Free samples for legally available medicines may be provided in modest quantities to the
prescriber.

18.3 Free samples for legally available non -prescription medicines should not be provided to the
general public for promotional purpose. However, subject to the approval of the Licensing
Authority, exceptions may be made with certain categories of medicines, which may be
distributed to the general public or to certain groups of people for promotional purpose. Such
categories of medicines may include nutritional supplements, oral rehydration substances, birth
spacing medicines & devices etc.

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18.4 No samples should be mailed to doctors except in response to a request. Samples which are
sent by post must be packed so as to be reasonably secured.

18.5 Where samples of “Prescription only” products are distributed by a representative, the
sample must be handed direct to the doctor or given to a person authorised to receive the sample
on his behalf. A similar practice must be adopted for products which would be unsafe to use
except under medical supervision.

18.6 Distribution of samples in hospitals should comply with individual hospital regulations, if
any.

IFTS AND INDUCEMENTS

19.1 Subject to Clause 19-2, no gift or financial inducement shall be offered or given to members
of the medical profession for purposes of sales promotion.

19.2 Gifts in the form of articles designed as promotional aids, whether related to a particular
product or of general utility, may be distributed to members of the medical and allied professions
provided the gift is not unreasonably expensive and relevant to the practice of medicine or
pharmacy.

19.3 The requirements of Clause 7.3 or Clause 7.4 do not apply if a promotional aid of the type
mentioned in Clause 19 -2 bears no more than one or more of the following particulars.

(i) The name of the product.

11) The name of the product license holder or the name of that part of his business responsible
for the promotion and/or sale of the product.

(iii) The address of the product license holder or the address of the part of his business
responsible for the sale of product.

IV) An indication that the product name is a trade mark.

19.4 For the promotional and of the type mentioned in clause 19.2 if brand name is mentioned it
must also carry the generic name of the product and the company identity.

20. HOSPITALITY

Entertainment or other hospitality offered to members of the medical and allied professions for
purpose of sales promotion should always be secondary to the main purpose of the meeting. It
should not extend beyond members of the professions.

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21. MARKETING RESEARCH

21.1 Marketing research is the collection and analysis of information and should not be used to
promote ones products to undermine other. The use to which the statistics or information is put
may well be promotional. The two phases should be kept distinct.

21.2 Methods used for marketing research must never be such as to bring discredit upon, or to
reduce confidence in, the pharmaceutical industry. The following provisions apply whether the
research is carried out directly by the company concerned or by organization acting on the
company’s behalf.

21.3 The following information must be made available to the informant at first approach:

(i) The nature of the survey.

(ii) The name and address of the organization carrying out the work.

(iii) The identity of the interviewer.

21.4 Questions intended to solicit disparaging references to competing products or companies

must be avoided.

21.5 Any written or oral statement given or made to an informant in order to obtain co-operation
must be both factually correct and honoured.

21.6 Any incentives offered to the informants should be kept to a minimum and be
commensurate with the work involved.

21.7 Marketing research must not in any circumstances be used as a disguised form of sales
promotion and the research operation must not have as a direct objective the influencing of the
opinions of the informant.

21.8 The identity of an informant must be treated as being confidential, unless he has specifically
agreed otherwise.

21.9 Precautions should be taken to ensure that no embarrassment results for informants
following on from an interview, or from any subsequent communication concerning the research
project.

22. RELATIONS WITH THE GENERAL PUBLIC AND LAY COMMUNICATION

MEDIA

22.1 Requests from individual members of the public for information or advice on personal
medical matters must always be refused and the enquirer recommended to consult his or her own
doctor.

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22.2 Medicines which cannot legally be sold or supplied to the public otherwise than in
accordance with a prescription, or which are legally limited to promotion for sale or supply only
on prescription, must not be advertised to the general public.

22.2 (a) Pharmaceutical products may be classified as :

(i) Prescription only medicines, and

(ii) Over the counter drugs.

The licensing authority will determine the classification of a product. Advertisement to the
general public in lay press may be permitted for over the counter medicines subject to prior
approval of the licensing authority.

22.3 Statements must never be designed or made for the purpose of encouraging members of the
public to ask their doctor to prescribe a particular product.

22.4 Information about medical products or matters related thereto, including scientific
discoveries or advances in treatment, should not in general be made available to t he general
public either directly or through any lay medium.

22.5 The importance of such information and the existence of legitimate public interest in
acquiring it may exceptionally justify holding a press conference or the issue of a press release.

22.6 A further exception may be acceptable when there exists a genuine mutual interest of a
financial or commercial nature justifying the disclosure of information about medical product or
related matters privately or to a restricted public. Examples are the interests of shareholders,
financial advisers, employees and creditors.

22.7 On all occasions the information whether written, or communicated by other means, must
be presented in balanced way so as to avoid the risk of raising unfounded hopes of successful
treatment or stimulating the demand for prescription of the particular product.

22.8 An announcement of the introduction of a new medical product must not be made by press
conference or formal press release until the appropriate steps have been taken to inform the
medical profession of its availability.

23. INTERPRETATION AND IMPLEMENTATION

23.1 The Code of Pharmaceutical Marketing Practices Committee (CPMPC) shall be formed by
the Ministry of Health and Family Welfare to execute periodic updatation of this Code and to
monitor its proper implementation. The CPMPC will settle any dispute arising out of the
provisions of this code, with the intent to provide interpretation and to decide on subject of such
dispute.

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23.2 The composition of the Code of Pharmaceutical Marketing Practices Committee (CPMPC)
shall be as follows:

1. The Director Chairman

Directorate of Drugs Administration

Representatives of the following organisations as the Members :

2. Bangladesh Medical and Dental Council Member

3. Pharmacy Council of Bangladesh Member

4. Bangladesh Association of

Pharmaceutical Industries Member

5. Bangladesh Pharm. Society Member

6. Bangladesh Medical Association Member

7. Deputy Director Drugs Administration Member Secretary

24. OPERATIVE DATE

The Code of Pharmaceutical Marketing Practices (CPMP) shall take effect on April 1, 1994.
Hasan, C. (1994, January)

4. Ways to Improve the Pharmaceutical Marketing Practice in Bangladesh

Marketing is the process by which companies create value for customers and build strong
customer relationships in order to capture value from customer in return. Marketing is the
backbone of all industries

1. Policies related to pharmaceutical sectors need to be in the right direction to keep on

encouraging this potential sector. The challenges hardening the way are ought to be identified
and necessary initiatives should be taken to help the sector emerge as a very thriving one tapping
the vast international market and earning bounties in foreign currencies.

2. API/Raw Material Production Plant: The major advancement of Bangladesh

pharmaceutical sector has been occurred only in the production of finished products.
Manufacturing of pharmaceutical products are vastly dependent on imported raw materials, as

24
almost 90% of raw materials are now being imported. This dependency on imported raw
materials is resulting in increased production cost of the finished products. Ultimately the
competition to offer export prize is becoming tougher, which is one of the major challenges of
pharmaceutical sector of Bangladesh.

3. Bioequivalence study of a product is a must for the registration of that product in many of the
moderately regulated and regulated countries of the world. There is no standard facility for
bioequivalence study in Bangladesh. In order to register a product, a pharmaceutical company
has to carry out this test in foreign country by spending of a huge charge. For this reason, many
pharmaceutical manufacturers don’t show interest to register their products in foreign countries
that require Bioequivalence study

4. Major limitation of drug control authority of Bangladesh that also affects pharmaceutical
export is unavailability of a modern, well equipped drug testing laboratory (DTL) with the
engagement of sufficient and skilled pharmaceutical scientists. Due to
lack of this, our drug control authority cannot monitor the quality of drugs manufactured by
different pharmaceutical companies in Bangladesh.

5. To register pharmaceutical products in regulated markets it requires highly standardized

documents.

6. Establishing Export cell by the govt./private Consultancy firms may promote Pharma export.

7. Conclusion: The goal of this thesis is to evaluate the evolution of pharmaceutical marketing
strategies since the beginning of the industry and how these marketing aspects could change in
the future. By elaborating on the historical timelines of the drug industry with reference to the
case studies of Aspirin, Valium and Lipitor, this report establishes that the pharmaceutical
industry has evolved so much in regard to its business dynamics, brand positioning and elements
of the promotional mix

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PMC. (2013, May 13)Pharmacy Council of Bangladesh rahat tower ... - [Link]..
Retrieved May17,2022, from
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e5ccaae5_0f7e_ 049_b3dd_7c7ab1e3de25/2021-04-06-03-33-
[Link]

. UCPMP,(2017, November) Uniform Code for Pharmaceutical Marketing Practices Decoded.

Uniform code for pharmaceutical marketing practices decoded. Retrieved May 17, 2022,
from [Link]
for-Pharmaceutical-Marketing-Practices_Decoded.pdf

Code on interactions with health care professionals. PhRMA Org. (2021, August 6).
Retrieved May 17, 2022, from [Link]
Interactions-with-Health-Care-Professionals

Pharmaceutical ethics - [Link]. (n.d.). Retrieved May 17, 2022, from

[Link]
Pharmaceutical-ethics%20(1).pdf

Lexchin, J. (1994). Section on the pharmaceutical industry - [Link]. Retrieved May 17,
2022, from [Link]

Hasan, C. (1994, January). Code of pharmaceutical Marketing - researchgate Retrieved

May 17, 2022, from
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_Practices

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