For the first time ever, Nigeria has received the World Health Organisation’s (WHO) prequalification for finished pharmaceutical products manufactured by Swiss Pharma (SWIPHA) Nigeria Limited and for the company’s factory.
WHO prequalification of medicines is a service provided by global health watchdog to assess quality, safety and efficacy of medicinal products.
The implication is that medicines worth billions of dollars purchased by or through United Nations (UN) agencies, every year, for distribution in resource-limited countries, could be procured from Nigeria.
Director General, National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Christianah Mojisola Adeyeye, yesterday, at a press conference in Lagos, announced that the WHO Prequalification Unit, on May 2, 2023, added Pediatric Zinc Sulphate tablet (20mg dispersible tablet) manufactured by SWIPHA Nigeria Limited to its list of prequalified medicines.
She said this laudable feat is the outcome of meaningful collaboration between Swiss Pharma Nigeria Limited and NAFDAC and a systematic implementation of policies.
She said: “With this achievement, SWIPHA has added another first to its arsenal of firsts. Being the first manufacturer to be recognised by WHO as operating at an acceptable level of compliance to Good Manufacturing Practice (GMP) requirements in West Africa, it is now also the first manufacturer of finished pharmaceutical products to attain prequalification in the West Africa sub-region.”
According to WHO, every year, billions of dollars worth of medicines are purchased by or through international procurement agencies – such as United Nations Children’s Fund (UNICEF), the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNITAID – for distribution in resource-limited countries.
On how the feat was achieved, the NAFDAC boss said: “At the inception of the current NAFDAC administration in 2017, the top management of NAFDAC had a mission to formulate policies and implement a strong collaboration, targeted at enhancing capacity of local drug manufacturers that meet global GMP standards.
“This started with building the internal capacity of NAFDAC by getting trained in international standards and receiving ISO 9001-2015 in 2019. At the same time, NAFDAC embarked on WHO Global Benchmarking that eventually resulted in attaining WHO Maturity Level 3.”
