Roland Ogbonnaya
9 December 2007
Lagos — Nestled on an expanse land at Idu, a dusty outskirt of Abuja, the Federal Capital Territory (FTC), the National Institute for Pharmaceutical Research and Development (NIPRD) is central to Nigeria's quest to produce its own drugs for various ailments. But due to a lot of factors, the research centre has done much in this direction in the past.
There was lot of factors that contributed to near prostrate position of the research centre in the past. One of them is the starving of funds by the Federal Government as well as lack of focus on the part of the past leadership of the centre even when it is endowed with some of the best research pharmacists.
The institute, since inception in 1989 has been operating from temporary structures provided for it by the engineering department of the Federal Capital Development Authority (FCDA). The structures were originally designed for temporary field offices and their conversion to laboratories was without the necessary adjustment in infrastructural support in terms of utilities and space. By 1999, the temporary buildings were in terrible state of disrepair with damaged doors, leaking and collapsed roofs, cracked wall, faulty electrical systems increasing the fire hazard and virtual absence of toilet facilities.
In the laboratories, furniture had collapsed with the plumbing system in appalling condition and in a state of untidiness and unsafe for workers. It also resulted in damage to some of the most critical and valuable equipment in the institute. According to THISDAY investigation, it was so bad at a point when virtually all of the research equipment broke down. The location of the institute with poor power and water supply situation and reasons of poor maintenance of generators, water pumps and other ancillary equipment contributed to the poor performance of the centre.
In addition to these entire myriad of problems was also lack of funds. Before now, NIPRD was faced with the dual problem of poor allocation, unpredictable pattern of release and in some cases non-release of the funds. The attitude was that of considering research as being of low priority and at best an expensive luxury which could wait until more important economic issues have been completely tackled. As a result, the institute was completely shut out of the budget planning process. Where some funds were approved, the process of actually accessing such funds was chaotic and unpredictable.
Apart from needing a responsible government to change things, it also requires a sound and focused manager to turn things around; and that is what has happened at NIPRD. With the visionary and purposeful leadership of the Director General, Dr. Uford Inyang, the institute is on the part of performing its statutory objectives. Apart from renovating the dilapidated structures, the team led by Inyang, one of the foremost Nigerian pharmacists, built some other structures that served as laboratories and offices.
Since he took over the running of the research centre, NIPRD has been able to carry out preliminary laboratory investigations on a number of phytomedicines for the treatment/management of fungal infections, malaria, HIV/AIDS and peptic ulcer amongst others. This was done at the same time when a large numbers of research staff were trained locally and internationally.
"As would be expected with the entire challenges outlined, the research output of the institute during this period was quite low. It was also unable to attract much collaborative research activities in spite of the fact that it had achieved some reasonable level of international attention. Even the sickle cell project which had received a lot of publicity and on which significant work had been done was stalled before the coming of my administration," Inyang told THISDAY in an interview in his office in Abuja recently.
He said since 1999 and especially, the institution of due process mechanism, the release of funds of approved budgetary provisions has been smooth and consistent, making it possible to plan, execute and most especially complete projects. The institute has also been involved in the various meetings to determine budgetary priorities where it has continually made the case for improved funding for pharmaceutical research and development. "So although funding is still far from the level desired, there are now more opportunities to make input which has resulted in slight improvement in the funding situation.
"Although all efforts to obtain funding to ensure completion of the laboratory complex in the institute have been unsuccessful so far, the present administration has provided funds for the total rehabilitation of the existing laboratory buildings and premises of the institute. Two buildings have been completed and commissioned to provide additional laboratory space which will encourage further collaboration with the international scientific community. These buildings have been provided with necessary laboratory infrastructure, such as benches, offices, fume, cupboards and ancillary services to make them fully functional as research laboratories," Inyang said.
In addition, new highly sensitive research equipment was purchased to enhance research output and ensure that results obtained in the institute meet internationally accepted standards. Such equipment purchased include complete high performance liquid chromatography set with all required accessories which is used mainly in drug quality analyses, a full set of Kent cardiovascular equipment for cardiovascular research, a PCR and flow cytometre for use in HIV/AIDS research, an FTIR for use in structure elucidation and differential scanning calorimeter for use in raw materials development.
The drug manufacturing unit has also been fully renovated to meet NAFDAC's regulatory standards with a view to obtain registration for the place as a certified drug manufacturing concern. Inyang also disclosed that the equipment have been renovated with additional equipment acquired to increase efficiency. He said the extractive pilot plant which was virtually moribund due to the faulty boiler was resituated recently and is now able to produce aromatic plant fragrances. It now works as a bulk extractor and extract concentrator, the institute's director general told THISDAY.
At the commissioning of the new laboratory facilities recently, the Minister of Health, Prof. Adenike Grange who was represented by the Minister of State for Health, Chief Gabriel Aduku, an architect, said a great need exist for rallying support to NIPRD for new drug discovery and development. He emphasised that the institute's scientists have participated in the discovery and development of new phyto-pharmaceutical that is currently being marketed and are working on more drugs for diabetes, HIV/AIDS, tuberculosis and ulcer amongst others. He further explained that NIPRD has a well developed capacity and valued national and international partnership with highly respected organisations like the National Institute of Health (NIH). Aduku told the audience that the institute has the intellectual capacity and expertise to manage their projects coupled with strong and dedicated team of researchers.
"There are potential social, political and economic benefits that a country derives from pharmaceutical research and development such as establishment of high value added, high technology sector and industry diversification; contribution to economic growth and trade surplus; development and commercialisation of public sector research; high quality jobs; reduction in brain drain; contribution to the global public good and improved healthcare through access to newer medicines amongst others," the minister stressed.
Aduku therefore appealed to Nigerian pharmaceutical businessmen, international investors and other interested individuals to come and invest in the establishment of chemical industry for the production of pharmaceutical (chemicals) ingredients for drugs. He said this could be in the spirit of the new policy on public private partnership (PPP) or any other arrangement to be negotiated and agreed with the government.
"We cannot continue to depend on imported finished pharmaceutical products and 100 per cent of API any more. NIPRD must be encouraged to research and develop pharmaceutical raw materials. Its work on the development of microcrystalline cellulose for use as an incipient in drug manufacturing in partnership with Howard University is highly commendable and represents a step in the right direction.
"The institute has over the years nurtured and developed useful innovative and rewarding partnership with research scientists at the national and international level. Their international partners have brought some rear expertise, needed technologies and other research facilities that they could not easily acquire with their level of funding. These partnerships, I am told are working hard to produce new drugs for the treatment and management HIV/AIDS, tuberculoses and diabetes amongst others," Aduku said.
Dr. Anthony Okam, the immediate past chairman of the governing board of the institute said under his leadership NIPRD currently has about seven compounds in the pipeline for development as antiviral agent. He said the research is going on at the institute and at the Institute of Human Virology, University of Maryland, USA with some senior scientist from NIPRD as member of the team.
He further said that the institute has also eleven compounds in the pipeline for development as anti-tuberculosis drugs in collaboration with the National Institute of Allergy and Infectious Disease (NIAID) of the National Institute of Health, USA. In addition, Okam stressed that a potent anti-diabetic agent developed by NIPRD is in phase II clinical trial and may soon hit the local market. The institute, according to the former chairman NICOSAN, an anti-sickling phyto-pharmaceutical agent developed by NIPRD for the management of sickle cell disease had been licensed out and is currently being produced and marketed by Xechem Pharmaceutical Nigerian Limited, Sheda, Abuja.
"Just last month, we concluded preclinical studies on an immunostimulant and antifungal cream which would be used for the management of fungal skin disease and for HIV/AIDS. NIPRD is the first public research institute to extract Artemisin from locally grown Artemisia annua.
"To move on comfortably and with a great measure of assurance for success, change will be needed to tackle the challenges ahead of the institute. We need a change in our funding mechanisms and sources of funds; we will need to upgrade the R&D technology at NIPRD. The institute has achieved a great measure of success so far because it has prioritised its research needs and have used the scarce resources given to it in the most optimal way," he said.
The former board chairman therefore appealed to the Federal Government to establish a special research grant support for drugs discovery and development domiciled at NIPRD. He said the funds would be used for infrastructure upgrade, equipment, high quality supplies and consumables and personnel exchange in collaborating institutions abroad. The funds in no small measure, Okam said would enhance the institutes ability to strengthen and sustain R&D of new drugs and capacity development amongst others.
According to investigation, in 1990, the Commission on Health Research for Development recommended that governments of developing countries should spend two per cent of their health budget on health research and that donor countries should spend five per cent of their aids for health on developing countries health research and the strengthening of research capacity. Unfortunately, Okam said Nigeria has never implemented this recommendation neither have they given up to five per cent of the Ministry of Health allocation to health research.
The institute's director general told THISDAY at the commissioning of the laboratory blocks that as apart of its efforts to ensure the availability of safe and efficacious drugs in the country, "we are involved in post-market surveillance, bioavailability, bioequivalence and stability studies of imported and locally produced drugs. We have conducted prevalence studies on fake and sub-standard antibiotics, multivitamins, anti-effective and anti-hypertensive in Nigerian market.
"One of our studies indicated that the prevalence of fake and substandard ampicilin/cloxacillin preparations in the country has dropped by up to 50 per cent when compared with the rate in the mid 1990s. We have used our expertise in this area to offer drug and food quality control services to over 20 private and public organisations including FCDA central medical stores, Taraba and Kogi States essential drug services, Shell Petroleum Development Company amongst others," Inyang said.
He added that in view of the new strategy for malaria and subsequent influx of various ACT preparations into the market as well as the availability of different brands and combinations of ARVs. The institute, he further said has an ongoing programme to assess the BA/BE and stability profile of these preparations in Nigerian population.
In 2005, NIPRD won a research grant in vitro anti-malarial screening on extracts and ingredients from Nigerian medicinal plants. WHO-TDR has now created a phytochemistry repository in the institute to receive and store medicinal plant extracts and ingredients for antimalarial and other disease screening. Over 100 samples have received and stored. A database has been developed for the repository.
In as much as the institute tries to perform its responsibilities, there are numerous challenges, especially in the commercialising research results in the pharmaceutical sector of health. "While the state of the economy makes it imperative for it to commercialise its results, it is paradoxically a potential obstacle as the poor economy and attendant lack of adequate infrastructure, poor industrial capacity utilisation and result of backward integration thus reducing the chances of commercialising research results. This should however deter us from pursuing the noble goal," the DG said.
Inyang identified delivery time a crucial factor in the commercialisation process. For example, he said if a line is down due to some process or material problems, no one will wait indefinitely for results of the research on the problem. He said that this is so because every minute lost is valuable money for the industry. However, due to poor funding of public sector institutions like NIPRD, they cannot work at the speed required to provide the pharmaceutical grade starch required for industry.
"Subsequent pressure by the industry on government on the effects of the ban on certain products results in reversal of some policies. This made the positive achievements in the research and development of PGS (though partial) useless and discouraged to various researchers involved. It is therefore obvious that it is important to provide ample funds that should be promptly released to ensure that these projects are useful and delivered in good time," Inyang said.
Added to the challenges are the inconsistent government policies on raw materials. The NIPRD boss said that it is quite difficult to have a long term strategy for the development of commercialisable raw materials. He said if government policies do not remain stable, there seems to be no change with the budget each year.
Though it appears the problems are daunting, Inyang said the prospects of commercialising research results in Nigeria are enormous as the returns are rich. He however said that it is doable.
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