Will Domestic Drug Makers Step up Amid Multinational Withdrawals?

Last week, the National Agency for Food and Drug Administration and Control gleefully announced the registration of over 100 new drug manufacturers, a development which should ordinarily come as a relief in the wake of the wave of exit of some multinational companies from Nigeria. However, analysts believe that what should bother the stakeholders include whether or not the regulators have what it takes to stem the tide of the proliferation of sub-standard products largely fuelled by lack of proper monitoring, corruption, and negligence, reports Festus Akanbi

In Nigeria, the rising cost of healthcare delivery is one of the headaches of the labour unions currently making a case for higher wages for its members. One of the arguments is that with the current level of inflation, their take-home cannot guarantee quality feeding not to talk of giving them access to good healthcare.

At the private sector end, employers of labour are said to be factoring the implication of the consistent rise in the cost of medical services in their calculations as Nigerians continue to pay the price of the exit of multinational drug companies in the country and the attendant upsurge in the prices of drugs.

In August 2023, GlaxoSmithKline (GSK) Consumer Nigeria Plc, the second-biggest drug producer in Nigeria, ceased operation in the country by terminating its marketing and distribution agreement and appointed third-party distributors to sell their medications and vaccines.

GSK is the producer of vaccines such as Ambirix for hepatitis A & B, Cervarix for human papillomavirus bivalent 16 & 18, cancer drugs such as Zejula, and other general medicines such as Amoxil, and Augmentin.

Sanofi and many other foreign pharmaceutical companies have also announced leaving Nigeria.

Speaking at a recent event, the Vice President of the African HealthCare Federation, Clare Omatseye, raised concern over the hike in the prices of cancer drugs as manufacturing companies of chemotherapy drugs exit the country.  Sequel to its over-dependence and reliance on importation, Nigeria is currently battling a national shortage in drug supply.

As NAFDAC Registers News Drug Manufacturers

However, according to NAFDAC, the exit of multinational pharmaceutical companies from Nigeria has not deterred indigenous operators from indicating their interest in the erection of drug manufacturing facilities in Nigeria.

NAFDAC said a total of 105 applications for the construction and erection of drug manufacturing facilities have been approved across the country, explaining that the approved applications, which were selected from a total of 143, meet the Good Manufacturing Practice (GMP) guidelines of the World Health Organisation (WHO) and NAFDAC GMP for Medicinal Products Regulations 2021.

The agency also revealed that over 20 newly registered local drug manufacturers have cumulatively invested over $2 billion in the erection and completion of WHO-compliant facilities that manufacture quality pharmaceuticals and essential medicines for Nigerians.

NAFDAC also announced that Emzor Pharmaceuticals Industries Limited is commencing the commercial manufacturing of four antimalarial Active Pharmaceutical Ingredients (APIs) following technical collaboration with NAFDAC and Indian-based WHO prequalified API manufacturers partners- Mangalam Drugs and Organics Limited.

It added that another cohort of six local manufacturers has concluded plans to initiate the local manufacture of different classes of widely used APIs and pharmaceutical excipients.

Production of Underdosed Drugs

As NAFDAC continues to celebrate the rising appetite of indigenous drug manufacturers for the Nigerian market, industry analysts’ headache is the capacity of the regulators to ensure that what comes out of their factories are world-standard drugs and not products that cannot stand the test of time.

Their worry was rekindled by a recent report which alleged that nearly all of the paracetamol tablets sold in Nigeria are possibly underdosed, falling short of the requirements specified by the British Pharmacopoeia and World Health Organisation (WHO), according to a recent investigation.

According to reports, samples from five different paracetamol brands, each claiming to contain 500mg, were tested and analysed using the spectrophotometric method, in the 2023 study titled ‘Comparative Analysis of Five Different Brands of Paracetamol Sold in Nigeria with British Pharmacopoeia Standards’.

The concentrations, according to the investigation, ranged from 185mg to 358mg, which was much lower than the suggested 500mg limit. 

The study’s researchers voiced concern about the possibility of treatment failure due to underdosed paracetamol tablets.

They emphasised that “Considering the current demands for cost-effective therapy, a prescribing and underdosing habit that could lead to treatment failure is of potential concern.”

The researchers, according to the study, believed that the development could lead to poor patient outcomes, polypharmacy, and a large expense to the healthcare system, as paracetamol, which is widely used in Nigeria for its analgesic qualities, is a basic pain reliever.

Published in the journal Communication in Physical Sciences, the study emphasises the importance of increased awareness and regulatory scrutiny to ensure the quality and efficacy of pharmaceuticals available to the public.

Ohuabunwa: Blame Proliferation of Sub-standard Drugs on Porous Ports, Borders 

However, speaking with THISDAY last week in an exclusive interview, former chief executive of Neimeth International Pharmaceuticals Plc and former president of the Pharmaceutical Society of Nigeria, Mazi Sam Ohuabunwa, said it is erroneous to assume that fake and substandard drugs come from the factories of registered drug manufacturing companies in Nigeria.

Ohuabunwa, who was also a former president of the West African Pharmaceutical Manufacturers Association and the former chairman of the Nigerian Economic Summit Group, said the incidence of fake drugs and low-quality drugs should be blamed on the activities of criminals who fake products in their hideouts in various parts of the country. He also blamed the porous border and the high level of corruption which enable criminals to bring their contrabands through the ports and borders.

When confronted with the reports of the sale of underdosed paracetamol products in the Nigerian market, Ohuabunwa said unless the report can single out a Nigerian manufacturer in the report, it is wrong to assume those drugs were manufactured locally.

He said drug sellers in Nigeria import their products from countries like Iraq, Afghanistan, and other parts of the world, saying “So it is not right to blame Nigerian manufacturers for the lapses observed in those products”.

He believed that NAFDAC has put in place a sort of process that will make it difficult for any local manufacturer not to follow the rules guiding their operations. 

He, however, maintained that as good as the government’s desire to encourage new entrants into the industry is, there is also the need to encourage the existing ones by looking into some of their grievances.

He called on the government to increase the ability of NAFDAC to effectively supervise the industry.

On why most operators rely on imported raw materials, Ohuabunwa, who was also a former President of the Nigerian Employers Association, said it is costly to embark on the local production of raw materials for drugs.

According to him, it will not make sense to commit huge resources to raw material production without a market for the products. However, he said Neimeth is already producing a certain sickle cell drug using local herbs.

NAFDAC and Capacity Building

For the new entrants, NAFDAC said it is preparing regulatory officers, manufacturers, and students with their professors in capacity-building through an international workshop on Local Manufacturing of Active Pharmaceutical Ingredients and Excipients, developed by NAFDAC.

“The first workshop took place in October 2023, and it attracted experts in the subject matter from China, USA, UK, and Nigeria,” NAFDAC Director-General, Prof Moji Adeyeye noted.

Pharmaceuticals are an integral component of healthcare systems worldwide, thus, regulatory weaknesses in the governance of the pharmaceutical system negatively impact health outcomes, especially in developing countries.

Despite the many reported reforms instituted by NAFDAC, facets of the pharmaceutical system in Nigeria remain fairly vulnerable to corruption. The most glaring deficiency seems to be the absence of conflict of interest guidelines which, if present and consistently administered, limit the promulgation of corrupt practices. 

However, in 2001, under the leadership of Dr. Dora Akunyili as the new Director General of the NAFDAC, the agency underwent dramatic restructuring and reform such as the re-orientation and retraining of NAFDAC staff, establishment of more NAFDAC state offices, among others. As a result, the circulation of counterfeit drugs was reported to have been reduced by over 80% from what it was in 2001, the number of drugs unregistered by NAFDAC in circulation was reduced from 68% to 19%, and the production capacity of local pharmaceutical industries increased tremendously. If Nigeria could do it then, certainly, it can do it better now.