FEDERAL REPUBLIC OF NIGERIA

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FEDERAL REPUBLIC OF NIGERIA
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ANTICOUNTERFEITING ACTIVITES THE CASE OF NIGERIA

• PROF. DORA N. AKUNYILI
• DIRECTOR-GENERAL
• NATIONAL AGENCY FOR FOOD AND DRUG
• ADMINISTRATION AND CONTROL
• (NAFDAC), NIGERIA.
• PRESENTATION
• TO
• WORKING CUSTOMS SEMINAR ON THE FIGHT AGAINST
  FRAUD AND COUNTERFEITING IN WESTERN AFRI CA
• ORGANISED BY
• AFRICAN INDUSTRAL ASSOCIATION IN PARTNERSHIP
  WITH WESTAFRICAN ECONOMIC AND MONETRY UNION
  (WAEMU) THE EUROPIAN COMMISSION
• AT

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OUTLINE

• Introduction.
• What is a Counterfeit Medicine
• Implications of Counterfeit Drugs
• Scope of the Problem of Fake/Counterfeit Drugs in
  Nigeria Prior 2001.
• Factors that encourage drug counterfeiting.
• Strategies employed by NAFDAC to Combat Drug
  Counterfeiting in Nigeria.
• Government Support
• Some of the Achievements and Gains Recorded so
  Far.
• Conclusion

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INTRODUCTION

• BACKGROUND INFORMATION
• Nigeria is a country in west Africa bordered to
  the East by Cameroun, the West by Benin Republic,
  the North by Niger Republic, North East by Chad
  and South by Atlantic Ocean.
• POPULATION Approx.150million
• TOTAL AREA 923,768Sq/Km
• LAND AREA 910,768Sq/Km
• WATER 13,OOOSq/Km
• GEO-POLITICAL ZONESSix(6)
• NO. OF STATES36
• CAPITAL Abuja
• OFFICIAL LANGUAGE English

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INTRODUCTION CONTD

• I am excited to have been invited to address this
  distinguished audience on a global burning issue,
  that is of interest not only to Drug regulatory
  authority but also the custom organizations.
• I have also been privileged to participate in the
  1st and 2nd Global Fora on Pharmaceutical
  anti-counterfeiting, organized by Reconnaissance
  International in Geneva and Paris, September 2002
  and March 2005, respectively. More recently we
  have equally shared our experience of
  anticounterfeiting activities with regulatory
  authorities from francophone west African
  countries in Senegal in October 2005
• I use the opportunities of such meetings to tell
  the world that drug counterfeiting is a reality,
• Share strategies that we have used in combating
  it,
• - So that countries that have already been
  invaded by drug
• counterfeiters will learn from our
  experience and know that it is
• possible to fight and defeat them despite
  the daunting
• constraints,
• - And countries without reports of counterfeit
  drugs to be
• proactive so as not to give drug
  counterfeiters the opportunity to
• come in and establish their network.

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INTRODUCTION CONTD

• Drug counterfeiters have succeeded in the past
  three decades largely because of lack of
  awareness and lack of cooperation among
  stakeholders nationally and internationally.
• The increasing worldwide reports of counterfeit
  medicines and the number of international fora
  focusing on drug counterfeiting, have sensitized
  all stakeholders including security operatives as
  yours to collaborate on the need to work together
  in order to make it difficult for drug
  counterfeiters to continue thriving in their
  nefarious activities.
• The negative impact of counterfeit drugs knows no
  boundaries and affects the health, social and
  economic life of all nations, therefore a forum
  such as this with officers versed in
  investigative skills is ideal for pooling
  resources to frustrate drug counterfeiters.
• At the end of this presentation I expect that we
  would all have learnt and imbibed the need for
  collaborative effort between customs and
  regulatory authorities, also between Nations of
  the world especially in the sub-region.

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• WHAT IS A COUNTERFEIT MEDICINE
• NAFDAC identified forms of fake/counterfeit
  drugs
• Drugs with no active ingredient(s)
• Drugs with insufficient active ingredients
• Drugs with active ingredient(s) different from
  what is stated on the packages
• Clones of fast moving drugs - these are drugs
  with the same quantity of active ingredients as
  the genuine original brand.
• Herbal Preparations that are toxic, harmful,
  ineffective or mixed with orthodox medicine.
• Expired drugs or drugs without expiry date, or
  expired and re-labelled with the intention of
  extending their shelf-life.
• Drugs without full name and address of the
  manufacturer.
• Drugs not registered by NAFDAC

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• IMPLICATIONS OF COUNTERFEIT DRUGS
• Counterfeiting of medicines is one of the
  greatest atrocities of our time. It is also a
  form of terrorism against public health, as well
  as an act of economic sabotage.
• Counterfeit drugs violate the right to life of
  innocent victims.
• The evil of fake drugs is worse than the combined
  scourge of malaria, HIV/AIDS and armed robbery
  put together. This is because malaria can be
  prevented, HIV/AIDS can be avoided and armed
  robbery may kill a few at a time, but
  counterfeit/fake drugs kill en mass.
• The social problem posed by hard drugs, cocaine,
  heroine etc. cannot also be compared with the
  damage done by fake drugs, because illicit drugs
  are taken out of choice, and by those that can
  afford them, but fake drugs are taken by all and
  anybody can be a victim.
• Treatment failures, drug resistance, organ
  dysfunction/damage, worsening of disease
  conditions and death.

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SCOPE OF THE PROBLEM OF FAKE/COUNTERFEIT DRUGS IN
NIGERIA PRIOR 2001.

• NIGERIAN EXPERIENCE
• Counterfeit drugs are most prevalent in
  developing countries.
• Developed countries are beginning to experience
  increase in reported cases, which are worsened by
  increasing sale of medicines on the Internet.
• AFRICA
• Prevalence of fake and counterfeit drugs in
  Africa worsens the
• existing burden of debt, poverty, illiteracy,
  diseases, wars, etc.
• Essential Drug Monitor (EDM) report on
  transforming drug supply in Dar es Salaam
  Tanzania, sums up the picture in most African
  countries as follows,
• There was chronic shortage of drugs at health
  facilities, supplies were erratic, as was
  government funding, poor drug supply management
  and irrational use of drugs.
• Drug quality was questionable and pharmacy
  premises were often unsuitable, hot, humid and
  cluttered with piles of drugs, some of them
  expired.
• Pharmacists have low professional visibility.
• This clearly mirrors the situation in many
  African countries, Nigeria not being an
  exception.
• In view of flow of trade on pharmaceutical
  products between Nigeria and neighbouring
  countries, the situation in Nigeria naturally
  reflects that of most African countries.

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SCOPE OF THE PROBLEM CONTD

• When the present management of NAFDAC came on
  board in April 2001,
• we were faced with an enormous task of
  reactivating a failed regulatory
• environment of over two decades.
• Fake/counterfeit/expired/unregistered drugs,
  substandard cosmetics, unwholesome food products
  and other regulated products were dumped into
  Nigeria.
• Nigeria was rated as one of the countries with
  the highest incidence of fake/counterfeit drugs.
  Consequently, made in Nigeria drugs were
  officially unaccepted in other West African
  countries.
• Fake drugs embarrassed our healthcare providers
  and eroded the confidence of the public on our
  healthcare delivery system.
• Due to unfair competition, local drug
  manufacturing became unattractive, and many
  multinational companies left Nigeria out of
  frustration e.g. Boehringer, ICI, Sandoz, Merck,
  Ciba Gaeigy, Boots, etc.

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SCOPE OF THE PROBLEM CONTD

• Estimates of the extent of counterfeit medicines
  in circulation in Nigeria ranged from 48 to 80
  from various studies before 2001.
• A study by Poole in Nigeria in 1989 indicated
  that 25 of samples studied were fake, 25
  genuine and 50 inconclusive.
• In 1990, Adeoye Lambo, a former WHO Deputy
  Director reported that 54 of drugs in every
  major pharmacy in Lagos were fake, and that the
  figure had risen to 80 in the subsequent year.
• Taylor et al reported that 48 of drugs tested
  were fake and substandard.

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SCOPE OF THE PROBLEM CONTD

• Antimalarials, antibiotics and vitamins are
  among the most used drugs in Nigeria. Out of the
  three, antimalarials as a group had the least
  proportion of products with standard active
  ingredients.
• Proportion of drugs with standard active
  ingredients.

Adapted from Adenika FB. Pharmacy in Nigeria
1998
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SCOPE OF THE PROBLEM CONTD

• In 2001, NAFDAC carried a baseline study to
  ascertain the level of incidence of fake drugs in
  Nigeria.
• This study measured the level of compliance to
  drug registration, and we found that 67.95 of
  drugs in circulation were unregistered.
• This study was repeated in 2003 and 2004.
• The second phase of the study is being conducted
  in collaboration with WHO and DFID, and this
  involves laboratory testing.

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• REPORTED CASES
• In Nigeria due to poor reporting system, cases of
  worsening disease
• conditions or deaths due to fake drugs abound,
  but unfortunately we
• dont have much statistics to support them.
• In addition, due to cultural cleavages, deaths
  are sometimes attributed
• to witchcrafts from the wicked ones or
  enemies. This again does not
• help our reporting system. A few examples of the
  reported cases of
• effects of counterfeit and substandard drugs are
  as follow
• In the early 80s, poorly compounded Chloroquine
  syrup killed several children in University of
  Nigeria Teaching Hospital (U.N.T.H),Enugu of
  which there is no statistics, partly because many
  of the deaths were not even reported.

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• REPORTED CASES CONTD.
• In 1990, the Paracetamol syrup disaster
  occurred when 109 children died in Ibadan and
  Jos, (Nigeria) after taking paracetamol syrup
  produced with the toxic ethylene glycol solvent
  instead of propylene glycol.
• This tragedy occurred more than fifty years after
  that of U.S.A.
• In 1996, without authorization from NAFDAC,
  clinical trial of a new antibiotic Trovan was
  carried out by Pfizer on 200 children in Kano
  Northern Nigeria during an epidemic outbreak of
  meningicoccal meningitis.
• Several (the exact number is disputed) of the
  sick children given the experimental drug died.
  Many more suffered lasting injuries. One Samaila
  Musa now a teenager was struck deaf and dumb. The
  case is currently in a U.S.A. court.
• In 2002, 3 patients reacted adversely to
  infusions manufactured by a Nigerian company.
  Investigations by NAFDAC on the offensive
  infusions collected from the hospital revealed
  that three (3) batches were heavily contaminated.

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REPORTED CASES CONTD.

• Fake cardiac stimulant (Adrenaline) was reported
  to have contributed to the death of 3 children
  during open-heart surgery in Nigeria in 2003.
• Further investigations by NAFDAC revealed that
  the muscle relaxant (suxametonium) had low
  potency and some of the infusions used for the
  surgery were contaminated.
• In 2004, 3 Nigerian hospitals reported cases of
  adverse reactions from the use of contaminated
  infusions produced by 4 Nigerian companies.
• Consequently we sampled infusions and water for
  injection from all over the country.
• Our results confirmed that some batches of
  infusions produced by the indicted companies were
  heavily contaminated with microorganisms.
• 147 of the 149 brands of water for injection
  screened were also not sterile.

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CAUSES OF PHARMACEUTICAL COUNTERFEITING

• CORRUPTION AND CONFLICT OF INTERESTS
• The first line of action by drug counterfeiters
  is to compromise regulators.
• When this fails, they resort to Intimidation,
  harassment, blackmail, threats and physical
  attacks.

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• INSECURE AND UNFRIENDLY ENVIRONMENT
• At some point, when all the other antics of drug
  counterfeiters failed, they resorted to physical
  attacks, vandalism, and arson against NAFDAC
  facilities and staff.
• This culminated in a shooting attack on my
  person on December 26, 2003. My family members
  and some NAFDAC staff remain constantly under
  threat.
• Gunmen fired at the vehicle I was travelling in,
  the back windscreen was shattered by bullets
  which pierced through my head scarf and burnt my
  scalp.
• During the shooting, a commercial bus was riddled
  with bullets and the driver died instantly.

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ASSASSINATION ATTEMPT- Car rear shattered wind
shield.
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ASSASSINATION ATTEMPT- Head Scarf showing bullet
holes
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ASSASSINATION ATTEMPT - Car front wind shield
with bullet hole
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ARSON ON NAFDAC Operational Headquarters Lagos
(Outside view)
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Wreckages of NAFDAC Operational Headquarters
Lagos destroyed by fire (Inside view).
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Wreckages of NAFDAC Kaduna Laboratory destroyed
by fire (Outside view)
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Wreckages of NAFDAC Kaduna Laboratory destroyed
by fire (Inside view)
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• DISCRIMINATORY REGULATION BY EXPORTING COUNTRIES
• Some countries have strong regulations for drugs
  consumed internally and little or no regulation
  for drugs meant for export.
• Discriminatory regulation Informed the decision
  of the NAFDAC management to prohibit the
  importation into Nigeria of products marked FOR
  EXPORT ONLY.
• Any product that cannot be used in the country of
  manufacture is officially unacceptable in
  Nigeria.
• Presently, there are 92 pharmaceutical
  manufacturing companies producing about 30 of
  Nigerias drug need while the rest are imported.
• Most of the fake/counterfeit drugs in Nigeria are
  imported from Asia, particularly India and China.
  
• From 2001 till date, we banned thirty Indian and
  Chinese companies and one Pakistani company
  (confirmed to be fake drug producers) from
  exporting drugs into Nigeria.

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• CHAOTIC DRUG DISTRIBUTION SYSTEM
• Drug distribution in Nigeria is very chaotic with
  drugs marketed like any other commodity of trade.
  
• Due to poor regulation over the years, drug
  markets evolved and got deeply established all
  over the country despite the illegality of such
  activities.
• Almost all drug manufacturers and importers
  supply to these drug markets.
• Drug sellers and even health professionals
  patronize the drug markets, which also service
  the hawkers that sell in streets and commercial
  buses.
• Efforts made by NAFDAC to create an orderly Drug
  Distribution System so as to enable us phase out
  the existing disorganized Drug Markets, suffered
  a set back due to its unacceptability by some
  Pharmacists who are the major stakeholders in
  drug matters.

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• FALSE DECLARATION BY IMPORTERS
• Some drug importers, in order to evade inspection
  and detection, make false declarations about the
  nature and contents of the products in their
  containers.
• They employ unimaginable concealment methods for
  their nefarious activities, such as stacking
  drugs in the inner part of containers containing
  other items like clothings, hair products, motor
  spare parts or household items, or wrapping the
  drugs inside clothings.
• We have made several seizures of drugs concealed
  inside t-shirts or baby wears

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• SOPHISTICATION IN CLANDESTINE DRUG MANUFACTURE.
• Sophistication in drug production has made it
  difficult for even brand owners to tell the
  difference between their brands and counterfeits.

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FAKE
ORIGINAL
AMOXIL
GENUINE
FAKE

• Blister has grey and red diagonal lines only
• There is no company Identification on the blister
• Counterfeit product with copied NAFDAC
• Not registered by NAFDAC

• Blister has grey, red and white diagonal bands.
• Each blister hasSB102M embossed on the edge
• Registered by NAFDAC
• NAFDAC 04-2481 Printed on the pack

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SIMILAR SOUNDING NAMES/LOOK-ALIKE COUNTERFEITS
DETECTED BY NAFDAC
ORIGINAL
FAKE
CIALIS
Look alike and sound-alike
GENUINE
FAKE

• Copied the name and address on the original
  product
• No colour change on brown hologram
•  Date markings are stated in numbers i.e. M05 03
  E 08 05
•  Counterfeit product not registered by NAFDAC
• Has no NAFDAC

• Address on product
• Eli Lilly Company Limited Basingstoke, England
•  Colour changes on brown hologram on exposure to
  light at different angles
•  Date markings are stated in words i.e. MAY 04
  Jun 06
•  Registered by NAFDAC
• NAFDAC 04-5196 Printed on the pack

•   No location address of manufacturer
•  Hologram absent
•  Date markings are stated in numbers
•  Look alike and sound-alike fake product not
  registered by NAFDAC.

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• LACK OF OR INADEQUATE LEGISLATION
• Almost in all countries, laws against drug
  counterfeiting are very weak. Consequently,
  criminals are shifting from smuggling of
  narcotics and running of weapons to
  counterfeiting of drugs because it is financially
  lucrative and of relatively low risk.
• The penalties for importing, producing or
  distributing fake and counterfeit drugs in
  Nigeria ranges from imprisonment for between
  three months and five years with the option of
  fine of USD70 - USD3600.
• In the interim we have strengthened our
  regulatory processes by putting in place some
  administrative guidelines within the law.
• Using the press to disgrace identified drug
  counterfeiters.

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STRATEGIES EMPLOYED BY NAFDAC TO COMBAT DRUG
COUNTERFEITING IN NIGERIA.

• NAFDACS VISION, MISSION, GOAL AND STRATEGIES
• Our VISION is to safeguard public health
• MISSION is to safeguard public health by ensuring
  that only the right quality products are
  manufactured, imported, exported, advertised,
  distributed, sold and used in Nigeria.
• Current GOAL is to eradicate fake drugs and other
  substandard regulated products.

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Strategies employed Contd.

• Staff Re-Orientation and Motivation
• At the inception of this administration, the
  inevitable need for staff re-
• orientation was glaring.
• Total change of mind-set and in fact, an
  organizational cultural revolution.
• Measures undertaken to reposition staff for
  better effectiveness
• Retrenchment of corrupt, redundant and
  incorrigible staff.
• Staff training and re-training.
• Effective delegation of duties and Staff
  empowerment.
• To encourage staff, hard work, dedication and
  integrity are adequately compensated while any
  form of laxity or corruption is severely
  sanctioned.
• When hard work and integrity are not recognized
  and rewarded, corruption and ineptitude are
  promoted.

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Strategies employed Contd.

• Restructuring NAFDAC and Modernization of our
  Regulatory Processes
• NAFDAC was restructured into eight functional
  directorates as against the previous six.
• The two new directorates created, the Ports
  Inspection and Enforcement further positioned the
  agency to effectively tackle the problems
  emanating from inspection lapses and poor
  enforcement activities.
• Other six Directorates are
• Laboratory Services
• Narcotics and Controlled Substances
• Establishment Inspection
• Registration and Regulatory Affairs
• Administration and Finance
• Planning, Research and Statistics

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Strategies employed Contd.

• Restructuring Contd
• Ten new state offices were established and the
  existing twenty-seven were strengthened to cover
  the thirty-six states and Federal Capital
  Territory.
• -Three special inspectorate offices were also
  established in the three towns with the biggest
  drug markets, Onitsha, Aba and Kano.
• Four laboratories are continuously upgraded, and
  two new ones are under construction.
• Constructed new warehouses and land border
  offices at some of our ports.
• New Standard Operating Procedures (SOPs) and
  Guidelines were developed.
• Automation of all our regulatory processes.

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Strategies employed Contd.

• Public Enlightenment Campaign
• Our most effective strategy in combating
  products counterfeiting, and creating effective
  regulation.
• Involves dialogue, education and persuasion
  because this addresses the fundamental issue at
  stake, which is BEHAVIOURAL CHANGE.
• Sustained using
• Print and electronic media such as jingles, alert
  notices, erection of billboards, publication of
  differences between identified fake and genuine
  products in the national dailies, etc.
• Workshops, seminars and meetings have been
  conducted for most stakeholders ranging from
  pharmacists, patent medicine dealers, traditional
  rulers, religious leaders, manufacturers,
  importers, transporters and even consumers.
• Grassroots mobilization campaign for rural areas
  is on- going.
• We have produced many publications, fliers,
  leaflets, posters (both in English and vernacular
  languages).

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Strategies employed Contd.

• Public Enlightenment Campaign Contd
• Extended to Nigerian High schools in order to
  catch them young, by organizing annual
  competitions and prize giving ceremonies on their
  understanding of the ill effects of fake drugs
  and other substandard products on the society.
• Also established NAFDAC Consumer Safety Clubs in
  most of these schools .
• These activities are geared towards educating the
  young ones on the dangers of fake drugs,
  inculcating in them the value of quality and
  encouraging them to join NAFDAC in the fight
  against counterfeit medicines.
• Our enlightenment campaigns have greatly
  empowered the public to recognize and reject
  expired, fake/substandard drugs and unwholesome
  food.
• In any country we visit, we hold meetings with
  exporters of drugs, food, cosmetics and other
  NAFDAC regulated products. Convinced many of them
  to set up industries in Nigeria.

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Strategies employed Contd.

• Stopping the Importation of Counterfeit Medicines
  and Other Substandard Products to Nigeria at
  Source
• In a bid to stop the importation of fake drugs
  from the countries of production to Nigeria,
  NAFDAC has put in place some administrative
  guidelines which include the following
• A factory must be GMP certified before it can
  export drugs, cosmetics or any other NAFDAC
  regulated product to Nigeria.
• NAFDAC officials must inspect factories anywhere
  in the world before we register or renew
  registration for their drugs, cosmetics, food and
  other regulated products.
• NAFDAC has appointed analysts in India and China
  who re-certify any drug from the two countries
  before importation into Nigeria.
• For drugs imported from any country, NAFDAC
  requires mandatory pre-shipment information to be
  provided by all importers before the arrival of
  the drugs.
• Nigerian banks insist on NAFDAC clearance before
  processing financial documents for drug
  importers. This agreement is now a government
  policy because of its adoption by Central Bank of
  Nigeria.

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Strategies employed Contd.

• Beefing Up Of Surveillance At All Ports Of Entry
• NAFDAC has re-enforced the two new directorates
  of Ports Inspection and Enforcement for more
  effective surveillance at all ports of entry, and
  better enforcement activities respectively. This
  has resulted in increased seizures of
  fake/counterfeit drugs and other substandard
  regulated products at the ports.
• Hitherto, land and sea borders were major routes
  of importation. The Agency, having considerably
  intensified surveillance at these borders, and
  the merchants of fake drugs resorted to the use
  of airlines. Consequently, NAFDAC issued a new
  guideline that any aircraft that lifts drugs to
  Nigeria without obtaining the Agencys
  authorization from their clients will be
  grounded.
• Due to NAFDACs strong surveillance at the
  borders, and governments ban on importation of
  drugs and other regulated products through land
  borders, these criminals have resorted to the use
  of speedboats and other water transports.

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Strategies employed Contd.

• Mopping Up Substandard and Fake Products Already
  In Circulation
• Cognizance of our many porous borders, NAFDAC
  embarks on planned, systematic, continuous and
  sustained surveillance at all markets and retail
  outlets for drugs.
• This has given rise to sealing of pharmacy retail
  outlets involved in selling counterfeit,
  unregistered or expired drugs, and also drug
  manufacturing factories, whose GMP status were
  found to be unsatisfactory.
• Closure of 2 major drug markets for between 3 6
  months.
• To achieve high level of success with our
  mopping up exercise, NAFDAC has put in place the
  following administrative guidelines
• Confiscation and subsequent destruction of drugs
  of sellers who fail to provide a proper invoice
  of purchase with full name and address.
• This is to enable us trace the big time importers
  and distributors of fake drugs.

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Strategies employed Contd.

• Mopping Up Fake Drugs Contd
• Faced with the frustrations of evacuating many
  lorry loads of fake drugs from warehouses on tip
  off without anybody accepting ownership, NAFDAC
  has notified the public that whenever the
  importer cannot be traced, the landlord of the
  premises used for the storage of fake drugs will
  be arrested, with a view to tracing the fake drug
  importer for necessary sanctions.
• In one occasion in Lagos, it was only after the
  landlord of the warehouse was arrested that the
  owner of the fake drugs gave himself up.
• Raids are regularly carried out on drug hawkers,
  and their drugs are confiscated and destroyed.
• We also trace fake drug dealers through reports
  from health professionals or victims and constant
  tip-off from the public.
• Routine sampling, checking and testing of all
  NAFDAC registered drugs in circulation.

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COUNTERFEITING-A REALITY!
Strategies employed Contd.

• Destruction of Seized Counterfeit Drugs by
  NAFDAC. (Health risk, national
• economic loss.)

45
Strategies employed Contd.

• Monitoring GMP of Local Manufacturers
• NAFDAC monitors local manufacturers of drugs
  routinely.
• Compliance directives are issued and enforced to
  the letter when lapses are observed.
• Prosecution is carried out as a last resort when
  necessary.

46
Strategies employed Contd.

• Streamlining and Strict Enforcement of
  Registration Guidelines
• NAFDAC has strengthened its registration
  processes with some administrative guidelines to
  ensure a strong and effective regulation, which
  is the most sustainable solution to dumping of
  fake products. These guidelines include
• All drugs must comply with laboratory standards
  and inspection requirements before they are
  registered.
• Renewal of registration of any drug is every five
  years.
• Renewal of Herbal Medicine registration is every
  year.
• NAFDAC insists on fixing of NAFDAC REGISTRATION
  NUMBER on the label of all products to enable the
  public identify drugs certified by the Agency.
• Drugs can be imported for only ten years, after
  which the importer must start producing locally.

47
Strategies employed Contd.

• OTHER INTERVENTIONS
• INTERNATIONAL
• Established cooperation with food and drug
  regulators of almost all continents.
• Constant dialogue with other West African
  countries Food and Drug Regulatory Authorities
  with a view to sharing strategies and carrying
  them along, so that the counterfeiters will not
  find a safe haven any where in the sub region.
• In 2002 in Hong Kong, NAFDAC originated the
  campaign for the setting up of an international
  convention on counterfeiting of pharmaceuticals
  just as we have for narcotics and psychotropic
  substances. We have continued to aggressively
  pursue this campaign in all international
  meetings and it is catching on.

48
Strategies employed Contd.

• DRUGS SAFETY MONITORING
• Established the National Pharmacovigilance Centre
  and admitted as the 74th member of National
  Centres, participating in the WHO Drug Safety
  Monitoring Programme.
• ACCESS TO ETHICAL DRUGS STRICTLY ON PRESCRIPTION
• It is common practice in Nigeria for prescription
  drugs to be purchased without prescription. This
  fuels irrational drug use which sustains drug
  counterfeiting.
• NAFDAC has started enforcing that ethical drugs
  are obtained strictly on prescription. In
  agreement with other stakeholders, we started
  with all injectables in addition to the sedatives
  that are already being enforced.

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GOVERNMENT SUPPORT

• We enjoy tremendous support from government under
  the able leadership of President Olusegun
  Obasanjo.
• Nigerian government banned importation of drugs
  through land borders and designated two airports
  and two seaports for drug importation.
• Recently, government also banned 17 drugs that
  our local manufacturers have capacity for.

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SOME OF THE ACHIEVEMENTS AND GAINS RECORDED SO FAR

• Sanitized the food and drug industry and created
  a reasonably well regulated environment which has
  saved the lives of millions of Nigerians and
  boosted our economy by encouraging local
  industries, genuine importers and foreign
  investors.
• Immense public awareness resulted in the
  participation of all stakeholders in the
  promotion of food and drug regulation in Nigeria.
  
• Awakened the international consciousness that
  Nigeria is no longer a dumping ground for fake
  drugs.
• The level of incidence of fake drugs has been
  reduced by over 80 from what it was in 2001.
• The production capacities of our local
  pharmaceutical industries have increased
  tremendously.
• 22 new drug manufacturing outfits were
  established in the last four and half years.

51

• ACHIEVEMENTS CONTD.
• The confidence of investors in the pharmaceutical
  industry has been reinforced as evidenced in the
  continuous upward movement in the share prices of
  the pharmaceutical companies quoted in the
  Nigerian stock exchange.
• Ban on made in Nigeria drugs have been lifted by
  other West African countries.
• Many Multinational Drug Companies are coming back
  to Nigeria due to improved regulatory
  environment.
• Lily, Ciba Geigy and Sandoz (merged as
  Novartis), Pharmacia, e.t.c.
• Cheering reports of declining number of kidney
  failure patients and death rates in our
  hospitals.
• Working in concert with all Government hospitals
  in Nigeria, by compiling the number of renal
  failure patients and deaths on monthly basis in
  order to establish a trend.
• Over US80 million worth of fake drugs have been
  publicly burnt in the last four years.

52
ACHIEVEMENTS CONTD

• Over 1100 containers of regulated products were
  placed on 'Hold' at the Port Harcourt and Lagos
  ports, and most of the owners have absconded.
• From 2001 to July 2005, over 1,000 raids were
  carried out on distribution outlets of fake
  drugs.
• 45 convictions in respect of counterfeit drugs
  related cases. Over 55 cases against violators
  pending in courts.
• Sanctions on erring manufacturers and importers
  are increasing steadily. 2,226 sanctions in 2002
  3,178 in 2003 and 3,460 in 2004.
• Sanitization of table water and sachet water
  production have greatly reduced cholera and other
  water borne diseases outbreaks, which used to be
  rampant in the country.
• NAFDAC monitors salt iodization in Nigeria and in
  this regard, UNICEF rated Nigeria as the first
  country in Africa to achieve universal salt
  iodization. We are currently working to achieve
  the same feat in vitamin A fortification of
  flour, sugar, vegetable oil and margerine.

53

• CONCLUSION
• Information technology has contributed to
  seamless borders between countries and fuelled
  high technical expertise of counterfeiters to the
  extent that counterfeiting is no longer a problem
  of the developing countries, but a serious global
  emerging issue
• It is only by networking among regulators,
  Industries, Law Enforcement Agencies and other
  stakeholders and collaboration among nations that
  we can effectively tackle the problem of drug
  counterfeiting. We must constantly share our
  experiences and strategies and build on what we
  have so as to always be a step ahead of these
  merchants of death.
• Customs organizations need to work hand in hand
  with drug regulators and other security
  organizations so that counterfeiters do not use
  the opportunity of interagency rivarry to escape
  detection.
• Counterfeiting of pharmaceuticals is beginning to
  get the attention it deserves, as evidenced by
  the number of anti-counterfeiting meetings
  organized by various interest groups around the
  world. It is my earnest desire that we will make
  the decision to fight counterfeit drugs and match
  it with necessary action no matter the cost.

54
CONCLUSION CONTD

• Pharmaceutical manufacturers should put in place
  anti-counterfeiting measures, like holograms,
  markers, special inks, etc, to safeguard their
  products, and also carry out regular post
  marketing surveillance in collaboration with
  regulatory authority.
• Country laws on drug counterfeiting should be
  severe enough to serve as deterrent.
• There is need for the African Union to table the
  issue of counterfeiting in their discussion
  Agenda to encourage Political will of Heads of
  African nations to fight counterfeiting in their
  respective countries.
• All concerned should embrace massive public
  enlightenment as it has proved to be a successful
  tool in fighting the Culture of Silence and
  secrecy, which enshrouds the counterfeiting
  problem.
• Counterfeiters can be overcome despite the
  dangers and threats from the criminal network. If
  we can fight drug counterfeiters to a stand-still
  in Nigeria, with courage, determination and
  sincerity of purpose, the west African sub region
  and the global community can succeed in
  eradicating counterfeit drugs in international
  commerce
• Thank you for listening

55
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