SPEECH BY THE PRESIDENT, PHARMACEUTICAL SOCIETY OF NIGERIA “EFFECTIVE REGULATION AS A TOOL FOR NATIONAL DEVELOPMENT: THE NAFDAC EXAMPLE” PRESENTED BY THE PRESIDENT OF THE PHARMACEUTICAL SOCIETY OF NIGERIA (PSN), PHARM. (MAZI) SAM I. OHUABUNWA AT THE NAFDAC SILVER JUBILEE (LAGOS CELEBRATION) Lagos City Hall, Catholic Mission Street, Lagos 28th March, 2019 INTRODUCTION All Protocols duly observed. I am most grateful to God for the grace to be here today. I wish to thank the Management of NAFDAC for this honour. Let me quickly congratulate the government of Nigeria for establishing NAFDAC when it did and to also acknowledge the great work the succeeding leadership, management and staff have done, from the pioneering role of Prof Osuide, to the revolutionary era of Prof Akunyili, to the stabilizing era of Dr Orhii to the coming of the current regime of Prof Adeyeye which is poised to take NAFDAC to the next level. It has been 25 years of arduous work paced with twists and turns, moments of success and times of trials and failure. But when all is considered, it is my view is that it has been 25 years of significant net positive impact on the health of Nigerian citizens and on the economy. IN THE BEGINNING Somewhere in my bible it is written:” In those days, there was no king in Israel; every man did that which was right in his own eyes”. So it was in Nigeria for a long time with regards to drugs control and administration. In 1982, I was the National Sales Manager for Pfizer Products Plc. We found a pass off of Pfizer’s Brand of Doxycycline- Vibramycin in use in some hospitals. It was claimed to have been made by “Pfizer, Niora”. On the surface, we thought that brand was a parallel import from Pfizer in ‘Niora’. We erroneously thought that there was a Country called Niora somewhere in the Universe. This product was selling for a quarter of price of locally produced Vibramycin in Nigeria. We really got worried when we discovered we were losing sales to this ‘Pfizer product from Niora’, we decided to get in touch with our” Niora” colleagues to persuade them to halt allowing this product to be shipped into our market. To our utmost surprise, we found that there was no country called “Niora” anywhere on God’s Earth. That rattled us and raised our suspicion that we could be dealing with a pass off or fake product. We sent the samples to our laboratories and found that instead of the 100mg doxycycline that was on the label, the capsules had between 10-12mg of doxycycline. We traced the importers of this substandard drug that was impersonating Pfizer Brand and reported them to the Police. A few arrests were made but after several months, the Director of Public Prosecutions (DPP) issued a report that they could not proceed with prosecution as it was a civil matter. The guys were discharged. Similar situation followed when we had all kinds of pass of our very popular antibiotic called TERRAMYCIN (Oxytetracycline). In addition to fake Terramycin, we had all kinds of look-a-likes, that were dressed like our brand but with little twists in Name: TERMYCIN, TRAMYCIN, TEREMYCIN etc. All we could do was to institute civil cases against those importers we could find (as many operated in the shadows with no known addresses). Given Nigeria’s judicial system, not much came out from these suits and we became frustrated. We were losing money, promoting our brands while counterfeits were taking advantage. Many companies had similar problems with their popular or fast selling products. Many Companies began to cut back operations and many of the multinationals began to review their investment in the Country. That’s when the Pharmaceutical Industry from about the mid-eighties began to press for criminalizing drug faking and the importation of counterfeit drugs. This was the season when the Health Minister then, late Professor Olikoye Ransome-Kuti announced to the Whole world that 70% of drug products in Nigeria were fake. It was the long drawn pressure put on President Babangida’s Government that resulted in the promulgation of the NAFDAC degree. NAFDAC’S MANDATE According to decree no 15 of 1993 as amended by decree no 19 of 1999 and now Act Cap N1, Laws of the Federation of Nigeria (LFN), 2004, NAFDAC is mandated to carry out a broad range of functions. Principally, it is mandated to: Regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of drugs, cosmetics, medical devises, bottled water, chemicals and detergents (Regulated Products). Further subsets of this central function are: Conduct appropriate tests and ensure compliance with standard specifications designated and approved by the Council for effective control of quality of regulated products and their raw materials as well as their production processes in factories and other establishments; Undertake appropriate investigation into the production premises and raw materials for regulated products and establish relevant quality assurance systems, including certification of the production sites and of the regulated products; Undertake the inspection of imported regulated products and establish relevant quality assurance systems including certification of the production sites; Compile standard specifications, regulations and guidelines for the production, importation, exportation , Sales, distribution and registration of regulated products; Undertake the registration of foods, drugs, cosmetics, medical devices, bottled water, chemicals and detergents; Control the exportation and issue quality certification of products intended for export; Establish and maintain relevant Laboratories or other institutions in strategic areas of Nigeria as may be necessary for the performance of its functions; Pronounce on the quality and safety of Products after appropriate analysis; Take measures to ensure that the use of narcotic drugs and psychotropic substances are limited to only medical and scientific purposes; Grant authorization for the import and export of Narcotic drugs and psychotropic substances as well as other controlled substances; Collaborate with NDLEA in the bid to eradicate drug abuse in Nigeria; Advice Governments, the Private sector and other interested bodies regarding the quality, safety and regulatory provisions on regulated products; Issue guidelines, grant approvals and monitor the advertisement of food, drugs, cosmetics, medical devices, bottled water, chemicals and detergents. HOW FAR? In line with Nigeria’s thought pattern and lingua, NAFDAC, how far after 25 years? I trust that the DG NAFDAC will dwell a lot on this assessment. Indeed the book launched in ABUJA earlier this week contains the story of NAFDAC and certainly will dwell a lot on the successes and challenges of NAFDAC. But to all keen observers, NAFDAC has done a lot and credit must be given to Prof Dora Akunyili who actually popularized NAFDAC, making it a household name and almost gave his life for it. My job at this point is to situate it’s performance with the subject of this lecture: Has NAFDAC used its regulatory role to enhance National Development? This question becomes very relevant as we have often seen government’s good intentions in setting up institutions and regulatory agencies become an opportunity for individuals to feather their nests without much care for the common good or the attainment of the critical objectives of government. Some regulators turn their institutions in to agents of oppression and corruption. In essence NAFDAC is expected to organize the food, Pharmaceutical, Chemical, and Bottled water industries to ensure that: their products (locally produced or imported) are registered; their products are of good quality on a consistent basis. It follows that any product not registered is not allowed to circulate in the Nation and any product (though registered) but of bad quality is not allowed to circulate in Nigeria. So one way to assess NAFDAC’s contribution to National Development is to ask: Do we have unregistered products circulating in the Country and do we have products of low or poor quality being offered to Nigerians? Indeed do we have unregistered products that are of low quality circulating in the Country? If the answer is no, that would be wonderful and indicate that NAFDAC has reached its zenith. But if the answer is Yes, then the follow up question will be: How has the rate changed over the 25 years of NAFDAC’s existence? What is the percentage of unregistered drugs today compared to 10 years ago or 20 years ago? What is the percentage of poor quality drugs in the market today compared to years back? The verifiable verdict is that there have been vast improvements on both score. What of the number of fake drugs in circulation. In 1989, it was estimated that the percentage of spurious and falsified Medicines circulating in the Country was nearly 70% but I know of sure that today, we still have these fake drugs but the percentage is less than 20% today. What a significant improvement. When we speak of National Development, we must ask: Has NAFDAC affected the growth of the Food and Pharmaceutical Industries for example? As a participant in the industry and in the economy for several years and as past chairman of the Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMG-MAN), I firmly believe that the industry has benefitted from the regulatory activities of NAFDAC in many respects. The reduction of Fake drugs (in all its ramifications- pass off, look alike, counterfeit, poor quality), has not only allowed the genuine products to grow and thrive, but has increased confidence in the Nigerian Pharmaceutical space, attracting new investments in the sector. Consequent on new investments including expansion of existing companies, more jobs have been created; Technology has been transferred all contributing to Nigeria’s GDP. It is the work of NAFDAC that has helped to cause the expansion of the membership of PMGMAN, the introduction and growth of other stakeholders in the Industry - NIROPHARM, APIN etc. and these are signs of a growing Industry. Indeed it is on record that NAFDAC has been supporting the industry to improve Good Manufacturing Practices (GMP) up-to the WHO standards. Above all NAFDAC is supporting the campaign to increase local industrial output to improve national medicine security. IS IT YET UHURU? Certainly not. There is still so much to do to get NAFDAC become a spectacular example of how effective Regulation can be used as a veritable tool for National Development. And listening to the current DG’s speech at this anniversary, it is reassuring that NAFDAC knows that the road yet untraveled is long. Hence her effort to build up capacity and internal competencies is on the mark. I will like to offer a few words of counsel as I begin to conclude. Firstly, NAFDAC must continue to improve its customer focus. It must treat all customers as partners and try to give them a good experience at each encounter. Secondly, it must further improve its responsiveness to customer mails, requests and complaints. As an agency that preaches standards, it must itself have standards when dealing with its stakeholders. There must be enforceable timelines and waiting period for registration of products or receiving other approvals. It must continue to simplify regulations. Thirdly, NAFDAC must continue to resist the temptation of turning the organization into a fund raising organization. It is common knowledge that the cost of doing business is so high in Nigeria, making our products globally uncompetitive. NAFDAC must be conscious of this when it fixes its fees. The concession in fees given to small businesses is a good gesture. Fourthly, the reputation of NAFDAC as Corruption free zone during the days of Dora Akunyili must be rebuilt. Fifthly and finally, it is important that NAFDAC thinks globally but acts locally. It is visionary to target American standards but the US FDA is over hundred years old while NAFDAC is just 25. We all need to go through a learning curve and so NAFDAC must always bear that in mind while introducing new regulations and standards. CONCLUSION Let me end by congratulating Prof (Mrs) Moji Adeyeye and the NAFDAC Council for taking the decision to organize this event. It presents a veritable opportunity to take stock and prepare for the journey ahead. All Nigerians are agreed that NAFDAC has done well for the Nigerian consumers of food and drugs by helping to safeguard their lives and all the stakeholders in the regulated industries (except one) are unanimous that NAFDAC has been a true example of how a regulator can be a game changer for good. We applaud this opportunity for NAFDAC to reinvent itself and move to the next level. All Nigerian Pharmacists and indeed the entire Pharmaceutical Industry is poised to offer NAFDAC all the support and cooperation to raise its game higher in the coming years. Bravo! Thank you for your attention. God bless Mazi Sam I. Ohuabunwa, OFR, MON, FPSN, FPCPharm, NPOM President, Pharmaceutical Society of Nigeria
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