SWIPHA’s paediatric zinc table gets WHO approval

By Doris Obinna

The National Agency for Food and Drug Administration and Control (NAFDAC), said that the World Health Organisation (WHO) Pre-qualification (PQ) unit has added paediatric zinc sulphate table (20mg dispersible tablet) to its list of prequalified medicines.

Director General, NAFDAC, Mojisola Adeyeye, said Swiss Pharma (SWIPHA) Nigeria became first manufacturer of pharmaceutical finished products to attain WHO prequalification: “This laudable feat is no doubt the outcome of meaningful collaboration between the Swiss Pharma Nigeria Limited and NAFDAC.

“It took a lot of efforts and self-determination for the company to attain this accomplishment of getting its product prequalified. Several attempts in the past received a number of non-conformance observations from the WHO.

“NAFDAC personnel provided immense technical support during the palatability studies for the now prequalified product, GMP reassessment of the manufacturer’s facility prior to the site inspection by the prequalification inspection team of the WHO.

“Also, a review of Corrective and Preventive Actions (CAPA) was taken to address the observed non-conformances. This is aside from several face-to-face meetings with NAFDAC officers, phone calls and virtual meetings with key personnel of SWIPHA.

“This attainment has reinforced our conviction that with the right attitude, collaboration and synergy, SWIPHA can become a force to reckon with in Sub-Sahara Africa and in the comity of nations.

“The advantages of having a prequalification in terms of trade cannot be overemphasised. Every year, billions of dollars worth of medicines are purchased by or through international procurement agencies for distribution in resource-limited countries.

“The WHO PQP helps ensure that medicines supplied by procurement agencies meet acceptable standards of quality, safety, and efficacy.

“With the increase in capacity and skills development of human resources ensuring and managing quality manufacture, SWIPHA has the advantage to compete successfully for contract manufacture for local and multinational organisations.

“This improvement in competitiveness is one of the key goals of this NAFDAC management for the pharmaceutical industry, especially as the country participates in the African Continental Free Trade Area (AfCFTA) agreement.”