Press Briefing by The Director General (NAFDAC) Professor Mojisola Christianah Adeyeye on Breakthrough: World Health Organization (WHO) Prequalification Approval Of Finished Pharmaceutical Product Manufactured By Swiss Pharma (SWIPHA) Nigeria Limited
May 9, 2023,
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.
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 Good Manufacturing Practice (GMP) standards. This started with building 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.
In parallel, as part of strengthening our regulatory framework, NAFDAC conducted a nationwide GMP roadmap which was supported by our technical partners (UNIDO and USAID). As a follow up of the outcome of the GMP roadmap, plus survey of the manufacturing capacity of local manufacturers, several policies were formulated. These included the 5+5 policy, the expansion of NAFDAC’s ceiling list, new policy on establishment of Pharmaceutical Plants in Nigeria and the centralized GMP inspection for Pharma plants.
The whole essence of these policies was to improve local drug manufacturing in line with global best practice and assure improved the competitiveness of Nigerian Pharma Industry in the global space while projecting toward self-sufficiency in production of essential medicines.
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 Nigeria’s 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 manufacturer’s 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.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. Today SWIPHA has this opportunity. Therefore, it is a new source of business, andthis will generate foreign currency to the company and Nigeria.
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 quality–assured products both externally and internallyimprove image and brand.
Lastly, 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 PQ 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. This is my goal for the industry and for Nigeria.
NAFDAC………safeguarding the health of the Nation!!!