Driving Pharmaceutical Operational Excellence in Nigeria
Nigeria’s pharmaceutical industry happens to be a major backbone for the country’s economy with reports of over 6 billion Naira made as GDP per annum. The industry is quite broad consisting of various arms of operation such as the sales and distribution, manufacturing, pharmacovigilance, research and development and many others. The importance of this industry cannot be overemphasized especially due to its direct impact on the health and vitality of the citizens of Nigeria and its indirect but profound impact on labor which in turn affects every other sector of the country.
Due to the critical role this industry plays in the country, a look into the Operational Excellence (OPEX) of the pharmaceutical industry in Nigeria is expedient in evaluating the efficiency and growth made by the industry over time. Generally, Operational Excellence in any business or industry zooms in on how effectively the industry can meet its customer’s demands and maximize profit at the same time and OPEX in Nigeria’s pharmaceutical industry is not an exception.
Customer demands or expectations as regards pharmaceutical products manufactured in the country revolves around drug quality, safety, efficacy, availability and affordability. Most patients and other drug consumers are usually very satisfied with pharmaceutical products manufactured in the country when these drugs are of good quality, certified and approved by NAFDAC. This invariably implies that these pharma products should be safe for use, affordable and available, with no adverse or life-threatening drug reactions and that they are effective in treating the ailment for which they were formulated. Research conducted has shown that based on the health and economic challenges peculiar to Nigeria, customers obtain satisfaction from pharmaceutical products when all these listed criteria are met and only then are these drug products accepted as good value for money spent.
However, the objective of every business is to maximize profit and even the pharmaceutical industry in Nigeria, irrespective of its’ health-oriented nature is not left out. An insight into how the industry satisfies its customer’s needs efficiently and still achieves this profit goal without either one of both elements suffering at the expense of the other summarizes Operational Excellence in the pharmaceutical industry. The major determinants in the evaluation of OPEX in the Nigerian pharmaceutical industry include strategic elements such as; customer satisfaction, product quality, leadership structure of the industry, efficiency of the industry’s workforce, the culture of the industry, the industry’s processes etc.
State of Operational Excellence in Nigeria’s Pharmaceutical Industry
Reports on drug quality and associated regulatory activities spearheaded by NAFDAC have exposed certain challenges relating to drug quality in Nigeria. These challenging issues include drug purity levels, amount of drug excipients and active pharmaceutical ingredients (APIs) present in drugs (compared to the amount approved by NAFDAC and other referenced international standards), drugs containing wrong excipients or APIs, drug manufacturing companies not adhering to GMP guidelines, drug packaging anomalies, etc. The operations of NAFDAC in the country has revolved around reducing these challenges to the barest minimum in order to improve drug quality in the country.
Nigeria has about 100 pharmaceutical manufacturing companies scattered across the 36 states of country with about 50% of these companies concentrated in Lagos state, the highest revenue-generating state in the country and a significant economic powerhouse in Africa. The major roles played by NAFDAC in regulating drugs produced in the country involves testing of locally manufactured drugs to ensure they are safe, effective and of good quality. The agency also monitors manufacturing processes by carrying out frequent regulatory checks to ensure pharmaceutical manufacturing companies adhere to GMP and their SOPs and the approval of new drugs in Nigeria, including pharmacovigilance and post-market surveillance activities.
The regulatory activities of NAFDAC provides a good insight into the state of drug quality in the country. Due to the frequency and severity of non-compliance with regulatory standards, primary research conducted demonstrates that the major control measures employed by the agency to ensure utmost quality of locally produced drugs include drug confiscation, issuing of warning letters, fines, suspension and the indefinite shutdown of defaulting pharmaceutical manufacturing companies.
However, the frequent rate of confiscation of poor-quality drugs by the agency depicts that there is still a long way to go in attaining Operational Excellence in the pharmaceutical manufacturing sector. The impact of the measures employed to curb substandard, counterfeit and fake drugs in the country alludes to the fact that most pharmaceutical companies do not make optimal profit due to support research and development, innovation and OPEX advancement. A focus on the customer satisfaction and drug quality elements of OPEX would positively impact the level of efficiency in the pharmaceutical industry in Nigeria.
Recent studies estimate the percentage of customer satisfaction with pharmaceutical products locally manufactured in Nigeria at about 55%. While a good number of patients have claimed to be satisfied with the drugs they consumed, a significant number have complaints regarding the affordability and availability of certain drugs, the severity of discomfort or drug reactions they experienced, and the efficacy of drugs produced in the country.
Hindrances to achieving OPEX in Nigeria’s Pharmaceutical Industry.
The launching of operation excellence in Nigeria’s pharmaceutical industry constitutes a true challenge, as there are several factors impeding the development and success of the industry and its level of operational excellence. For instance, in 2018 the WHO released a report listing Nigeria’s health sectors as one of the most poorly funded in relation to other African countries. This of course affects the pharmaceutical industry, limiting their access to high-tech and international manufacturing standards that ensures drugs are within the approved level of purity, safety and efficacy.
Furthermore, it was noted by the WHO in 2010 that approximately 40% of drugs manufactured in Nigeria were either fake, counterfeit or substandard. This is in part due to the inadequate regulatory checks performed by NAFDAC resulting in companies deviating from guidelines and SOPs that control each aspect of their operation. Lastly, the increasing rate of unemployment and corruption within the country has resulted in a reduced number of competent and experienced professionals within the pharmaceutical industry. Despite this, some of the industries do nothing or little to train and equip their workforce to ensure that they have adequate knowledge and skills to maintain and achieve operational excellence.
The Way Forward.
In spite of the various challenges hindering operational excellence within the Nigerian pharmaceutical industry, we must however continue to persist and overcome every hurdle present. To do this, we must develop a good understanding of the impact of major elements of OPEX in Nigeria. One of which is the customer’s satisfaction with the quality of drugs produced in the country, as it determines how effectively the industry is able to maximize profit and scale up the ladder of Operational Excellence. Another, is the leadership structure within the industry, as it is the foundation on which critical decisions that improve or retard the growth of the industry are hinged on. Therefore, it is critical that competent, experienced and credible individuals are chosen to lead and drive OPEX in the industry. Also, good manufacturing practices must be strictly adhered to and constantly reviewed and updated in line with both international and national standards.
However, for real and lasting change to occur within the pharmaceutical industry, the governments must ensure that a substantial amount of the country’s budget is prioritized into developing and improving OPEX in the pharmaceutical industry. Also, the regulatory bodies within the country must not be negligent in their role of ensuring companies are adhering to the standard operating procedures and guidelines. Only when these hurdles are overcome can we achieve optimal operational excellence within Nigeria’s pharmaceutical industry.