Challenges of Entering New 

Pharmaceutical Markets in Nigeria and 

Ghana 

 

Thato Sebabatso Motshoane 

Student number 2398759 

 

A thesis presented to the Faculty of Commerce, Law and 

Management, University of the Witwatersrand, in partial fulfilment 

of the requirements for the degree of Master of Business 

Administration. 

 

Johannesburg, 2024 

Protocol number: WBS/BA2398759/357 



i 
 

DECLARATION 

I, Thato Motshoane, hereby declare that this research article titled ‘Challenges of 

entering new pharmaceutical markets in Nigeria and Ghana’ is of my own creation. I 

have cited and acknowledged all ideas and concepts that I have come across. This 

serves as my partial submission to the University of the Witwatersrand, Johannesburg, 

for the Master of Business Administration degree requirements. This thesis was not 

previously submitted to another University for an assessment or a degree. 

 

…………………………….. 

Thato Sebabatso Motshoane 

Signed at Johannesburg 

27 February 2024 

  



ii 
 

ACKNOWLEGEMENTS 

I take this opportunity to express my gratitude and acknowledge all the individuals 

listed below for their unwavering support: 

• Dr Emmanuel Quaye, my supervisor, for his guidance, recommendations, and 

support 

• My sponsor, Organon South Africa, WBS staff and syndicate members for my 

incredible journey at the Wits Business school 

• Organon South Africa, Roche Nigeria and PharmaSymbiosis (Ghana and 

Nigeria) respondents for their time and value insights 

• My mother, family and best friend for their unwavering support and 

encouragement. 

  



iii 
 

SUPPLEMENTARY INFORMATION 

Nominated journal: BMJ Global Health Management Journal  

Supplementary files: Interview  

Supervisor: Dr Emmanuel Quaye 

Word count: 20708 

  



iv 
 

ABSTRACT 

Background: The pharmaceutical market is renowned for its stringent regulations and 

continuous production of superior drugs and products intended for human 

consumption. This study investigates the regulatory landscape of two African 

countries, namely Nigeria and Ghana, and the challenges of entering these economies 

as a result of the absence of regulatory harmonisation. The goal is to establish a 

regulatory framework that will facilitate the introduction of novel medicines and medical 

supplies into the market.  

Method: The research methodology employed involved the collection, processing, 

and evaluation of empirical evidence. The chosen strategy was qualitative research. 

Results: Entering new or foreign pharmaceutical market requires careful 

consideration, planning, and abiding by the regulatory requirements of the respective 

countries. Sustained prosperity will be guaranteed by enhancements in quality control 

and partnerships with local distributors and manufacturers. Partnering with local 

consultants who are familiar with the regulatory landscape, as well as local laws and 

policies is crucial. Lastly, it is important to be familiar with regulatory requirements from 

NAFDAC and the FDA to ensure ongoing compliance with evolving regulations. 

Conclusion: Improving the local pharmaceutical market in both countries encourages 

the entry of foreign international pharmaceutical corporations, thus stimulating the 

economy of both nations. Local pharmaceutical companies in Ghana and Nigeria can 

strengthen their competitive edge by increasing barriers to entry. This can be achieved 

by raising the calibre of goods produced, increasing operational effectiveness, 

lowering production costs, and engaging in local innovation initiatives. Locals should 

maximize local government subsidies while utilizing the local context, including the 

nation's culture and consumer base to their advantage. 

 

Key words: Ghana, Nigeria, challenges, entrance, opportunities, pharmaceutical, 

regulation, government, counterfeit, new, foreign, policies, production and local.  



v 
 

Table of Content 

DECLARATION...............................................................................................................i 

ACKNOWLEGEMENTS ................................................................................................ ii 

SUPPLEMENTARY INFORMATION ........................................................................... iii 

ABSTRACT ................................................................................................................... iv 

LIST OF FIGURES .........................................................................................................x 

LIST OF TABLES ..........................................................................................................x 

LIST OF ACRONYMS ................................................................................................... xi 

CHAPTER ONE: INTRODUCTION .............................................................................. 1 

1.1 Background and Context of Study .................................................................. 1 

1.1.1 South Africa's Pharmaceutical Industry ....................................................... 2 

1.1.2 Nigeria's Pharmaceutical Industry ................................................................ 3 

1.1.3 Ghana's Pharmaceutical Industry ................................................................ 4 

1.2 Research Conceptualisation ............................................................................ 5 

1.2.1 Research Problem Statement ................................................................... 5 

1.2.2 Research Questions ................................................................................... 6 

1.2.3 Research Objectives .................................................................................. 6 

1.3 Defining of the key terms ................................................................................. 6 

• 1.3.1 Regulation.............................................................................................. 6 

• 1.3.2 Emerging market .................................................................................. 7 

1.4 SIGNIFICANCE OF THE RESEARCH STUDY ................................................. 7 

1.5 DELIMITATIONS, LIMITATIONS & ASSUMPTIONS OF THE STUDY ........... 8 

1.5.1 Delimitations ................................................................................................ 8 

1.5.2 Assumptions ............................................................................................... 8 

CHAPTER TWO: LITERATURE REVIEW ................................................................. 10 



vi 
 

2.1 Pharmaceutical Production Sector in Africa ............................................... 10 

2.2 Theoretical foundation .................................................................................... 11 

2.2.1 Institutional theory ....................................................................................... 11 

2.3 Models that explain how South Africa can enter the Nigeria and Ghana 

markets.................................................................................................................... 12 

2.4 To identify challenges of entering new pharmaceutical markets in Nigeria 

and Ghana ............................................................................................................... 12 

2.4.1 Limited pharmaceutical industries and high costs of raw materials .......... 12 

2.4.2 Weak regulatory systems ........................................................................... 13 

2.4.3 Lack of government investment in pharmaceutical sector ........................ 13 

2.4.4 Unfavourable Manufacturing Conditions .................................................... 14 

2.4.5 Circulation of fake and counterfeit medicines ............................................ 14 

2.4.6 Lack of effective pricing and price regulations ........................................... 15 

2.4.7 Patent issues and limited investment on research and development ....... 15 

2.5 To determine the regulatory framework in Nigeria and Ghana ................. 15 

2.6 Conclusion ....................................................................................................... 22 

CHAPTER THREE ...................................................................................................... 23 

METHODOLOGY ........................................................................................................ 23 

3.1 Philosophical Assumptions ........................................................................... 23 

3.1.1. Research Paradigm ................................................................................. 23 

3.2 Research methodology ................................................................................... 24 

3.2.1 Qualitative approach ................................................................................ 24 

3.3 Research Design.............................................................................................. 24 

3.4 Sampling Approach ......................................................................................... 25 

3.4.1 Probability sampling .................................................................................... 25 

3.4.2 Non-probability sampling ............................................................................ 26 



vii 
 

3.5 Data Collection ................................................................................................. 26 

3.5.1 South African respondents ..................................................................... 27 

3.5.2 Ghana and Nigeria respondents ............................................................. 28 

3.5.3 Research Instrument/Interview Guide.................................................... 30 

3.6 Data Analysis ................................................................................................... 31 

3.7 Ethical Considerations.................................................................................... 32 

3.7.1 Ensuring participant give informed consent ........................................ 32 

3.7.3 Ensuring that permission is obtained .................................................... 33 

3.7.4 Ensuring confidentiality and anonymity ................................................ 33 

CHAPTER 4: ANALYSIS OF DATA AND INTERPRETATION OF RESULTS ....... 34 

4.1 Response Rate ................................................................................................. 34 

4.2 Demographic Information ............................................................................... 34 

4.2.1 Gender of Respondents.............................................................................. 35 

4.2.2 Age distribution ........................................................................................... 35 

4.2.3 Years of experience .................................................................................... 36 

4.2.4 Respondents departments ......................................................................... 36 

4.3 Data Analysis and Interpretation of Findings .............................................. 37 

4.3.1 Objective 1: To identify challenges of entering new pharmaceutical 

markets in Nigeria and Ghana. ......................................................................... 37 

4.3.2 Objective 2: To determine the regulatory framework in Nigeria and 

Ghana................................................................................................................... 44 

CHAPTER 5: DISCUSSION OF FINDINGS .............................................................. 48 

5.1 Introduction ...................................................................................................... 48 

5.2 To identify challenges of entering new pharmaceutical markets in Nigeria 

and Ghana. .............................................................................................................. 48 

5.2.1 Local pharmaceutical market in the countries ..................................... 48 



viii 
 

5.2.2 Foreign pharmaceutical companies benefit from expansion into the 

market .................................................................................................................. 48 

5.2.3 Legal and compliance requirements are needed prior to entering the 

market .................................................................................................................. 49 

5.2.4 Current regulatory challenges of entering the market ........................ 49 

5.2.5 Problems that modern pharmaceutical companies encounter when 

entering new emerging markets ...................................................................... 50 

5.2.6 Government policies foster the development of the pharmaceutical 

sector ................................................................................................................... 50 

5.2.7: Local producers successfully compete with import .......................... 50 

5.2.8: Government invests in the pharmaceutical sector ............................. 51 

5.2.9 Conclusion on the challenges of entering new pharmaceutical markets

 .............................................................................................................................. 51 

5.3 To determine the regulatory framework in Nigeria and Ghana ................. 52 

5.3.1: Supportive and safe regulations for the pharmaceutical sector....... 53 

5.3.2 Four major challenges of entering new pharmaceutical markets in 

order of priority .................................................................................................. 53 

5.3.3: Government policy or policies hinder(s) or make(s) new market 

production and distribution processes more difficult .................................. 53 

5.3.4 Conclusion regulatory framework in Nigeria and Ghana .................... 54 

CHAPTER 6: CONCLUSION AND RECOMMENDATIONS ..................................... 55 

6.1 Summary ........................................................................................................... 55 

6.2 Recommendations........................................................................................... 56 

6.3 Limitations ........................................................................................................ 59 

6.5 Recommendations for future studies ........................................................... 59 

REFERENCES ............................................................................................................ 60 

APPENDIX A: LETTER TO RESPONDENTS ....................................................... 70 

APPENDIX B: CONSENT FORM ........................................................................... 71 



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APPENDIX C: INTERVIEW GUIDE ........................................................................ 72 

APPENDIX D: PERMISSSION LETTER ................................................................ 75 

APPENDIX E: ETHICAL CERTIFICATE ................................................................ 78 

 

  



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LIST OF FIGURES 

Figure 2.1 World GDP Trends for Advanced and Emerging  

Market Economies.……………………………………………..……………………………11 

 

LIST OF TABLES  

Table 2.1 List of countries supply medication……………………….………….………....9 

Table 3.1 Demographic: South Africa…………………………………………….………..26 

Table 3.2 Demographic: Ghana……………………………………………………………..27 

Table 3.3 Demographic: Nigeria……………………………………………………….……28 

Table 3.4 Themes section……………………………………......………………………….29 

Table 4.1 Response rate………………………………………………………….…….……32 

Table 4.2 Gender of respondents………………………………………………….….…....33 

Table 4.3 Age of participants……………………………………………………….…….....33 

Table 4.4 Respondents year of experience……………………....………………….…….34 

Table 4.5 Respondent position in the organisation………………....…………………….34 

 
  



xi 
 

LIST OF ACRONYMS 

API                   Active Pharmaceutical Ingredients 

FDA                  The Food and Drugs Authority 

PCN                  Pharmacists Council of Nigeria 

SSA                  Sub-Saharan Africa 

SA                     South Africa              

NAFDA             The National Agency for Food and Drug Administration and Control  

PCN                  The Pharmacists Council of Nigeria 



1 
 

CHAPTER ONE: INTRODUCTION  

1.1 Background and Context of Study 

The present study aims to investigate the challenges of entering new pharmaceutical 

markets. The study explores the realities of two African countries, namely, Nigeria and 

Ghana. The researcher explores the regulatory landscape and the challenges of 

entering these economies due to the absence of regulatory harmonisation. The study 

seeks to establish a regulatory framework that simplifies the introduction of novel 

drugs and medical supplies to the market.  

 

The pharmaceutical sector is widely recognised as one of the most meticulously 

regulated sectors, producing consistently high-quality drug products intended for 

human consumption (Lawrence & Kopcha, 2017). These products are designed to 

achieve the desired pharmaceutical therapeutic effects for the treatment of a broad 

spectrum of illnesses (Berg, 2019).  Only a few countries in sub-Saharan Africa — 

Kenya, Nigeria, and South Africa —have a somewhat large industry, with numerous 

corporations manufacturing goods for their own markets and occasionally exporting to 

neighbouring nations (Azevedo & Azevedo, 2017). 

 

According to Conway (2019), local producers should participate in a small portion of 

the value chain. The majority of them are producers of drug products, meaning they 

buy active pharmaceutical ingredients (APIs) from other producers and blend them 

into completed tablets, syrups, creams, capsules, and other forms of finished 

medication. In sub-Saharan Africa, up to a hundred factories are confined to the 

packaging industry, where they buy pills and other completed pharmaceuticals in large 

volumes and repackage them into packs intended for consumers (Abbott & Dukes, 

2009). There are only three generating APIs — two in South Africa, and one in Ghana 

— and neither of them are heavily involved in research and development. 

Pharmaceuticals are essential to population health and well-being (Usar & Bukar, 

2020). They can, however, be poisons, and drug tragedies like the thalidomide incident 

and other less publicised instances of drug harm serve as a constant reminder of the 

necessity of pharmaceutical monitoring and oversight. Thus, in the context of 

pharmaceutical care, policymakers typically use a variety of regulatory levers to 



2 
 

balance consumer access to safe, effective, and inexpensive medicines (Panteli et al., 

2016).  

 

1.1.1 South Africa's Pharmaceutical Industry 

Government policies, the current state of the economy, and the evolving needs of the 

domestic market are driving the rapid evolution of the pharmaceutical industry in South 

Africa. The dominant framework of globalisation is also a component of this mix of 

forces. To create pharmaceutical products, the South African biotechnology industry 

requires funding. Developing nations had difficulty obtaining COVID-19 related 

pharmaceutical items from wealthy nations throughout the pandemic, especially 

during vaccination roll-outs, as developed nations prioritised their own populations 

(Uctu & Eksteen, 2022). As a developing nation, South Africa requires prosperous 

pharmaceutical endeavours. The biotechnology industry is the area where the majority 

of medical research is required and where production, trials, and less strict restrictions 

may be more readily applied (Montague & Oosthuizen, 2010). South Africa imports 

70% of its pharmaceuticals. Imports drive up prices, particularly when the rand 

depreciates against other currencies in response to international trade. 

 

Market access continues to be the largest obstacle facing South African 

pharmaceutical companies. The government's rigidity on pricing and the high level of 

regulation in South Africa have made effective price competition difficult, thereby 

impeding patient access to novel medications (EyeForPharma, 2015).  

 

Although local pharmaceutical production is well-established on a regional basis, 

South Africa still significantly depends on pharmaceutical imports to meet domestic 

demand for specific drugs (Horner, 2022). Increasingly, Chinese and Indian 

manufacturers of generic medications are eyeing South Africa as a springboard into 

the continent's quickly expanding economies. Nonetheless, local drug manufacturers 

enjoy a competitive edge since they are well-positioned to gain from government 

programmes aimed at bolstering the home market because of their local presence. 

Some Indian companies, such as Cipla and Lupin, have operations in South Africa in 

order to profit from this.  

 



3 
 

The pharmaceutical sector in South Africa is the most lucrative in sub-Saharan Africa, 

despite its relatively small size globally. Pharmaceutical sales in South Africa were 

estimated at US $3.428 billion in 2018 (Research, 2019). Sales of generic drugs were 

projected to reach US $1.251 billion in 2018. Over time, their market share is expected 

to increase due to single-exit pricing, the expansion of middle-income populations, and 

an emphasis on cost control (Research, 2019). Although HIV/AIDS remains the 

leading cause of death, the most popular therapies in terms of money (as opposed to 

volume) are those for heart disease and hypertension (Research, 2019). Due to 

apartheid's legacy of a divided health system (Africa, 1996, as cited in Horner, 2022), 

the pharmaceutical sector in South Africa is heavily influenced by the public sector, 

accounting for approximately 31 percent of the just over $3 billion US industry in 2017 

(Foundation, 2018). 

 

1.1.2 Nigeria's Pharmaceutical Industry  

According to Statista (2022), Nigeria has a population of 216.7 million, possibly making 

it the largest domestic market in Africa. Infectious and non-infectious diseases afflict 

a sizable section of the populace, yet their purchasing power is limited due to the 

extreme poverty. The size of the pharmaceutical market in Nigeria is estimated to be 

substantially different. According to Statista (2022), the Manufacturers' Association of 

Nigeria (PMG-MAN) Pharmaceutical Manufacturing Group projected that the yearly 

value of the pharmaceutical and healthcare goods industry would exceed US$ 2 

billion. According to estimates, the market for over-the-counter (OTC) medications is 

approximately US$ 900 million, and the market for prescription (P&T) ethical 

medications is around US$ 500 million. The Nigerian market for biological products, 

such as insulin, interferon, vaccines, and other items, is estimated by PMG-MAN to be 

worth roughly US$ 100 million. Related lifestyle and healthcare products bring in an 

additional $500 million or more (Find Source). 

 

According to the prognosis, the pharmaceutical industry in Nigeria is anticipated to 

expand at a 9.1% compound annual growth rate (CAGR), with a projected value of 

$5.3 billion by 2024 (Lodha International Lodha Pharma Group, 2021). Until the middle 

of the 20th century, affluent individual entrepreneurs or multinational pharmaceutical 

corporations supplied completed medicinal products to numerous developing African 



4 
 

nations, including Nigeria (Lodha International Lodha Pharma Group, 2021). The local 

manufacture of processing equipment and raw materials was not given enough 

attention. However, this trend has shifted, and several crucial factors — like locally 

produced dosage and processing equipment — are receiving increased focus. 

Currently, Nigeria imports a significant amount of dosage forms from Brazil, Europe, 

China, India, and the United States. However, the government is working to support 

regional manufacturing (Lodha International Lodha Pharma Group, 2021). 

 

The Nigerian pharmaceutical industry is confronted with a number of challenges. One 

of the main issues is the unfair competition from foreign goods and international 

corporations. Furthermore, several medications with herbal origins circulating in the 

country need to be standardised (Lodha International Lodha Pharma Group, 2021).   

 

1.1.3 Ghana's Pharmaceutical Industry  

The government's intentions to implement universal healthcare would help Ghana's 

pharmaceutical sector to grow in the upcoming years. However, cost-cutting measures 

would likely result in a slower rate of expansion for the industry. In the long run, local 

generic medication manufacturers should find more opportunities as efforts to 

stimulate the industry pay off. If COVID-19 causes a protracted disruption, it could 

have a detrimental effect on Ghana's access to and cost of medications. 

 

Ghana's pharmaceutical sales were USD 589 million in 2019, with projected statistics 

indicating growth to USD 620 million in 2020. In the future, revenues are predicted to 

expand at a 9.8% compound annual growth rate (CAGR) to reach USD 941 million by 

2024. Sub-Saharan Africa boasts several pharmaceutical markets with double-digit 

growth rates. The significant rise in medicine sales in these regions is mostly attributed 

to higher volume consumption in the generic medications subsector. 

The Ghanaian government, like many other African nations, has emphasised the need 

to increase local pharmaceutical production over the next ten years. Colonial rule in 

Africa negatively impacted the growth of local pharmaceutical industries in countries 

such as Nigeria, Ghana, and South Africa negatively (Azevedo & Azevedo, 2017). For 

example, under British rule in Nigeria, the focus was primarily on extracting natural 

resources rather than developing healthcare facilities. This left Nigeria dependent on 



5 
 

imported medicines with little local production even after independence. Similarly, 

during British colonial times in Ghana, the priority was gold extraction rather than 

healthcare development (Azevedo & Azevedo, 2017). This led to Ghana’s reliance on 

imported drugs and a weak local pharmaceutical industry. 

In South Africa under British, Dutch, and later apartheid rule, pharmaceutical facilities 

mainly served the white minority population. They had access to advanced medical 

supplies and imported drugs, while the black majority struggled to acquire affordable 

medicines. This unfair system benefited multinational drug companies over local 

makers (Azevedo & Azevedo, 2017). The legacy of colonial policies in these countries 

is a continued dependence on imported medicines, underdeveloped local production, 

and challenges with regulation and affordable access. Overcoming these deep-rooted 

issues requires major investments in facilities, training, and reform to allow domestic 

pharmaceutical manufacturing. Understanding this colonial history is key to 

addressing the current barriers to building strong, self-sufficient pharmaceutical 

industries in Nigeria, Ghana, and South Africa. 

 

1.2 Research Conceptualisation 

1.2.1 Research Problem Statement 

The African subregion is highly dependent on the importation of pharmaceuticals and 

raw materials for the production of pharmaceuticals, particularly in rural areas 

(Akande-Sholabi & Adebisi 2020). These rural areas consistently experience delays 

in accessing imported medicines and locally manufactured drugs due to their 

geographical inaccessibility. Furthermore, any alterations in supply chain logistics or 

changes in importation policies can lead to medicine shortages, exacerbating the 

problem of limited access to essential medications.  

 

The availability of drugs in these areas is contingent upon supply chain logistics, which 

are subject to fluctuations in demand and supply  (Adebisi, Umah, Olaoye, Alaran & 

Sina-Odunsi, 2020). Although there is little evidence to support the idea that African 

governments are actively working to guarantee universal access to medications, the 

necessity for reasonably priced and easily available therapies is acknowledged 

(Nations, 2017; Organization, 2022).The affordability of medications, an integral 



6 
 

component of access, is closely linked to drug prices and the economic capacity of 

end-users. Since Africa's independence, there have been ongoing challenges with 

local production of medical supplies. Regarding Nigeria and Ghana, there is a need 

for the South Africa pharmaceutical market to enter their markets to address the 

problem of drug shortages.  

 

1.2.2 Research Questions 

The study's questions are detailed below: 

What are the challenges of entering new pharmaceutical markets in Nigeria and 

Ghana? 

• What are the regulatory frameworks in Nigeria and Ghana? 

• What are the proposed future strategies for improving the challenges of entering 

new pharmaceutical markets in Nigeria and Ghana? 

 
1.2.3 Research Objectives 

The research objectives of the study are detailed below: 

• To identify the challenges of entering new pharmaceutical markets in Nigeria and 

Ghana. 

• To determine the regulatory framework in Nigeria and Ghana. 

• To offer recommendations to overcome the challenges of entering new 

pharmaceutical markets in Nigeria and Ghana. 

 

1.3 Defining of the key terms  

• 1.3.1 Regulation 

Regulation is the continuous and targeted control that a public body exercises over 

activities valued by society. Within the field of healthcare, it encompasses any external 

pressures or regulations that enforce behavioural norms beyond the scope of medical 

practice or administration. Broadening access to high-quality pharmaceutical devices 

in low- and middle-income nations requires efficient regulatory regimes that are 

harmonised to global standards. 

 



7 
 

As a result, disputes over the ownership, distribution, and marketing of medical 

products have turned the pharmaceutical industry and its governance into a significant 

source of conflict (Pezzola & Sweet, 2016). A recent study that examined industrialised 

countries demonstrated, at the very least, the shortcomings of the regulatory 

framework in several pharmaceutical markets. Research by Olsson et al. (2010) 

indicates that the public supported the pharmaceutical regulatory bodies in fewer than 

half of the world's least developed countries. 

 

• 1.3.2 Emerging market 

According to Bank (2006), the goal of categorising countries so that others could 

quickly gather information and categorise countries of interest, has affected our 

definition of emerging markets. In terms of socioeconomic, cultural, and regulatory 

elements, emerging economies greatly depart from the assumptions of theories 

developed in the West. They provide an engaging learning environment where one 

can learn more about marketing science and practise, challenging our preconceived 

notions. Marketers are starting to see past the negative connotations associated with 

typical emerging market stereotypes. When attempting to explain how context 

influences business performance in emerging markets, institutional theory is the most 

effective (Peng et al., 2008).  

 

1.4 SIGNIFICANCE OF THE RESEARCH STUDY 

Nigeria's pharmaceutical market is subject to stringent regulations governed by 

agencies such as the National Agency for Food and Drug Administration and Control 

(NAFDAC). Understanding and complying with registration requirements, quality 

standards, labelling regulations, and pricing policies are essential for market entry. 

Undoubtedly, the recent economic downturn in Nigeria had a significant impact on the 

cost and availability of high-quality raw materials for the pharmaceutical manufacturing 

sector, which in turn hindered the ability of local pharmaceutical companies to 

manufacture their products locally. Therefore, it is undeniable that the nation's current 

emphasis on industrialisation and the support of domestic manufacturing sectors like 

the pharmaceutical industry is a step in the right direction towards lowering its reliance 

on crude oil.  



8 
 

Ghana's pharmaceutical market is regulated by the Food and Drugs Authority (FDA), 

which oversees the registration, importation, manufacturing, distribution, and 

marketing of pharmaceutical products. Understanding and complying with regulatory 

requirements, including registration procedures, quality standards, labelling, and 

pricing regulations, are essential for market entry. Understanding cultural beliefs, 

healthcare-seeking behaviour, and socioeconomic factors influencing consumer 

preferences is essential for successful market entry. Tailoring marketing strategies, 

product formulations, and packaging to align with local preferences and needs can 

enhance acceptance and adoption. 

Given the study's goals, the South African pharmaceutical industry will benefit from 

this research in terms of understanding the challenges of entering the Ghana and 

Nigeria markets. 

1.5 DELIMITATIONS, LIMITATIONS & ASSUMPTIONS OF THE STUDY 

1.5.1 Delimitations 

Global companies continue to face challenges in gaining a home ground advantage, 

such as conducting interviews with local Nigerian and Ghanian stakeholders. 

Research conducted solely through telephone, emails, and virtual meetings might not 

always yield the best results. Outdated studies of global companies that entered the 

Nigerian and Ghanian markets may not be relevant, as circumstances have changed 

over time. The business landscape before the pandemic and lockdown differs from the 

post pandemic era, with new laws and policies potentially being implemented. 

Identifying the right stakeholders (Regulatory department and the department of 

Health) in Nigeria and Ghana for interviews may present a challenge. 

 

1.5.2 Assumptions 

The researcher can better illustrate the significance of a study by using assumptions 

(Corbin  & Strauss, 2007). The assumptions underlying this study include the following: 

• This study applies to the pharmaceutical markets in Ghana and Nigeria, which 

will be evaluated in this study. 

• The relationship between different variables will be evaluated in this study. 



9 
 

• The adapted interview research instrument is relevant to the pharmaceutical 

industry and the participants in this study. 

• Participants will be able to assess the challenges of entering new 

pharmaceutical markets in Nigeria and Ghana. 

 

 

 



10 
 

CHAPTER TWO: LITERATURE REVIEW 

2.1 Pharmaceutical Production Sector in Africa 

Africa's pharmaceutical sector accounts for a relatively small fraction of the global 

pharmaceutical industry. In 2007, the International Finance Corporation (IFC) 

projected that Africa, excluding North Africa, accounted for less than 0.6% of the global 

pharmaceutical industry (IFC, 2007). This market was projected to be worth $934.8 

billion in 2017 and was predicted to increase at a rate of 5.8% to reach $1.17 trillion in 

2021 (The Business  Research Company, 2023). Health technology company, 

Quintiles IMS Health, predicted that in 2014 the African market was worth about $24 

billion, and by 2020, it may be worth between $40 billion and $65 billion (Holt et al., 

2015). For instance, the Cameroonian market was projected to be worth $36 million in 

2016, Ghana’s market to be worth $600 million, Kenya’s market to be worth $1.2 

billion, Morocco’s market to be worth $2 billion, Nigeria’s market to be worth $3 billion, 

and South Africa’s market to be worth $5 billion. Nevertheless, there has not been a 

commensurate rise in local manufacturing capacity to keep up with the development 

in pharmaceutical markets (United Nations Economic Commission for Africa, 2020). 

Table 2.1: Countries supplying medicines to Cameroon, Ghana, Kenya, 

Morocco, Nigeria, and South Africa (2015/16) 

 

Source: Data from key informant interviews. Information on Nigeria collected during 

the programme validation exercise. 

 



11 
 

Over 70% of medications are imported, according to data acquired during the 

exercise's nation visits. Only Morocco, out of Cameroon, Ghana, Kenya, Morocco, 

Nigeria, and South Africa, has a domestic pharmaceutical industry that meets more 

than half of its needs (UNECA, 2020). 

Table 2.1 illustrates how access to pharmaceutical products in the majority of African 

countries is skewed towards importation rather than manufacturing. There is ample 

evidence that the manufacturing sector is crucial to the development of developing 

nations' economies. Manufacturing, which is not limited to medicines, can significantly 

boost a nation's economy by increasing productivity, promoting reach and 

development, and encouraging future investments (UNECA, 2020). 

2.2 Theoretical foundation 

2.2.1 Institutional theory 

Institutional theory was used to explain how South Africa can enter these two markets. 

Emerging markets have been major players in the global economy during the past ten 

years, and by the end of 2014, their purchasing power is expected to surpass that of 

the world GDP (Figure 2.1) (Davis & Marquis, 2005). Although managers and investors 

are very interested in the rapid rise and development of nations like China, India, 

Brazil, and South Africa in the twenty-first century, our ideas have not kept up with this 

quick pace of change (Davis & Marquis, 2005). 

 

Figure 2.1 World GDP Trends for Advanced and Emerging Market Economies. 

 

Source: International Monetary Fund, April 2014 World Economic Outlook Database. 

 



12 
 

According to Institutional theory, “organizations implement business practices 

because doing so enhances their legitimacy” (DiMaggio & Powell, 1983). This idea 

can offer insightful information on the adoption of newly developed tools and practices. 

Decisions about "green" sustainable activities and environmental management can be 

explained by institutional theory, which takes into account changes in legislation, 

technological advancements, and cultural values (Tate et al., 2012). Although 

institutional theory is widely acknowledged as one of the most well-known 

methodologies in organisational research today (David & Bitektine, 2009; Greenwood 

et al., 2017), there are significant disagreements among academics concerning the 

fundamental assumptions about how social norms and expectations impact 

organisations, as well as the referents of key concepts.   

 

2.3 Models that explain how South Africa can enter the Nigeria and Ghana 

markets  

Generally, the most developed, diverse, and productive economy in Africa is found in 

South Africa. An obvious choice for American businesses looking to enter the Sub-

Saharan African market is South Africa, which boasts one of the most business-

friendly environments on the continent. Growing populations and rising levels of 

consumption are two of the main factors propelling the pharmaceutical industry's 

expansion, which is why emerging markets like South Africa have the highest growth 

rates. According to McKinsey (2018), health care spending is increasing 

disproportionately with rising household income. By 2020, the pharmaceutical sector 

in Africa is projected to be valued between USD 40 billion and USD 65 billion per year. 

In Sub-Saharan Africa, South Africa continues to be the largest pharmaceutical 

market.  

 

2.4 To identify challenges of entering new pharmaceutical markets in Nigeria 

and Ghana 

 

2.4.1 Limited pharmaceutical industries and high costs of raw materials 

A major barrier to the ease of access to medications is the scarcity of drug 

manufacturing businesses in Africa in comparison to the high cost of raw materials. 

Disappointingly, Africa produces only 3% of the world's pharmaceuticals (Bright et al., 

2021) despite having 11% of the world's population and carrying 24% of the world's 



13 
 

disease burden (Ahen & Salo-Ahen, 2018). According to a 2019 McKinsey analysis, 

there are only about 375 drug-producing industries in Africa, predominantly in the 

northern region, for the continent's 1.1 billion inhabitants (McKinsey, 2019). Nine out 

of 46 countries contain a significant concentration of people from sub-Saharan Africa 

(McKinsey, 2019). When compared to China and India, which have 10,000 and 5000 

pharma makers, respectively, providing for 1.1 billion people, this number is quite 

insignificant (McKinsey, 2019). 

 

Nigeria, South Africa, Ghana, Kenya, and Zimbabwe possess industrial potential that 

could be leveraged for the manufacture of pharmaceuticals to meet local or 

international market demand, according to a 2005 World Bank study (World Bank, 

2022). However, the study warned that this potential is at risk of depletion if the costs 

of expanding local manufacturing capacity are substantial or if the quality of the 

products is inadequate (WorldBank, 2022). The accessibility of unprocessed 

materials, particularly active pharmaceutical ingredients, which are the main 

substances used in the creation of pharmaceuticals, has a significant impact on both 

the cost of production and the quality of drugs produced. The majority of the equipment 

and raw materials required to produce drugs in Africa are imported, which raises 

production costs considerably (Ekeigwe, 2019). As a result, enterprises are compelled 

to rely heavily on imports and consequently bear exorbitant costs.  

 

2.4.2 Weak regulatory systems 

Pharmaceutical supply chains suffer from inadequate regulatory frameworks in 

several countries in Sub-Saharan Africa (SSA). The issue of low-quality medications 

in the pharmaceutical supply chains is a serious one, in addition to being a challenge 

in and of itself. Up to 90% of national drug regulatory organisations in Sub-Saharan 

Africa are unable to carry out their basic regulatory duties in an efficient manner (Giralt 

et al., 2017b).  

 

2.4.3 Lack of government investment in pharmaceutical sector 

Drug access is impacted by the general government's indifference and lack of political 

will, encapsulated by a persistent lack of investment in healthcare (Adebisi et al., 

2020). The lack of financial support for manufacturers, high taxes imposed on the 

pharmaceutical industry, heavy research and development funding requirements, and 



14 
 

generally insufficient funding for healthcare all point to a severe lack of incentives to 

support local manufacturing of pharmaceuticals (Adebisi et al., 2020). Furthermore, in 

many African regions, the Primary Health Care Policy and other existing programmes 

are not being implemented adequately (Organization, 2018).  

 

In Africa, government funding for healthcare is incredibly inadequate (Public Financing 

for Health in Africa: from Abuja to the SDGs, 2020). A substantial portion of the 

populace is unable to obtain insurance services due to the appallingly inadequate 

coverage of the programmes. As a result, there is an unsettlingly large un-pooled 

source of payment for medical services and goods, including public out-of-pocket 

spending, which can make up as much as 70% of all health expenditures in the region 

(Adebisi et al., 2020). 

 

2.4.4 Unfavourable Manufacturing Conditions 

Africa primarily uses small plants with low yields and capability for drug production 

(Ekeigwe, 2019). This restricts the ability to make enough tablets in the case of solid 

dosage forms, for example, to realise economies of scale and reduce overall 

production costs. African producers must create half a billion tablets annually, 

according to a McKinsey estimate, in order to compete on price with India (McKinsey, 

2019). Nevertheless, the current lack of manufacturing capacity frequently results in 

high drug costs and deters local drug production. Furthermore, high electricity costs, 

regular power outages, and other infrastructure problems like inadequate logistics and 

transportation systems further impair the productivity and efficiency of manufacturing 

facilities (Ekeigwe, 2019).  

 

2.4.5 Circulation of fake and counterfeit medicines 

A further significant issue that needs to be addressed is the growing prevalence of 

fake and counterfeit medications. Counterfeit medications are those that are 

deliberately and deceitfully mislabelled about their identity and/or origin (Organization, 

1992). According to a WHO study, 42% of medical product counterfeiting and 

substandard cases worldwide have been found in Africa alone (WHO, 2017).  

 



15 
 

2.4.6 Lack of effective pricing and price regulations 

A non-binding framework called the Pharmaceutical Manufacturing Plan for Africa 

aims at "pursuing, with the support of our partners, the local production of generic 

medicines on the continent," was approved by the 55 members of the African Union 

in 2007. Still, a significant chunk of Africa's impoverished population lack access to 

healthcare due to the high cost of necessary medications (Organization, 2017). 

Regularly used generic medications, such as paracetamol, can cost up to 30 times as 

much in Zambia, Nigeria, Senegal, and Tunisia as they do in the UK and the USA 

(Cameron et al., 2009). Furthermore, a large number of African countries are unable 

to control or monitor prescription drug pricing; consequently, they are paying more 

than international accords for essential prescriptions (Cameron et al., 2009). For 

instance, the Sudanese drug regulatory agency permitted the importation of 

medications 10 times more expensive than the worldwide reference price (Lucero-

Prisno et al., 2020). Many people in developing countries are currently unable to afford 

treatments for chronic illnesses due to ineffective laws and regulations governing 

pricing. This has led to private sector pharmacy prices continuing to be higher than 

global rates (Cameron et al., 2009).  

 

2.4.7 Patent issues and limited investment on research and development 

Access to medications in Africa is hampered by patent access restrictions and the 

incapacity of regional producers, researchers, and scientists to obtain patents. Due to 

inadequate investment in research and development, the pharmaceutical industry in 

many African countries are not producing new medications at their best. Due to 

insufficient support for innovation, the majority of African countries have high rates of 

disease burden (Bigdeli et al., 2013). Research has also shown that African 

governments find it difficult to fulfill their obligations to research and development, 

resulting in limited types of research and insufficient application of the research that is 

conducted (Ekeigwe, 2019).  

 

2.5 To determine the regulatory framework in Nigeria and Ghana 

Policies and laws governing the pharmaceutical industry's operations are created by 

governments in every nation on the planet. The overall efficiency of the sector is also 

determined by a government's capacity to offer incentives to producers and, when 

required, enforce sanctions on them (Cohen, 2000). Pharmaceutical regulation 



16 
 

encompasses a wide range of operations, including product registration, 

pharmacovigilance, quality monitoring, factory licencing, and intellectual property 

control. Its purpose is to safeguard the environment, human and animal health, and 

safety, ensuring the effectiveness, safety, quality, and accessibility of necessary 

medications. Nonetheless, three primary categories of general pharmaceutical 

regulations that control drugs, pharmacy employees, and medications, respectively, 

oversee the pharmaceutical industry globally.  

 

Regulation is the process by which the government consciously manipulates factors 

like quality, quantity, and price to control or influence the actions of actors or individuals 

(Kumaranayake et al., 2000). The following sections provide an overview of current 

regulations in Nigeria and Ghana, highlighting characteristics, strengths, and 

weaknesses of the two national systems. 

 
Legal and Policy Framework for Pharmaceutical Regulation in Nigeria  

Global pharmaceutical regulation is hampered by the incapacity of nations to carry out 

essential regulatory functions, with Africa exhibiting the least capacity (Ndomondo-

Sigonda & Ambali, 2011). Any country with inadequate pharmaceutical regulations 

risks exposing drug users to potentially dangerous medications, inferior and 

counterfeit goods, and encouraging the illogical prescribing of pharmaceuticals (Doua 

& Van Geertruyden, 2014). Lack of competent and skilled enforcement personnel, 

insufficient funding, and poor legal and regulatory frameworks have all been attributed 

to regulatory shortcomings. According to (Lowe & Montagu, 2009), drug regulations 

and policies are crucial to regulatory processes and should be comprehensive, 

incorporating every facet of pharmaceutical practice. Regulatory bodies depend on 

them to have the authority and capacity to perform crucial regulatory functions. Nigeria 

has notably lax pharmaceutical regulations, which are marked by sporadic regulatory 

inspections, lax enforcement, widespread violations, and unfavourable health 

consequences (Usar et al., 2017). Causative issues have included underfunding of 

regulatory organisations, official corruption, weak and frequently overlapping 

legislation, and inadequately qualified personnel (Esimone et al., 2001). 

 

Nigeria has several legislative and policy tools to govern and manage the 

pharmaceutical sector. These highlight the government's broad commitment to 



17 
 

ensuring people have access to safe, effective medications and that they are used 

appropriately. They consist of: 

 

National Drug Policy 1990: The objectives of this policy are to enhance access to 

reasonable, safe, effective, and inexpensive medications as well as their appropriate 

usage for all Nigerians. Additionally, it seeks to support the sustainable growth of local 

produce of essential medicines. 

.  

Poisons and Pharmacy Act, Cap 366 of 1990: The Act governs how medications 

and medical supplies are compounded, distributed, marketed, and dispensed in 

Nigeria. 

 

Food and Drugs Act Cap 150 of 1990: This forbids the sale of specified medications, 

foods, cosmetics, equipment, and medications in conjunction with certain medical 

problems. It also forbids the import, export, distribution, and sale of specific 

medications. In addition, it outlaws spreading false information about drugs and the 

production of food and medications in filthy conditions. 

 

Counterfeit and Fake Drugs (miscellaneous provisions) Act, Cap 73 of 1990: This 

Act prohibits the country from producing, importing, distributing, or selling any illegal, 

phoney, adulterated, or counterfeit medications. Additionally, it forbids anyone from 

selling pharmaceuticals in public marketplaces without the regulatory authority's 

consent. 

 

Pharmacists Council of Nigeria, Decree 91 of 1992. The decree established the 

Pharmacists Council of Nigeria (PCN), which establishes and maintains a register of 

individuals certified to practise pharmacy and specifies the minimum level of 

knowledge and expertise needed by applicants to become registered members of the 

pharmacy profession. Additionally, it mandates the PCN to create and oversee the 

pharmacists' code of conduct, as well as oversee and manage pharmacy practice in 

all its forms.   

 

National Agency for Food and Drug Administration and Control Decree No. 15 

of 1993: The agency oversees the manufacturing, marketing, distribution, sale, and 



18 
 

usage of medications, foods, cosmetics, medical equipment, bottled water, chemicals, 

and devices. It also regulates and controls imports and exports.  

 

Drugs and Related Products (Registration) Decree No. 19 of 1993: It is against the 

law to manufacture, import, export, advertise, sell, or distribute medications, medicine 

goods, cosmetics, or medical devices without first registering them. Additionally, it 

specifies clinical trials, the registration process, and the circumstances under which 

certificates of registration may be suspended or revoked (Health, 2005). The latter is 

responsible for establishing standards, registering and licencing pharmacy graduates, 

and managing facilities and professional practice. On the other hand, NAFDAC is in 

charge of licencing manufacturing facilities, regulating import and export, inspecting 

manufacturing facilities and distribution routes, controlling drug promotion and 

advertising, marketing authorization, product quality monitoring, pharmacovigilance, 

quality control, and managing drug-related clinical trials (National Agency for Food, 

2011). 

 

Legal and Policy Framework for Pharmaceutical Regulation in Ghana 

The Ghanaian Food and Drugs Authority (FDA), a relatively well-established drug 

regulatory authority, and an open economic policy are two advantages that the 

country's pharmaceutical sector has over those of its neighbours. Ghana's 

establishment of a more stringent regulatory environment, including its own drug-

testing facilities as part of its post-marketing surveillance strategy, is encouraging for 

global drug manufacturers. Although this is positive for investor sentiment and 

compares positively to other pharmaceutical markets, Ghana's drug regulatory 

framework still needs stronger policy enforcement and a tighter supply chain. 

 

The registration and inspectorate section is in charge of reviewing applications for 

medicine registration before medical products are registered. The Public Health Act's 

safety-monitoring and clinical trials division guarantees the security of products under 

regulation. The government of Ghana has been able to assist domestic 

pharmaceutical manufacturers and restrict foreign direct investment (FDI) in recent 

years due to the establishment of a more stringent regulatory framework. In Ghana, 

the process of registering drugs takes six to eighteen months, which is not excessively 

long compared to other African nations. However, due to poor purchasing power and 



19 
 

high financing costs, FDI and returns are severely constrained. Local pharmaceutical 

manufacturers have also begun modernising their facilities to comply with global Good 

Manufacturing Practice (GMP) guidelines. 

 

Within the Economic Community of West African States (ECOWAS), a regional 

pharmaceutical regulatory body has been proposed by the Pharmaceutical 

Manufacturers Association of Ghana (PMAG) to improve access to medications and 

to foster the expansion of pharmaceutical companies. Nevertheless, regional 

harmonisation is still a long way off due to lax drug laws and lax border controls in 

other ECOWAS member states. Respecting Trade-Related Aspects of Intellectual 

Property Rights (TRIPS) will draw foreign pharmaceutical companies seeking to enter 

into joint ventures or licencing arrangements in Ghana. This would ultimately enable 

pharmaceutical producers to export larger quantities of drugs both inside and outside 

of West Africa. 

 
Medications, vaccines, and medical devices are examples of medical products, and 

are essential parts of any country's healthcare system. As part of their national duty to 

safeguard public health and safety, national medical regulatory authorities (NMRAs) 

must be established to ensure the availability of high-quality, safe, and effective 

medical products (Ndomondo-Sigonda et al., 2017). The food and drugs authority 

(FDA) Ghana is the National Medicines Regulatory Authority legally mandated by 

Parts 6, 7 and 8 of the Public Health Act 2012 (Act 851) to safeguard the safety, quality, 

and efficacy of medical products in Ghana. The Food and Drug Authority (FDA) Ghana 

is the National Medicines Regulatory Authority legally mandated by Parts 6, 7, and 8 

of the Public Health Act 2012 (Act 851) to ensure the efficacy, safety, and quality of 

medical products in Ghana. The mission of FDA Ghana is "to protect the health and 

safety of people in Ghana and to be a global centre of excellence for food and medical 

product regulation" (Ghana, 2012).  

 
▪ Drug Evaluation and Registration Department 

In order to register medical items, applications for medication registration must be 

evaluated by the Drug Evaluation and Registration Department. A list of the 

department's accomplishments is shown below: 



20 
 

• Over the previous 16 years, a well-regulated system for the registration of 

medicinal products has been developed to guarantee uniformity in operations 

and regulatory judgements regarding all applications for medication registration. 

• A competent committee for dossier evaluation exists within the department, and 

examines every section of the dossiers that are filed for registration. Currently, 

two assessors are part of the WHO Prequalification Assessment Team. At the 

moment, the department is assisting with the harmonisation of the West African 

Health Organization (WAHO). 

• The agency maintains a thorough set of guidelines to regulate product names, 

product attributes, and patient information leaflets. This is closely monitored to 

make sure that information about the product provided to patients and medical 

professionals is accurate. To prevent prescription errors, brand names and 

colour schemes for products are also regulated. 

• The department has a mechanism in place to guarantee that applications are 

monitored following registrations. This includes keeping track of modifications to 

applications for registration. 

 

▪ Herbal Medicine Department 

In order to register herbal medicines in Ghana, applications for registration of dietary 

supplements and herbal medicines must be evaluated by the Herbal Medicine 

department (Asase, 2023). The department's accomplishments are listed in full below: 

• Enhancements have been made to the packaging of herbal medicine sold in 

pharmacies. 

• The manufacture of herbal medicinal products has been enforced in designated 

facilities with basic GMP for herbal medicine facilities. 

• More than 300 producers of herbal medicines and practitioners of traditional 

medicine have been trained in GMP and registration requirements for 

impromptu preparations. 

• Training has been provided on the establishment of a regulatory framework for 

the regulation of herbal medicines to officials of National Drug Regulatory 

Authorities from several African nations (Asase, 2023). 

 

Propositions for South African (SA) pharmaceutical firms 



21 
 

Propositions for South African pharmaceutical firms to take advantage of regulatory 

frameworks in Nigeria and Ghana include: 

• Harmonisation of Regulations 

SA pharmaceutical firms could advocate for the harmonisation of regulatory 

requirements between Nigeria, Ghana, and other West African countries. 

Harmonisation would streamline the registration process for pharmaceutical products 

across borders, reducing barriers to market entry and facilitating trade within the 

region. 

 

• Regulatory Compliance Assistance 

SA pharmaceutical firms could offer expertise and support to local manufacturers in 

Nigeria and Ghana to help them navigate regulatory compliance requirements. This 

could include assistance with product registration, quality assurance, Good 

Manufacturing Practice (GMP) standards, and pharmacovigilance activities, 

enhancing local capacity and competitiveness. 

 

• Market Access Partnerships 

SA pharmaceutical firms could establish partnerships with local distributors, 

wholesalers, and healthcare providers in Nigeria and Ghana to expand market access 

for their products. Collaborating with local partners who understand the regulatory 

landscape and market dynamics can help SA firms overcome entry barriers and 

effectively penetrate the market. 

 

• Advocacy for Regulatory Reforms 

SA pharmaceutical firms could engage with regulatory authorities in Nigeria and 

Ghana to advocate for reforms that promote transparency, efficiency, and innovation 

in the regulatory process. This could involve proposing reforms to streamline 

registration procedures, expedite approvals, and enhance regulatory oversight while 

maintaining safety and quality standards. 

 

• Investment in Local Manufacturing 

SA pharmaceutical firms could consider investing in local manufacturing facilities in 

Nigeria and Ghana to strengthen their presence in the region and address supply 

chain vulnerabilities. Investing in local production would enhance product availability, 



22 
 

reduce dependency on imports, create employment opportunities, and contribute to 

the expansion of the local pharmaceutical sector. 

 

These propositions highlight opportunities for SA pharmaceutical firms to leverage the 

regulatory framework in Nigeria and Ghana to expand their market presence, enhance 

regulatory compliance, and foster sustainable growth in West Africa. By addressing 

research gaps related to regulatory frameworks and market dynamics, SA firms can 

develop strategic approaches to capitalise on emerging opportunities and contribute 

to the advancement of healthcare delivery in the region. 

 

2.6 Conclusion 

 
It is impossible to guarantee optimal health, well-being, and an adequate healthcare 

system without reliable access to medical resources. It is evident that new 

pharmaceutical companies seeking to enter the African market face many obstacles, 

and it is important for the continent to address these challenges as it works to improve 

its healthcare systems and achieve universal health coverage. Using specialised 

procedures and nationally appropriate tactics, African governments and national 

health authorities must prioritise activities and initiatives aimed at enhancing access 

to medications. 

 

In this regard, as observed from the above literature, the study aims to identify 

challenges of entering new pharmaceutical markets in Nigeria and Ghana. The 

regulatory framework for both countries was also explained in detail.  

  



23 
 

CHAPTER THREE 

METHODOLOGY 

This chapter focuses on the research design, approach, and methodology utilised to 

gather and analyse data to meet the study's goal. It describes the research population, 

sample, and sampling method, providing a systematic approach to gathering 

information necessary to answer the research question and address the stated 

research issue. The qualitative research approach was employed to acquire qualitative 

data from the chosen case study. Additionally, this chapter outlines and discusses the 

study design, approach, and methodology used. It also covers the research 

population, sample, and sampling procedure, the instruments used for data collection 

and analysis. Finally, the chapter details the ethical issues considered in the study. 

 

3.1 Philosophical Assumptions  

According to Saunders (2016), a philosophical assumption is defined as the 

researcher's system of beliefs and assumptions regarding knowledge generation. 

These include presumptions regarding human comprehension (epistemological 

presumptions), research realities (ontological presumptions), and the degree to which 

a person's personal opinions influence the research process (axiological 

presumptions). The study is grounded in the two research philosophies of positivism 

and phenomenology (Creswell & Poth, 2016). 

 

3.1.1. Research Paradigm 

In order to understand the realities of the study participants, this study adopted 

interpretivism as a research paradigm. Interpretivism assisted the researcher to gain 

a deeper understanding of the individual meanings and contribution of the participants 

(Alharahsheh & Pius 2020; Davies & Fisher, 2018). The interpretivist paradigm 

involves considering individuals' subjective, real-world experiences and viewpoints 

(Alharahsheh & Pius 2020). Furthermore, it examines how humans experience reality 

(Davies & Fisher, 2018), predicated on the idea that different people might interpret 

the same experience differently, and that each person's version of that experience is 

reality.  



24 
 

3.2 Research methodology 

A methodical approach to problem-solving in research is known as research 

methodology. It can be thought of as a science that studies how scientific research is 

conducted (Kothari, 2019). There are three types of research approaches, which are 

quantitative, qualitative, and mixed method approaches. A qualitative approach was 

chosen for this study and is discussed next. 

 

3.2.1 Qualitative approach 

The primary goal of qualitative research is to comprehend the social reality of 

individuals, groups, or cultures. Denzin and Lincoln (2005) define qualitative research 

as an approach that utilises a naturalistic method seeking to understand phenomena 

in context-specific settings, such as real-world settings, where the researcher does not 

attempt to manipulate the phenomena of interest. Qualitative research methods were 

useful for this study because the researcher  aimed to gather data from the perspective 

of the sampled participants.  

 

3.3 Research Design 

Research design is defined as the procedural plan that is used by researchers to 

answer questions accurately and reliably (Creswell & Poth, 2016). The process that 

researchers employ to provide precise and reliable answers to questions is known as 

the study design (Leavy, 2017). A research design involves making and 

communicating decisions regarding the proposed study design, including how the 

information is collected from identified respondents, how the respondents are 

selected, how the collected information is analysed and how the results are 

communicated (Leavy, 2017). There are five generic research designs, namely: cross-

sectional, longitudinal, case study, comparative, and experimental.  

The researcher used exploratory research, which mainly utilised a qualitative research 

method. Swedberg (2020) argues that exploratory research is a methodology that 

examines research questions which have not previously been researched in depth. 

Since the research questions of this study have not been examined before, an 

exploratory research design was considered appropriate for this study. Furthermore, 

the selected research design was necessitated by the nature and type of data to be 

https://www.scribbr.com/research-process/research-questions/


25 
 

collected and the problem statement to be addressed. To provide a thorough 

understanding of these issues and explain the extent to which challenges associated 

with entering new pharmaceutical markets in Nigeria and Ghana can be overcome, 

the research problem identified in this study necessitates a thorough examination of 

the issue under consideration and a scientific exploration of themes.  

Exploratory research is carried out when there is a lack of information available 

regarding a phenomena or a problem that has not been precisely characterised 

(Swedberg, 2020). It aims to study the research issue at different depths, rather than 

to offer definitive answers to the research questions. Consequently, its focus is on 

addressing novel issues for which there has been little to no prior research (Brown, 

2006). Exploratory research, even in the worst scenario, establishes the initial 

research design, sampling strategy, and data collection technique and serves as the 

foundation for more definitive research (Singh, 2007). 

3.4 Sampling Approach 

Sampling is a process which utilises data provided by a small representative group to 

draw conclusions about entire populations (Martinez-Mesa et al., 2016). Smaller 

samples are thereby used to determine results for entire populations. There are two 

types of sampling techniques: probability and non-probability (Sekeran & Bougie, 

2016). In non-probability sampling, the likelihood of choosing a certain element within 

the population is not known. To guarantee that all significant demographic groupings 

are represented in the sample, the population is stratified prior to sample selection. 

3.4.1 Probability sampling  

Sekaran and Bougie (2013) state that probability sampling entails participants in the 

recognised population having a known chance (also referred to as a nonzero chance) 

of being nominated in the sample. According to Denscombe (2014), probability 

sampling takes place when every unit in the population has a known and equal chance 

of being selected for the sample.  

 



26 
 

3.4.2 Non-probability sampling 

According to Sekaran and Bougie (2013), non-probability sampling entails the 

participants in the group not having a known or fair chance of being nominated as part 

of the sample. Non-probability sampling comprises seven techniques, namely: 

• Convenience or accidental sampling: members are chosen according to 

availability. 

• Purposive sampling: associates of a group are decisively pursued. 

• Modal instance sampling: associates have the utmost commonality in a defined 

group and consequently are desired. 

• Expert sampling: associates perceived to be of high quality are elected for 

participation. 

• Proportional and non-proportional quota sampling: associates are verified until 

precise scopes of certain sorts of data are attained or until enough data in 

different categories are collected. 

• Diversity sampling: members are globally selected throughout the possible 

types of responses to capture all opportunities. 

• Snowball sampling: members are sampled and afterward entreated to help in 

identifying other members to sample and this process continues until enough 

samples are gathered (Creswell & Poth, 2016). 

 

This research embraced the purposive sampling, where the sample group is targeted 

to have specific attributes. Purposive sampling is a type of non-probability sampling 

that involves representatives of the subject population who meet certain practical 

criteria, such as ease of access, geographical proximity, availability of specific 

moments or willingness to participate in research purposes (Maree, 2007).  As a result, 

purposive sampling utilized because the sample was relevant to the study and are 

likely to provide key insights as well as contribute to important results. In this study, 

ten participants were sampled. 

 

3.5 Data Collection 

The research utilised a qualitative approach where in-depth interviews were conducted 

with individuals from the target population to address the research questions (Creswell 



27 
 

& Poth, 2016). Additionally, dense case studies were conducted through archival 

studies of documents, from which research themes and theories were inductively 

developed. The study used semi-structured interviews as a tool to gather the data. 

Interviews are a common technique for collecting data. Open-ended questions were 

designed and handed to participants (Denzin & Lincoln, 2005). The research was 

conducted via Microsoft Teams due to differences in the countries. The respondents 

who participated in completing the questions were assured that their responses would 

remain anonymous. The permission letter was granted by Organon South Africa, 

Roche Nigeria and Pharma Symbiosis Nigeria and Ghana respectively. Data was 

collected in South Africa because Organon South Africa distributes medication in 

Nigeria and Ghana. It was important for the researcher to understand how Nigeria and 

Ghana facilitate this distribution process in order to identify whether it is ideal to expand 

Organon in these two countries.  

 

The Microsoft Teams individual interview questions were divided into two sections. 

The interview was divided into three categories including the following sections: socio-

demographic characteristics of respondents, questions for the Organon South Africa, 

challenges of entering new pharmaceutical markets in Nigeria and Ghana, the 

regulatory framework in Nigeria and Ghana, and recommendations to overcome 

challenges. 

 

3.5.1 South African respondents 

As per the Standard Operating Procedure of the organisation, the line manager was 

informed about the research study. HR and the compliance director were emailed to 

request permission to conduct interviews with respondents from the organisation. This 

was followed with presentation to the Managing Director requesting a letter of 

permission from the organization. An email was sent to respondents seeking their 

consent to participate in the study, after which Microsoft Teams meeting were 

scheduled with respondents. 

 

 

 

 

 



28 
 

Characteristics of Respondents  
 

Respondents were asked to provide the following demographic information by ticking 

the appropriate response as indicated in Table 3.1. 

Table 3.1 Demographic: South Africa  

  

1. Age  Below 26  

26-35 2 

36-55 2 

56-65 1 

Above 65  

2. Gender Female 3 

Male 2 

 
Other  

3. Year of experience  Under 5 years  1 

6 - 9 years 1 

10 - 15 years   

16 - 20 years 2 

21 - 25 years 1 

 Regulatory affairs 3 

4. Position in the organisation Commercial 
1 

 Compliance 1 

 
 
3.5.2 Ghana and Nigeria respondents 

The second section was for participants from Ghana and Nigeria. The aim was to 

understand the challenges of entering the market according to knowledgeable 

participants in Ghana and Nigeria. For participants from Ghana and Nigeria, data were 

collected through calling, emailing, or directly messaging potential respondents with a 

link to the Microsoft Teams interview. Potential respondents were identified via 

LinkedIn based on their profiles in the regulatory and commercial fields of the 

pharmaceutical industry, or through referrals. This method was chosen as it allowed 

easy access to potential respondents. The process involved requesting a letter 



29 
 

granting permission from the organisation, followed by an email seeking consent from 

respondents. Thereafter, a Microsoft Teams meeting was scheduled with the 

consenting respondents. 

Respondents were asked to provide the following demographic information by ticking 

the appropriate response as indicated in Table 3.2 and Table 3.3. 

Table 3.2 Demographic: Ghana 

  

1. Age  Below 26  

26-35 1 

36-55 1 

56-65  

Above 65  

2. Gender Female 1 

Male 1 

 
Other  

3. Year of experience  Under 5 years  1 

6 - 9 years  

10 - 15 years   

16 - 20 years 1 

21 - 25 years  

 Regulatory affairs  

4. Position in the organisation Commercial 
2 

 
 
 
 
 
 
 
 
 
 
 
 
 
 



30 
 

Table 3.3 Demographic: Nigeria 
 

  

1. Age  Below 26  

26-35  

36-55 3 

56-65  

Above 65  

2. Gender Female 1 

Male 2 

 
Other  

3. Year of experience  Under 5 years   

6 - 9 years  

10 - 15 years  1 

16 - 20 years 2 

21 - 25 years  

 Regulatory affairs 1 

4. Position in the organisation Commercial 
2 

 Compliance 
 

 

 

3.5.3 Research Instrument/Interview Guide 

 

This study opted for semi-structured interviews as an instrument for data collection. 

The interview questions were divided among participants from Organon South Africa, 

Nigeria, and Ghana. Organon South Africa is a subsidiary of a multinational 

pharmaceutical company headquartered in the United States. Their main priorities are 

developing and distributing women's health medications under well-known brands, 

including those for asthma, dermatology, cardiovascular disease, pain management, 

and respiratory conditions.  

To guarantee there is no conflict of interest, the researcher is currently employed at 

Organon South Africa. The researcher made it a point not to contribute to or interrupt 

employees while they were speaking, allowing them to express their opinions without 



31 
 

interference. Since employees are required by the firm's code of conduct to act in the 

employer's best interests, the researcher ensured that the employees spoke from their 

own professional experience rather than relying solely on the corporation’s viewpoints. 

The instrument consisted of three sections and a total of seventeen questions, 

designed to answer the research questions and address the research objectives. The 

interview questions for this study are attached as Appendix C. 

Table 3.4 below shows the three sections, themes, and data that the researcher 

intended to collect. These questions covered the work experience of the participants, 

the challenges of entering the Ghanaian and Nigerian markets, and the regulatory 

frameworks in Nigeria and Ghana. 

Table 3:4 Themes section 

Section  Themes Information required from the  

Respondents 

1 Level of experience  Researcher seeks to establish  

level of experience of the  

participants at Organon South Africa, Ghana, 

and Nigeria 

2 Challenges of entering 

Ghana and Nigeria 

markets  

In this section, the researcher  

seeks to establish the  

understanding of the  

challenges in entering Ghana and Nigeria 

markets 

3 Regulatory framework 

in Nigeria and Ghana 

The section, researcher seeks to  

establish the relevance of Regulatory 

framework in Nigeria and Ghana 

 

3.6 Data Analysis 

Data analysis is the process by which researchers take the data they have gathered 

and turn it into information that can be used to discuss the study's goals (Kumar, 2018).  

This study gathered qualitative data, which was transcribed and coded. In order to 

assist with answering the research questions of the study, a thematic analysis was 

utilised to categorise and arrange the field notes and transcripts. According to Lune 



32 
 

and Berg (2016), data analysis involves a “careful, detailed, systematic examination 

and interpretation” of collected data to “identify patterns, themes, biases and 

meanings”.  According to Bryman (2016) a thematic analysis entails identifying themes 

in the data that are subsequently applied to address the research questions directed 

by the analytical framework and the literature review.  

 

3.7 Ethical Considerations 

A collection of values that guide study designs and methods are known as ethical 

considerations in research. These guidelines include collecting informed consent, 

assuring that participants will not suffer harm, safeguarding participants' identities and 

confidentiality, and confirming that consent has been granted (Cader, 2016). In this 

study, ethical norms regarding the voluntary nature of participation and the freedom of 

individual employees to opt out were respected and upheld. Information and data were 

gathered specifically for this academic research. The following ethical issues were 

addressed in this study: 

 

3.7.1 Ensuring participant give informed consent  

A participant grants their voluntary participation in a research study by signing a legal 

document known as informed consent. Not only is informed consent a necessary 

component of ethical research involving human subjects, but may also be seen as its 

cornerstone. The ideas of autonomy and respect for individuals provide the 

philosophical foundation of informed consent. Enough information about the study is 

provided to participants so they can decide whether or not to engage in the study 

voluntarily and rationally and provide their informed consent. This information includes:  

• The purpose of the study  

• Study procedures 

• Information on their right to decline or withdraw  

• Potential risk, discomfort or negative impacts  

• Whom to contact for questions 

 

In this study, the participants were provided with a letter informing them that their 

participation is voluntary and that all necessary steps were taken to protect their 

identity.  



33 
 

 

3.7.2 Ensuring that no harm comes to participants 

The research study should not harm participants. The researcher must follow ethical 

guidelines and ensure that participants are not placed in situations where their 

participation could put them in danger. Physical and psychological harm are two 

different ways to describe harm. No harm came to participants because the questions 

were asked in a way that did not cause physical or emotional harm. The questions 

asked in the interview were structured carefully, making sure that no offensive terms 

were used.  

 

3.7.3 Ensuring that permission is obtained 

It is important for a researcher to obtain permission to collect data for the study, in this 

case, from the Organon South Africa, after the approval of the proposal. The 

researcher requested permission from the company to conduct the research. The 

letter of permission is attached as Appendix D. Obtaining ethical approval 

demonstrated that the researcher has adhered to the accepted ethical standards of a 

genuine research study. 

 

3.7.4 Ensuring confidentiality and anonymity 

Separating or altering any identifiable personal information that participants may have 

contributed from the data is referred to as maintaining confidentiality. Details were 

provided about what happens to any personal data collected during the study. The 

researcher has an obligation to protect the privacy of the information provided by the 

participants. This obligation requires researchers to put measures in place to preserve 

participant confidentiality at every turn of the study process. Anonymity is the state in 

which researchers are unaware of the identity of specific participants. In this study, the 

participants' confidentiality was protected by not including their names in any of the 

paperwork. The researchers sought to assure participants that every effort is made to 

ensure that the information they submit cannot be linked to them in reports, 

presentations, or other forms of distribution.  



34 
 

CHAPTER 4: ANALYSIS OF DATA AND INTERPRETATION OF RESULTS  

This section presents, examines, and discusses the empirical results of the primary 

data gathered from the semi-structed individual interviews that were conducted for ten 

pharmaceutical employees in Nigeria, Ghana, and Organon in South Africa Organon. 

The first section provides socio-demographic data of the participants and the final 

section discusses the themes that emerged regarding the challenges of entering new 

pharmaceutical markets in Nigeria and Ghana.  

 

4.1 Response Rate 

Table 4.1 outlines the number of participants in the study, indicating that all the 

participants that were sampled for the study were successfully interviewed by the 

researcher.  

 

Table 4.1 Response rate 

 Frequency Percentage 

Responded  10 100 

Not Responded  0 0 

Total  10 100 

 

The researcher interviewed 10 participants from three African countries, namely, 

Nigeria, Ghana and South Africa. All the participants were able to share their 

experiences, as demonstrated by 100% participation in the study by the sampled 

participants.  

 

4.2 Demographic Information 

The research sample was identified by collecting demographic data, which included 

the respondent's age, gender, years of experience, and position within the business.  

 

 

 

 

 

 



35 
 

4.2.1 Gender of Respondents 

A discussion of the gender analysis findings can be found below.  

 

Table 4.2 Gender of respondents  

South Africa  Females: 3 Males: 1 

Ghana  Females: 1 Males: 1 

Nigeria  Females: 2 Males: 2 

 

 

Gender Frequency Percentage 

Female 5 50 

Male 5 50 

Total 10 100 

 

Five of the ten respondents were men, and the other five were women. As such, both 

genders were equally represented in the study, therefore, the study was not gender 

biased.  

 

4.2.2 Age distribution 

A discussion of the age analysis findings can be found below. 

 

Table 4.3 Age of participants 

 Frequency Percentage 

Under 26 0 0 

26-35 3 30 

36-55 6 60 

56-65 1 10 

Above 65 0 0 

Total 10 100 

 

Table 4.3 indicates that 60% of the participants were in the 36- to 55-year-old age 

range. Of the total number of respondents, 30% belonged to the age range of 26–35, 

10% to the age range of 56–65, and 0.00% to the age groups under 26 and above 65 

years. The findings indicate that the research did not include all age groups of 



36 
 

employees, which is a disadvantage as the views of employees under the age of 26 

and above 65 years are not represented in the study. Therefore, the findings of the 

study only represent the views of participants between the ages of 27 to 64 years.  

 

4.2.3 Years of experience   

A discussion about the findings regarding the number of years of experience can be 
found below. 
 

Table 4.4 Respondents year of experience 
 

 Frequency Percentage 

Under 5 years 2 20 

6 - 9 years 1 10 

10 - 15 years 1 10 

16 - 20 years 5 50 

21 - 25 years 1 10 

Total 10 100 

 

As displayed in Table 4.4, the majority of participants (50%) had between 16 to 20 

years of work experience. Participants with 5 years of working experience made up 

20%. Participants with 6 to 9 years of working experience comprised 10%. Participants 

with 10 to 15 years of working experience, and those with 21 to 25 years of working 

experience each comprised 10%. The abovementioned indicates that a significant 

segment of the participants possess adequate professional expertise to furnish 

pertinent data regarding challenges of entering new pharmaceutical markets in Nigeria 

and Ghana. Thus, the information gathered is quite dependable because the data 

were gathered from respondents with sufficient work experience.  

 

4.2.4 Respondents departments 

The information below provides the background information of departments that 
respondents are assigned to within their organisations. 
 
 
 
 
 
 
 



37 
 

Table 4.5 Respondent departments 
 

 Frequency Percentage 

Regulatory affairs 4 40 

Commercial 5 50 

Compliance 1 10 

Total 10 100 

 

As indicated in Table 4.5, 50% of the respondents are in the commercial department, 

followed by 40% in the regulatory affairs department, and the remaining 10% in the 

compliance department. This distribution reflects diverse perspectives in the 

responses, informed by the activities of the respective departments. Based on the 

results, it can be observed that the pharmacy has a tall hierarchical organisational 

structure within each department. This has resulted in respondents being diversified 

across various departments within the organisation. 

 

4.3 Data Analysis and Interpretation of Findings 

Data was presented in themes and sub-themes to address the objectives and goals 

of this study in relation to the study participants’ responses.   

 

4.3.1 Objective 1: To identify challenges of entering new pharmaceutical 

markets in Nigeria and Ghana.  

The first objective of the study was concerned with identifying the challenges of 

entering new pharmaceutical markets in Nigeria and Ghana. The presentation and 

interpretation of the research findings are discussed in this subsection in relation to 

the challenges of entering new pharmaceutical markets in Nigeria and Ghana. 

 

4.3.1.1 Theme 1: Various Challenges of entering new pharmaceutical markets 

in Nigeria and Ghana 

Sub-Theme 1.1: Local pharmaceutical market in the country 

Local pharmaceutical market was identified as the reason that has led to challenges 

for new pharmaceuticals entering the market. This was highlighted during the research 

process. The following views were expressed by Gab01: 



38 
 

Stagnation of local market: “The Nigerian pharmaceutical market has remained 

stagnant at $1.5 billion to $2.5 billion, despite its potential to hold 30 to 40 percent of 

the African pharma market given new policy interventions. Nigeria has a low level of 

local production of quality assured, low-cost pharmaceuticals to meet national needs. 

This affects the accessibility and affordability of medicines for the population, 

especially the poor and rural areas.”  

Essential resources: “Nigeria heavily depends on other countries for essential 

resources, such as raw materials, equipment, and technology. This makes the country 

vulnerable to supply chain disruptions and price fluctuations.”  

Quality and regulation of products: “Ghana faces issues related to the quality and 

regulation of pharmaceutical products, such as substandard and falsified medicines, 

weak enforcement of standards and laws, and inadequate infrastructure and human 

resources.”   

Low level of local produce of essential medicines: “Ghana has a low level of local 

production of essential medicines, especially vaccines and biologics, which are mostly 

procured through donor-funded programs or international organizations. Ghana 

imports about 80% of its pharmaceutical products, mainly from India and China, 

making it dependent on foreign sources and vulnerable to price fluctuations and supply 

disruptions.” 

The above quotations from Gab01 highlight how Nigeria and Ghana are both heavily 

reliant on imported medicines and medical devices, leaving them open to changes in 

the price of these products as well as to supply chain interruptions. The Nigerian and 

Ghanian pharmaceutical markets are further hampered by the combination of high 

reliance on medical imports and inadequate regulatory enforcements. 

Sub-Theme 1.2: Foreign pharmaceutical companies benefit from expansion into 

the market 

Foreign pharmaceutical companies can benefit from expanding into the Ghanaian and 

Nigerian market in several ways. Some of the potential benefits were highlighted 

during the research process. The following views were expressed by Gab02:  

Quality and affordable medicines: “Accessing a large and growing population of 

consumers, who have increasing demand for quality and affordable medicines. Nigeria 



39 
 

has the largest population in Africa, with about 200 million people, and is expected to 

grow to 400 million by 2050 and Ghana has a population of about 30 million people, 

and is expected to grow to 50 million by 2050.  

Economic development: “Contributing to the public health and economic 

development of the country, by providing essential medicines, creating jobs, 

transferring technology, and enhancing capacity. Nigeria faces a high burden of 

infectious and non-communicable diseases, and has a low level of health expenditure 

per capita.” 

National policies and incentives: “Taking advantage of the national policies and 

incentives that support local production and reduce import barriers, such as the Ghana 

Pharma Industrial Park. This is a project that aims to provide a conducive environment 

and incentives for local and foreign investors to set up pharmaceutical manufacturing 

plants in Ghana.” 

Gab02 highlights that by filling the growing need for accessible, high-quality 

medications, promoting economic growth, and utilising favourable national regulations 

and incentives to encourage domestic production, international pharmaceutical 

businesses can reap the rewards of expanding into Nigeria and Ghana. 

Sub-Theme 1.3: Legal and compliance requirements are needed prior to 

entering the market 

Legal and compliance requirements were identified as the reasons that have led to 

challenges for new pharmaceuticals entering the market. This was highlighted during 

the research process. The following views were expressed by Gab03: 

Requirements: The requirements are to follow the guidelines and standards of the 

Nigerian Investment Promotion Commission (NIPC), which is the agency that 

promotes and facilitates foreign investment in Nigeria. 

Corporate Affairs Commission: Registering with the Corporate Affairs Commission 

(CAC), which is the primary agency that governs the formation and maintenance of 

companies in Nigeria. Obtaining approval from the National Agency for Food and Drug 

Administration and Control (NAFDAC), which is the regulatory body that oversees the 

quality and safety of pharmaceutical products in Nigeria. 



40 
 

Registrar General’s Department: Registering with the Registrar General’s 

Department, which is the primary agency that governs the formation and maintenance 

of companies in Ghana. Complying with the tax laws and regulations, such as the 

Income Tax Act, the Value Added Tax Act, and the Customs Act. Adhering to the 

labour and immigration laws and regulations, such as the Labour Act, the Immigration 

Act, and the Ghana Investment Promotion Centre Act. 

Gab03’s remarks describe the rigorous legal and compliance procedures, which 

include registering with many agencies, receiving regulatory licences, and abiding by 

tax, labour, and immigration regulations, making it difficult for new pharmaceutical 

businesses to enter the Nigerian and Ghanaian markets. 

Sub-Theme 1.4: Current regulatory challenges of entering the market 

Regulatory challenges were identified as a reason that has led to challenges for new 

pharmaceuticals entering the market. This was highlighted during the research 

process. The following views were expressed by Gab04: 

Weak regulatory capacity and oversight: The identified challenges of entering the 

market are the weak regulatory capacity and oversight of the National Agency for Food 

and Drug Administration and Control (NAFDAC), which is the main body that oversees 

the quality and safety of pharmaceutical products in Nigeria and Ghana. 

Following the guidelines and standards: Following the guidelines and standards of 

the Nigerian Investment Promotion Commission (NIPC), which is the agency that 

promotes and facilitates foreign investment in Nigeria.  

Inadequate legislation: The inadequate and often overlapping legislation, which 

creates confusion and uncertainty for investors and manufacturers. The official 

corruption, which undermines the effectiveness and credibility of the regulatory system 

and creates opportunities for illicit trade and practices. 

The issues highlighted above by GABO04 reduce the efficacy of regulations and cause 

uncertainty among investors, while also discouraging potential investors.  

Sub-Theme 1.5: Problems that modern pharmaceutical companies encounter 

when entering new emerging markets 



41 
 

Problems that modern pharmaceuticals experience were identified as the reasons that 

have led to challenges for new pharmaceuticals entering the market. This was 

highlighted during the research process. The following views were expressed by 

Gab05: 

Culture: Understanding local cultures, languages, and healthcare practices as it is 

crucial for pharmaceutical companies to effectively market and distribute their products 

in Nigeria and Ghana. Failure to address these cultural nuances hinders market 

penetration. 

Evolving regulatory frameworks: Pharmaceutical companies often encounter 

complex and evolving regulatory frameworks in emerging markets like Ghana and 

Nigeria. Navigating these regulations related to drug approval, pricing, and distribution 

can be a significant challenge. Navigating these regulations, obtaining necessary 

approvals, and ensuring compliance can be time-consuming and costly. 

Inadequate infrastructure: In many emerging markets, including Nigeria and Ghana, 

inadequate infrastructure such as transportation, storage facilities, and healthcare 

systems can pose significant challenges for pharmaceutical companies in distributing 

and delivering their products effectively. Accessing remote areas and establishing 

efficient distribution networks can be difficult due to poor road networks and limited 

access to healthcare facilities in Nigeria and Ghana. This can impact the timely 

delivery of pharmaceutical products. 

Counterfeit products: The prevalence of counterfeit pharmaceutical products in 

emerging markets like Nigeria poses a significant threat to the reputation and market 

share of legitimate pharmaceutical companies. It also undermines patient safety and 

public health. 

All of these factors highlighted by Gab05 impede efficient distribution and market 

penetration. 

Sub-Theme 1.6: Government policies foster the development of the 

pharmaceutical sector 

The challenges of entering the pharmaceutical sector often intersect with government 

policies that either facilitate or hinder the development of the industry. This was 



42 
 

highlighted during the research process. The following views were expressed by 

Gab06: 

Foster the development : The Ghana government polices foster the development by 

embarking on infrastructure projects, such as the Agenda 111 hospital project, to 

improve accessibility to health care and boost the number of medical staff across the 

country. These investments are expected to enhance pharmaceutical services. 

National Health Insurance Scheme: The introduction of the National Health 

Insurance Scheme has significantly improved access to health care in Ghana. It 

provides insurance coverage for essential health services, including pharmaceuticals. 

This policy has facilitated better healthcare delivery and increased demand for 

medicines. 

Collaborations: In Nigeria there is collaborations between the government, private 

sector, and international organizations drive investment, technology transfer, and 

capacity building in the pharmaceutical sector. Public-Private Partnerships support 

initiatives such as drug research and development, technology transfer, and 

healthcare training programs. 

Local production policies: Nigeria has policies that encourage local pharmaceutical 

production. By promoting local manufacturing, the government aims to reduce 

dependence on imported drugs and enhance self-sufficiency. Implementing policies 

such as preferential procurement for locally manufactured drugs and providing support 

for local manufacturing capacity building can promote domestic pharmaceutical 

industry growth. 

All these factors mentioned by Gab06 assist in supporting local production and 

manufacture. 

 

Sub-Theme 1.7: Local producers successfully compete with import  

The challenges of entering the pharmaceutical sector, particularly for local producers 

aiming to compete with imports, are multifaceted and often deeply intertwined with 

various factors. The following views were expressed by Gab07: 



43 
 

Adherence quality assurance standards and compliance requirements: Nigeria 

Local producers should prioritize adherence to stringent quality assurance standards 

and regulatory compliance requirements to ensure that their products meet safety, 

efficacy, and quality benchmarks. Investing in Good Manufacturing Practices (GMP) 

and obtaining certifications from regulatory authorities such as the National Agency 

for Food and Drug Administration and Control (NAFDAC) enhances credibility and 

consumer trust in local pharmaceutical products. 

Some medications that are exempted from importation: In Ghana, the government 

has also introduced a policy where there are some medications that are exempted 

from importation. It promotes products that the local manufacturers. In addition, local 

producers should strive to optimize their production processes, minimize production 

costs, and achieve economies of scale to offer c