THE FIGHT AGAINST FAKE DRUGS BY NAFDAC IN NIGERIA

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ABSTRACT

 

The problems of fake drug proliferation in Nigeria have affected the credibility of the Healthcare system and can exert very harmful effects on the consumer resulting to illness; disability and even death and anyone can be a victim. Some of the incidences have resulted in death even among children because most times the consumers do not know the quality of what they are buying or taking. This makes it imperative that there is need to intensify effort in fake drug eradication. National Agency for Food and Drug Administration and Control (NAFDAC) is the government agency in Nigeria that is fully empowered to regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of drugs in order to ensure that safe and quality drugs are available to the public. As NAFDAC tasks herself dutifully in fighting fake drugs, more challenges comes up from unscrupulous drug dealer who sometimes have the backings of lawmakers and politicians making the stipulated drug laws and standard unattainable.

 

General objective: The objective of the thesis is to review the work done at my workplace (NAFDAC) in the efforts made in controlling the circulation of fake drug products.

Methods: I reviewed the work of NAFDAC to identify their strength and weaknesses in the fight against sale of fake drugs as well as the drug regulating authorities of some other countries to identify their areas of success. The major player in fake drug business and factors that influences fake drug proliferation was also identified

 

Study outcome/findings: The inability to close the unmonitored, unlicensed, unregulated chaotic open drug market that forms major drug distribution centre where many drug outlets patronize, has brought a wider spread of fake drugs without control. Government on the other hand, does not help the situation, as there is political setback in giving adequate penal sanctions to offender as stipulated in the drug laws. Some country’s DRA under study monitors easily drug channels from licensed manufacturers down to the dispensary, and they license these channels before they can distribute drugs. Hence, they are able to know when fake drugs filters into the market. The reasons why people patronize drug outlets as their first line for treatment are that they are cheap, close proximity, no consultation fees, flexible payment method, perception of confidentiality; they feel that the quality of care and attention received are adequate, high stock out rate at the health facilities. Hence, closing such outlets, seizing, destroying and penalizing the violators, as often done by NAFDAC though good, but it might not give a lasting solution to fake drug proliferation, as availability, accessibility and affordability is low, consumers will always demand for such services.

 

Conclusion: NAFDAC has not been able to achieve good success in the fight of fake drug in Nigeria even with their intense efforts to do so. Some of the reasons are lack of adequate and continuous support of the government. Inadequate support from some stakeholders that are expected to join team with NAFDAC in the fight such as the customs, police and the judiciary. 

 

Recommendations: The government should have a clear, firm and equitable legislation that addresses all important issues with appropriate sanctions for drug violators, provide financial support to the DRA especially in areas of staffing, GMP inspection, quality control laboratories and enforcement, should stand its ground in defense of situation concerning public health. In addition, give full support when legislated sanctions are given to drug offenders. Support NAFDAC in closing the chaotic drug market by implementing the stipulated drug laws that drugs should not be sold at open market unless they are licensed to do so by the drug regulating authority.

NAFDAC with the help of the government should adapt the strategy used in Tanzania and Ghana where the government started a program for accreditation of drug dispensing outlet (ADDO). Through this initiative, unlicensed drug vendors are licensed, regulated and trained to understand basic pharmacy ethics in order for them to provide better services to consumers that patronizes them. 

 

Recommendations for further research

      How to provide good quality, affordable medicines in government clinics and hospitals.

      Action research on the strategies of licensing, training and regulating illegal drug vendors in Nigeria, as done in Ghana and Tanzania. 

 

 






TABLE OF CONTENTS

 

TABLE OF CONTENTS.........................................................................................................................I

TABLE OF CONTENTS..................................................................................................................... II

DEDICATION............................................................................................................................................III

ACKNOWLEDGMENT............................................................................................................................IV

ABBREVIATIONS ......................................................................................................................................V

ABSTRACT.................................................................................................................................................. 1

 

INTRODUCTION........................................................................................................................................ 3

GENERAL INTRODUCTION............................................................................................................... 3

CHAPTER 1. ................................................................................................................................................ 3

1.1 BACKGROUND INFORMATION ON NIGERIA......................................................................... 3

 

CHAPTER 2. PROBLEM STATEMENT, PRELIMINARY LITERATURE REVIEW, OBJECTIVE

OF THESIS AND METHODOLOGY........................................................................................................ 7

2.1 PROBLEM STATEMENT ............................................................................................................... 7

2.2 PRELIMINARY LITERATURE REVIEW.................................................................................... 9

2.3 OBJECTIVE OF THESIS................................................................................................................10

2.4  METHODOLOGY...........................................................................................................................11

 

 

CHAPTER 3. DOMAIN OF DRUG CONTROL AND THE INFLUENCING FACTORS.................13

3.1 THE PLAYERS IN THE FAKE DRUG BUSINESS:.....................................................................13

3.1.1 DRUG MANUFACTURERS .......................................................................................................13

3.1.2 DRUG IMPORTERS/WHOLESALERS/RETAILERS..................................................................13

3.1.3 DRUG PROFESSIONALS (THE PHARMACISTS) ....................................................................14 3.1.4 INFORMAL DRUG SELLERS....................................................................................................15

3.1.5 DRUG BUYERS (CONSUMERS)...............................................................................................15

3.1.6 THE CONTROLLER (NAFDAC ENFORCEMENT) ..................................................................15

3.2 FACTORS INFLUENCING FAKE DRUG PRODUCTION, SALE AND DEMAND:...............16

 

CHAPTER 4: DRUG REGULATING AGENCIES IN OTHER COUNTRIES IN THE FIGHT.......21 4.1 LICENSING OF PREMISES AND PERSONS..............................................................................21

4.2 INSPECTION OF MANUFACTURERS AND DISTRIBUTIONS..............................................22

4.3 PRODUCT REGISTRATION AND ASSESSMENT.....................................................................23

4.4 ENFORCEMENT.............................................................................................................................24 4.5 QUALITY CONTROL OF DRUGS................................................................................................25

4.6 PUBLIC AWARENESS ...................................................................................................................25

4.7 CONTROLLING FAKE DRUGS IN THE ILLEGAL MARKET................................................26

 

CHAPTER 5: FIGHTING FAKE DRUGS IN NIGERIA (STUDY RESULTS/FINDINGS) ..............28 5.1 NAFDAC ACTIVITIES AND INTERVENTIONS IN CONTROL OF FAKE DRUGS WITHIN

THE LEGAL MARKET:.......................................................................................................................28

5.1.1 INSPECTION PROCESSES AS A CHECK TO DRUG FAKING ...............................................28 5.1.2 DRUG PRODUCT REGISTRATION AS A CHECK TO DRUG FAKING .................................29

5.1.3 ENFORCEMENT ACTIVITIES AS A CHECK TO DRUG FAKING..........................................31

5.1.4 PUBLIC ENLIGHTENMENT PROGRAM AS A CHECK TO DRUG FAKING.........................32 5.2 NAFDAC ACTIVITIES AND INTERVENTIONS IN CONTROL OF FAKE DRUGS WITHIN

THE ILLEGAL MARKET:....................................................................................................................34

      5.3 SWOT ANALYSIS OF NAFDAC AS ORGANIZATION.............................................................35

 

CHAPTER 6. DISCUSSION OF STUDY RESULTS/FINDING............................................................37

6.1 DISCUSSION OF LESSONS LEARNT..........................................................................................37

 

CHAPTER 7. CONCLUSION AND RECOMMENDATIONS ..............................................................39

7.1 CONCLUSION .................................................................................................................................39

7.2. RECOMMENDATIONS (THE WAY FORWARD).....................................................................39

REFERENCES............................................................................................................................................43 ANNEX.........................................................................................................................................................48

 

 

LIST OF TABLES: TABLE 1: KEY HEALTH INDICATORS OF NIGERIA................................................. 5

TABLE 2: REASONS ADDUCED FOR AVAILABILITY OF FAKE DRUGS IN NIGERIA....................................... 16

TABLE 3: MULTI-COUNTRY LICENSING OF PREMISES AND PERSONS............................................................ 22

TABLE 4:MULTI-COUNTRY INSPECTION OF MANUFACTURERS AND DISTRIBUTION.................................. 23

TABLE 5: MULTI-COUNTRY PRODUCT REGISTRATION AND ASSESSMENT.................................................. 24

TABLE 6: MULTI COUNTRY QUALITY CONTROL OF DRUGS............................................................................ 25

TABLE 7: MULTI COUNTRY PUBLIC AWARENESS OF DRUGS..................................................................... 26

TABLE 8: SWOT ANALYSIS OF NAFDAC AS ORGANIZATION............................................................................ 35

 

 

 

LIST OF FIGURES:

FIGURE 1. PROBLEM ANALYSIS DIAGRAM OF THE FACTORS INFLUENCING SALE OF FAKE DRUGS ...................12

FIGURE 2:  LEGITIMATE SUPPLY CHAIN ..........................................................................................................18

FIGURE 3: ILLEGITIMATE SUPPLY CHAIN ........................................................................................................18

FIGURE 4: STUDY FRAMEWORK SHOWING KEY COMPONENTS OF DRUG REGULATION FUNCTIONS..................21

FIGURE 5: GOOD GOVERNMENT DIAGRAM ....................................................................................................42

 

 

LIST OF ANNEX:

ANNEX 1: FUNCTIONS OF VARIOUS DIRECTORATES IN NAFDAC:................................................48 ANNEX 2: GLOBAL PERSPECTIVE ON FAKE DRUGS..........................................................................53 ANNEX 3: NAFDAC LIST OF SOME IDENTIFIED FAKED DRUGS......................................................56 ANNEX 4:NIGERIAN MEDICINE LAWS..................................................................................................57

ANNEX 5: NAFDAC STANDARD OPERATING PROCEDURES (SOP).................................................59

  

 

 

 

 

ABBREVIATIONS

ABPI               : Association of the British Pharmaceutical Industry

ADDO             : Accreditation of Drug Dispensing Outlets

ASEAN           : Association of South-East Asian Nations 

BMJ                      : British Medical Journal

COPP               : Certificate of Pharmaceutical Product (COPP)

CSFDA            : Chinese State Food and Drug Administration

DRA                : Drug Regulatory Agency

DCA                : Drug Control Authority (Malaysia)

EAASM           : European Alliance for Access to Safe Medicines

EDM                : Essential Drug Monitor

EID                  : Establishment Inspectorate Directorate

FRD                : Federal Research Division

GDP                : Good Distribution Practices

GFDB             : Ghana Food and Drug Board 

GMC  : General Medical Council

GMP                : Good Manufacturing Practices

HAI                 : Health Action International

IMPACT          : International Medicinal product Anti-counterfeiting Taskforce

IT                    : Information Technology

MCA               : Medical Control Agency

MCC               : Medicines Control Council (South Africa)

MHRA            : Medicine and Healthcare products Regulatory Agency 

NAFDAC        : National Agency for Food and Drug Administration and Control

NBA                : Nigerian Bar Association

NDHS             : Nigeria Demographic and Health Statistics

NDLEA           : Nigeria Drug Law Enforcement Agency 

NHIS          : National Health Insurance Scheme

NNPC              : Nigeria National Petroleum Cooperation

NoMA             : Norwegian Medicines Agency

NPC                : National Pharmacovigilance Centre 

OTC       : Over The Counter

PID                  : Port Inspectorate Directorate

PMS                 : Post marketing surveillance

POA                : Power of Attorney 

PRS                 : Planning Research and Statistics

PSN                 : Pharmaceutical Society of Nigeria

QC                   : Quality Control

RPSGB            : Royal Pharmaceutical Society of Great Britain  

SAP                 : Structural Adjustment Program SON              : Standard Organization of Nigeria

TFDA              : Tanzanian Food and Drug Authority

UNESCAP      : Economic and Social Commission for Asia and the Pacific

UNODC (CP) : United Nations Office for Drug Control and Crime Prevention 

USFDA         : United States Food and Drug Agency

WHA               : World Health Assembly

                        WHO              : World Health Organization

WIPO               : World Intellectual Property Organization

 

                                   

                                              



 

 

 

 

 

INTRODUCTION

GENERAL INTRODUCTION

 

Drug Faking is a global public health problem, because the effects can be felt from both the country of manufacture to the recipient countries. Hence, national measures for combating of fake drugs in country might be insufficient because of the advanced sophistications of those who manufactures and sells them (bates, 2008).

Nigeria is not an exception in the problems of fake drugs till date. Some people still prefer to self medicate when they are ill, and often time the drugs are bought from unlicensed drug vendors, whose drug quality is not sure. Through the past two decades in Nigeria, the problem of fake drugs has been a very big issue. In addition, fake drugs proved a major factor in contributing to high death rates. Over 150 children died in 1989 as a result of a formulation error in a drug. Such problems led to the establishment of NAFDAC, which would help create a fake-drug-free environment (NAFDAC consumer safety, 2003). The intent was to ensure effective registration of good quality drugs that are inexpensive in Nigeria. Since the inception of the new NAFDAC in April 2001, Professor Dora Akunyili the Director General has worked hard in combating the problems of sale of fake drugs, but yet the existence of such still continues and this makes me to wonder why. My questions are, ‘why does Nigeria still have in existence open drug markets? Why do Nigerians in Drug Business breech the stipulated drug laws and still get away with it and continue with their business, committing mass murder and smiling to their banks? How long do we fight the battle of fake drug even with the threats on our lives who want to preserve the health of the Nation? 

 

The consistent raids by my organization on fake drug dealers who contravene the applicable laws and regulations, have helped in clamping down on the illegal drug traders But when things seems as if its getting better, these illegal drug sellers begin to emerge from their hideouts. I continue to wonder, why? Could it be that the Agency is not doing enough to stop the evil activities, or could the problem be from the drug sellers themselves. The tragic irony is that the problems of fake drug have refused to go away from the shores of Nigeria.

 

My thesis is by no means going to provide a solution to the drug problems in Nigeria. However, it prepares me on the challenges to be faced at home in finding the next alternative solution to the problem, and insight to my colleagues in combating the menace of fake drugs sold in the streets and open markets resulting in adverse effects to the consuming public. My work is therefore to review the program at my workplace and the way forward for a lasting solution.

 

 

CHAPTER 1.

1.1 BACKGROUND INFORMATION ON NIGERIA

This chapter provides information on Nigeria demographic, economy, and health profile. The aim of this chapter is to elicit the situational analysis of the country.

 

Background

The influence and control by British Empire over what would become Nigeria grew through the 19th century. In addition, 1 October 1960, Nigeria gained their independence. In 1999, a new constitution was adopted, after nearly 16 years of military rule that resulted to a peaceful transition to civilian government. The government continues to face the daunting task of reforming a petroleum-based economy, whose revenues have been mismanaged. In addition, ethnic and religious tensions is a long-standing experience in Nigeria, although both the 2003 and 2007 presidential elections were marred by significant irregularities and violence, Nigeria is currently experiencing its longest period of civilian rule since independence. The general elections of April 2007 marked the first civilian-to-civilian transfer of power in the country's history. (FRD, 2006)

 

Demography

Nigeria is the most populous country in the African continent and has a population of over 135million people with birth rate of 40.2 births/1,000 population in 2006. The population growth rate is 2.3%. Life expectancy at birth is 47 years. It is made up of 36 states and 1 territory, with more than 250 ethnic groups, the most populous and politically influential are the Hausa & Fulani 29%, Yoruba 21%, Igbo (Ibo) 18%, Ijaw 10%, Kanuri 4%, Ibibio 3.5%. Tiv  2.5%. The religions: are Muslim 50%, Christian 40%, indigenous beliefs 10%. The literacy level in the population among male is 75.7% and female is 60.6 % (NBS, 2005). The death rate is 16.6% death(s)/1,000 populations (HAI Africa, 2008).

 

Economy

Nigeria possesses a wealth of natural resources including oil and gas deposits, long hobbled by political instability, corruption, inadequate infrastructure, and poor macroeconomic management. It is undertaking some reforms under a new reform-minded administration. Although the country is primarily agrarian, the economy is now over- dependent on the capital-intensive oil sector because of failure of former military rulers to diversify the economy; the oil sector provides 20% of GDP, 95% of foreign exchange earnings, and about 80% of budgetary revenues. The largely subsistence agricultural sector has failed to keep up with rapid population growth - once a large net exporter of food, now must import food (FRD, 2006). The National poverty rate is estimated at 34.1% and 70.2% live on less than one dollar a day. The level of poverty affects everything from social cohesion and security to health (FRD, 2006).

 

Health

Nigeria runs a decentralized system with three levels of government. The federal that handles university teaching hospitals, the state handles general hospitals and local governments are mostly dispensaries. All three levels of government are responsible for provision of health care services. Although the country has tremendous potentials for growth and development, the health system still lacks basic amenities due to problems of inadequate funding, lack of political commitment and poor implementation plans. The total expenditure on health as percentage of GDP is 4.6%, and from government expenditure, it is about 1.5% (FRD, 2006). The Nigerian health system has been under reorganization. It promoted community-based methods of increasing accessibility of drugs and health care services to the population partly by implementing user fees. The idea was to increase access through community-based healthcare reform, but it was not working (Uzochukwu et al, 2002). The introduction of the National Health Insurance Scheme (NHIS) became a major concern to government due to the suffering from medical negligence of Nigerians especially the poor who cannot afford basic health need. The majority of people still pay out of pocket for their medicine purchase as the NHIS is still in its pilot stage (Iyioha, 2007).  Major illnesses are childhood diseases, malaria and HIV/AIDS with infant mortality estimated as 100 per 1,000 live births (NDHS, 2003) 

 

 TABLE 1: KEY HEALTH INDICATORS OF NIGERIA

 

 

 

 

191

 

 

 

99

 

 

                   -

278

 

 

                   %

15.7

 

 

                    %

6.3

 

 

                   %

24.1

 

 

                   %

20.1

 

 

                   %

26.1

 

 

                   %

5.0

 

 !

 

3547

 

 

 

1100

 

 

 

209

 

 

 

615

#

"

$

47

 

 

$

30

 

Source: World Health Statistics, 2008

 

 

 

Definition of terms:

NAFDAC: National Agency for Food and Drug Administration and Control.

 It is a Nigerian government agency responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and prepackaged water. Its creation was inspired by a 1988 World Health Assembly resolution requesting countries' help in combating the global health threat posed by counterfeit pharmaceuticals, and amidst growing concerns about the growing problem of fake and poorly regulated drugs in Nigeria. (Nigeria First 2003)

In December 1992, NAFDAC's first governing council was formed. In January 1993, supporting legislation was approved as legislative Decree No. 15 of 1993, and January 1, 1994 NAFDAC was officially established, as a “parastatal of the Federal Ministry of Health”. NAFDAC replaced an earlier Federal Ministry of Health body, the Directorate of Food and Drug Administration and Control, which had been deemed ineffective, largely due to a lack of laws concerning fake drugs and political issues. (NAFDAC 2005)

 

Fake/counterfeit drug:

World Health Organization defines a “counterfeit” as A medicine, which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.” (WHO, 2006). 

There is no universal definition of fake drug as every country has there own meaning. In this thesis the definition of fake drug as defined by the Nigerian Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) will be used which is:

      Any drug product which is purported to be; or

      Any drug or drug product which is so colored, coated, powdered or polished that the damage is concealed or which is made to appear to be better or of greater therapeutic value than it really is, which is not labeled in the prescribed manner or which label or container or anything accompanying the drug bears any statement, design, or device which makes a false claim for the drug or which is false or misleading; or 

      Any drug or drug product whose container is so made, formed or filled as to be misleading; or

      Any drug product whose label does not bear adequate directions for use and such adequate warning against use in those pathological conditions or by children where its use may be dangerous to health or against unsafe dosage or methods or duration of use; or

      Any drug product which is not registered by the Agency in accordance with the provisions of the Food, Drugs and Related Products (Registration, etc) Decree 1993, as amended. (WHO, 2008) 

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