A KEY NOTE ADDRESS: IMPERATIVES FOR NATIONAL DRUG SECURITY
BY
PROF. MOJISOLA CHRISTIANAH ADEYEYE
THE DIRECTOR GENERAL NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC)
AT
THE 21ST ANNUAL NATIONAL CONFERENCE OF ASSOCIATION OF INDUSTRIAL PHARMACISTS OF NIGERIA (NAIP) HELD ON THE 18TH OF APRI, 2018 AT KWARA HOTELS, ILORIN, KWARA STATE
PROTOCOL
Distinguished Ladies and Gentlemen
It gives me great pleasure to be here today at this very important annual NAIP conference with the theme – Imperatives for National Drug Security. I particularly applaud the Association for the choice of theme which is very pivotal to the Pharmaceutical industry and the entire healthcare delivery system in Nigeria.
The threat of drug insecurity in the country dates back to the 60s but reached a climax in the 80s and 90s when “briefcase importers” of drugs created overwhelming situations of chaotic supply and distribution of drugs of questionable quality, with the attendant effects of increased morbidity, treatment failures, drug resistance and deaths.
The establishment of National Agency for Food and Drug Administration and Control (NAFDAC) by decree No. 15 of 1993, now NAFDAC Act CAP N1, LFN 2004, was a fall-out of the federal government’s initiative at that time to tackle the menace. Hence, NAFDAC became saddled with the responsibility to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of drugs, food, cosmetics, medical devices, chemicals, and packaged water. This is similar to the creation of Food, Drug & Cosmetic Act of United States that resulted from tragedies of unsafe and untested drugs. The goal of the mandate of any regulatory agency is to ultimately ensure drug security.
Drug Security
Drug Security is defined as measures put in place to ensure that quality, safe and efficacious medicines are produced by facilities that meet the right standards and, that the integrity of such medicines are not compromised during its distribution along the supply chain from the manufacturers down to the consumers. The imperative of national drug security is enshrined in our national drug policy which is to make available at all times to the Nigerian populace adequate supply of drugs that are effective, affordable, safe and of good quality; to ensure the rational use of such drugs and to stimulate increased local production of such drugs. The Sustainable Development Goal – SDG goal number 3 speaks to good health and wellbeing with one of its targets being Universal Health Coverage, access to quality essential healthcare services and access to safe, effective, quality and affordable essential medicines and vaccines for all.
Recently at the state house medical center in Abuja, there was an alleged incidence of non-availability of drugs and medical devices; one wonders what the case would be at a primary healthcare center in a remote rural area. The reality of drug security in Nigeria can be dire; many times it is disease- or population target-based. According to the report of the Federal Ministry of Health, drugs used for diabetes or cancer cost 2-day wage or five times the monthly wage of a minimum wage worker respectively. This is exacerbated if the patient is at the low-income level, where 62% of Nigerians belong. For people living with HIV/AIDS, access to drugs has posed a threat of insecurity. For example out of 3.5 million people living with HIV in Nigeria, only about 30% of adults and only 20% of children have access to treatment with ARV drugs. Some other threats to the security of drugs in Nigeria are discussed below with attendant means of reducing such.
Threats to Drug Security and Mitigation
Substandard and Falsified Medicines (SF) Low-Priced Drugs: This has contributed greatly to drug insecurity in Nigeria. The public health implications of substandard and falsified medical products are serious and critical. The outcomes include treatment failure, high treatment cost, and development of resistance. This may ultimately result in fatality and death, and loss of confidence in the healthcare providers and healthcare system. In the drug distribution chain, the threat of substandard and falsified medicines is more predominant in the private sector that comprise of NGOs, private clinics, community pharmacies and retailers compared to the government sector such as government state hospitals and national health programmes. NAFDAC encounters daily unregulated, substandard and falsified medicines from unscrupulous importers.
Populating the market with SFs is a result of the following: greed, lack of patriotism, low premium placed on life, weak legislation, ignorance and criminality. This calls for change in mindset, allowing agencies to carry out the mandates of drug control in importation and exportation, and vigilance in enforcement and public advocacy on the dangers of selling and using SFs. A critical starting point in ensuring SFs and low-priced drugs is the planned return of NAFDAC to the ports to properly carry out its mandate in drug control. It is not until this takes place that NAFDAC is able to carry out its mandate of controlling drug importation, starting from point of entry and significantly reduce SFs.
All hands must be on the deck to ensure that the community is continually educated on the dangers of SFs. NAFDAC had stepped up greatly the vigilance in the inspection despite the past hindrances in the processing of its mandate. The agency is daily intercepting unregulated and illicit drugs at the ports, at the community and market levels, arresting the lawbreakers, charging them to court and ensuring that the appropriate sentence is meted out.
Importation of Pharmaceutical Drug Products and Materials: A major contribution to drug insecurity is high level of importation of drugs products and raw materials. Currently, in Nigeria, importation accounts for 70 – 80% of our prescription medicines (POMS) needs leaving local manufacture with only 20-30%, sourced from about 150 registered local manufacturers, which are mostly small or medium scale.
Number of Registered POMS (NAFDAC Data)
| YEAR | IMPORTED (%) | LOCAL (%) | TOTAL |
| 2005 | 870 (78%) | 247 (22%) | 1117 |
| 2012 | 1321 (85%) | 231 (15%) | 1552 |
| 2017 | 551 | 89 | 640 |
The huge dependence on importation is attributable to many factors that have negatively impacted local production. These factors include lack of basic research and development – understanding of APIs and excipients and their interactions, insufficient capacity in pharmaceutical analysis and bioanalytical techniques in academia and the industry, inadequate training in current good manufacturing practices (cGMPs) and non-existence of API or excipients manufacturing facilities.
This heavy reliance on imported pharmaceutical products is a great challenge that can be turned into an opportunity for the country. This can be done through early phase collaboration of local manufacturers with foreign contract research organizations. Manufacturing of API and excipients should be encouraged through joint partnership of foreign/local investors. Proactive involvement of academia in collaboration with the pharmaceutical industry is needed for translatable research that could result in development of bulk drugs and excipients and subsequently ensure drug security. However, the local industry has to be strengthened through government intervention and deliberate financing to reduce importation and establish pharmaceutical R&D.
The need of government intervention for drug security in Nigeria is underscored by the dismal contribution of pharmaceutical sales to the GDP. This is partly due to low local manufacturing capacity and heavy reliance on importation as mentioned. Globally, the pharmaceutical industry has become a major contributor to the global economy with estimated market share of about $857 billion. In Nigeria, the pharmaceutical market is worth only about $1.3 billion accounting for less than 0.25% of the national Gross Domestic Products (GDP). In Nigeria, pharma sales is extremely low – 0.2 billion in Nigeria compared to the US market of 381 billion according to PriceWaterHouse. This is partly due to the forex exchange that lowered the buying capacity of the pharma industry in equipment, active pharmaceutical ingredients (APIs) and excipients and other needed machineries.
Government Initiatives and policies: The recently signed Federal Government of Nigeria “Executive Order”-EO1 and EO3, on Promotion of Transparency and Efficiency in the Business Environment, with the purpose of boosting patronage of locally made goods is laudable. It will aid in facilitating the drive for attainment of self- sufficiency, if adequately implemented and would help local pharmaceutical manufacturers and improve drug security.
Means of boosting patronage include use of existing Public Procurements Act 2007, special incentives for processing international certification, obtaining WHO prequalification, and implementation of Central Bank of Nigeria (CBN) policy to enhance direct forex sourcing from commercial banks by the pharmaceutical manufacturers. Appropriate application of the guidelines on import tax exemption of finished products packaging and critical pharmaceutical raw materials will also boost local manufacturing and enhance drug security.
The local pharmaceutical manufacturers should become very creative in reversing the current status of 70-80% of imported essential medicines, and ensuring that the national drug supply policy which stipulates that 40% spending of MDA must be on locally manufactured goods and services becomes a reality. These initiatives will pave way for immense reduction in the cost of local production resulting in increased capacity utilization of local manufacturers.
Compromised Supply Chain Integrity: Another threat to drug insecurity is compromised supply chain. The drug distribution system in Nigeria currently is chaotic, porous and poses as a grave menace to the National Drug Security. Supply chain integrity can prevent falsified medicines if every batch of the drugs manufactured from the point of origin is tagged with an identifier and every batch handled as a blockchain that is then transferred digitally to warehouses (wholesalers/distributors) and similarly distributed to the local pharmacy or central store in case of government distribution. This is a goal that should be part of the pharmaceutical industry practice. However, the presence of the open drug markets has become a challenge in the control of SFs and maintaining integrity in the supply chain. Collaboration of sister agencies – NAFDAC and PCN and the manufacturers is needed to ensure that supply chain integrity is established and drug security is ensured.
Overlapping Regulatory control: There is no gainsaying about national drug security without mention of effective and efficient regulation and control, but a situation where a sector is subjected to burden of over-regulation through multiplicity of Agencies for the same purpose can be quite disturbing as it is in the case with the pharmaceutical industries .Currently the local pharmaceutical industrial sector is heavily yoked with regulatory control by various Agencies with over-lapping functions like NAFDAC, Standard Organization of Nigeria (SON), NDLEA, CUSTOMS AND EXCISE, Consumer Protection Council (CPC), Pharmaceutical Council of Nigeria (PCN), etc.
Insufficient Advocacy to Rational Use of Drug (RUD): There is a great need for improvement in the use of medicines by the general public and health workers. The abuse and misuse of drugs such as tramadol, codeine, opioids, amphetamine etc., is a threat to drug security due to the predictable negative outcomes on the social, economics and family life. Adequate advocacy will reduce morbidity and mortality of youth, criminality and terrorism. The resources spent on tracking, interception, destruction of seizures of drugs of abuse could be better spent on enhancing capacity, inspection, and post marketing surveillance that could monitor drug security.
ENSURING NATIONAL DRUG SECURITY
Drug quality centered on current Good manufacturing Practice (cGMP) is paramount to drug security. Prior to this time, the GMP status across our local pharmaceutical plants was barely encouraging. However, with the intervention of NAFDAC and WHO, the local GMP has witnessed some level of improvements that led to four (4) Nigeria pharmaceutical companies attaining WHO cGMP compliance. Albeit this is commendable but it remains a far cry from the desired target considering our huge population and that over 150 pharmaceutical companies are registered in Nigeria. Unfortunately, the huge investment deployed by these four companies is yet to yield any WHO Prequalification of Products.
Although there has been slight improvement in compliance to cGMP standards, for majority of local industries, compliance to these standards remains a concern when benchmarked with indicators for WHO/ Global GMP standards. This picture has been further buttressed by the ongoing GMP roadmap baseline assessment.
In a bid to address this disparaging situation, NAFDAC in collaboration with WHO, UNICEF, USP, UNIDO and other technical partners, have worked assiduously to support and encourage the local manufacturers invest in quality, attain compliance with global standards as well as adhere to regulatory requirements.
Furthermore, an offshoot of the NAFDAC/UNIDO collaboration is the Risk Categorization of Finished Pharmaceutical Product (FPP) manufacturer. This approach intends to stimulate improved compliance to cGMP requirements by evaluating and stratifying manufacturers according to levels of risk. This in return, will ultimately confer product safety, acceptability and promote drug security.
REGULATORY MEASURES TO IMPROVE DRUG SECURITY
Registration, Market Authorization and Expansion of Quality Medicines in Africa: The Nigerian pharmaceutical industry can seize the opportunity for market authorization and expansion by registering their commercially available products under the ECOWAS West African Medicines Regulation Harmonization (WA-MRH) and African Medicine Regulation and Harmonization (AMRH). The two regulatory bodies are setting up policies and regulations that would allow manufacturers to register their products regionally and continentally after having obtained marker authorization from the home regulating agencies. The WA-MRH is in the process of evaluation of dossiers from three local manufacturers in Nigeria. If the dossiers are successfully evaluated and approved, market opportunities would open up for the Nigerian manufacturers which as a result could then increase their capacities in R&D and pharmaceutical needs supply. Such companies could expand their product lines to include essential medicines that could later be submitted for WHO prequalification and FDA abbreviated new drug application (ANDA).
NAFDAC’s focus is to streamline our regulatory process and remove bottlenecks to Ease of Doing Business. We are in constant engagement of stakeholders with a view to strengthening medium and small-scale enterprises. We have introduced the use of ICT in the regulatory space and are re-equipping our laboratories and encourage capacity building. All these are geared towards repositioning the Agency in carrying out its mandate.
There has been an increase in the number of local pharmaceutical industries in the country however, this has not translated to an increase in local production of quality medicines. Thus, it is essential that a conscious and concerted effort is put in place to change the country’s status from a huge consumer of foreign medicines to a self-sufficient producer of medicines and in the long run, a huge exporter of medicines within sub-Saharan Africa and beyond.
NAFDAC is putting measures in place to encourage local content and promote self-sufficiency in the area of drug production to address the drug security challenge within the local pharmaceutical industry. These include reviewing the differential in tariff for imported products, the Federal Government Drug Prohibition list and the NAFDAC ceiling list.
The Agency post marketing surveillance, renewed nation-wide inspection of open markets and community pharmacy practice sites will contribute greatly to minimizing SFs, unregistered products, chemicals and illicit drugs, further strengthening maintenance of drug security.
NAFDAC supports the strengthening of the Quality Management Systems of indigenous facilities. The Agency is currently undergoing training of the staff in agency-wide QMS as a model for good business and regulatory practice. The UNIDO/WAHO/NAFDAC GMP Roadmap initiative is an ongoing project in this regard. Currently, four (4) facilities are WHO GMP certified and more are in line for certification. The ultimate goal of all these is to improve the quality, safety and efficacy of the medicines produced by our indigenous facilities.
NAFDAC recognizes and appreciate the need for drug security and continues to strengthen its regulatory processes with a fully functional regulatory framework. The Agency regulatory function is working toward stringent regulatory policies and at the same time guiding and enabling the local manufacturers in quality management and better productivity.
From product development up until when the product reaches the patient – various structures of the Agency come into play – be they clinical trial oversight, laboratory analysis, ports inspection, narcotic control, chemical evaluation, pharmacovigilance, registration, GMP inspection, investigation and enforcement. All of these allow for continued compliance with legislative provisions and policies of government that ultimately result in drug security.
CONCLUSION
NAFDAC will continue to play its role in strengthening and regulating the pharmaceutical industry with an ultimate view to assuring drug security by improving the quality, safety and efficacy. Other relevant stakeholders are enjoined to do same as the Agency is ready to collaborate in this regard. Finally, I would like to seize this opportunity to express my sincere gratitude to the organizers and urge all participants to make constructive contributions. On this note, I wish you a productive conference. Thank you
Projected Burden of Diseases in Nigeria: Non-communicable diseases, total, DALYs, World Health Organization (WHO),
