CHAPTER ONE
1.0 INTRODUCTION
The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigerian Government Agency under the federal ministry of health that is responsible for regulatory and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drug, cosmetics, medical devices, chemicals and prepackaged water. The current Director General of NAFDAC Dr. Paul Orhii, holds a PHD in Medicine.
In Nigeria today, there is an influx into the market of fake machine parts, fake motor spare part, take chemicals, fake adulterated food items, amongst others. It may appear that almost every existing product has a fake counterpart. The era 1985-2000 in Nigeria has heralded the regime of faking and quackery, counterfeit drugs, quack doctors, illegal chemist shops ad hospitals. Drugs are no exception (Ohuabunwa, 2002). The menace of fake drug became prevalent in the last decade and the present situation is alarming in the West African Sub-region, including Nigeria. Empirical observations have shown that there may be more fake than genuine drug in circulation (Osibo, 1998).
A disturbing aspect of the counterfeit drug menace is that the effects of consuming such drugs go unnoticed most of the times except in such cases where it results in mass deaths. There are generally no reliable data on the mortality or morbidity arming from the consumption of counterfeit drugs in Nigeria. In 1947, 14 children were reported dead after being administered Chloroquine phosphate injections and in 1990, 1909 children died after being administered fake Paracetamol (Aluko, 1994). Usually such incidence stimulates governments into taking positive steps, principally arising from public outcry.
The trend in the last decade prompted the public and particularly the professional bodies notably pharmaceutical society of Nigeria, to pressure the government to take definite steps towards controlling the preponderance of fake drugs in Nigeria, the government responded by promulgating the counterfeit and fake drugs (miscellaneous provisions) decree No.21 of 1988. This decree prohibited the sale and distribution of counterfeit, adulterated, banned and fake drugs or poisons in open markets and without License of registration. It also created penalties for the breach of the responsibility of seizing any drug or poison illegally displayed unlicensed or unregistered premises. Shortcomings in the degree led to its being repealed by decree No.21 in 1989 and subsequent amendments.
The drug situation in Nigeria:
There is a large market for drugs in Nigeria. out of over 130 existing pharmaceutical manufacturers only 60 are in active manufacturing. This is despite the installed capacity of the industry to produce between 50% and 75% of the nation’s drug needs. Capacity utilization is below 30% and about 70% of the drugs are thus imported, (Okoli, 2002).
Drug availability in the public and private health care delivery system in Nigeria is a poor state. Various reasons have been adducted for this trend (Ertun, 1996). These include:
a. Inadequate funding of hospitals pharmacies and the “out of stock syndrome”.
b. Involvement of unqualified persons in the procurement and distribution of drugs.
c. Inadequate storage facilities, transportation and distribution.
The adoption of an essential drugs program through the promulgation of decree 43 of 1989 on essential drug was a step taken to ensure the availability of drugs. Ordinarily, banded drug prescribing is still quite common in much public health institution, contrary to specification of the essential drug Act. (Govt. of Nigeria). This has partially eroded the expected gains of the essentials drugs program.
The drug distribution network in Nigeria is in a state of chaos because it consists of markets patent medicine stores, community pharmacist, private and public hospitals, wholesalers/importers and pharmaceutical manufacturers. It is a common scene in Nigeria to see petty traders who sell kola nuts, cigarette and oranges among other items, in market kiosk, motor parks and road sides hawking drugs that range from over the counter items to antibiotics (popularly called Capsules) (Adelusi Adeluyi, 2000). The medicines are usually left under the sun in such conditions that could facilitate the deterioration of the active ingredients. Patent medicine stores are owned by the holders of patent and proprietary medicine vendor’s licenses ordinarily, the patent medicine should be sold in their original packs. Over the counter (OTC) drugs are the only drugs authorized to be sold by vendors but they generally sell all types of drugs as determined by their financial capability. Considering the knowledge base of these vendors, whose minimum academic requirement to obtain a license is the First School-Leaving-Certificate.
Community pharmacies are statutorily registered with the pharmacist’s council of Nigeria. a superintending pharmacist, who is also registered and licensed overseas the pharmacy anytime it is opened for business with such pharmacies there should not be any serious problem of sale of fake drugs. Unfortunately however, there are many unregistered pharmacies thriving. And in such premises drugs are purchased from doubtful sources with its attendant danger to the health of the public (Erhun and Adeola, 1995).
1.1 STATEMENT OF THE PROBLEM
The major problem encountered in this study was the initial reluctance of regulatory bodies to divulge vital information that will reveal their level of performance.
a. Adequacy of the laws governing the eradication of counterfeit drugs in Nigeria
b. Why counterfeit drugs are common
c. The performance of the state task forces
d. Methods employed by the task forces in carrying out their duties and the major problem affecting performance.
e. How seized goods are prevented from going back into the drug distribution chain