The National Agency for Food, Drug Administration and Control (NAFDAC) has applauded Swiss Pharma (SWIPHA) Nigeria Limited as the World Health Organization (WHO) pre-qualified one of the pharmaceutical company’s products.
On the 2nd of May 2023, the WHO Prequalification Unit added a Paediatric Zinc Sulphate tablet (20mg dispersible tablet) manufactured by SWIPHA to its list of prequalified medicines.
The director-general of NAFDAC, Professor Mojisola Adeyeye, gave the commendation on Tuesday in Lagos while addressing the press on the breakthrough, while noting that the feat was an outcome of meaningful collaboration between the Swiss Pharma Nigeria Limited and NAFDAC, as well as a systematic implementation of policies by the agency.
She noted that with this achievement, SWIPHA had added another first to its arsenal of firsts, being the first manufacturer to be recognized by the WHO as operating at an acceptable level of compliance to GMP requirements in West Africa.
She added that the manufacturer has now become the first manufacturer of finished pharmaceutical products to attain prequalification of its product in the West Africa sub-region.
While noting that several attempts in the past to get a pre-qualification received a number of non-conformance observations from the WHO, Adeyeye explained that NAFDAC personnel provided immense technical support during the palatability studies for the now prequalified product, GMP reassessment of the manufacturers’ facility prior to the site inspection by the prequalification inspection team of the WHO, and review of Corrective and Preventive Actions (CAPA) taken to address the observed non-conformances.
“This commendable attainment, without an iota of doubt, has reinforced our conviction that with the right attitude, collaboration and synergy, Nigeria Pharma Industries can become a force to reckon with in sub-Saharan Africa and in the comity of nations,” she said.
WHO Prequalification of Medicines Programme (PQP) helps ensure that medicines supplied by procurement agencies meet acceptable standards of quality, safety and efficacy.
WHO Prequalification is the fundamental prerequisite for quality assurance of key medical products to be purchased by UN agencies, and international organizations like Global Funds and the United States Agency for International Development (USAID) to procure and distribute products locally and internationally.
With the pre-qualification received by SWIPHA, a new source of business, this will generate foreign currency for the company and Nigeria.
The DG, therefore, encouraged other frontline local drug manufacturers, in particular, to emulate this feat through the harmonization of collective aspiration and synergy of efforts with the agency.
She added that as a customer-focused and agency-minded organization, NAFDAC’s doors are open to serious minded manufacturers who intend to achieve a similar feat and attain global recognition as provided by the WHO prequalification programme.
