OBG talks to Paul Orhii, Director-General, National Agency for Food and Drug Administration and Control (NAFDAC)

Interview: Paul Orhii

What are the key challenges for regulating pharmaceutical imports and monitoring distribution?

PAUL ORHII: The counterfeit pharmaceuticals market is a sizeable problem across the world. Recent estimates by the World Customs Organisation put the counterfeit products market at $75bn-200bn globally. Developing countries like Nigeria are of course a target for a host of reasons. The country has a high burden of malaria compared to the rest of the world and, naturally, anti-malaria drugs come into Nigeria in high quantities. The country’s population is 167m, its territory is vast, and its borders porous and poorly manned. This is worrying given that 70% of essential medicines consumed in Nigeria are imported. When all these factors are taken into account, the country appears rather conducive to counterfeit medicine activity. There are many positive steps being taken to deal with this issue. At the borders, there is improving cooperation and collaboration between Customs, the Drug Enforcement Agency and various security agencies to help stop these products from coming into the country. We are increasingly able to ensure authenticity of drug imports through mobile laboratories, TruScan detection and an SMS authenticating service. The packaging of anti-malarials and antibiotics now contains a code that can be sent by SMS to access information about the authenticity of the drug. Massive awareness campaigns are also in effect, with close to a N1bn ($6.4m) a year spent to finance them. Regulatory policies must be crafted differently to those of developed countries, which have fully informed consumers. In Nigeria, the poverty level, especially in the rural areas, forces the consumer to prioritise cost over quality. For a difference of N5000 ($32), many consumers will knowingly purchase a counterfeit drug. Simply because the packaging is the same, many consumers dismiss any argument regarding authenticity. The distribution of drugs remains a large problem in Nigeria. We still have a chaotic distribution system where you can buy drugs in open markets, making it difficult to control the chain. The government has intervened by developing drugs distribution centres and state distribution centres, which will be financed in large part by private investors. Medicine will originate at the drugs distribution centres and will then be delivered to the state centres before finally being sold to the consumer. This process will create a new operational framework making it much easier to ensure quality at each stage of the distribution process.

What are the major constraints on local drug production facilities in Nigeria?

ORHII: As I mentioned earlier, we depend on imports for 70% of our drugs. There are many operating constraints. Local producers, for example, depend on generators due to regular power outages, while significant investment is needed in water treatment facilities. There is, however, a strong impetus to upgrade local facilities and maintain international standards. The World Health Organisation (WHO) evaluated eight firms for WHO product prequalification, and six have the potential to receive prequalification for their products within the next two years. Once the prequalification process sees results, Nigeria can become more self-sufficient in its supply of essential medicines. Moreover, since standards will meet WHO criteria, the country will also be able to export pharmaceuticals products.

What is being done to ensure compliance with WHO standards and good manufacturing practice (GMP)?

ORHII: Initially, one problem was the stringent standards implemented by the WHO. Some investors were simply unable to meet such standards. But the gap is closing. The federal government has established a N200bn ($1.28bn) pharmaceuticals intervention fund that will enable local manufacturers to borrow money at single-digit interest rates and allow them to upgrade their facilities. The WHO has been offering increased training to local health inspectors, while many joint inspections have also taken place, helping to ensure GMP.