The World Health Organisation (WHO) is
set to pre-qualify five Nigerian pharmaceutical firms, Evans
Pharmaceuticals, SWIPHA, CHI Pharmaceuticals, May and Baker, and Fidson
HealthCare Plc, this year, after final facility inspection.
The listed firms have met most of WHO’s conditions for pre-qualification.
Nigerian pharmaceutical firms are
currently not in a position to participate in international tenders for
medicines against the three pandemics that require WHO
pre-qualification. Experts say this development has been a major
constraint on the local supply of medicines, especially anti-retroviral
(ARVs), anti-malarial and anti-tuberculosis agents.
Until now, the WHO and the Global Fund
are believed to spend over N20 billion annually on procuring drugs for
Malaria, TB and AIDS intervention programmes in Nigeria. The drugs for
these projects are procured especially from India and Brazil because no
pharmaceutical firm in Nigeria is pre-qualified by WHO.
WHO prequalification ensures that drugs
purchased by international agencies such as WHO, the United Nations
Children’s Fund (UNICEF), Global Fund to Fight AIDS, TB and Malaria, for
health interventions across the globe, meet international standards of
quality, safety and efficacy.
With the backing of the National Agency
for Food Drug Administration and Control (NAFDAC), WHO had last year
endorsed these pharmaceutical firms for pre-qualification within two
years.
In a recent interview with BusinessDay,
Paul Orhii, Director-General, NAFDAC, explained “We are on course in our
efforts to get Nigerian companies pre-qualified by the WHO. Officials
of the WHO have been visiting the companies to ensure they are complying
with the directives towards prequalification. With the reports we are
getting, the companies are set and the WHO officials are happy with the
level of compliance.”
BusinessDay investigations reveal that
the WHO inspection team is to visit Nigeria in April 2013 probably for
the final inspection of the five pharmaceutical firms and the likelihood
of final declaration on the prequalification status of the firms before
December 2013.
Ola Ijimakin, General Manager,
Marketing, Fidson Healthcare Plc, revealed that the company (Fidson
Healthcare Plc) has corrected certain technical requirements as
requested by WHO, as well as built and upgraded its facilities at Sango
Ota, Ogun State, in readiness for pre-qualification.
“We are among the five companies
selected by the WHO team for prequalification. We are putting up a
completely new facility at Sango Ota that will come on stream this year.
The facility is designed and built to conform to the latest WHO-Good
Manufacturing Practice (WHO-GMP) standards,” Ijimakin said.
He explained that when a pharmaceutical
firm intends to export to countries in Europe, it needs to export
products that meet WHO prequalification standards.
“The first thing we want to do is get
our GMP standard, so that we can say that our products compare with the
rest in the world, so that we should be able to export them to other
parts of Africa, Asia and even Europe. WHO prequalification process is a
long one which could take a year to two to get,” Ijimakin said.
Stakeholders in the pharmaceutical
sector believe that the quest by Nigerian pharmaceutical firms to attain
WHO pre-qualification status would ensure that locally manufactured
pharmaceutical products in Nigeria gain international acceptance. The
nation can then request that drugs donated to Nigeria are purchased
locally.
This feat, they believe, would help
reduce the challenges confronting the pharmaceutical sector, such as low
capacity utilisation, high production cost, drug counterfeiting, and
continued dependency on the importation of drugs and pharmaceutical
inputs for drug production.
The inability to compete in the global
market is hinged on the fact that as of today, the nation’s
pharmaceutical industry cannot withstand the huge drug imports from
China and India, which have better cost advantages.
Indian pharmaceutical manufacturers
supply 70 percent of drugs consumed in their local environment, and for
export. Between 2009 and 2010, the industry, made up of many large and
small firms, exported $9.1 billion worth of drugs and made a turnover of
$21.7 billion.
Indian firms manufacture at far lower
costs than their counterparts in developed countries. This is one half
of its success, as India spends $23 billion on Research and Development
(R&D), has 160,348 researchers, 40,711 research articles, and 1,234
patents.
With the pharmaceutical industry seen as
one of the most valuable economic segments of the global economy, it is
considered to have installed capacity that only caters for about 50 to
75 percent of the nation’s drug needs.
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