Assignment on Code of Pharmaceutical Marketing Practices in BANGLADESH

Assignment on Code of Pharmaceutical Marketing Practices in BANGLADESH

Executive Summary :

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.

Formulation of any policy or code of practices is not so difficult a task as it is to ensure its proper implementation. The responsibilities for the appropriate practice of this Code is mainly attributable to the pharmaceutical manufacturers of our country and I am positive that they will shoulder this noble responsibility as one of their major objectives. I am also confident that the doctors and the pharmacists of Bangladesh will assure necessary professional compliance to the spirit of this Code.

The Code of Pharmaceutical Marketing Practices, like any other such document, will require regular updatation in keeping with the developments in the health care sector. I hope that this important task would be taken care of in the future by the concerned organizations.


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.


2.1 “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.

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, whether of enquiry or comment, including letters published in a medical journal.

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.


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.

The Code emphasizes the importance in the public interest of providing the health professionals (doctors, pharmacists, nurses as relevant) with accurate, fair and objective information on 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 media (including publishers and editors of medical journals and related publications), and the public.

To use these criteria as appropriate to their spheres of competence, activity and responsibility.

To adopt measures based on these criteria as appropria te, and monitor and enforce their standards.


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.


5.1 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. Claims should not be stronger than such evidence warrants. Every effort should be made to avoid ambiguity.

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. However, this provision is not intended to abridge the right of the scientific community and the public to be fully informed concerning scientific and medical progress. It is not intended to restrict a full and proper exchange of scientific information concerning a pharmaceutical product, including appropriate dissemination of investigational findings in scientific or lay communications media, nor may to restrict public disclosure to stockholders and others concerning any pharmaceutical product as be required or desirable under law, rule or regulation.

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.


6.1 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. Claims should not imply that a medical product, or an active ingredient, has some special merit, quality or property unless this can be substantiated.

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, or any therapeutic indication, which has been generally promoted, for more than twelve months in Bangladesh.

6.6 Comparisons of products must be factual, fair, and capable of substantiation. In presenting a comparison, care must be taken to ensure that it does not mislead by distortion, by undue emphasis, or in any other way.

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.


7.1 The products or services of other companies should not be disparaged either directly or by implication. Substantiated comparative claims inviting fair comparisons with a group of products or with other products in the same field are permissible, provided that such claims are not presented in a way which is likely to mislead, whether by distortion, undue emphasis or otherwise.

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


8.1 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.

c. At least one authorised 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.

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. A loose insert included in such a publication cannot be an abbreviated advertisement.

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. Relevant human figures and photographs may be used in promotional materials subject to approval of licensing authority. Such illustration should respect the radiation, culture and social values of the people of Bangladesh.

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.

Where an advertisement consists of a double -sided insert in a journal, neither side must be false o r 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.

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.


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.


10.1 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.


11.1 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.


12.1 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.

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.


13.1 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. (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.


15.1 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.

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.


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.


17.1 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 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.

I7.ll 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.


18.1 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.

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.


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.


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. The level of hospitality should be appropriate and not out of proportion to the occasion;


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 an organisation 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 organisation 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.


22.1 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.

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.

Invitations to attend such a conference, or the distribution of such a press release, should be confined to persons who are qualified either in medical, pharmacy or nursing profession, or established as the representatives of the medical, pharmaceutical or scientific press, or as the medical correspondents of a responsible medium.

In the circumstances set out above as to the significance of the information, and in response to an unsolicited enquiry from a person of the standing described, information may also be released in an informal manner.

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.


23.1 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.

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


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