PROTOCOL
The National Agency for Food and Drug Administration and Control (NAFDAC) was set up by act of the parliament (Act Cap N1 LFN 2004 as amended) 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.
The current NAFDAC administration had for the umpteenth time reiterated its commitment to formulate policies targeted at enhancing capacity of local drug manufacturers that meet global Good Manufacturing Practice (GMP) standards. These several policies which include the 5+5 policy, the expansion of NAFDAC’s ceiling list, new policy on establishment of Pharmaceutical Plants in Nigeria, the centralized GMP inspection for Pharma plants have convinced us beyond any reasonable doubt we are headed in the right direction to assure improved competitiveness of Nigerian Pharma Industry in the global space while projecting toward self-sufficiency in production of essential medicines.
Recall that on the 2nd of May 2023, the WHO Prequalification Unit added Pediatric Zinc Sulphate tablet (20mg dispersible tablet) manufactured by Swiss Pharma 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).
It is with great joy and delight that I have the privilege of informing our stakeholders and the teeming Nigeran public that the WHO prequalification unit has prequalified yet another product, Sulphadoxine/Pyrimethamine tablet from the same manufacturer to its lists of prequalified product (https://extranet.who.int/prequal/news/swiss-pharma-nigerias-sulfadoxinepyimethamine-dispersible-tablet-prequalified) thus making Swiss Pharma Nigeria Limited the first indigenous manufacturer in Nigeria to achieve this laudable feat in West and Central Africa. This 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, Swiss Pharma 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 in 2013, the manufacturer is now also the first manufacturer of finished pharmaceutical product to attain prequalification of 2 products in the West Africa and Central Africa Sub-region within the time space of 15months.
Our designated GMP inspectors in NAFDAC provided immense technical support prior to WHO’s site inspection by the prequalification inspection team and provided valuable insight into objective review of Corrective and Preventive Actions (CAPA) taken to address the few observed non-conformances recorded during WHO’s inspection. This is aside several face-to-face meetings, phone calls and virtual meetings with key personnel of Swiss Pharma Nigeria Limited.
This additional feat without an iota of doubt has reinforce our believe that with the right attitude, collaboration, synergy and appropriate policies, Nigeria Pharma Industries can become a force to reckon with in the comity of nations. With this achievement, Swiss Pharma Nigeria Limited has undoubtedly become the trail blazer, a global supplier of quality essential medicines for public health program and is set to improve its fair share of the Pharma market.
The top management of NAFDAC hereby encourage other well-meaning local drug manufacturers to emulate this feat through harmonization of collective aspiration and synergy of effort with the NAFDAC’s relevant directorates as we can together as a team achieve more.
As a customer-focused and Agency-minded organization, we are open to support more local manufacturers who have over the years shown a history of continued compliance to our extant regulations. Together, especially at a time like this in our Nation’s history when the Federal Government has pronounced executive orders to support indigenization of drug manufacturing, we can replicate this achievement and propel more local manufacturers to attain similar global recognition.
NAFDAC………safeguarding the health of the Nation!!!
Prof Mojisola Christianah Adeyeye, FAS
Director General/CEO
