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Bangladesh Journal of Bioethics 2018; 9 (3): 1-10 

 

 

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Pharmaceutical Promotion in Bangladesh: Assessing the Strength of 
Regulatory Documents  
 

Fatema Johora1* and Md Sayedur Rahman2 

 

1. Assistant Professor, Department of Pharmacology, Army Medical College Bogura, Bogura Cantonment, 

Bangladesh. Email: fatemajohora.0801@gmail.com; Orcid id: http://orcid.org/0000-0002-9030-5224 
2. Professor, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. 
Email: srkhasru@bsmmu.edu.bd ; Orcid id: https://orcid.org/0000-0002-5960-0161  

 

Corresponding Author: Fatema Johora, Email: fatemajohora.0801@gmail.com 

 
Abstract: Pharmaceutical promotion is a negative influencing force for prescribing. However, 

very few regulatory initiatives are taken to overcome this unwarranted influence. The present 

research was conducted in such context with an attempt to review the regulatory documents 

related to pharmaceutical promotion in Bangladesh including Code of Pharmaceutical Marketing 

Practices (CPMP), and to compare CPMP with different global guidelines. The studied 

guidelines demonstrate effort to regulate promotion, though that varies to a great extent, 

particularly in enforcement aspects. Clearly defined ethical and legal prohibitions, provisions of 

punishment for violations and entrusted agency with defined authority are crucial.  

    

Key Words: Ethical pharmaceutical promotion, Code of Pharmaceutical Marketing Practices, 

Drug Policy, Laws, Regulation of promotion, Bangladesh situation  

    

Background: Pharmaceutical promotional 

activities- issue of concern from the very 

beginning and are highly successful to alter 

physicians’ prescribing habit [1]. The impact 

of promotion on physicians prescribing 

practice is enormous, ranging from the 

selection of inappropriate, unnecessary, 

costly medicine to low prescribing quality [2-

3]. Frequent interactions with industries and 

positive attitudes towards them have been 

related with less evidence-based prescribing 

of physicians [4]. And Weak control over 

promotional activities has been linked to 

poor prescribing [5]. There are lots of 

controversies and no resolution or consensus  

 

yet achieved towards this direction. Various 

interventions have been taken  throughout 

the world to control and regulate 

pharmaceutical promotional activities [2], [5]. 

International Federation of Pharmaceutical 

Manufacturers & Associations (IFPMA) and 

World Health Organization (WHO) acted as 

pioneers to introduce and develop guidelines 

to support and encourage the improvement 

of healthcare through rational use of 

medicinal drug. In many countries, national 

guidelines exist, which usually specify that 

the promotional information should be 

accurate, complete and good in taste. 

Guidelines also cover the use of samples, 

gifts and participation in promotional 



Bangladesh Journal of Bioethics 2018; 9 (3): 1-10 

 

 

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conferences as well as in clinical trials [6-8]. 

However, mere presence of guidelines is not 

sufficient to control promotion [9-10].  

The market size of pharmaceuticals in 

Bangladesh is around US$ 1.68 billion [11]. 

276 companies have marketed around 27000 

products in our country [12] and 

pharmaceutical companies conduct 

promotional activities to increase market 

share of their products. From time to time, 

Bangladesh formulated several policies, acts 

and code to promote rational use of 

medicine. In 1994, Code of Pharmaceutical 

Marketing Practices (CPMP) was approved 

to promote and support continuous 

development of and strict adherence to the 

ethical principles of marketing of 

pharmaceutical products [13-14]. The present 

study has attempted to explore current 

regulatory documents regarding 

pharmaceutical promotion and compare with 

global documents in this particular issue. For 

analyzing national regulatory documents of 

Bangladesh regarding pharmaceutical 

promotion, following related policy and 

regulatory documents of Bangladesh were 

reviewed- National Drug Policy 1982, The 

Drug (Control) Ordinance, 1982, National 

Drug Policy, 2005, The Consumer Rights 

Protection Act, 2009, and Code of 

Pharmaceutical Marketing Practice, 1994. 

Later, During selection of national 

guidelines, two countries from high income 

group, two from the middle income group 

and two from the low income group were 

selected. National guidelines/ code of 

conducts of Australia (Medicines Australia 

‘Code of Conduct’), United Kingdom (ABPI 

‘Code of Practice for Pharmaceutical 

Industry’), Malaysia (PhAMa ‘Code of 

Conduct’), India (‘Uniform Code of 

Pharmaceuticals Marketing Practices’), 

Nepal (Guidelines on Ethical Promotion of 

Medicine) and Zimbabwe (Advertising 

Guidelines) were analyzed and reviewed in 

order to evaluate status of ambiguity and 

inadequacy of the existing Code of 

Pharmaceutical Marketing Practices of 

Bangladesh. 

Regulation of Pharmaceutical Promotion 

Around the World: IFPMA published 

‘IFPMA Code of Pharmaceutical Marketing’ 

in 1981 to regulate the promotional activity 

of pharmaceutical industries, and 

extensively revised in 2006 and 2012 [6]. 

This code is now considered as an 

international model for effective 

development of local codes. It is a 

requirement of IFPMA membership that the 

member associations acknowledge and 

adhere to the conditions of the IFPMA 

Code. In addition, they need to adopt codes 

that meet local requirements, which are 

consistent with and as comprehensive as the 

IFPMA Code [15]. 

WHO published ‘Ethical Criteria for 

Medicinal Drug Promotion’ in 1988 [7]. And 

this was intended as guidance for countries 

to use when developing their regulations and 

practices around medicinal drug promotion. 

The document is still used by regulators, 

governments, and academics as a yardstick 

for measuring the acceptability of 

promotional activities. WHO guidance 

document is particularly playing important 

role in countries where local regulation is 

absent or insufficient [5]. 

In most of the countries, pharmaceutical 

promotion is regulated through self-



Bangladesh Journal of Bioethics 2018; 9 (3): 1-10 

 

 

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regulation approach. Under self-regulation, 

government is the legislative authority to 

control promotion in some or all aspects 

along with national industry associations. 

These associations voluntarily formulate 

their own codes or guidelines, and the 

members of the associations are obliged to 

follow these. In this approach, monitoring of 

promotion has been maintained by the 

complaint system, from both physicians and 

competing companies, and publication of 

complains. Issuing a corrective 

advertisement, withdrawal of promotional 

materials, fines or expulsion from the 

association and publication of sanctions are 

used to control promotional activities. 

Government can take steps, only if serious 

violations occur. Australia, Sweden and the 

UK are examples of self-regulation approach 
[5], though the success of this approach is not 

out of question [16].   

In Australia, promotional activities of 

pharmaceutical industry were strictly 

controlled and regulated by both government 

and national industry association, and 

industries were repeatedly fined for 

violations of code of conduct [17].  

The Pharmaceutical Association of Malaysia 

(PhAMA) adopted “Code of Pharmaceutical 

Marketing Practices” in 1978, for self-

regulation of pharmaceutical marketing and 

promotion in Malaysia. This includes 

separate codes of conduct for prescription 

and OTC products. The codes has been 

amended from time to time [18], though the 

effect of this regulatory framework was 

never evaluated. 

In India, Department of Pharmaceuticals 

introduced “Uniform Code of 

Pharmaceutical Marketing Practices” in 

2014 to detect and stop malpractices in 

pharmaceutical marketing and/or promotion, 

which includes provision prohibiting gift to 

physicians [19]. Beforehand, Organization of 

Pharmaceutical Producers of India (OPPI) 

introduced “Code of Pharmaceutical 

Practices”, which was the guideline for 

pharmaceutical industry [15]. 

Nepal is a country where domestic 

pharmaceutical companies share only 35% 

of the total market and remaining portion is 

met through import. In 2007, Department of 

Drug Administration (DDA) of Nepal 

introduced “Guidelines on Ethical 

Promotion of Medicine” to encourage 

ethical promotion of medicine. The same 

department is authorized to regulate 

promotion and/or advertising of medicines. 

Yet, there is no national code of conduct 

concerning advertising and promotion of 

medicines formulated by the industries [20]. 

Nevertheless, Harper et al. [21] revealed 

significant presence of unethical promotion 

in Nepal. 

In Zimbabwe, 14 domestic pharmaceutical 

manufacturers share 47% of market. 

Transnational (TNCs) innovator and generic 

competitor companies have no direct 

presence in Zimbabwe. They are all 

represented either by distributors or 

wholesalers and there are 104 

pharmaceutical wholesalers who are 

permitted to import. Medicine Control 

Authority of Zimbabwe (MCAZ) introduced 

“Advertising Guidelines for Medicine” in 

2011, which includes promotional materials 

but does not mention anything about other 

forms of promotional activities [22]. Another 

related regulatory guideline named 



Bangladesh Journal of Bioethics 2018; 9 (3): 1-10 

 

 

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“Medicine and Allied Substances Control 

Act” was found ineffective to control and 

regulate drug advertisements [23].  

The USA and France are among the few 

countries where government directly 

regulates pharmaceutical promotion. US-

FDA by its Office of Prescription Drug 

Promotion (OPDP) regulates pharmaceutical 

promotion. OPDP regulates and monitors 

promotional activities. Also, by 

administering OPDP Bad Ad Program, 

OPDP educate healthcare providers to 

recognize misleading promotion. 

Enforcement was done by notices of 

violation, warning letters injunction, consent 

decree seizures and criminal action, civil and 

monetary penalties [24]. The big 

pharmaceuticals were repeatedly fined and 

penalized in billions for illegal off-label 

marketing of drugs and paying kickbacks to 

healthcare professionals to encourage them 

to prescribe promoted drugs. But the 

financial penalties were actually a small 

amount in comparison to company profits 
[25].Later on, an act named ‘the Sunshine 

Act’ was passed in 2010 as part of the 

“Affordable Care Act” that requires 

manufacturers of drugs, devices, biologicals 

and medical supplies to report annually 

every payment and other transfers of value 

to physicians and teaching hospitals [26]. A 

project supported by ProPublica provided a 

unique opportunity for every citizen of the 

USA to know their doctor’s financial 

relationship with industry through a program 

titled ‘Dollars for Docs’ [27].  

Regulation of Pharmaceutical Promotion 

in Bangladesh: Current laws and the Code 

of Pharmaceutical Marketing Practices 

provide the regulatory framework for the 

control of advertising and promotion of 

medicines in Bangladesh. Code of 

Pharmaceutical Marketing Practice (CPMP) 

was developed according to global standards 

including the WHO Ethical Criteria for 

Medicinal Drug Promotion, IFPMA Code of 

Pharmaceutical Marketing Practices, and 

ABPI Code of Practice for the 

Pharmaceutical Industry [13]. Studies [14, 28] 

found that the Code of Pharmaceutical 

Marketing Practices (CPMP) was ineffective 

in improving the quality of information 

provided in advertisement published in 

medical journal as well as in pharmaceutical 

promotional literature. In 2010, WHO and 

later on, USAID-funded Systems for 

Improved Access to Pharmaceuticals and 

Services (SIAPS) program explored the 

regulatory framework for pharmaceutical 

promotion, specified the weaknesses and 

recommended some changes [13], [29].  

Table I. Review Regulatory Documents of 

Bangladesh Related to Pharmaceutical Promotion 

 

Indicators National 

Drug 

Policy 

1982 

Drug 

Control 

Ordinance 

1982 

National 

Drug 

Policy 

2005 

Consumer 

Protection 

Act 2009 

Code of 

Pharmaceutical 

Marketing 

Practice 

1994 

Form of 

promotion 

Not 

stated 

Not 

stated 

Not 

stated 

Not 

stated 

Clearly 

defined 

Monitoring 

of 

promotion 

Not 

stated 

Not 

stated 

Not 

stated 

Not 

stated 

Not stated 

Interpretati

on and 

implementa

tion 

procedure 

for 

regulation 

of 

promotion 

Not 

stated 

Clearly 

defined 

Not 

stated 

Not 

stated 

Not stated 



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Table II. Structured Review of National guidelines and Code of Conducts about ‘background 

information’ and ‘form of promotion’ 

Points Bangladesh Australia UK India  Malaysia Nepal Zimbabwe 

A.Background 

information 
       

i)Edition 1 18 16 3 19 1 1 

iii)Types of 

regulation 

Govt. Self Self Self Self Govt. Govt. 

iii)Regulatory 

body 

DGDA TGA, MA  MHRA, 

ABPI 

CDSCO, 

OPPI 

MAB, 

PhAMA 

DDA MCAZ 

B.Form of 

promotion 

       

i)Printed 

promotional 

materials 

       

a)Standards of 

information 

Clearly defined Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

b)Text/ Font size Ambiguously 

defined 

Clearly 

defined 

Not 

mentioned 

Not mentioned Clearly 

defined 

Not mentioned Not mentioned 

ii)Gift        

a)Types of gift 

allowed 

Clearly defined Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Not mentioned Not mentioned 

b)Types of gift 

prohibited 

Not mentioned Clearly 

defined 

Clearly 

defined 

Not mentioned Clearly 

defined 

Not mentioned Not mentioned 

c)Monetary value 

of gift 

Not mentioned Not 

mentioned 

Clearly 

defined 

Not mentioned Clearly 

defined 

Not mentioned Not mentioned 

iii)Sample        

Quantity of 

sample 

Not mentioned Clearly 

defined 

Clearly 

defined 

Not mentioned Not mentioned Not mentioned Not mentioned 

iv)Symposia & 

other scientific 

meeting 

Not mentioned Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

(prohibited) 

Clearly 

defined 

Clearly 

defined 

Not mentioned 

v)Hospitality Not mentioned Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

(prohibited 

Clearly 

defined 

Clearly 

defined 

Not mentioned 

 

ABPI: The Association of the British Pharmaceutical Industry; CDSCO: Central Drug Standard Control Organization; DDA: Department 

of Drug Administration; DGDA: Directorate General of Drug Administration; MA: Medicine Australia; MAB: Malaysia Advertisement 

Board; MCAZ: Medicine Control Authority of Zimbabwe; MHRA: Medicines and Healthcare Products Regulatory Agency; OPPI: 

Organization of Pharmaceutical Producers of India; PhAMA: Pharmaceutical Association of Malaysia; TGA: 

Therapeutic Good Australia. 

 

 



Bangladesh Journal of Bioethics 2018; 9 (3): 1-10 

 

 

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Table III. Structured Review of National guidelines and Code of Conducts about ‘systems 

required for monitoring of promotion’ and ‘systems required for enforcement of regulation 

of promotion’ 

 

Points Bangladesh Australia UK India  Malaysia Nepal Zimbabwe 

C.Systems 

required for 

monitoring of 

promotion 

       

i) Governmental 

system for 

monitoring 

Not mentioned  Not 

mentioned 
Not 

mentioned 
Not mentioned Not mentioned Not mentioned Not mentioned 

ii)Mechanism of 

monitoring 

Not mentioned  Clearly 

defined 

Clearly 

defined 

Not mentioned Not mentioned Not mentioned Not mentioned 

ii i)Body 

responsible for 

monitoring 

Not mentioned  Clearly 

defined 
Clearly 

defined 

Not mentioned Not mentioned Not mentioned Not mentioned 

iv)Complaint 

system 

Not mentioned  Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Not mentioned Clearly 

defined 

V)Publications of 

complaints 

Not mentioned  Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Not mentioned Clearly 

defined 

D.Systems 

required for 

enforcement and 

regulation of 

promotion 

       

i)Responsible 

body for 

enforcing and 

regulation of 

promotion 

Clearly defined Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

ii)Sanctions Not mentioned Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Not mentioned Not mentioned 

iii)Publication of 

sanctions 

Not mentioned Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Not mentioned Not mentioned 

iv)Appeal 

mechanism 

Not mentioned Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Clearly 

defined 

Not mentioned Not mentioned 

 

Policy and Regulatory Documents of 

Bangldesh in Context with Global 

documents: : : : In 2011, the Medicines 

Transparency Alliance (MeTA) and the 

Health Action International (HAI) global 

Program, under the guidance of an advisory 

group of international experts, has 

developed a methodology to help countries 

gain an overview of the national regulatory 

framework regarding medicines promotion, 

and a ‘data compilation tool’ has been 

developed [30]. This data compilation tool 

was divided into four categories 

(background information, scope of 



Bangladesh Journal of Bioethics 2018; 9 (3): 1-10 

 

 

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regulation, monitoring of promotion and 

enforcing medicine promotion).  As these 

national guidelines and code of conducts 

were drafted on the socio-economic and 

cultural background as well as setting and 

market size of pharmaceutical industry of 

those particular countries, selected indicators 

(background information, forms of 

promotion, systems required for monitoring 

and regulation for enforcement) of 

HAI/MeTA ‘data compilation tool’ were 

used to review them. And findings were 

categorized as ‘not mentioned’, ‘ambiguous’ 

and ‘clearly defined’. 

In Bangladesh, Code of Pharmaceutical 

Marketing Practices is the only regulatory 

document to address pharmaceutical 

promotion although interpretation and 

implementation procedure was only clearly 

defined in Drug Control Ordinance 1982 

(Table I). Countries like Australia, Malaysia 

and UK regularly updated their regulatory 

framework, whereas CPMP of Bangladesh 

was never updated after introduction (Table 

II). A recent study revealed that majority of 

the physicians and medical representatives 

of Bangladesh are not aware about the 

existing CPMP, and the conflicting 

relationship between physician and 

pharmaceutical industry was labeled as 

‘unholy alliances’ [31]. The national 

guidelines have tried to guide or regulate 

pharmaceutical promotion, which is an 

indirect acknowledgment about it’s 

detrimental influence. The studied 

guidelines demonstrate that there was effort 

to regulate promotion and bring those 

activities under the framework of scientific 

justification. This study revealed that the 

regulatory measures of different countries 

particularly differ in enforcement aspects 

(Table III). Among the documents, presence 

of clear directive for punishment in case of 

unethical promotion varies greatly among 

countries. In countries like Australia and 

UK, in every occasion, there are some 

instructions and provisions in the documents 

that prohibit the industry from doing certain 

activities and there are definite punishments 

mentioned in the laws and regulations in 

case of violations. In addition to those laws, 

different countries adopted special measures 

like Sunshine Act in USA [32] and voluntary 

reporting by competing companies and 

healthcare professionals or consumers in 

Australia. Moreover, the monitoring 

approaches are found to be effective because 

of existence of supporting laws to ensure the 

punishment for violations [33].  

The present study found that the frameworks 

of Bangladesh, India, Malaysia, Nepal, and 

Zimbabwe only mentioned the areas but the 

authority of the entrusted agency after 

identifying any violation was not defined 

(Table II and Table III). This deviation is 

crucial because whether there is 

commitment of the relevant bodies stated in 

the document or not, whether specific 

activities are referred as prohibited or not, 

whether some appropriate criteria are 

mentioned in the document or not, more 

importantly whether the violating industry 

will be punished or not, and finally whether 

the regulatory authority is authorized to 

punish the case of violation are the key 

determinant for the regulation of 

pharmaceutical promotion in any country. If 

these are not mentioned clearly in the 

regulatory documents and are not supported 

by law, actually these documents are not that 



Bangladesh Journal of Bioethics 2018; 9 (3): 1-10 

 

 

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effective [34]. Possibly, this incompleteness 

of regulatory frameworks responsible for 

weaker enforcement. 

 

Conclusion and Recommendations: The 

regulatory frameworks to control 

pharmaceutical promotion vary to a great 

extent from country to country. Clearly 

defined prohibitions, specific legal 

provisions for violations and entrusted 

agency with defined authority to punish in 

case of violations are absent in the related Code 

of Bangladesh. Code of Pharmaceutical 

Marketing Practices of Bangladesh requires 

updating which should include the limit of 

acceptance of gift or other support from the 

industry along with specific prohibitions and 

legal provision of punishments for 

violations. 

 

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Conflict of interests:  Md Sayedur Rahman was one 

of the contributors of Code of Pharmaceutical 

Marketing Practices. Researchers got funding from 

Research Grants Committe of Bangabandhu Sheikh 

Mujib Medical University. 

Author Contributions 

1st author conceive the idea, done literature review 

and wrote the manuscript. 2nd author guide to the 

conception of idea, manuscript writing and check the 

manuscript meticulously 


