Fidson Healthcare plc’s new factory is set for operations by July 2014. The said factory which conforms with WHO-Current Good Manufacturing Practice (WHO-GMP) standards will enable the Company, when WHO pre-qualified, participate in bulk purchase of medicine for distribution for health intervention programmes across the globe, BusinessDay reveals.
The new factory, located in Sango Ota, Ogun State, will ensure the identity, strength, quality, and purity of drug products by requiring that the company establish strong quality management systems, obtain appropriate quality raw materials, establish robust operating procedures, detect and investigate product quality deviations, as well as maintain reliable testing laboratories.
Ola Ijimakin, general manager, marketing, Fidson Healthcare plc, explained that when a pharmaceutical firm intends to export medicines globally and participate in bids for health interventions, such pharma firm needs to manufacture medicines that meet WHO pre-qualification exercise.
With Nigerian pharmaceutical firms not currently in a position to participate in international tenders for medicines against the three pandemics that require WHO pre-qualification, health experts identify this as a major constraint on the local supply of medicines, especially anti-retroviral (ARVs), anti-malarial and anti-tuberculosis agents.
The World Health Organisation is set to pre-qualify some Nigerian pharmaceutical firms – Evans Pharmaceuticals, SWIPHA, May and Baker, and Fidson HealthCare plc, this year after final facility inspection by March 2014, having met most of WHO’s conditions for pre-qualification.
According to Ijimakin, “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, Asian and even Europe. WHO pre-qualification process is a long one which could take a year to two to get pre-qualified,” Ijimakin explained.
“WHO pre-qualification will facilitate access to medicines that meet unified standards of quality, safety and efficacy for HIV/AIDS, malaria and tuberculosis. This will afford Nigerian pharmaceutical companies the opportunity to participate in international bidding of drugs and other pharmaceutical products. This will in turn generate revenue for Nigeria and employment opportunities,” Ijimakin explained.
Paul Orhii, director general, National Agency for Food, Drug Administration and Control (NAFDAC) disclosed that Nigerian pharmaceutical firms getting pre-qualified by WHO means the products attains international standards.
Orhii stated that the quest by Nigerian pharmaceutical firms to attain WHO pre-qualification status would not only ensure that locally manufactured pharmaceutical products in Nigeria gain international acceptance, the country can also request that drugs donated to Nigeria are purchased locally.
By: Alexander Chiejina