So Much Done, Not Much Found: A CML Investigation Of Nigerian National Institute for Pharmaceutical Research and Development Projects
In the second part of the series, the Civic Media Lab looks at the National Institute for Pharmaceutical Research and Development and its activities and output in the last five years
The National Institute for Pharmaceutical Research and Development left no commercial footprint on the pharmaceutical industry between 2015 and 2019, Civic Media Lab has found. This is based on the lab’s search of their budgetary provisions between 2015 and 2019 on the institute’s website, a check on their brand with doctors and pharmacists and Google searches.
The institute might have been hampered by the low funding it received for capital projects. In five fiscal years, NIPRD received a capital envelope of N1.03bn, while Special Duties-SGF, an office that was in the care of the Secretary to the Government of the Federation within the period under review, received approval for 1.34bn in 2019 alone, it lowest funding in three years.
Notwithstanding, the agency received N50m for clinical trials on four different ailments in 2015, and made budgetary provisions of more than N200m to develop and commercialise products for the pharmaceutical industry but was largely unable to do so, the lab discovered.
The National Institute for Pharmaceutical Research and Development, Abuja
In 2015, the total recurrent expenditure allocated to the agency was N666.70m while total capital spending was N50m. The non-reoccurring envelope was used to fund a project entitled, “Ethical Review/NIPRD Special Project/PHASE II and III Clinical Trials for Medicinal Products for management of Malaria, Sickle Cell, Diabetes, Ebola and Lassa Fever.”
According to the pharmaceutical arm of GSK in Nigeria, there are three mandatory clinical trial phases a drug destined for the Nigerian market must pass through. The institute’s decision to lump four different trials together as ‘phase II and III,’ makes it impossible to note what drug was undergoing what stage of testing.
CML found that the institute had a sickle cell drug developed in 1998 and patented in 2003 in the USA. It had allegedly sought a foreign patent because it was unable to get any pharmaceutical company in the country to offtake the product and produce it at a commercial scale.
Despite its best efforts, the company has been unable to get the drug, Niprisan, into the hands of sickle cell patients in the country. A source at the Sickle Cell Foundation in Lagos, to which the Minister for Health nominates a board member, said Paludrine, a UK patented drug, is the routine product it recommends for its members.
The institute had, before 2015, trademarked a diabetic drug, Nipridab and an anti-malaria drug Niprimal. In 2016, NIPRD also trademarked an Ebola treatment, Nipribol. Out of five doctors and two pharmacists asked about the NIPRI brand, only one pharmacist had heard of the institute’s trademark, saying, ‘it’s not popular.’
During that year, the agency received N626.38m for the payment of salaries, emoluments and overheads. For purchase, construction, research and other non-fixed expenses, it received a reduced sum of N48.72m. In turn, the agency had just one research/development/surveillance project: “Research and Development of Pharmaceutical Products Including Commercialisation.” The vague line item failed to specify how many products it intended to develop and commercialise.
In 2017, the institute received approval to drawdown on N626.38m for reoccurring spending. Capital expenditure increased this year to N147.66m. The increased allocation to capital projects did not mean more money was pumped to develop, test and commercialise drugs. The drug producing agency had two similar-sounding projects: “Research and Development of Pharmaceutical Products Including Commercialisation “and “R&D of Pharmaceutical Products, “collecting a combined sum of N20.74m.
In January 2018, the agency’s two-time Director-General, Karniyus Gamaniel, said in his valedictory speech that six products had been developed under his watch. He listed them to include, an immune booster; Niprimune, Niprimal, an antifungal; Niprifan, an airwave cleanser and air freshener; Nipri Oil, Nipribol and Niprisan. Earlier in 2014, he had claimed that Nipridab, Niprimune, Niprimal and Niprisan had been commercialised.
In 2018, the agency earned approval for N683.98m as recurrent expenditure and N251.48m for productive spending.
The agency applied the fund to three projects: “Data Collection for Operational Research survey,” “Research and development of Phytomedicines/ herbal medicines and pharmaceutical products for the treatment of endemic diseases, including their commercialisation to national pharmaceutical industries,” and “Support for the development of the Nigerian herbal medicine industry to national and international standards,” all valued at N36.99m. Quartz Africa claimed in a report on the history of Niprisan that an agreement had been reached with the Nigerian arm of the British firm, May and Baker, in 2018 to begin reproducing the sickle cell management drug in Nigeria. This is one year after the institute’s right to its formula for the product had expired. Quartz reported that an Illinois -based firm Xickle was said to have started producing an anti-sickling drug based on NIPRD’s formula soon after. The company claimed that its potion was more potent.
In 2019, the agency was assigned N754.04m for recurrent spending. Capital expenditure, on the other hand, received N542.01m. The institute invested some of its capital expenditure on five product-themed research and development projects. N200m was given to: “Research development of Phytomedicines/herbal and pharmaceutical products for the treatment of epidemic diseases including commercialisation to the pharmaceutical industry.”
Another line item from last year, “Data Collection for Operational Research Survey,” Picked up the tiniest amount of support – N2m. The other projects were: “Support for the development of the Nigerian traditional herbal medicine industry to national and international standards,” the “Development of active ingredients / raw materials and provision of scientific services to support the growth of the Nigeria Pharmaceutical Industry based on their needs,” as well as, “Research and development activities for next line generation of herbal products.”
Media reports show that the focus of the institute, under the management of Peter Adigwe, has been to build partnerships with state governors, other agencies of the federal government and the private sector, with the hope of seeking increased funding. In one of such reports, Adigwe said the institute had five products on the verge of commercialisation and 22 others in various stages of development.
Since the COVID-19 pandemic started, the institute has been able to develop a hand sanitiser, according to the information found on its blog. The Minister of Health, Osagie Ehanire, said on Friday’s COVID-19 briefing that any herbal practitioner who has developed a product should reach out to the NIPRD, the ministry’s traditional complementary medicine department or NAFDAC.
Between 2015 and the week ending May 2 2020, Nigeria has recorded 1,885 Lassa fever cases. NCDC said in its 18th week of reporting that the number of confirmed cases in 2020 was 991 from 987 the previous week. This might have been a miscalculation on their part. The centre said five positive cases were reported in the week ending May 2, which should have brought the total to 992. Before the week in review, 188 persons had died from the virus.
Two people were reported to have lost their lives to the virus but the agency said it had recorded 191 deaths. NIPRD has, so far, been unable to account for the outcome of the Lassa fever clinical trial it conducted in 2015 and may have conducted in past years, as it would have needed to complete a lab trial before applying for a test on humans.