From nigeriafirst.org


NAFDAC: Battle against fake drugs
By
Mar 4, 2003, 16:34

Destruction of fake drugs

The National Agency for Food and Drug Administration and Control (NAFDAC) is Nigeria’s sole body that regulates and controls the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and locally produced prepackaged water.

It is a parastatal of the Federal Ministry of Health, and came into being on 1st January 1994.

NAFDAC was established in response to the resolution of the World Health Assembly in 1988 that in order to combat the threat that fake drugs posed to global health, countries should initiate a programme for the prevention and detection of counterfeit pharmaceutical products.

NAFDAC replaced an earlier body, the Directorate of Food and Drug Administration and Control of the Federal Ministry of Health whose performance were limited by factors including legislation that were inadequate to discourage the production and distribution of fake drugs. Product registration was also almost non-existent.

Consequently, between 1974 when the first food and drug decree was enacted and 1994, when NAFDAC was established, no fake drug manufacturer or importer was ever prosecuted for endangering the lives of people. There was public outrage when no culprits were indicted over the death of over 150 children who died in 1989 as a result of a formulation error in a drug.

In December 1992, the maiden governing council of NAFDAC was inaugurated under the chairmanship of Ambassador Tanimu Saulawa. The supporting legislation (Decree No 15, 1993) was only signed into law in January 1993, according to which:


  • NAFDAC is imposed with responsibility “to protect public health by promoting wholesomeness, quality, safety and efficacy of processed food, medicines, cosmetics, medical devices, chemicals and prepackaged water through an effective quality assurance system, public enlightenment, in addition to inspectorate and enforcement activities as part of the nation’s efforts of emphasising prevention of illnesses in all residents in Nigeria.


  • The agency is also charged with the responsibility of formulating regulations and compiling standard specification for compliance by manufacturers, importers and exporters of regulated products.



The structure of NAFDAC
The National Agency for Food and Drug administration and Control is headed by a chairman who presides over a governing council appointed by the president on the recommendation of the Minister of Health.

Other members of the governing council are: the Permanent Secretary of the Ministry of Health, the Director-General of NAFDAC, Standard Organisation of Nigeria (SON), the National Institute for Pharmaceutical Research and Development (NIPRD), the chairman of the Pharmacists’ Council of Nigeria (PCN), the chairman of the National Drug Law Enforcement Agency (NDLEA), a representative each of the Pharmaceutical Group and the Food and Beverages Group of the Manufacturers’ Association of Nigeria. Three people from the general public are also represented on the council.

The agency is divided into six directorates - registration and regulatory affairs, inspectorate, laboratory services, narcotics, planning research and statistics, finance and administration.

The first Director-General of NAFDAC, was Professor G. E. Osuide, a former professor of clinical pharmacy at the University of Benin. He left office in August 2000.

Change at the helm
In spite of improvements in the regulation and control of drugs with the establishment of NAFDAC, continued to rate as one of the countries with the highest incidence of fake and counterfeit drugs. So much so that neigbouring countries such as Ghana and Sierra Leone officially banned the sale of drugs made in Nigeria. Similarly, a number of multinational drug manufacturers companies that could not compete with faked drugs either divested from Nigeria or folded up.

The drug distribution system in the country was so chaotic that drugs were hawked even in commercial buses just as there are no reliable statistics on the incidence of fake drugs in Nigeria.

The market was flooded with toothpastes without fluoride; non-iodised salt, expired processed foods that were expired and even preserved with toxic chemicals; bread baked with potassium bromate—a product that was banned in the early 1990s; and cosmetics containing harmful chemicals.

It was further observed that most Nigerian companies did not conform to requirements of Good Manufacturing Practice (GMP). Many imported drugs were registered without overseas factory inspection.

President Olusegun Obasanjo Administration dissolved the management of NAFDAC in August 2000. In April 2001 a new management, with Dr Dora Nkem Akunyili as Director-General, was inaugurated.

What then is new since 2001?

The new management has since restructured and re-organised the agency.

New directorates were created for registration and regulatory affairs, laboratory services, narcotics and controlled substance, planning research and statistics, administration and finance, ports inspection, establishment and enforcement.

New inspectorate offices were opened in all the nation’s 36 states, including Abuja, and three special inspectorate offices, six zonal offices and three narcotic offices were introduced. Laws that the new management considered out of step with global trends in the war against drugs were also reviewed and sent to the National Assembly.

The Agency has focused on enforcement activities, which had been identified as the weakest link in the chain of NAFDAC’s regulatory activities. The activities of the ports inspection and enforcement directorates were strengthened, and surveillance and establishment inspection activities were intensified. The measures yielded dramatic results.

There has been a phenomenal increase in seizures and destruction exercises of fake drugs carried out by the agency. To date, the agency has carried out a total of 60 destruction exercises valued at over N4 billion, ($28 million) and has placed about 3,760 metric tonnes of regulated products on “hold”. In the Port Harcourt zone alone, NAFDAC has put on hold 229 containers of regulated products.


The basis for the string of successes NAFDAC has recorded in recent past are due to three new policies enunciated by the Federal Government:


  • The outright ban on the importation of drugs and other regulated products through land borders


  • The designation of Calabar and Lagos (Apapa) sea ports, Murtala Muhammed and Aminu Kano international airports as exclusive ports of entry for the importation of drugs and pharmaceutical raw materials


  • Release of shipping and cargo manifests by the Nigerian Ports Authority, shipping lines and airlines to NAFDAC inspectors.



Currently, all factories must be GMP certified before they are allowed to import drugs into Nigeria. NAFDAC must also inspect factories anywhere in the world before it registers or renews the registration of their products. For instance, NAFDAC has appointed analysts in India who certify all drugs before they leave India for Nigeria.

Similarly NAFDAC now requires compulsory pre-shipment information from all importers before the arrival of their products.

Meanwhile, NAFDAC has engaged the public proactively in the war, by publishing regularly the list of genuine products and their fake versions so that the public can make informed choices in the market place.



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