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Establishment of New NAFDAC Offices

The thrust of NAFDAC mandate is to safeguard the health of the nation and the only way to actualize this mandate is to ensure that the people at the grassroot level are adequately covered.The new NAFDAC which was born in April 2001 promptly established three (3) Special Zonal Offices to fight fake/counterfeit drugs and unwholesome regulated products in Aba Abia State, Onitsha Anambra State and Kaduna, Kaduna State.

For effective control while positively touching the lives of Nigerians in a special way, the new NAFDAC ensured that there is presence of NAFDAC in the remaining twelve (12) States not previously covered by NAFDAC offices

The fight against fake/counterfeit regulated products, has produced rewarding results because the awareness/enlightenment campaigns and enforcement activities embarked upon by NAFDAC is now touching on the lives of all in the 36 states of the Federation and FCT Abuja without any exception.

Three special zonal offices established in the high incidence areas of distribution of faking/counterfeiting of regulated products Onitsha, Aba, and Kaduna in addition to Lagos, have assisted NAFDAC in confiscating and destroying fake drugs and other regulated products and destroying fake drugs and other regulated products worth several billions of Naira.

As at now, all the offices of the Agency put together are fully operational for effective accessibility and enhance efficiency. These office include:

  • Corporate Headquarters, Abuja
  • Lagos Administrative Office
  • 37 Inspectorate Offices
  • 3 Special Inspectorate Offices
  • 6 Zonal Offices
  • 5 Laboratories at Oshodi Lagos, Yaba Lagos, Kaduna and Maiduguri. The Laboratory in Port Harcourts is currently being refurbished
  • 3 Narcotics offices in Abeokuta, Lagos and Port Harcourt.

Most of our state and zonal offices had no sufficient furniture and equipment. The Agency embarked on procurement of office furniture and equipment. To date, all our zonal and state offices are equipped with computers and other communication accessories necessary for good data processing and record keeping. They are also provided with appropriate vehicles for more effective monitoring and control of regulated products in their zones and states.

In the same time, communication equipment was procured and installed for our enforcement unit. This has enhanced the Agency’s activities. It is now easy for field officers to be in constant touch with one another.

 

Public Enlightenment Campaigns

  • Workshop on Packaged Water, Fruit Juices and other Water-Based Drinks
  • Workshops for Patent Medicines Dealers
  • Workshops for Drug Importers
  • Workshop for National Union of Road Transport Owners and Workers
  • Workshop for Licensed Clearing and Freight Forwarders
  • Workshops for Herbal Medicine Practitioners of Nigeria
  • Workshop for Cosmetics Manufacturers and Ethics Association of Nigeria.

In consonance with the Agency’s new beginning, a National Workshop on packaged water and water-based drinks was flagged off in Lagos on 21st of June 2001. The target participants are the producers (whether registered or aspiring to register) of packaged water, juices, yogurt and other water based drinks.

The objectives of the workshop are to inform and enlighten everyone about the health implications of drinking contaminated water, educate the producers on proper methods for manufacture of good drinking water, to expose the participant to the right type of equipment used in the production and packaging of water (some of which were displayed and their functions explained during the course of the workshop), as well as to educate them on the processes involved in registration and advertisement of their products with NAFDAC, so as to encourage the producers to come forward and register their products. The workshop has been carried out in almost all the states of the Federation and Abuja.

This workshop has revealed the ignorance of the vast majority of the manufacturers and the general public on the health implications of producing packaged potable water without due process. The Agency has now exposed the manufacturers to modern equipment for production, and has also simplified the registration process without compromising quality. Other workshops held with various stakeholders dwelt on the dangers of fake drugs, unwholesome regulated products and new guidelines for drug Importation and ban on unauthorized advert of herbal medicines by the media and emphasis on registration of herbal preparations.

The Agency currently runs public enlightenment jingles cast in English Language in the network stations of NTA and FRCN. Similarly, the vernacularversions of the jingles are also being aired in the Kaduna, Enugu and Ibadan regional stations of FRCN. Plans are afoot to start a new Television and Radio weekly discussion programme.

Billboards have been erected in strategic parts of the country. Several posters and stickers warning against the health hazards of fake drugs and other substandard products have also been produced and circulated nation-wide. The Agency also publishes a Bi-annual NAFDAC NEWS magazine and consumers safety Bulletin.

Regular Publication of NAFDAC list of Identified Fake Products

The insurgence of fake, adulterated and substandard regulated products gave the present leadership of the Agency sleepless nights. Consequently an articulated and educative periodic publication of identified fake, adulterated and substandard products was embarked on. This is towards creating a massive awareness that will eventually render the distribution of such products ineffective.

These days, people scrutinize their medicines, food and other regulated products for genuiness expiry date and even NAFDAC registration number, where applicable, before purchase and use.

In NAFDAC’s bid to rid the country of fake, adulterated, substandard and unwholesome processed foods, drugs and other regulated products, manufacturers of NAFDAC regulated products and other stakeholders are approached to assist in identifying the salient distinguishing features between their genuine products and fake ones.

The manufacturers of regulated products are equally encouraged to bring to the attention of NAFDAC all incidences of identified faking for investigation and publication. This is then referred to the enforcement Directorate for necessary action. This helps to engender and sustain good working relationship between NAFDAC and these stakeholders.

Importers and manufacturers of unregistered products are spurred by these publications to initiate registration of their products due to the negative publicity and reduction in sales they get from the publication.

NAFDAC also engages in periodic publication of blacklisted companies, both local and international, who do not conform to World Health Organization (WHO) certified Good Manufacturing Practice (GMP) or produces substandard products, to warn importers and consumers so as to shun products from these companies. The list of identified companies involved in the activity, in India and China, has been forwarded to the Honourable Minister of Health for further directive.

Creation of Enforcement Directorate

The Task Force(s) on Counterfeit and Fake Drugs were established under Decree No. 17 of 1989, when it became clear to government that the Food and Drugs Decree No. 35 of 1974 was not adequately addressing the manufacture, importation and distribution of Fake and Counterfeit Drugs which reached crises stage by the mid 80’s. The Counterfeit and Fake Drugs Decree No. 17 of 1989 was therefore to serve as a deterrent to perpetrators from importing, manufacturing and distributing or selling fake and counterfeit drugs.

In May 1999, Decree No. 17 of 1989 was repealed and replaced with Decree No. 25 of 1999 which retained most of the provisions of the former Decree and, also has the inclusion of “Unwholesome processed Foods” and provided for stiffer penalties including the forfeiture of products once such products have been found to violate the provisions of the said Decree.

The overall responsibility for enforcing the provisions of this Decree including Decree No. 15 of 1993 which established NAFDAC, the Drug and Related Products (Registration etc) Decree No. 19 of 1993 as amended, and other relevant Decrees and Regulations rests on the Federal Task Force on Counterfeit and Fake Drugs, hitherto a unit under the office of the Director – General.

In enforcing the provisions of these Decrees and Regulations, the Federal Task Force encountered widening and increasing responsibilities such as:

  • Coordinating the state Task Forces by the Federal Task Force as provided by the Law.
  • Tracking down the increasing perverseness of spurious products fakers and importers.
  • Coping with increasing sophistication of the criminals involved in faking products.

In order to address these problems squarely, the new management decided to create a new directorate to deal with matters bordering on enforcement in all its ramifications.

In doing this, the new management derived its powers from section (8) paragraph (g) of Decree No. 15 of 1993 setting up the Agency. At present, the Directorate works with a detachment of police officers from Force CID Alagbon, some officers from NDLEA as well as the normal duty officers of NAFDAC, all under a Director of Enforcement.

Within the period of its existence, the Enforcement Directorate has been involved in so many enforcement activities such as prosecution of manufacturers and importers of fake/counterfeit regulated products, destruction of spurious products including the ones at Onitsha. This has justified the vision of the Director General and her management team in setting up the Directorate.

Reconstitution of the Legal Unit of NAFDAC

A Legal Unit is a vital component of any corporate organization. The National Agency for Food and Drug Administration and Control as a responsible and dynamic organization has shown enough responsiveness in not only embracing this creed but also actualizing it as a corporate entity.It is pertinent to note that prior to the reconstitution of the legal unit by the current management on 15th August, 2001, the unit was only a concept but its deliberate efforts to reposition it (the Legal Unit) for effectiveness has started yielding the following dividends:

  • Within the period under review, the unit reviewed various laws relevant to the operations and effectiveness of the Agency. The draft bills have been forwarded to the appropriate government bodies for necessary action.
  • The Legal Unit spearheaded the promulgation of the National Agency for Food and Drug Administration and Control Tariff Regulations 2001 and ensured its publication in the Federal Republic of Nigeria Extra Ordinary Official Gazette No. 8 of Vol. 89 of 28 January, 2002.
  • The Legal Unit has tremendously enriched the control and regulatory decisions of the Agency. This could be seen in the outcome of consultative meetings.
  • In the present democratic culture, the legal unit has guided the Agency out of legal minefield without incurring liabilities in the hands of professional litigants and/or mischief-makers.
  • The prosecution of violators of the Counterfeit and Fake Drugs and Unwholesome Processed Foods (miscellaneous provisions) Decree No. 25 of 1999 has been revitalized by the legal unit with its attendant signal to counterfeiters and merchants of death that the law is not a paper tiger.
  • The Legal Unit has safeguarded the Agency’s interest in the conduct of searches of titles, vetting and drafting of legal documents and handling of civil suits.
  • Finally, the unit has evolved a strategy and provided a framework for the preparation and drafting of regulations, which will provide the requisite legal cum technical details for the protection of the Agency.

Staff Welfare/Working Environment

The welfare of staff has been one of the Director-General’s top priorities, since she assumed duty. This she did in several ways e.g.

  • At the time she assumed duty, the morale of NAFDAC staff was very low. Her coming and meeting with staff re-assured the workers.
  • She actualized her promises by providing more conducive working environment. These include generators, computers, air conditioners etc.
  • Staff buses and utility vehicles were repaired, while new vehicles were purchased.
  • Car re-furbishing loan has been resuscitated.
  • Two clinics in addition to Government hospitals were approved.
  • Harmonized the banking system to the advantage of staff. We now enjoy fast track bank services anywhere in the country.
  • Assistance is now being given to staff involved in functions such as burials, wedding etc

Advocacy meetings with Law Enforcement Organizations

Inspector-General of Police

The Director-General paid an advocacy visit to the Inspector-General of Police, soliciting his cooperation and assistance in the following areas:

  • Eradication of fake, adulterated, and substandard drugs in the country.
  • Dismantling of open drug markets that have constituted a menace to public health.
  • Crackdown on illegal premises of drug distribution.
  • Eradication of illegal manufacturing outfits of foods, drugs, fruit juices, and cosmetics.
  • Checking the growing number of unregistered packaged water products in the market.
  • Checking the nefarious activities of importers of substandard regulated products.
  • Furthermore, they agreed that the Police would provide NAFDAC with Policemen to assist in its regulatory activities, especially in arresting, and prosecuting of offenders; as well as, protecting its facilities.

Chairman, National Drug Law Enforcement Agency (NDLEA)

The Director-General paid a courtesy call and advocacy visit to the Chairman of NDLEA to find ways of working together with the counter-narcotics body. The two sister Agencies agreed to collaborate in their operations.

  • The NDLEA boss promised to provide:
  • Security back-up for NAFDAC’s enforcement activities.
  • Technical assistance in training of NAFDAC’s enforcement unit.
  • Cooperation in information exchange.
  • Use of NDLEA’s anti-drug facilities at the zones.

Comptroller-General of Customs

The Director-General also paid courtesy call to the Comptroller General of Customs and sought his assistance and cooperation in checking the nefarious activities of importers of fake, adulterated and/or substandard regulated products into the country. The Comptroller agreed to:

  • Ensure that Customs Service Officers avail and/or present importation/shipping documents e.g. bill of entry/lading, etc to NAFDAC inspectors to enable close examination, with a view to identifying those containing regulated products for inspection.
  • Ensure that Customs Service Officers routinely invite NAFDAC inspectors for the joint examination of regulated products, and to physically examine their contents and remove official samples intended for laboratory analysis.
  • Collaborate in ensuring that stop and seizure notices issued by NAFDAC inspectors for violating products are honoured.

Honourable Minister of Aviation

The Director-General also held top level meeting with Hon. Minister of Aviation, Dr. Kema Chikwe, Managing Director of Federal Airport Authority of Nigeria (FAAN) and Airline officials over the airlifting of fake drugs and substandard regulated products by Ethiopian Airline, KLM and some courier companies.

A major fall out of the meeting was the new standing policy that any airline carrying fake regulated products will be prosecuted by NAFDAC apart from having their aircrafts grounded. This is a practical approach towards tackling the latest dimension of using airports as route for importing fake drugs into the country.

Review of NAFDAC operational guidelines

The Decree setting up NAFDAC mandated it to regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, bottled water and chemicals. This implies that any person wishing to engage in any of the above activities must require the Agency’s approval. In order to actualize this mandate, the Agency developed guidelines for its operations.

The stakeholders viewed the guidelines, which are systematic instructions of the procedures, to be grossly inadequate. The Director-General then set as one of her major agenda, the review of the guidelines of NAFDAC operations.

A committee comprising of expert consultants and NAFDAC staff was set up, which not only reviewed the existing guidelines but also prepared Standard Operating Procedures (SOP) for all the divisions of various Directorates with special emphasis on Registration and Regulatory Affairs, Inspectorate, Laboratory Services and Narcotics and Control Substances Directorates.

The guidelines cover:

  • Registration of locally manufactured food, drugs, cosmetics, medical devices, water, detergent and chemicals.
  • Registration of imported food, drugs, cosmetics, medical devices, water, detergent and chemicals.
  • Exportation of locally manufactured regulated products.
  • Importation of regulated products.
  • Issuance of Narcotics and Controlled Substances permit.
  • Registration of vaccines and biologicals, etc.

The new guidelines are quite comprehensive and will improve communication between the stakeholders and the Agency while the SOP will reduce decision-making time in registration procedures thereby eliminating unnecessary bottlenecks that existed in the past.

Return of NAFDAC to the Ports

In 1996, the Federal Military Government by its Port Reform Decree, banned some Government Agencies from being in the ports. NAFDAC was affected by this decree, as the decree, provided that the Agency should perform its statutory functions in the ports only on invitation by the Nigeria Customs Service.

The Agency had to depend solely on the discretion of the Nigerian Customs for inspection and release of regulated products. This resulted in proliferation of fake and substandard regulated products as they moved freely through the ports, unchecked by the Nation’s health authority.In recognition of the seriousness of this problem, the Director – General NAFDAC of worked tirelessly towards convincing the government on the need for NAFDAC not only to be returned to the ports but to also strengthen its port operations.

The return of NAFDAC has been achieved with the support of the President and Commander-in-Chief of the Armed Forces Chief Olusegun Obasanjo (GCFR) who granted the approval after the courtesy call by the Director-General of NAFDAC.The return of NAFDAC to the ports has resulted in several seizures of consignments of fake and substandard products. Also a lot of unregistered regulated products have been intercepted at the ports.

The Director-General of NAFDAC has also consulted with the Comptroller-General of Customs to seek the co-operation of the Customs in the war against fake and substandard regulated product. This has also made a significant contribution to the efforts of NAFDAC as more and more Custom Officers are becoming aware of dangers of releasing regulated products without NAFDAC clearance.The Comptroller-General of Customs has recently directed that any Customs officer who aids and abets the clearing of regulated products without NAFDAC approval runs the risk of instant dismissal from service. Arising from NAFDAC return to the ports, there has been increased surveillance and sanction activities which has led to several successful prosecutions of erring companies and individuals.

Creation of Port Inspection Directorate

Following the approval granted to NAFDAC by Mr. President, Chief Olusegun Obasanjo (GCFR) to return to the ports; and to ensure more effective control of regulated products coming into the country through our ports of entry, the Agency using the provisions of section (8) paragraph (g) created Ports Inspection Directorate in June, 2002. The Directorate is in charge of all Seaports, Murtala Muhammed International Airport Lagos, Kano Airport, Land border posts (Seme, Idiroko) in the country.

The functions of the Directorate are to:

  • Control and Regulate the Importation of Food, Drugs, Cosmetics, Medical Devices, Chemicals and Bottle Water.
  • Undertake the inspection of regulated products at the ports.
  • Compile guidelines for the importation and exportation of regulated products.
  • Control the exportation and issue quality certificates of Food Drugs, Cosmetics, Medical Devices, Bottled Water and Chemicals intended for export.

The Agency officials with the assistance of the Minister of Aviation, Dr. Mrs. Kema Chikwe in August, 2002 were issued with On Duty Cards (ODC) which gave them access to the Tarmac, baggage halls of the Murtala Muhammed International Airport (MMIA), Lagos. Letters were sent to some airlines which were implicated in the dumping of fake drugs and substandard regulated products in Nigeria to desist from this act or have their planes grounded. Similar letters are to be forwarded to Shipping Agencies soon.

The return of the Agency to ports coupled with the access to the Tarmac, baggage Halls of MMIA has led to an increase in the surveillance activities of the Directorate. The Directorate from time to time holds meetings with representatives of Nigeria Ports Authority, Nigeria Customs Service, Clearing Agents, Freight Forwarders and other relevant Government Agencies to solicit their co-operation in its war against the importation of fake, substandard and unwholesome products.

 

Pre-approval inspections to assess overseas plants

Inspection and licensing of pharmaceutical manufacturing facilities on the basis of compliance with Good Manufacturing Practice (GMP) standard is a vital component of drug control.The inspection activity is a process of sequential examination of production and control activities on the basis of the GMP guidelines issued by WHO.

A National Drug Control Authority is expected to inspect manufacturing and quality control facilities prior to granting marketing authorization. This is to verify that production and quality control procedures employed in the manufacture of regulated products are performed correctly in accordance with data supplied in the relevant licensing applications.Prior to the inception of the present management, NAFDAC as a drug control authority, has not been undertaking this important requirement for GMP assessment of oversea plants that export their products to Nigeria.

The Director-General (NAFDAC) in realization of the health implications of this lapse, initiated the process of oversea visits to assess plants. This is to ensure that marketing authorization is not granted to products produced under unsatisfactory Good Manufacturing Practice (GMP).Currently, a number of factories have been inspected in India, China, Germany, Netherlands, Italy, Indonesia, Malaysia etc. and the process is continuous.

 

Registration of regulated products

Arising from the deluge of complaints on the time frame for registration of regulated products which in the past ranged from 7 months to 2 years, the DG (NAFDAC) set up a committee which considered the various stages in processing registration of products. At the end of the exercise, a 2 months time frame was approved by the management.

This decision has resulted in the 100% increase in the number of registered products as reflected in the table below

The above representation shows that a total number of five thousand, seven hundred and thirty five (5,735) products were registered by NAFDAC in seven years while three thousand six hundred and thirty (3,630) products were registered just in a year and four months. The Agency will continue to strive to evolve new policies that will ease the registration processes and procedures in order to reduce the difficulties experienced by companies in this area.

Some Administrative Guidelines

  • A factory must be WHO certified before they can export drugs to Nigeria.
  • NAFDAC officials must inspect factories anywhere in the world before we register or renew registration for their drugs, food, juices etc. This is at no cost to the importer.
  • NAFDAC has appointed analysts in India who now certify any drug before it leaves the shores of India to Nigeria.
  • For imported products from all countries, India inclusive, NAFDAC now requires mandatory pre-shipment information to be provided by all importers before the arrival of the products at our ports.
  • Renewal of registration of any drug or any other regulated product is done every five years. One of our new guidelines is that if there is no evidence of commencement of product renewal three months after the expiration of the product registration, the registration of the product will be automatically cancelled, and when this is done, it will not be revisited for any reason.
  • Importers must insist that their foreign partners affix NAFDAC registration number on the packaging of their products to be imported into Nigeria.
  • Confiscation and subsequent destruction of the drugs of any drug seller who fails to provide a proper invoice of purchase with full name and address. This is to enable us trace the big time importers and distributors.
  • Faced by frustrations of evacuating many lorry loads of fake drugs on tip off without anybody accepting ownership of the evacuated drugs, 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.

Some other actions taken to eradicate fake products, and to create a strong regulatory environment are as follows:

  • Reorganization of the Agency for better effectiveness.
  • We had to work hard for total reorientation of staff. This Cultural Revolution is paramount, in view of the fact that for a regulatory Agency like NAFDAC, honest, dedicated and hardworking staff is more important than sophisticated equipment.
  • As earlier stated, NAFDAC has created two new Directorates; Ports Inspection and Enforcement Directorates for more effective surveillance at all ports of entry and better enforcement activities respectively. This has resulted in increased seizures of fake and counterfeit drugs at the ports, sealing of supermarkets for sale of unregistered and expired items, sealing of food and drug manufacturing factories whose GMP status were found to be unsatisfactory, and the closure of Ariaria drug market in Aba among others.
  • We have embarked on planned, systematic, continuous and sustained surveillance at all our entry points and in all markets and shops as opposed to sporadic raids.
  • Advocacy by the Agency resulting in better relationship and co-operation with International Agencies and National Regulatory Authorities. e.g. NDLEA, Customs, Regulatory Authorities in India, China, etc.
  • NAFDAC in recognition of long usage of herbal products by our people, and in line with WHO recommendation of accepting herbal products based on
  • long history of safe use in a locality, decided to use acute toxicity test as a safety parameter for herbal preparations while reserving efficacy tests, detailed analysis and clinical trials for more complex products such as those claimed to be HIV/AIDS herbal preparations. We also recognize the positive effect of some placebo on certain patients, this is why we emphasize more on quality and safety.
  • To further enhance the effectiveness of these activities, NAFDAC undertook public enlightenment activities for herbal medicines practitioners. Out of the multitude of herbal medicines in circulation, only about 20 are registered, of which most are imported.
  • The Agency has solicited the assistance of media practitioners in ensuring that only adverts with NAFDAC Advert-Permit are carried by our print and electronic media.

Conclusion

The achievements of the Agency under the dynamic leadership of Dr. (Mrs.) Dora N. Akunyili (OFR) during the period under review are outstanding and encouraging.

NAFDAC is now a household name as her aggressive crusade against fake and counterfeit drugs and unwholesome processed food has reached the grassroots through the creation of awareness and enlightenment programmes.The populace now scrutinize regulated products for the manufacture and expiry dates and NAFDAC registration number. Importers and manufacturers of regulated products are now aware of the need to have their products registered before distribution.

This new desire for registration of products is as a result of motivation arising from considerable reduction in the registration period. Exporters of regulated products are also taking advantage of the conducive atmosphere now prevailing at NAFDAC.With sustained tempo of the present activities embarked upon by the Director-General the incidence of faking and counterfeiting of regulated products would be reduced to the barest minimum and gradually eradicated.

 

 

 

 
 
 

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