NLIPW Trademarks Law Volume 2 Number 4
(Counterfeiting and Quality of Medicines in Nigeria)
December 9, 2013
Over the last decade, a number of reports have been prepared by researchers based on quantitative field studies conducted to assess the quality of medicines within Nigeria. Some of these include: Okeke amd Lamikanra (1995), Shakoor et al, (1997), Taylor et al, (2001), Odeniyi et al, (2003), Babalola et al, (2004), Ofonaike et al, (2007), Odunfa et al. (2007), Esimone et al, (2008), Bate et al, (2009), Eiche et al, (2009), Nnamdi et al, (2009), and Onwujekwe et al, (2009).
In addition to the above, studies have been conducted by organizations such as the National Agency for Food and Drug Administration and Control (NAFDAC) — which is the drug regulating body in Nigeria, Department for International Development (DFID), and World Health Organization (WHO), in order to assess the incidence of counterfeit drugs in Nigeria.
This article provides a synopsis of the results from some of these studies conducted between 1990 and 2012, that have assessed the quality of medicine in Nigeria as well as studies highlighting the incidence of counterfeit drugs in Nigeria.
A study conducted in Nigeria by the former Deputy Director of WHO, Professor Adeoye Lambo, showed that 54 percent of drugs in major pharmacies in Lagos were counterfeits.
A study by Shakoor et al, (1997) on chloroquine formulations sampled from Nigeria and Thailand found two formulations from Nigeria and three from Thailand that did not contain any active ingredient and were classified as counterfeits. The overall failure rate for the antimalarial and antibacterial drugs that were studied was 36% for samples from Nigeria and 40% for those from Thailand.
NAFDAC carried out a baseline study to ascertain the level of compliance to drug registration in Nigeria in 2001. The results revealed that 67.95 percent of the drugs in the Nigerian market lacked the prerequisite NAFDAC registration and approval for use in Nigeria. Counterfeiting stood at 40 percent.
Again, a quality assessment study conducted by Taylor et al, (2001) also showed that 48 percent (279 samples) of randomly sampled drugs (antibiotics and anti-parasitic) from Nigeria failed to comply with set pharmacopoeial standards. A total of 581 samples of 27 different drugs from 35 pharmacies in Lagos and Abuja were collected and analyzed.
2003 – 2005
NAFDAC repeated the baseline study to ascertain the level of compliance to drug registration in 2003 and 2004 and the results showed a significant reduction in the number of unregistered drugs in the Nigeria market and by the end of 2005, counterfeiting stood at 16.7 percent, according to NAFDAC.
Between April and June 2008, WHO collected data from six countries, including Nigeria, in order to access the quality of anti-malaria drugs in those countries. Nigeria provided the largest number of samples for testing (75 samples). Data collected as part of this survey enabled comparison of the results of quality testing by country, distribution level, geographical region, domestic production or import, product types, registration status and prequalification status.
In Nigeria, the highest failure rate was found in Jos (83 percent), followed by Lagos (70 percent), Onitsha (50 percent) and Kano (43 percent). No failure was found in Calabar. The overall failure rate was 64 percent.
Onwujekwe et al, (2009) studied some anti-malaria drugs available in south-east Nigeria. Of the anti-malaria drugs studied, 37% failed to meet pharmacopoeial specifications, with some products containing no active ingredient at all.
2010 – 2012
Between January 2010 and April 2012, NAFDAC carried out a National Survey on the Quality of Medicines Using Truscan Device, across 29 states in Nigeria, including the Federal Capital Territory, Abuja. A total of 5,790 samples were tested. The results showed that 5419 samples passed (93.6 percent) and 371 sample failed (6.4 percent).
With regard to anti-malaria drugs, the results showed that of 910 anti-malaria drugs tested, 732 samples passed (80.4%) and 178 samples failed (19.6%). This result signified an improvement on the figures obtained from 2008 study on the Quality of Anti-Malarials in Sub-Saharan Africa (QAMSA).
From all the studies above, it is obvious that while there are still issues with the quality of medicines sold in the Nigerian market, there also seems to be a progressive decrease in the incidence of counterfeit medicines each year in Nigeria: According to NAFDAC, counterfeiting stood at 40% in 2001 as against 16.7% in 2005 and the National Survey on Quality of Medicines using Truscan Device showed that counterfeiting was at 6.4% in 2012. It is hoped that more detailed studies are carried out to access the current state of the quality of medicines in Nigeria and the incidence of counterfeit drugs.
This article is intended to provide general information about the subject matter. Professional legal advice should be sought about specific circumstances.