Imperatives of boosting quality in local drug manufacturing
Several studies have shown that drug manufacturing is key to nation building. Local manufacturing not only provides employment to the Nigerian citizens, it also contributes to Gross Domestic Product (GDP) growth and to a reasonable extent conserves scarce foreign reserves which is constantly being depleted through unnecessary import of drugs that have local production capacity.
To make the local drug manufacturing companies compete internationally, they must attain the World Health Organisation (WHO) Good Manufacturing Practice (GMP) certification and their products must be prequalified by the apex United Nations (UN) health agency.
Unfortunately, in Nigeria, only four local drug manufacturing industries have achieved WHO GMP Certification- CHI Pharmaceuticals, Swipha, May & Baker and Evans- their facilities have also been certified by the WHO, but none of their products have been pre-qualified.
Having WHO GMP certification essentially means that the production facility meets global standards. It means that the product quality is not only internally consistent to the local regulatory agency quality standards, but also externally competitive to any other global quality standards known to man at least for today.
Until now, there have been calls for pharmaceutical companies in Africa to invest in both facilities and quality management systems to achieve GMP compliance.
Several studies have shown that compliance to international GMP standards is important to the attainment of WHO prequalification.
However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity.
Until now, the WHO supports the development of local manufacturing companies in developing countries and, in particular, Africa. It has been shown that WHO GMP compliance is important for attaining of WHO prequalification, which offers great opportunity for local West African pharmaceutical companies being able to distribute locally manufactured drugs to other Economic Community of West African States (ECOWAS) countries through the application for international medicines tender.
Unfortunately, none of the medicines produced currently by pharmaceutical manufacturers in West Africa has achieved WHO prequalification.
But more reasons have emerged on why local drug manufacturing companies should invest in quality improvement and attain WHO GMP certification and product prequalification.
A United States (U.S.)-led study published this month in BMC Health Services Research journal concluded that it is cost-beneficial for local manufacturing companies to invest in quality improvement interventions.
The study is titled “Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer.”
Dr. Chimezie Anyakora of the Promoting the Quality of Medicines Programme (PQM), U.S. Pharmacopeial Convention, Rockville, MD led the researchers.
The BMC journal series is a collection of high-quality, peer-reviewed journals covering all areas of biology and medicine, focusing on the needs of the research communities, which they serve.
The researchers concluded: “… Investment made to improve quality also has enormous benefit to the countries where the local manufacturing companies are located because of substantial foreign exchange savings and job creation. It is therefore imperative that governments and regulators in African countries support pharmaceutical companies striving to invest or that have already invested in improving their quality.
“Further, adapting the curriculum of pharmacy schools and chemistry programs in order to create a pipeline of quality assurance professionals will improve the sustainability of the processes and quality of new pharmaceutical companies. Collaboration of local manufacturing companies with global companies will further improve the former’s quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.”
The other researchers include: Obinna Ekwunife, Faith Alozie, Mopa Esuga, Jonathan Ukwuru, Steve Onya and Jude Nwokike.
Anyakora is the chief of party in Nigeria for the PQM, U.S. Pharmacopeial Convention. Ekwunife is a senior lecturer in department of Clinical Pharmacy, Nnamdi Azikiwe University, Awka, Anambra State. Alozie is affiliated with the Centre for Applied Research on Separation Science, Lagos. Esuga and Ukwuru are staff of the PQM, U.S. Pharmacopeial Convention. Onya is the Managing Director of Chi Pharmaceutical Limited, Nigeria. Nwokike is the Director of the PQM, U.S. Pharmacopeial Convention.
The US PQM researchers recommend an appraisal of a local West African company that has attained WHO GMP certification or, better still, WHO prequalification, which they said can act as an incentive to other local manufacturers. “It is also important to examine how drug regulatory agencies of different West African governments could drive local manufacturers to invest in quality to attain GMP compliance and adhere to ethical and regulatory obligations.”
The leader of the team of researchers, Anyakora, told The Guardian: “This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations.
“The cost benefit of improving the quality of Chi Pharmaceuticals Limited’s facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR).
“Cost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95 per cent confidence interval of 5.0–5.5).
“Investment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.”
Other studies have shown that the African continent has poor health indicators compared to other continents, largely because the governments of African countries have not fully addressed health challenges facing their populace. One such health challenge is the lack of access to quality medicines by the populace, particularly those living in rural areas, which in turn is caused by the small size of local pharmaceutical industry.
Researches indicate that high dependence on imported medicines (estimated to be about 79 per cent) is as a result of its weak pharmaceutical industry. Importation of medicines increases the cost of health care and also may result in an interrupted supply of medicines.
In 2015, more than 190 world leaders committed to 17 sustainable development goals (SDGs) to help end extreme poverty, fight inequality and injustice, and fix climate change. One of the targets of the third goal of SDGs is to achieve universal health coverage, including financial risk protection; access to quality essential health care services; and access to safe, effective, quality, and affordable essential medicines and vaccines for everyone.
Indeed, medicines or pharmaceuticals play an important role in the health care sector. They are needed for prognosis, diagnosis, prevention, treatment of diseases, and even maintenance of health status.
Notably, the quality of pharmaceuticals is at the core of the WHO constitution as health care systems are compromised by the availability of substandard drugs. Pharmaceutical manufacturers are responsible for ensuring that medicines produced are of quality and fit for purpose and for use by the general public.
According to earlier studies, the consequences of poor quality drugs include an increase in deaths and morbidity, in- creased adverse drug reactions (ADRs), and the development of drug resistance. It also reduces confidence of patients on the health care system.
It has been shown that overreliance on donor funds for provision of health care and pharmaceutical products in Africa is not sustainable since there is high demand for the supply of medicines in Africa.
Previous reports indicate that Africa is home to 75 per cent of Human Immuno-deficiency Virus (HIV) cases and 90 per cent of malaria deaths and the continent needs local medicine production to ensure continuous supply of medicines capable of handing the health challenges facing Africa rather than rely on external sources, which may disrupt supply and possibly increase the cost of health care provision. In addition to increasing availability and affordability of medicines, production of quality drugs would lead to reduced infiltration of substandard medicines into the market.
It is with this in mind that local pharmaceutical companies are viewed as being important in bringing sustainable solutions to the health problems in Africa.
Stakeholders are unanimous that local pharmaceutical companies in Africa must evolve in their capacity to provide high-quality pharmaceutical products to meet the growing health care need of the continent.
Onya said there are eight to nine countries that have achieved WHO GMP certification in Africa, one in Kenya, one in Morocco, one in Egypt and one in South Africa and four in Nigeria.
Meanwhile, the Pharmaceutical Manufacturers Group (PMG) of the Manufacturers Association of Nigeria (MAN) has commended the recent Executive Order on support for local content in public procurement.
Acting President, Prof. Yemi Osinbajo had on May 18, 2017, signed the Executive Order, which mandated all Ministries, Departments and Agencies (MDAs) of government to give preference to local goods and services in their procurement activities.
The order also directed that made-in-Nigeria products should be given preference in the procurement of relevant items as it stipulated that 40 percent of spending by the MDAs must be expended on locally manufactured goods and services.
Section 4F as a key category covered by the Executive Order also specified locally made medicines as those to be patronised.
Chairman of the PMG, Mr. Okey Akpa, told The Guardian that industry analysis of the Executive Order indicated that the directive would help Nigeria to achieve medicines’ security, as well as boost self-sufficiency in pharmaceuticals and related health commodities.
Akpa argued that the Executive Order represented the most expeditious and effective approach to guarantee the country’s sustainable access to high quality and affordable medicine.
Other positive outcomes of the directive include its potential to stimulate employment in the sector, improve the economy and facilitate export of Nigerian medicines to neighbouring countries.
Akpa said PMG-MAN, the umbrella body of over 120 local manufacturers of medicine, not only plays a key role in how Nigerians are able to access medicine, but also has great potential to contribute to the economy.
He however, warned that these objectives would not be achieved without a faithful implementation of the order.