• Inferior drugs kill 500,000 persons in Nigeria, Sub-Saharan countries yearly
• 267,000 deaths due to fake antimalarial medicines, 169,271 killed by substandard antibiotics
• Only 2000 NAFDAC staff saddled with 58,020 registered products, post-market surveillance
• 97.1% of N7.648b budget goes to salaries, 2.9% left for capital expenses
• Regulatory agency now dependent on foreign donors for sensitive equipment

With the recent spike in the cost of pharmaceutical products nationwide, the menace of fake and substandard drugs has also hit a new record – raising fresh posers on the regulatory duties of the National Agency for Food, Drug Administration and Control (NAFDAC).

Perception from health professionals suggests that cases of illnesses, disabilities and even deaths may not be unconnected with the influx of counterfeit and inferior drugs selling at premium.

Findings, however, showed that NAFDAC is just as handicapped as the poorly regulated drug market. The agency is battling the challenges of inadequate staff strength, poor funding, and inefficient post market surveillance of registered products.

Besides paying salaries, the regulatory agency has very little left for relevant capital ventures to effectively police 58,020 registered products and a rash of drug markets nationwide.

It will be recalled that a recent report by the United Nations Office on Drugs and Crime (UNODC) estimated that substandard drugs kill 500,000 persons in sub-Saharan Africa each year.

As many as 267,000 of the deaths were linked to falsified and substandard antimalarial medicines. Another 169,271 deaths are due to fake and low-quality antibiotics used in the treatment of severe pneumonia in children. NAFDAC has similarly raised the alarm on the influx of adulterated cough syrups, antibiotics, and other children’s pharma products.

But the drug business has become more lucrative, with the cost of health consumables now over 300 per cent (compared with six months ago), and a fresh incentive for ‘merchants of death’ importing fake and substandard substitutes.

Statutorily, NAFDAC is saddled with the conduct of regular post-marketing surveillance of medicines at retail premises, followed by quality control detection and tests of these medicines; and periodic survey of medicines in hospitals and at Federal and State Medical stores all over Nigeria. But the agency is far from effective, if not a shadow of its old self.

Inquiries by The Guardian showed that poor budgetary allocation to the body has confined it to a status of a toothless bulldog against more powerful cartels in the drug business.

For instance, NAFDAC has just 2000 staff nationwide and they have the duty of post-market surveillance and pharmacovigilance all year round.

According to NAFDAC’s Registered Product Database, a total of 58,020 products including drugs, herbals, drugs, foods, cosmetics, medical devices, chemicals, vaccine, biological, veterinary/animal feeds etc., and narcotics are registered by the agency. The NAFDAC Greenbook: Nigeria’s Registered Drug Product Database, shows 6350 of the agency’s registered products are drugs.

Yet, the 2023 Appropriation Bill shows that out of a total of N7.65 billion N7.43 billion are for personnel and payment of salaries, and only N222.7 million left for capital expenditure.

The Guardian investigation also revealed that the staff are not well paid. A NAFDAC staff on Grade Level (GL) 8 earns N1,247, 854 per year. That works out to approximately N103,987 per month before pension and tax deductions. Also, NAFDAC employees on GL 7 get paid N1,073,217 per year. That works out to approximately N89,434 per month before pension and tax deductions.

NAFDAC employees are eligible for certain allowances in addition to their base wages. However, these allowances are subject to certain requirements such as year of service, location, post held, and so on. Yet, as one advances up the service ladder, the pay increases.

The source, who preferred anonymity, said the average wage at NAFDAC is N137,480.
However, Director General of NAFDAC, Prof. Mojisola Adeyeye, said the agency is not unaware of those challenges, assuring of the plan to increase staff strength by 100 per cent in the next few years.

Adeyeye said to expand Post Marketing Surveillance (PMS), the agency would recruit more staff and provide tools, capacity building and make enforcement nimbler for sustained response.

She said: “We need staff. In one of our states, we have only 12 staff and they are expected to do a lot of things in the state. They are supposed to do surveillance, inspection, follow up, registration and many others.

“We are currently about 2000 now, but by the end of the year 2024, 2025 or thereabout, we would have reached 4000. Because that is part of our post marketing surveillance. We are going to improve on that with the little that we have, but we are praying that the government will bail us out with funding.”

In the interim, NAFDAC is counting on international donors for support. Adeyeye said courtesy of the partnerships, the agency has made strides through the implementation of pharmaceutical traceability, pharmacovigilance, post marketing on the field checking for substandard falsified medicines, and other system strengthening interventions.

The effort was made possible through vital support from the Global Fund’s Resilient and Sustainable Systems for Health (GF-RSSH) grant, with the National Agency for the Control of AIDS (NACA) as the principal recipient.

Former President, Pharmaceutical Society of Nigeria (PSN), Olumide Akintayo, said the poor state of drug regulation in Nigeria today has generated major challenges including falsified medicines and drug abuse. This twin evil, he said, has become a huge public health menace in Nigeria.

The pharmacist explained: “On paper NAFDAC appears well funded but it can do more. Government intelligence framework needs to be deployed to assist NAFDAC logistics operations in cracking the network of drug fakers in their countries of origin. The factories where death potions are synthesised internationally and locally need to be blacklisted.”

Founder and the Chief Executive Officer of Emzor Pharmaceutical Industries, Dr. Stella Okoli, told journalists that “NAFDAC is doing a good job but they need to do more. So, NAFDAC needs to do a lot of post market surveillance. We need to ensure that Nigeria and West Africa is not a dumping ground.”