09/05/23
GABRIEL O D
Nigeria has recorded a major Breakthrough in it’s quest for medicine security and improved quality of Pharmaceutical Products with the WHO Prequalification of a Locally manufactured drug “Pediatric Zinc Sulphate tablet (20mg dispersible tablet)”
On the 2nd of May 2023, the WHO Prequalification Unit added Pediatric Zinc Sulphate tablet (20mg dispersible tablet) manufactured by Swiss Pharma (SWIPHA) Nigeria limited to its list of prequalified medicines (Swiss Pharma Nigerias dispersible zinc tablet prequalified | WHO – Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control).
This laudable feat is no doubt the outcome of meaningful collaboration between the Swiss Pharma Nigeria Limited and NAFDAC as well as a systematic implementation of policies earlier mentioned.
With this achievement, SWIPHA has 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, the manufacturer is now also the first manufacturer of finished pharmaceutical product to attain Prequalification of its product in the West Africa Sub-region.
Definitely, it has taken a lot of efforts and self-determination for the Company to attain this heroic 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 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 is aside several face-to-face meetings with NAFDAC officers, phone calls and virtual meetings with key personnel of Swiss Pharma Nigeria Limited.
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-Sahara Africa and in the comity of nations.
The advantages of having a prequalification(PQ) in terms of Trade cannot be overemphasized as Every year, billions of US dollars worth of medicines are purchased by or through international procurement agencies for distribution in resource-limited countries.
The WHO Prequalification of Medicines Programme (PQP) helps ensure that medicines supplied by procurement agencies meet acceptable standards of quality, safety, and efficacy. Below are some advantages of PQ of a product to a company.
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 United States Agency for International Development (USAID) to procure and distribute products locally and internationally.
Upon prequalifying a product, WHO also has an important pathway called the Collaborative procedure for product registration to accelerated registration of the product in other countries making the PQ products available for commercialization on time. Improving market access or business opportunities and capacity utilization for the company.
Global recognition of the company with a status associated with producing qualityassured products both externally and internallyimprove image and brand.
With the Increase in capacity and skillsdevelopment of human resources ensuring and managing quality manufacture.
SWIPHA has the advantage to compete successfully for contract manufacture for local and multinational organization. This improvement incompetitiveness is one of the key goals of this NAFDAC management for the pharmaceutical industry, especially as country participates in the The African Continental Free Trade Area (AfCFTA) agreement.
WHO Prequalification will create huge public health and economic impact in Nigeria by ensuring an increased availability of quality, efficacious and safe medicines and reducing reliance on imports for public health intervention.
The top management of NAFDAC hereby encourage other frontline local drug manufacturers in particular to emulate this feat through harmonization of collective aspiration and synergy of effort with the Agency as we can together as a team achieve more. As a customer-focused and Agency-minded organization, our doors are open to serious minded manufacturers who intend to achieve a similar feat and attain global recognition as provided by the WHO prequalification program.
I am convinced this is the beginning of more companies joining the new era of Nigerian pharmaceutical products receiving prequalification approval for many medicines and become active traders in the global market. Attaining Maturity Level 4 will further boost this reality.
The National Agency for Food and Drug Administration and Control (NAFDAC) was set up by ACT of the parliament to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of Food, Drugs, Cosmetics, Medical Devices, Packaged Water, Chemicals and Detergents (collectively known as regulated products). This mandate no doubt bestow on the Agency the onerous responsibility of ensuring that only regulated products that are safe, effective and of the right quality are available and accessible for Nigerians at all times.
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