Nigeria 'getting there' in fake drugs fight, says analyst

Nigeria continues to suffer under the burden of the counterfeit medicine trade, but recent initiatives implemented by the government could mark the beginning of a trek along the road to solving the problem, albeit a long and arduous one.

That is the view of analyst Roxy Nader at Business Monitor International, which has just published its latest quarterly report on the $680m Nigerian pharmaceutical market.

Current estimates are that around half of the medicines circulating in Nigeria are fakes. The World Health Organization cites a figure of 50 per cent, while in 2006 the country's regulatory authority NAFDAC (National Agency for Food and Drug Administration and Control) gave a more modest figure of 16 per cent. Meanwhile, the Ebonyi State Task Force on Counterfeit and Fake Drugs has said it believes that 48 per cent of drugs entering Nigeria are fake.

"There is no one reliable source for drug counterfeiting data and many conflicting views on the issue," she told SecuringPharma.com. "Generally speaking, the problem is not to be underestimated."

The country has been battling the counterfeiters for years, with the NAFDAC leading the charge first under former director Dora Akunyili and latterly Paul Orhii, with a sustained campaign of raids, arrests, pharmacy closures and court cases.

"NAFDAC's effectiveness is still relatively low considering the scale of the problem," said Nader. "But this is a case of an overwhelmed regulatory body with limited capacity to deal with a nationwide problem."

In August 2009, the authorities proposed a new strategy for the reduction of counterfeiting in the country, which includes a number of initiatives such as only allowing accredited and qualified personnel to stock medicines, and creating purpose-built medicines distribution hubs, each headed by a Superintendant Pharmacist.

The Zonal Drug Distribution Centres (ZDDCs) envisaged in the proposals have yet to be implemented but are a "logical" response to the counterfeit medicines problem, according to Nader.

"Having a centre in designated regional zones within the country for receiving large batches of medicine would tighten the supply chain," she said. Under the proposal, "local health providers would receive their medicine from this source, distributed through reputable couriers with appropriate drug storage capabilities."

In the meantime, however, Nigeria is struggling to provide effective healthcare to its population against an environment where just 0.3 per cent of Gross Domestic Product (GDP) is spent on medicines and the market is extremely dependant on imported drugs.

This means that, even if a product is suspected of being counterfeited, "removal is not a viable option when there is no replacement for a particular medicine," according to BMI.

"Unless there is an actual means of testing for fake medicines on the spot, then a simple suspicion is not enough to shut down a pharmacy and confiscate the drugs, particularly if those are essential medicines for which there is no alternative," explained Nader.

NAFDAC's recent purchase of hand-held TruScan scanners from Ahura Scientific, which can identify the content of drugs, could have an important impact.

"A scan could tell whether a vendor is selling fake medicines, and then stores could be shut – against proper evidence," she said.

Meanwhile, the Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMG-MAN) recently unveiled plans to construct a testing laboratory for raw pharmaceutical ingredients.

This should be cheaper than relying on foreign testing facilities and, it is hoped, help avoid other supply chain security issues such as the contamination of teething syrup with diethylene glycol (DEG) which killed more than 80 children between November 2008 and January 2009.

"The teething gel scandal was a result of multiple failures – in the manufacturing process not meeting national or international standards, in the lack of verification of testing, in the poor import controls which allowed illegal ingredients to enter the country in the first place and in the relatively slow response of the authorities to recall products and record all cases of adverse side effects," commented Nader.

The building of the testing facility is long overdue, but the fact that counterfeits are produced and transported within the country is part of a broader issue of weak pharmaceutical regulation and law enforcement.

"Suspected fake products should be tested before entering the country at customs and ports – however the borders are not entirely tight and not all officials are trained to recognise fake medicines," she pointed out.

"Nigeria is getting there," said Nader, "but the central problem is the lack of resources for enforcing laws and lack of trained personnel for inspections."


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