Keywords

Consumer Protection, Product safety, Marketing Excellence and Pharmaceutical Industry.

Introduction

Consumer protection on health care products produced by pharmaceutical firms in Nigeria is aimed at protecting the rights and interest of consumers against unethical marketing practices of the firms in the market economy (UNCTAD, 2016; 2020). Despite the global awareness of consumer protection laws especially from the developed economies of the world, consumer protection in Nigeria have been noted to be on the low state due to the unethical practices of many firms in the market environment (Dibie et al., 2018; Chinwuba et al., 2018 & Emmanuel et al., 2016). Subsequently, Ogechukwu (2013); Nto et al. (2018) see this unethical marketing behaviours of the firms as a market failure that revolves around the 4ps market offerings (product, price, promotion and distribution/place) adopted by the firms in the market environment. The situation was also attributed to poor regulatory government supports and ineffective resolution/redress mechanisms.

However, scholars of extant literatures, such as Abasilim (2014); Chinwuba (2018) and Utum et al. (2020) has emphasised on this unethical operations of the firms in the market place as a great concern that requires a quick intervention and attention of the government/non-governmental bodies to enforce good regulatory measures for the appropriate protection of consumers right in the Nigerian market economy. Subsequently, while significant progress had been made in Nigeria in recent decades, especially under the leadership of The Late Dora Akunyili (Then Director-General of NAFDAC), that accorded her regime as the most affected Nigerian government agency (NOI–Gallup 2007-2008), recent results has appeared to be below expectations (Emmanuel et al., 2016; Dibie et al., 2018).

Research Hypothesis

H0: Product safety role by government agencies does not have a significant influence on the product strategy of pharmaceutical firms.

Literature Review

Concept of Consumer and Consumer Protection

Scholars in the field of marketing have raised a series of debates about the proper meaning of the term “consumer” that needed to be protected (UNCTAD, 2016). According to Abasilim (2016), the modern concept of customer is “the ultimate user of a good or service offered in the market for full profit and satisfaction.” A buyer, according to the description, is not actually the person who buys the product, but rather the person who uses up the product's value, thus exhausting its exchangeable value. As a consequence, the above characteristics reflect the significance of the consumer in both economic and business theories (UNCTAD, 2020). On this note, customers are seen not only in terms of marketing, but also in terms of all facets of business practices as people whose interests should be preserved at all times. Furthermore, the early consumerist movement, which was sparked by global economic challenges in the early 1970s, resulted in consumers raising their voices in protest against manufacturers' and sellers' unethical practices. Hence, consumer protection according to UNCTAD (2020) is a concept that addresses internal differences that exist between the producers/suppliers and consumers of goods and services over power imbalance, knowledge and resources. This power imbalance according to Chinwuba et al. (2018) tend to profit the producer more than the consumers due to age long philosophy that were based on the assumption of “caveat emptor” (a believe that buyers are aware of the products they buy). Subsequently, consumer protection for health-care goods has recently become a global phenomenon and an important challenge for economic growth, attracting the attention of many developing countries around the world, including Nigeria (Chinwuba et al., 2018; Rajini, 2016 & Utum et al., 2020).

Product Safety Role by Government Agencies

According to Salim & Mohammed (2017), product safety by modern law is all about the reduction and prevention of fake products from reaching the market place or consumers. Hence, it is not enough for manufacturers to produce products intended to be safe without specifying through instructions and warnings on the method of usage to the consumer. Subsequently, it has been observed that the Nigerian consumers are plagued with a myriad of problems in the area of product quality and safety (Ogechukwu, 2013; Abasilim, 2014). This observation can be attested to the recent reports on circulation of substandard and falsified product drugs during the covid 19 pandemic crises. According to World Custom Organisation report from the United Nations office on drug and crime, Covid 19 was seen as a catalyst for the trafficking of fake and substandard health care products that does not meet the United Nation safety standard and thus, have imposed danger and major threats to the health of citizens (UNODC, 2019). More so, other notable shreds of evidences on product safety abuse in Nigeria.

According to Egboro & Ehikwe (2017) and Salim & Mohammed (2017), manufacturers of health care products have resorted in the production and proliferation of homogenous health care product brands due to free market economy without a clear indication of the differences among the products. Notably, according to Akinrinmade (2016), imposing strict product liability on health care organisations on defective products has not received the required attention but rather has been on the bases of fault principles. Hence the need to regulate the safety of health care products built on proper theories, principle and marketing offerings should be seen as a primary goal rather than a controversy. It is on the above stated notes that this study determines how government agencies role on product safety influences the product strategy of pharmaceutical firms.

In addition, the need to regulate the safety of products should no longer be a source of controversy. It should be the primary goal of any policy to protect the consumers. This is due to the fact that there are a lot of consumer goods that are heterogeneous and more technologically advanced, which are constantly being introduced to consumers (Salim & Mohammad, 2017).

However, governments of nations both at the national and international levels have demonstrated their dedication and interest in promoting and protecting consumer rights against counterfeits and skewed activities by manufacturers, distributors, and sellers of goods and services in the market environment. In particular, Ogechukwu (2013); Ijewere (2011); Chinwuba et al. (2018) emphasized that it is against this backdrop that the Federal Government of Nigeria establishes a number of regulatory bodies and laws (Acts) guiding consumer protections in various sectors of the economy and entrusting them with a variety of responsibilities. However, these regulatory bodies were limited in this study based on the objective and their product safety role to consumer protection. They include: Pharmacists Council of Nigeria (PCN), Standard Organisation of Nigeria (SON) Consumers’ Protection Council (CPC), National Agency for Food and Drug Administration and Control (NAFDAC), Drug and Regulated Products Advertisement Regulations (DRPAR), Counterfeit and Fake Drugs and Unwholesome Processes Foods (CFDUPF), National Drug Law Enforcement Agency (NDLEA), Federal Competition Consumer Protection Agency (FCCPA).

Pharmacists Council of Nigeria (PCN)

The Pharmacists' Council of Nigeria according to Oseni (2019) is a federal parasternal agency established by Act 91 of 1992 with the following responsibilities:

i. To provide a level of knowledge and skills for pharmacists and technicians in Nigeria.

ii. To develop and maintain a strong pharmacy practice in Nigeria.

iii. To issue pharmaceutical ethics and code of conducts.

iv. Recruitment and use of pharmaceutical inspectors in Nigeria to ensure successful pharmaceutical operations.

Standard Organization of Nigeria (SON)

Standard Organisation of Nigeria according to Dibie et al. (2018) and Udoma & Osagie (2019) was created by Act No. 56 of 1971 and was later amended to Act No. 18 of 1990 with the following responsibilities:

i. The authority to work for uniform requirements and quality system assurance for producers, industrial, and imported goods and services, as well as to ensure conformity with government standardization policies.

ii. They are in charge of product recalls, certification, and assisting in the production of high-quality goods.

iii. They also impose harsh penalties on manufacturers, inspectors, and sellers who do not follow the law ethics or do not meet the SON standard.

Consumer Protection Council (CPC)

According to Dibie et al. (2018); Emmanuel et al. (2016); Udoma & Osagie (2019); Piwuna (2016) Consumer Protection Council is a parasternal of the Federal Government of Nigeria created by Act No. 66 of 1992; to protect consumers' rights in the following areas: The right to be safe and free from dangerous goods and services.

i. The right to be aware and shielded from fraudulent, deceptive, or misleading activities, as well as to have access to reliable information and data required to make informed choices and decisions.

ii. The right to select and have access to a range of goods and services at fair and competitive prices.

iii. The right to be heard, as well as the ability to articulate and represent consumer preferences in economic and political decisions.

iv. The right to consumer education and to become a professional and knowledgeable consumer capable of working efficiently in the marketplace.

v. The right to redress and compensation for misrepresentation of shoddy products or services; and the right to redress and compensation for misrepresentation of shoddy goods or services (CPA Act, 1992). The Act establishes a federal council and a state committee in each of the country's states to improve operating performance and provide convenient access to customers.

National Agency for Food and Drug Administration and Control (1993)

National Agency for Food and Drug Administration and Control according to Dibie et al. (2018) and Udoma & Osagie (2019), was created in 1988 as a result of the World Health Organization's (WHO) request for member states to help tackle the global health threat posed by fraudulent, adulteration, and counterfeit pharmaceuticals. This commission was established in response to the deaths of over 150 children in 1988 as a result of false medications with the following responsibilities:

i. Regulate and monitor the importation, exportation, manufacture, marketing, delivery, sale, and use of medicines, cosmetics, medical devices, bottled water, and chemicals.

ii. Conduct appropriate investigations, tests, and ensure compliance with standard specifications designated and authorized by the council for the effective control of quality food, drugs, cosmetics, medical devices, bottled water, and chemicals.

iii. Certify manufacturing sites and register food, medications, and medical equipment, as well as bottled water and chemicals. (The agency has several offices across Nigeria to make it more accessible to customers and to improve its efficiency).

Drug and Regulated Products Advertisement Regulations (DRPAR)

The agency was created with all the enabling powers attached by the authority vested in her governing council of NAFDAC by sections 5 of 30 of Cap NI LFN of 2004. The legislation ensures that all drug products are accurate, understandable, and thorough, maintaining reputation and trust among the general public and healthcare professionals (NAFDAC, 2019).

Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions)

The agency according to The Nations (2013) was created by Act 1990 under section 2(1) of the counterfeit and fake drugs (miscellaneous provisions) laws, with the following specified rules: It is a crime to mislead, sell, or present any kind of drug or toxic drug of any kind in the market environment or illegal locations.

The National Drug Law Enforcement Agency (NDLEA)

According to UNODC, (2019), National Drug Law Enforcement Agency was created by Decree No. 48 of 1989. The agency is in charge of enforcing the law and fighting Nigeria's high rate of counterfeit and adulterated drug development. Persons charged with illicit drugs and other similar matters are investigated by the department. They also oversee the importation, exportation, processing, distribution, advertisement, sales, and use of medicines, chemicals, cosmetics, and medical devices, as well as a number of other duties.

Subsequently, notable cases of product safety abuse were indicated on Table 1 and Table 2 below.

Table 1 Cited Cases on Product Safety Abuse in Nigeria
S/N	Notable cases on unethical issues on product safety abuse in Nigeria
1	1986 case of Omotayo filed against Ragolis producers that went in favour of the plaintiff in 1988 (Oko & Linus, 2013)
2	1989 death of innocent children as a result of fake chloroquine infected malaria drug (Chinwuba et al., 2018; Abasalim, 2014)
3	1996 – Trouafloxarcin (Trauma) manufactured by Pfizer international incorporated that allegedly killed 11 children while injured 181. (Abasalim, 2014)
4	1998 – NAFDAC case report of Marcel Nnakwe and Onitsha business based man imported loads of fake, expired chymoral tablets into Nigeria (Abasilim, 2014)
5	1998 – killer beans that claimed many lives out of consumers (Chinwuba et al., 2018)
6	May, 2004 – The incumbent regime of Dora Akunyili saved Nigeria consumers  from Indomie poison and also seized an expired imported toothpaste worth N10 million (Ebitu, 2014)
7	May 6th 2007 – NAFDAC embarked on destruction and closure of Onitsha main market drug section for alleged importation of fake drugs worth N6.5 million
8	The case of Yemi Olukoya V. against Nigerian PLC breach of duty care of Harp Larger beer contamination that nearly claimed the life of the plaintiff. (Oko & Linus, 2013)

Table 2 Covid-19 National Issues on Product Safety Abuse
S/N	Notable cases on National issues related to product safety on Covid-19 pandemic (UNODC, 2019)
1	Massive trafficking of substandard and falsified medical products that did not meet safety standard such as personal protection equipment (PPE)
2	Three thousand three hundred (3,300) trafficking thermometers seized in Thailand, Italy and three other countries
3	Sales of falsifying hydroxychloroquine sulphate, Remdesivir  and others that did not meet the safety standard
4	Substandard cases of seized test kits including anti-body test and face mask
5	Substandard case of imported ventilators seized in Russia, UK, Bosnia and Herzegovinian, Egypt, Balkan, Islamic Republic of Iran, Morocco and Nigeria with cases of related cybercrime frauds in other countries. (UNODC, 2019)

Product Strategy

Kotler & Armstrong (2012) defined a product as anything offered in the market place that can attract attention, acquisition, use, or consumption that might satisfy a want or need. They also emphasized that a consumer product is the product bought by the final consumer for personal consumption. Consumers buy products frequently, with careful planning, and by comparing brands based on price, quality and style. Product strategy in other word refers to all consumer goods and services that a company offers to the target market for the purpose of satisfying needs. It also includes physical products, services, information, places, organizations or ideas that can be offered for acquisition or consumption that might satisfy a want or a need (Muchiri, 2016). With more emphasis, the physical appearance of the product, packaging, and labelling information can contribute to consumer awareness of a product in the market, through examination and purchase, thus, the product is an important component of the marketing mix that determines whether the organization survives or dies (Daniel, 2018).

Product strategy consists of elements such us packaging, branding, labelling and product attributes that are of good quality, style, features and design. Strong brand preference is an added feature to the product (Muchiri, 2016). However, The Chartered Institute of Marketing (2009) opined that there is no point in developing a product or service that no one wants to buy, yet many businesses decide what to offer first and then hope to find a market for it afterwards. On the contrary, successful businesses find out what customers need and then develop the right products with the right quality to meet those needs at the present and in the future. In developing a product, it should provide value to the customer, it does not have to be tangible, and the customers’ needs must be regularly evaluated. Hence, product is the first element of marketing mix produced and sold by manufactures to end users. It is more than a simple set of tangible features. It is a complex bundle of benefits that satisfy customer needs (Suherly et al., 2016). Table 3 depicted that products can be categorized in two types, tangible products and intangible products /services according to (Mohammad, 2019).

Table 3 Categories of Products
Tangible Product	Actual physical product such as a car, an electronic device, and an item of clothing or a consumer good.
Intangible Product	Not physical product but can be felt indirectly. Example insurance policy, health treatment by doctors, legal advice of layers, and educational services.

Išoraitė (2016), also classified products based on consumer product, necessary product and exclusive products and they are explained as follows:

i. Consumer product: it (toothpaste, bread, newspapers, clothes, household appliances, etc. The product they purchase for their personal use and these products are still divided into minimum, valuable, exclusive and unmarketable (not intended to search)

ii. Necessary product: A product that the consumer buys frequently and almost immediately without comparing it to other products of the same type, (Pharmaceutical products)

iii. Valuable product more consumer-oriented product, which the consumer usually compares to others, considers its suitability, the quality, price and style.

iv. Exclusive product is consumer product that has unique characteristics or is distinguished by its brand, which is bought by a large group of customers; Transgressed (not intended to search) the product (blood donation, life insurance) - Consumer is a product which a user does not know, and if he knows he has no intention to buy it.

Stimulus Organism Response Model

Stimulus organism response (S.O.R) was propounded by Woodworth (1929) as an extension to the classic theory of the stimulus response model by Pavlov (1927). The (S.O.R) model is comprised of three constructs (stimulus, organism and response) as shown in Figure 1 below.

In the context of this research, the stimulus reflects the government policy (regulations) and its outcomes on product safety that affects the internal operational state of business marketing organisations (pharmaceutical firms) (Pandita et al., 2021). Organism, according to Fu et al. (2021) is the ‘internal processes and structures taking place between the external stimulus (government policies) to the organisations and their final actions/responses. Thus, organism in this study represents the organisations response to the government policy measures on product safety.

Application of Stimulus Organism Response in the Marketing Organisation

Stimulus responses have been examined by extant literatures such as Qi et al. (2021); Pandita et al. (2021) as an adaptation and sensemaking processes to changes in the competitive business environment. According to the authors, the adaptive capacity of business organisations to changes in the competitive business environment is critical to responses at various challenges. Hence, the ability of business organisations to respond to policies and adjust to changes is believed an important factor to be considered by marketing organisations owing to the high magnitudes of business practices by firms operating in the market environment that inevitably demand for adaptive capacities (Bryce et al., 2020).

However, the government (stakeholders) as a principal actor, plays a major role with an inclusive policy framework to compel marketers adapt to unprecedented changes in the market business environment (Qi et al., 2021). Without these policies, business resilience especially the reactive strategies by organisations may fail to adapt to unprecedented system renewal changes triggered by policy interventions in the business environment.

Subsequently, business interpretation of cues (changes) and sensemaking actions were identified by Hall et al. (2018); Sandberg & Tsoukas (2020), as an adaptation process into action to strategic changes and decision making of organisations to policies. Hence, regulatory policy actions in the market environment were seen as one of the commonsense making cues that trigger organisational compliance to market stimulus.

Overall, government interventions, adaptation and sensemaking changes have been noted and recognised by extant researchers, Aguinis & Glavas (2019); De Rond et al. (2019); Konlechner et al. (2019); Kubickova (2019); Nazir & Islam (2020); Rasoolimanesh et al., (2020); Schildt et al. (2020); Siakwah et al. (2020), as an influencing and effective imposing factors that have commanded meaningful changes and results in organizational responses to market stimulus.

Relevance to Study

Stimulus organism response (SOR) is well accepted and adopted by researchers in the area of consumer marketing to study the behaviour of consumers in the context of retail buying, social media engagements, organizational performance behaviour, business relationships and healthcare organisations (Chen & Yao, 2018). Hence, the model is useful and applicable to the objectives of this study.

Methodology

The study assessed the relationship and resultant effect of product safety on product strategies of selected pharmaceutical firms in Lagos State, Nigeria. A mix method approach of quantitative and qualitative method of data collection that made use of descriptive and explanatory research design was employed to achieve the objective of the study. The quantitative aspect of the research design adopted the use of structured questionnaire to measure the variables in the objective of the study, while the qualitative aspect of the study utilised a secondary data collection approach that involved interview session to determine the experiences of the respondents based on consumer protection and product safety.

The study was carried out in the five divisions of Lagos State metropolis of Nigeria which includes Ikeja, Badagry, Ikorodu, Lagos-Island and Epe (IBILE). The five pharmaceutical firms selected for this study were: May and Baker Nigeria Plc, Fidson Healthcare Plc, Mopson Pharmaceutical Ltd, Emzor Pharmaceutical Plc and Neimeth International Pharmaceuticals Plc. The selection of the pharmaceutical companies was based on their maximum potential, productivity relevance, contributions and impacts recorded over the past years on economic development of Nations and Nigeria at large (25^th February, 2020).

The total population for the study consists of the employee heads made of managers/supervisors in the head offices of selected pharmaceutical firms, selected managers/supervisors of Consumer Protection Council (CPC), National Agency for Food and Drug Administration Control (NAFDAC), and one of the most popular radio-stations in Nigeria (Raypower 100.5 FM, Alabgado). The sample size for the total population of the managers/supervisors in head offices of selected pharmaceutical firms were 187 which was determined based on census enumeration approach. The sample was further administered across the managers/supervisors of selected pharmaceutical firms. The data collected was analysed to demonstrate the response rate of managers and supervisors of the selected pharmaceutical firms. For the qualitative, the interview sessions were conducted with three (3) senior officers each in CPC, NAFDAC and African Independent Television (AIT) on separate days for logistic reasons. The interview with CPC was held with the Consumer Education and Enforcement Departments, NAFDAC with Pharmaco vigilant and post marketing surveillance directorates department and AIT with Marketing and Sales Department. Each session was very rewarding with officers of the agencies sharing information on all issues placed before them by the researcher. The following themes were identified for this study:

Correlation and Simple Regression Method (CSRM) with Statistical Package for Social Sciences (SPSS) was adopted to determine the impact of one variable on the other. Reliability and fitness were also carried out while convergent and biased analysis was employed to determine construct validity. The study also adopted the use of 5-point Likert Scale to obtain the participants responses and to determine the degree of responses and agreement among the participants with the specific items in the instrument.

However, hypotheses were tested to determine the differences in data among the five (5) divisions used in this study. For the hypotheses, ANOVA and cross-tabulation statistical expression were used to analyse data and to establish the difference(s) in data. Correlation coefficient was also adopted to establish relationship in variables. These testing procedures were employed to determine the mean differences in samples used.

Data Analysis

The findings from the descriptive statistics revealed that product safety role of government agencies is of great importance in sustaining consumer protection. This implies that sustainable consumer protection mechanisms can be made visible through the product safety role of government agencies. The descriptive statistics of each firm in terms of product strategies of the pharmaceutical firms in Nigeria are also presented in Table 4.

Table 4 Frequency Distribution for Product Strategies of Pharmaceutical Firms
s/n	Items	Frequency and Percentage					Total	Mean	SD
		SA	A	U	D	SD
Product strategies of pharmaceutical firms
1	The drugs we produced are of good quality and standard.	28 (18.5%)	63 (41.7%)	34 (22.5%)	16 (10.6%)	10 (6.6%)	151 (100%)	3.549	.8116
2	We use good packaging and designs for our drugs.	35 (23.2%)	86 (57%)	12 (7.9%)	13 (8.6%)	5 (3.3%)	151 (100%)	3.880	.9724
3	Consumers love the brands of pharmaceutical drugs because of the purpose they serve.	29 (19.2%)	85 (56.3%)	18 (11.9%)	14 (9.3%)	5 (3.3%)	151 (100%)	3.788	.9702
4	We produce varieties of drugs to meet consumer’s choice demand.	66 (43.7%)	71 (47%)	7 (4.6%)	7 (4.6%)	-	151 (100%)	4.298	.7641
5	We use discounts and bonuses to sell our drugs in the chemist shops to attract consumer loyalty.	43 (28.5%)	77 (51%)	10 (6.6%)	16 (10.6%)	5 (3.3%)	151 (100%)	3.834	.8041
Average Means Score								3.870	0.864
Decision: Satisfied (3.870)

Table 4 indicated the measures of product safety strategies of the selected pharmaceutical firms in Nigeria. From the table above, it was revealed that 28(18.5%) and 63(41.7%) of the respondents strongly agreed and agreed that the selected pharmaceutical firms produced drugs that are of good quality and standard; 34 (22.5%) were undecided, while 16(10.6%) and 10(6.6%) of the respondents disagreed and strongly disagree with the statement. This implies that majority of the directors and managers representing 60.2% affirmed that the selected pharmaceutical firms produced drugs that are of good quality and standard.

It was also revealed that 35(23.2%) and 86(57%) of the respondents strongly agreed and agreed that the selected public pharmaceutical firms use good packaging and designs for their drugs; 12(7.9%) were undecided, while 13(7.6%) and 5(3.3%) of the respondents disagreed and strongly disagree with the statement. This infers that majority of the directors and managers representing 80.9% confirmed the relevance of good packaging and designs for their drugs.

However, 29(19.2%) and 85(56.3%) of the respondents strongly agree and agreed to the statement that the consumers love the brands of their pharmaceutical drugs because of the purpose they serve, 18 (11.9%) were undecided, while 14(9.3%) and 5(3.3%) disagreed and strongly disagreed with the statement. This indicates that majority of the directors and managers representing 75.5% affirmed that the consumers love the brands of their pharmaceutical drugs because of the purpose they serve.

Additionally, 66(43.7%) and 71(47%) of the respondents strongly agreed and agreed with the statement that the selected pharmaceutical firms produced varieties of drugs to meet consumer’s choice demand, 7(4.6%) were undecided, while 7(4.6%) disagreed with the statement respectively. This denotes that majority of the respondents (directors and managers) representing 90.7% claimed that the selected pharmaceutical firms produced varieties of drugs to meet consumer’s choice demand.

Nevertheless, 43(28.5%) and 77(51%) of the respondents strongly agree and agreed to the statement that the pharmaceutical firms use discounts and bonuses to sell our drugs in the chemist shops to attract consumer loyalty, 10 (6.6%) were undecided, while 16(10.6%) and 5(3.3%) disagreed and strongly disagreed with the statement. This indicates that majority of the directors and managers representing 79.5% affirmed that the selected pharmaceutical firms use discounts and bonuses to sell our drugs in the chemist shops to attract consumer loyalty. The average mean score of product safety strategies of the selected pharmaceutical firms in Nigeria in Table 4 is in consonance with the frequency and percentage section. Using the criteria for understanding the mean scores of satisfaction level. It can be depicted that all pharmaceutical firms ranging from Pharma #1 to Pharma #5 were satisfied (with an average mean score of 3.870) and affirmed that significance of product safety strategies of the selected pharmaceutical firms in Nigeria.

The findings from the descriptive statistics revealed that regulation requires the pharmaceutical industry to engage in a wide range of pharmacovigilance activities with the sole purpose of ensuring that the benefit-risk ratio of a medicinal product is always in the patient's favor. There have been several instances in which previously approved medicines with extraordinary efficacies had to be recalled from the market following a review of real-world safety data gathered after approval. This clearly demonstrates the importance of fostering the continued growth of good pharmacovigilance practices within the industry, as well as the adoption of such practices by all stakeholders. Since the industry practices described above are primarily targeted towards regulatory compliance, it becomes important for us to see how the regulatory agencies respond to the safety information submitted by the industry.

To support this result, the mean values of each firm in terms of the assessments of product safety role by government agencies and the product strategies of pharmaceutical firms are also presented in Table 5.

Table 5 Mean Assessments of Product Safety and Product Strategy
Items	Pharma #1	Pharma #2	Pharma #3	Pharma #4	Pharma #5	Total
Product Safety Role by Government Agencies
We offer identical and quality drugs to the market place to meet consumer needs.	4.166	3.593	3.971	3.966	3.458	3.830
The drugs my company produced are well packaged with accurate information for consumer awareness.	4.133	3.906	4.342	3.700	3.250	3.866
The drugs we offered in the market place meet the standard of NAFDAC.	4.433	3.656	4.371	3.866	4.250	4.115
The drugs we offered in the market place were certified by NAFDAC.	4.200	3.437	4.228	4.100	3.791	3.951
The company ensures regular supply of quality products in the rural areas to meet consumers need	3.866	3.156	3.914	3.800	3.083	3.563
Ave. Score	4.160	3.550	4.165	3.886	3.566	3.968
Product Strategy of Pharmaceutical Firms
	Pharma #1	Pharma #2	Pharma #3	Pharma #4	Pharma #5	Total
The drugs we produced are of good quality and standard.	3.400	3.343	4.028	3.666	3.166	3.520
We use good packaging and designs for our drugs.	4.000	3.843	4.114	3.966	3.333	3.851
Consumers love the brands of pharmaceutical drugs because of the purpose they serve.	3.800	3.968	3.942	4.000	3.041	3.750
We produce varieties of drugs to meet consumer’s choice demand.	4.366	4.468	4.314	4.000	4.333	4.296
We use discounts and bonuses to sell our drugs in the chemist shops to attract consumer loyalty.	3.433	4.187	4.314	3.433	3.666	3.806
Ave. Score	3.800	3.962	4.142	3.813	3.508	3.845

Table 5 shows the mean and standard deviation of each item for the assessments of government agencies role of product safety influences the product strategy across the five (5) selected pharmaceutical firms in Nigeria. The mean represent average that measures central tendency while standard deviation measures the extent of variation compared to mean. The decision rule for mean on a Likert scale of five (5) indicates that when the mean value is between 1.00-1.80, it is said to be extremely dissatisfied; the mean value between 1.81-2.60 is regarded as dissatisfied, 2.61-3.40 it is undecided; while the mean value between 3.41-4.20 is regarded as satisfied and 4.21-5.00 is demonstrated as extremely satisfied.

The average means score product safety role by government agencies and product strategy across the five (5) selected pharmaceutical firms in Nigeria. Using the criteria for understanding the mean scores of satisfaction level. It can be depicted that all the selected pharmaceutical firms ranging from Pharma #1 to Pharma #5 agreed (with an average mean score of 3.968) that they offer identical and quality drugs to the market place to meet consumer needs; ensure the drugs offered in the market place certified and meet the standard of NAFDAC and finally, ensures regular supply of quality products in the rural areas to meet consumers need. Pharma ‘1’, Pharma ‘3’ and Pharma ‘4’ had the highest mean scores (4.160, 4.165 and 3.886) while Pharma ‘2’ had the least mean scores (3.550).

On the other hand, the average means score product strategy across the five (5) selected pharmaceutical firms in Nigeria is also displayed in Table 5. Using the criteria for understanding the mean scores of satisfaction level. It can be depicted that all the selected pharmaceutical firms ranging from Pharma #1 to Pharma #5 agreed (with an average mean score of 3.845) that the drugs they produced are of good quality/standard, engage in producing varieties of drugs to meet consumer’s choice demand and they also use discounts and bonuses to sell our drugs in the chemist shops to attract consumer loyalty. Pharma ‘3’, Pharma ‘2’ and Pharma ‘4’ had the highest mean scores (4.142, 3.962 and 3.813) while Pharma ‘5’ had the least mean scores (3.508).

By implications, this study revealed that Product recalls and safety concerns are bringing pharma manufacturing to the forefront of public attention, as well as the pharma supply chain that supports biologics-based manufacturing. This focus on quality and compliance is also a result of shifting biopharmaceutical trends that have an impact on cold chain logistics. Pharmaceutical companies have realized the need for more efficient processes over the last decade and have shifted from traditional manufacturing to agile, flexible operations. The changes had an impact on the finer points of manufacturing as well as the equipment required to stay competitive. The selected firms have engineered a variety of products that reliably support operations from R&D to production as the pharmaceutical industry adapts to changing market needs.

Test of Research Hypothesis One

To complement the descriptive statistics, a factor-loading test was conducted for product safety role by government agencies and product strategy of Pharmaceutical firms. This test comprised factor loading (FL), error variance (EV), composite reliability (CR), average variance extracted (AVE) and Cronbach’s alpha (CA). It must be reported that factor loading depicted in Table 6 for all the items of product safety role by government agencies and product strategy were above the minimum threshold of 0.70 and as well statistically significant at 0.05 level of significance as suggested by Fornell & Larcker (1981); Newkirk and Lederer (2006).

Table 6 Factor Loading for Product Safety and Product Strategy
	Factor Loading	Error Variance	Composite Reliability	AVE	Cronbach's Alpha	No. of Indicators
Indicators	> 0.7	< 0.5	≥ 0.8	≥ 0.5	≥ 0.7
Product Safety			0.841	0.590	0.723	5
PSA1	0.700	0.300
PSA2	0.745	0.255
PSA3	0.763	0.237
PSA4	0.780	0.220
PSA5	0.719	0.281
Product Strategy			0.863	0.604	0.788	5
PST1	0.740	0.260
PST2	0.891	0.109
PST3	0.766	0.234
PST4	0.762	0.238
PST5	0.709	0.291

Fornell & Larcker (1981) recommended the threshold for all the scales and measurement items. First, the factor loading must be above the minimum threshold value of 0.70. Second, the construct composite reliability must be equal or greater than 0.80. Third, the construct average variance extracted estimate (AVE) must be above the minimum threshold of 0.50. Finally, the Cronbach Alpha must be equal or above 0.70 for the instruments to be reliable. From the table above, it can be depicted that all the constructs of customer redress action have values higher than 0.80 and 0.70, which means that they have composite and Cronbach Alpha reliability respectively. The factor loadings for the specific measures of construct ranged between 0.700 and 0.891. None of the items had a factor loading less than 0.7. Hence, the instrument is adjudged reliable and valid since the entire requirement for the degree of fitness was satisfactorily met.

The following hypothesis stated in null form was tested in this study.

H01: Product safety role by government agencies does not significantly affect product strategy of the pharmaceutical firms in Nigeria

To test the hypothesis, multiple regression analysis was used. Data for the product safety components were created by summing responses of all items for the variables. The results of the analysis are presented in Table 7.

Table 7 Summary of Regression for Product Safety and Product Strategy
Model Summary
Model	R	R Square	Adjusted R Square	Std. Error of the Estimate
Product Safety	0.603	0.364	0.337	.7847463
Pharma ‘1’	0.506	0.256	0.248	.663533
Pharma ‘2’	0.541	0.293	0.286	.836353
Pharma ‘3’	0.531	0.282	0.275	.768726
Pharma ‘4’	0.420	0.176	0.160	.682726
Pharma ‘5’	0.479	0.229	0.212	.696354
ANOVA
Model	Sum of Squares	Df	Mean Square	F			Sig.
Regression	10.737	1	10.737	13.293			0.000b
Residual	120.349	149	0.808
Total	131.086	150
Co-efficient
	Unstandardized Coefficients		Standardized Coefficients		T		Sig.
	B	Std. Error	Beta
(Constant)	3.888	.099		17.109		0.000
Product safety	0.489	.054	0.603	6.826		0.000
a. Independent Variable: Product safety
b. Dependent Variable: Product strategy of the pharmaceutical firms in Nigeria

The findings indicated a positive relationship between the product safety role by government agencies and product strategy of the pharmaceutical firms in Nigeria as presented in Table 7. Regression analysis establishes how an independent variable causes the dependent variable to change, and the results of the analysis is expected to change if independent and dependent variables are swapped. Table 7 is a model fit which establish how fit the model equation fits the data. The R2 was used to establish the variance power of the study model.

All the research variables have been measured using a structured questionnaire with a five Likert scale. The product safety role by government agencies, which is the latent variable, was measured with five (5) items while product strategy of the pharmaceutical firms in Nigeria was also measured with five (5) items as shown in Tables 5 and 6 respectively.

In other words, the model investigated whether the product safety role by government agencies is a predictor of product strategy of the pharmaceutical firms in Nigeria. The result shows that product safety role by government agencies has positive and significant effect on the product strategy of the pharmaceutical firms in Nigeria (r=0.603, r2=0.364, p=0.000). The correlation coefficient of 0.603 indicates that the predictor variable (product safety role by government agencies) has a strong and positive relationship with product strategy of the pharmaceutical firms in Nigeria.

The regression results further reveal the coefficient of determination also called the R square. An R2 value of 0.71 - 0.90 is considered strong, an R2 value of 0.51 – 0.70 is regarded as satisfactory, an R2 value of 0.31 – 0.50 is regarded as moderate and an R2 value of 0.10 - 0.30 is considered as weak. In this study, the path model of 0.364 was observed for the endogenous latent construct. This implies that product safety role by government agencies explained 36.4% of the variations in product strategy of the pharmaceutical firms in Nigeria in the model suggesting a weak explanatory power. This implies that the other variables not studied in this model contributed 63.6% of the change in product strategy of the pharmaceutical firms in Nigeria.

The determination of co-efficient (R-square) for the product safety role by government agencies was also analysed. Basically, the R2 of Pharma ‘1’ (r= .506, r2 = .256) is weak; Pharma ‘2’ (r= .541, r2 = .293) is relatively weak; Pharma ‘3’ (r= .531, r2 = .282) is relatively weak; Pharma ‘4’ (r= .420, r2 = .176) is extremely weak; and Pharma ‘5’ (r= .479, r2 = .229) is weak. Overall, the result shows that the variance of product strategy is explained by the product safety of the selected pharmaceutical firms in Nigeria is moderate.

Furthermore, the table shows the results of ANOVA (overall model significance) test which revealed that the combined independent variable; product safety components have a significant effect on the product strategy of the pharmaceutical industry in Nigeria. This can be explained by the F value (13.293) and p-value <0.5 (0.000) which is statistically significant at 95% confidence interval. This therefore implies that product safety role of government agencies has significant effect on the product strategy of the pharmaceutical industry in Nigeria. This finding was in line with the study of Chinwuba et al. (2018) study on assessment of consumer attitude towards consumerism and the impact of government regulations on business practices in Enugu state that supported the findings of Abasilim (2016) and Oko & Linus (2013). Based on the results, the null hypothesis one (H01) which states that product safety role of government agencies has no significant effect on product strategy of the pharmaceutical industry in Nigeria is hereby rejected.

The result from the interview supported the findings of the quantitative analysis. The first question focused on what the agency (IES) did in ensuring the safety of pharmaceutical products. From the interview, it was revealed that the agency embarks on yearly survey plan with regular test. They also collect and conduct analysis on selected sample product drugs of different companies to test for a quality laboratory test on aflatoxins, mycotoxins, addictive and the authenticity of the product contents without the prior knowledge of the companies. Additionally, the agency equips and updates their laboratories to fall in line with the newest technological standards for updated results.

It was also revealed that the agency has an established T.V programme with AIT T.V station titled “NAFDAC and Your Health” where the agency educates the general public on all the issues that has to do with NAFDAC regulated operations on product safety and in return receives feedback and open questions from the general public. More -so, the agency monitors and regulate drug distribution through good distribution inspection practices of supply chain (from supplier-distributor-consumer) by ensuring that drugs are maintained with good temperature in the cold chain where they are preserved as specified by the manufacturers.

The researcher also endeavored to examine the measures the agency(ies) put in place to make sure that pharmaceutical products are safely distributed to the rural and urban area to meet consumer needs and demand. It was revealed that the role of the agency is majorly on product safety to regulate importation. Exportation and distribution of product drugs for safety purposes. One of the participants had this to say:

“The agency makes sure that the companies concerned present their registered certificate with Pharmaceutical Council of Nigeria and NAFDAC before the agency could assess their product information to the general public.” (IDI, Respondent 4, Specialised Agency).

Another respondent claimed that:

“We aim to protect public health as an agency by ensuring that only high-quality pharmaceuticals, food, and other regulated items are made, imported, and distributed. In conjunction with other international authorities, we have made various attempts to combat the distribution and use of counterfeit pharmaceuticals. As we work diligently to combat fake drugs, new obstacles arise from unethical drug dealers who, in some cases, have the support of lawmakers and officials, rendering the drug laws and standards unachievable.” (IDI, Respondent 1, Specialised Agency).

One of the respondents also described their efforts in fight any fake drug and ensuring full protection of the consumers’ right. He had this to say:

“On a daily basis, we fight any drug or drug product that is so coloured, coated, powdered, or polished that the damage is hidden, or that is made to appear to be better or of greater therapeutic value than it is, or that is not labelled in the prescribed manner, or that has any statement, design, or device on the label, container, or anything that comes with the drug that makes a false claim for the drug. Or Any drug product whose label lacks adequate directions for use and adequate warnings against using it in pathological conditions or by children where it could be harmful to their health, or against using it in unsafe dosages, methods, or durations; or any drug product that has not been registered by the Agency in accordance with the provisions of the Food, Drugs, and Related Products (Registration, Labeling, and Labeling, and Labeling, and Labeling, and Labeling, and Labeling, and Labeling, and Labeling.” (IDI, Respondent 2, Specialised Agency).

Some of the respondents also spoke after the consequential effect of fake drugs that are in circulation:

“In underdeveloped countries, such as Nigeria, the distribution of pharmaceuticals by untrained peddlers is a prevalent practice. Consumers who use these medication vendors for reasons like as convenience, supply reliability, and inexpensive prices frequently make them their primary point of contact for health care. The reason for this is that most customers are unable to obtain medications through government clinics, and licenced pharmacies are frequently located in remote locations that are too expensive. The incapacity of consumers to assess the quality of the medications they take has become a major public health issue; as such pharmaceuticals can be ineffective and dangerous.” (IDI, Respondent 4, Specialised Agency)

Another respondent had this to say:

“We monitor corporations and individuals suspected of breaking NAFDAC regulations and conduct investigations into such individuals and businesses. We also pay unannounced inspections to all ports of entry and border posts, as well as suspect interrogation. Let's not forget that we send samples of NAFDAC-regulated products to the lab, compile case files, and coordinate state task force actions.” (IDI, Respondent 3, Specialised Agency).

This suggests that the agency is not only involved in the quantity distribution and circulation of the drugs but was more concerned with the monitoring and safety arrival of the product drugs in circulation. In conclusion, the agency only follows up product drugs from the source of importation to Nigeria till the time of consumption. In case there is complaint of product effects from the consumer, the agency will trace it to the manufacturer’s source.

To complement the responses from the agencies, the official of the media organisation (i.e. Raypower 100.5 FM, Alagbado, Ifako-Ijaiye, Lagos) were also interviewed. The major question was to know what the media organisations do to ensure that consumers receive appropriate information on the safety of pharmaceutical products they buy. The following responses were annexed:

“Our media station makes sure that It adhere and follow the Nigerian Broadcasting Commission safety rules to regulate our broadcasting activities towards product safety. Also, our media makes sure that the information manufacturers bring to their station is well examined, and scrutinized before announcing it to the general public to harvest. (IDI, Respondent 1, Media Organisation).

“Our media has an established AIT television platform where we educate the consumers on product safety and advise them to report any product hazard on fake and adulteration experience to the Consumer Protection Agency and Federal Competition and Consumer Protection Council office. In addition, we enlighten the general public through TV programs on the adverse effects of local product drugs that were not fully certified or endorsed by NAFDAC and advised them to desist from such products.” (IDI, Respondent 3, Media Organisation)

“Access to essential medicines by the general public, regardless of income status, is critical for the success of healthcare delivery services. People pay exorbitant prices for medicines, making it impossible to obtain them (Lambo 2006). Fake drug circulation is aided by a disorganised drug distribution network and a large number of illegal shops. The lack of responsibility in pharmaceutical disposal hampers the job of the drug regulating body (NAFDAC).” (IDI, Respondent 2, Media Organisation)

“On a daily basis, we fight any drug or drug product that is so coloured, coated, powdered, or polished that the damage is hidden, or that is made to appear to be better or of greater therapeutic value than it is, or that is not labelled in the prescribed manner, or that has any statement, design, or device on the label, container, or anything that comes with the drug that makes a false claim for the drug.” (IDI, Respondent 1, Media Organisation)

According to the findings, the government's efforts to protect the health of its inhabitants are critical. It can ensure that high-quality medicinal items are distributed through a well-established, regulated supply chain overseen by professionals, reducing the number of fakes, improving the monitoring system, and instilling customer confidence. Monitoring the drug distribution chain is critical for detecting fraudulent drugs. The UK MHRA uses Good Distribution Practice inspectors to supervise the chain, and every level of the chain, from the producer through the distributors, wholesalers, retailers, and dispensers, must be licensed. This assists them in ensuring that counterfeit pharmaceuticals do not enter the supply chain.

Only licenced pharmacists are allowed to participate in medication manufacturing, importation, distribution, and dispensing in South Africa. Drug dealers are encouraged to keep doing what they're doing because the rules aren't strong enough to deter them. The Nigerian judiciary isn't helping matters, as cases drag on far too long in court. Even when the Agency has sufficient evidence and witnesses against drug dealers, justice is often denied. How can any intervention strategy operate effectively if the regulations that govern it are ignored by the same hands that created it? The Chinese government has imposed harsh punishments for drug law violators, including license revocation and restriction of drug manufacturing.

The findings indicated that the selected agencies specifically receive consumer related complaints from aggrieved consumers whose rights have been infringed upon by either Sellers of unwholesome and unsafe goods and service providers whose services are sub-standard and do not meet the needs of the people, pharmaceutical Companies inclusive. The agency ensures adequate promotion and protection of consumers’ rights and amicable resolution of consumer related issues is handled and restored through Alternative Dispute Resolution which could either be through mediation, negotiation or conciliation.

Furthermore, the findings revealed that the agencies ensure the replacement of hazardous products with safe products or goods and seeks ways and means of eliminating hazardous products from markets in conjunction with other units of the Agency through monitoring /enforcement Department and other relevant Agencies. The agencies make sure that offending company, firm, trade association or individual to compensate or provide relief to injured consumers or communities as a result of adverse effects of harmful products. The agency (i.e. CPC) makes sure that the interest of consumers receives due consideration.

It can be concluded from the findings that the agency (IES) make sure that there are constant and regular checks by the Sellers of goods and products that are being displayed on their shelves are not expired or devoid of sufficient product information. The agency makes sure that there is constant, regular and unannounced monitoring of market places for unwholesome products and enforcement of compliance by the Sellers and Manufacturers alike by the Agency. The agency puts in place stringent penalty/fines as being enacted by the Consumer Law on any non-conformists. The agency Introduces and makes use of Task Force outfit within the market places to also check for any unfair trade practices or any infractions being committed.

Discussion

The findings indicated that Consumer Protection Council (CPC) has actually sensitized the consumers but more roles need to be carried out in order for Nigerian consumers to know and adhered strictly to their right. This is owing to the fact that the Consumer Protection Council (CPC) and NAFDAC, has been doing a lot of things to protect the consumers but the problem of Nigerian consumers is lack of time consciousness, most of the time they do not have time to complain or go to court to lodge their complaints. In other words, they are complacent about their predicaments, leading to lack of enforcement of the laws meant to protect them and consequently resulting in the absence of consumerism and the absence of litigations against producers and sellers even in the cases of obvious infringement of their rights (Abasilim, 2016). These situations still placed the Nigerian consumers in the perilous position of being easily exploited by producers of goods and providers of services with impunity.

The findings also support the stimulus organism response theory model employed in this study which seeks the protection and benefit of the public at large through enforcement of organizational compliance to adaptive measures and sensemaking actions to unprecedented system renewal changes triggered by policy interventions in the business environment.

The findings of the study also revealed that there are several challenges of consumer protection experienced by consumers in the manufacturing sector of the economy but most prominent is the lack of sensitization and information awareness of consumers as a result of their ignorant. Hence, the study recommends the need for consumer education and enlightenment on the relevant agencies to approach with their complaints on any right violation. The finding is also in line with the research objectives of the study which examines how firms adopted strategies can influence consumer buying decision on their products. The finding of this theory contributes in predicting the intention, behaviour, decisions and outcomes of consumer buying decision making process.

Conclusion

This work has revealed that although the regulatory activities of agencies performing consumer-related functions are geared towards the protection of consumers, the low level of awareness about such activities and available rights pushes the matter to the exclusive domain of the regulators and service providers. Conceded that consumers benefit from the activities of regulatory agencies via improved quality of products and services, the fact remains that lack of active participation or involvement of consumers in the scheme of things reduces them to mere spectators. This denies them the opportunity to act as real and recognized drivers to influence the market place as envisaged in this study. Given that the work of consumer protection by CPC requires collaboration/cooperation of other agencies, the researcher sought to know the relationship between CPC and these agencies. According to the researcher, the CPC have a working relationship with some of these other agencies. In the case of products that require SON certification, if CPC discover that the product does not have, or does not require the technical expertise of SON they simply deal with the problem but may consult or refer to other organisations if necessary.

Many consumers noted the existence of substandard and fake products in the Nigerian market. When asked if they had ever bought any fake product, many said they had at one time or the other. Litigation imposes extreme hardship. This was a recurring factor identified during the interview sessions. Non-governmental organisations are known to provide an independent voice to consumers. In Nigeria many of the existing NGOs lack the capacity to influence the system. Capacity building and financial support will position them to perform better. Those with the capacity to do so should be supported to offer pro bono services to aggrieved consumers.

Recommendation

i. The study recommends a good collaboration among the statutory and non-statutory government regulatory bodies in Nigeria and other countries to have a common goal with initiative measures on effective enforcement and monitoring of health care products /services in both imported and locally produced drugs in Nigeria.

ii. The National Agency for Food and Drug Administration Control (NAFDAC) should collaborate with the security agents in the border posts and port authorities of Nigeria to ensure accurate scrutiny and proper sanitisation of imported and exported product drugs in Nigeria with the aim to restore safety and consumer protection. Based on the qualitative findings of the study, it is recommended that the Federal Government should encourage the services of local indigenous production of pharmaceutical product drugs in Nigeria for easy close monitoring and proper assessment of the drugs against counterfeit and adulteration geared towards safety.

iii. The health care product providers especially the pharmaceutical firms should consider it important to incorporate the government regulatory measures as part of their management policies for the goal of ethical marketing that will result to controlled marketing offerings, consumer satisfaction and the safety of their products in the market environment

Suggestions for further Studies

i. The study builds its focus in the Nigerian context and hence can be replicated in the context of other developed countries for comparative study. Similar study can be extended to other sectors of the economy such as service sectors (hospital, telecommunication and banking industries for a comparative result.

ii. The study employed in-depth interviews as a qualitative data collection approach. Further studies could employ semi structured interviews as a qualitative data collection process to enrich the study.

Acknowledgement

Covenant University Center for Research, Innovation, and Discovery (CUCRID) has my undivided gratitude and appreciation for their support and contributions to this project. Thank you for your generous support.

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