Nigeria insists on mobile authentication of medicines

Nigeria's medicines regulatory authority has started enforcing a requirement for antimalarial and antibiotic drugs to deploy a text message-based authentication system.

The clampdown fulfills a pledge made by Dr. Paul Orhii when he was re-appointed for another five-year term as director general of the National Agency for Food and Drug Control (NAFDAC) in January of this year to expand usage of the Medicines Authentication System (MAS).

The MAS involves placing a code on the medicine pack that can be texted by any of the 100m Nigerian cell phone users to an associated phone number in order to verify the authenticity of a pack of medicines. Within a short time, their cell phone will receive a text message that indicates whether the code sent - and by extension the pack - is genuine or bogus.

As each code is unique and can be verified only once, the idea is that counterfeiters will find it harder to profit from the production of imitations.

Nigeria initially implemented a requirement for antimalarial drugs to carry verification codes and subsequently extended the mandate to include antibiotics, two drug classes which have historically been targeted by counterfeiters.

NAFDAC has taken a soft approach to encouraging pharmaceutical manufacturers to adopt the system to date, but is now clamping down on companies that are resisting the move. Officials from the regulatory authority have started seizing products found on the market without the codes.

NAFDAC's director of pharmacovigilance and post-marketing surveillance, Adeline Osakwe, said manufacturers have 90 days to ensure they are distributing drugs with the codes, according to a report in The Guardian newspaper.

Companies providing codes for use in the MAS in Nigeria include Sproxil, PharmaSecure and Kezzler. Sproxil said earlier this month it had received more than 10 million verification requests from consumers on products which include the GlaxoSmithKline (GSK) antibiotic brand Ampiclox (ampicillin and clavulanic acid) and Johnson & Johnson's Nizoral (ketoconazole) antifungal range.

A World Health Organization (WHO) study called the Quality of Anti-Malaria Medicines in Sub-Saharan Africa (QAMSA) in 2011 estimated that the circulation of falsified medicines was around 20 per cent, which tallies closely with a NAFDAC study the following year which found a prevalence of 19.6 per cent.

The studies reveal the impact on the circulation of fake drugs of the MAS and other measures, such as routine screening of medicines using Thermo Scientific's handheld Truscan spectrometer. A similar study by WHO in 2008 estimated 64 per cent of antimalarial drugs in Sub-Saharan Africa were fake.