FEDERAL REPUBLIC OF NIGERIA
1
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
OUAGADOUGU, BURKINA FASO
NOVEMBER 28th – 30th, 2005
.
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
3
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 ZONES:Six(6)
NO. OF STATES:36
CAPITAL:
Abuja
OFFICIAL LANGUAGE: English
4
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
5
come in and establish their network.
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 subregion.
6
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 relabelled with the intention of extending their shelf-life.
•
Drugs without full name and address of the manufacturer.
•
Drugs not registered by NAFDAC
7
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.
8
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.
9
SCOPE OF THE PROBLEM CONT’D
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.
10
SCOPE OF THE PROBLEM CONT’D
•
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 CONT’D
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
12
SCOPE OF THE PROBLEM CONT’D
•
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.
13
REPORTED CASES
In Nigeria due to poor reporting system, cases of worsening disease
conditions or deaths due to fake drugs abound, but unfortunately we
don’t 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 80’s, 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.
14
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.
15
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
16
not sterile.
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.
17
 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.
18
ASSASSINATION ATTEMPT- Car rear shattered wind shield.
19
ASSASSINATION ATTEMPT- Head Scarf showing bullet holes
20
ASSASSINATION ATTEMPT - Car front wind shield with bullet hole
21
ARSON ON NAFDAC Operational Headquarters Lagos (Outside view)
22
Wreckages of NAFDAC Operational Headquarters
Lagos destroyed by fire (Inside view).
23
Wreckages of NAFDAC Kaduna Laboratory destroyed by fire (Outside view)
24
Wreckages of NAFDAC Kaduna Laboratory destroyed by fire (Inside view)
25
 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 Nigeria’s 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.
26
 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
27
matters.
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 tshirts or baby wears
28
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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.
30
ORIGINAL
FAKE
• Blister has grey and red
diagonal lines only
•Blister has grey, red and white
diagonal bands.
•There is no company
Identification on the blister
•Each blister has”SB102M”
embossed on the edge
•Counterfeit product with copied
NAFDAC #
•Registered by NAFDAC
•Not registered by NAFDAC
•NAFDAC #04-2481 Printed on
the pack
SIMILAR SOUNDING NAMES/LOOK-ALIKE COUNTERFEITS
DETECTED BY NAFDAC
ORIGINAL
FAKE
Look –
alike and
soundalike
• 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
•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 #
• No location address
of manufacturer
• Hologram absent
• Date markings are
stated in numbers
• Look –alike and
sound-alike fake
product not registered
by NAFDAC.
 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. 33
STRATEGIES EMPLOYED BY NAFDAC TO COMBAT DRUG
COUNTERFEITING IN NIGERIA.
NAFDAC’S 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.
34
Strategies employed Contd.
 Staff Re-Orientation and Motivation
At the inception of this administration, the inevitable need for staff reorientation 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.
– Leadership by example is highly emphasized.
35
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
36
Strategies employed Contd.
 Restructuring Cont’d
• 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.
37
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).
38
Strategies employed Contd.
 Public Enlightenment Campaign Cont’d
•
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.
39
Strategies employed Contd.
 Stopping the Importation of Counterfeit
Substandard Products to Nigeria at Source
Medicines
and
Other
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 preshipment 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
40
because of its adoption by Central Bank of Nigeria.
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 Agency’s
authorization from their clients will be grounded.
• Due to NAFDAC’s strong surveillance at the borders, and government’s
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.
41
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.
42
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.
43
Strategies employed Contd.
COUNTERFEITING-A REALITY!
 Destruction of Seized Counterfeit Drugs by NAFDAC. (Health risk, national
economic loss.)
44
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.
45
Strategies employed Contd.
 Streamlining
Guidelines
and
Strict
Enforcement
of
Registration
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
46
importer must start producing locally.
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.
47
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.
48
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.
49
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.
50
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 US$80 million worth of fake drugs have been publicly burnt in
the last four years.
51
ACHIEVEMENTS CONT’D
•
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
52
A fortification of flour, sugar, vegetable oil and margerine.
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.
53
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
54
Website:
www.nafdacnigeria.org
Email:
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
CONTACT PHONE NUMBERS
ABUJA: + 234 9 5240994
Fax:
+ 234 9 5241461
LAGOS: + 234 1 4524259
Fax:
+ 234 1 4528031
Mobile:
+ 234 80 33112282
OR
+ 234 80 34514470
55
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