Press-Briefing on the National Institute for Pharmaceutical Research and Development

All over the world, management of disease conditions revolves around access to new technologies and good medicines. Universal Health Coverage and the Rapid Result Initiative of the Federal Ministry of Health may not be achievable in Nigeria without strong research support and a robust Pharmaceutical industry.

> NIPRD is a parastatal of the Federal Government of Nigeria established by Government order No. 33 Vol. 74 of 11th June 1987 part B under the Science and Technology Act Cap 276.

> Through PSN and PMG-MAN Initiative, NIPRD became functional in the year 1989.

> In 2001, following a Federal Executive Committee decision NIPRD and NIMR were moved to the Federal Ministry of Health (FMOH).

To build a Center of Excellence in research and development of phytomedicines, pharmaceutical and biological products, drugs and diagnostics towards improving the health and well being of Nigerians and mankind.

– To apply appropriate modern science and technological resources to stimulate local production of drugs through effective collaboration with the industry and experts within and outside Nigeria;

– Develop herbal and phytomedicines to pilot stage for commercialisation;

– Develop quality standards for phytomedicines, drugs and diagnostics for the purpose of control and regulation;

– Provide quality assurance services on all drugs used in healthcare delivery;

– Provide safety data and essential information on herbal and other drugs towards achieving self-sufficiency in the production and control of essential drugs in such a way that would guarantee the overall health of Nigerians and mankind in general.

1. Provide an account of NIPRD’s stewardship in Pharmaceutical R&D for National Development

2. Provide answers to questions that might arise

3. Touch on sundry issues of importance

4. Solicit for support in the coming year

>standardization and quality assessment,

>regulatory approval in Nigeria;

>Patenting;

>Establishing benefit-sharing agreements;

>Demonstrating clinical efficacy and safety;

>securing US-based commercial partner Xechem;

>Being awarded orphan drug status by the US Food and Drug Administration;

>Relationships with domestic and international groups.

>The core competence of the Institute is in the area of phytomedicine development from indigenous medicinal plant knowledge, including ethnobotanical/ethnomedical survey, plant identification, bioassay-guided extraction of medicinal plant products, pharmacological screening, medicinal plant standardization, microbial studies, formulation studies, clinical trials and product commercialization.

>Phytochemical screening, safety, efficacy and toxicity studies.

>Pharmaceutical technology (nanotechnology, biotech etc) and pharmaceutical quality assessments including stability, shelf life, moisture content, microbial load, limit tests etc, bioanalytical methods, chromatographic methods, finger printing.

>Bioequivalence and Bioavailability (BE and BA) studies for generic drugs.

>Food and water analysis, diagnostics, as well as clinical facilities for drug trials.

>NIPRD generates new concepts, processes and products that are useful in driving the Nigerian economy especially in the health and industrial sector.

>Drug development value chain exists at NIPRD.

>Five Research and Development (R&D) Departments (Discovery to development)

>Animal Facility Centre (Animal House)

>Research Clinic

>Pilot plant

>Drug Manufacturing Unit (DMU)

>Patent innovations,

>Technology incubation and Commercialisation

Opportunities exist to support the development of herbal pharmaceutical industries with medicinal plant products as raw materials viz:

1) In crushed or powdered form,

2) Crude extracts preparations (ACE)

3) Isolates of active principles or intermediates

4) Converting intermediates into active principles.

5) Commercialization

Thus boosting job creation and promoting economic and health status of citizens.

There is opportunity to document medicinal plants used in traditional medicine and pharmaceutical R&D of indigenous drugs used against various diseases.

The development, production and sales of herbal medicinal products industry is a money spinner that could create jobs and wealth while at the same time provide health, economic and environmental benefits.

The cultivation of herbal medicinal products in all the 774 local government councils in Nigeria is conservatively estimated to provide up to 1,000,000 jobs.

Internal trade in herbal medicines when fully developed is also estimated by the Committee to generate up to N100 billion annually creating up to 500,000 jobs.

Export potential when adequately developed could also generate up to $2.5 billion per annum.

>NIPRD has successfully developed and commercialised NIPRISAN™, a phytomedicine used in the management of sickle cell anaemia.

>Co-formulation of NIPRISAN studies sponsored by Africa Network for Drug Diagnostic and Innovation (ANDi).

>NIPRD has successfully completed and commissioned the Laboratory Complex with 12 new laboratories and Conference Hall,

>Established QMS (Based on ISO 9001:2008) and awarded certification.

>Commenced the process of ISO 17025 certification of our laboratories by the United States Pharmacopoeia (USP) supported by the United States Agency for International Aid (USAID).

>Completion of Transition Training Course for NIPRD Quality Management Team for ISO 9001 :2015.

>Revived Drug Manufactory Unit (DMU) – on going,

>Reclaimed NIPRISAN license, Trade Marked it and obtained legal protection by the Attorney General of the Federation (AGF) for its social and commercial production.

>Recently, four (4) new products have been added:

– Treatment of Malaria,

– Fungal infection,

– Diabetes and

– Immune boosting.

>Trademarked as; NIPRIMAL, NIPRIMUNE, NIPRIFAN, and NIPRIDAB and Patented them at the Ministry of Commerce, Trade and Investment.

>>> NIPRD have established a platform for quality assessment and analytical services offered to regulatory agencies, government agencies, herbal medicines producers and entrepreneurs e.g. NDLEA, NAFDAC, Atomic Energy Commission, Universities, state governments etc.

Through this, NIPRD generates revenue and keeps the skillful staff busy while client’s demands are met with ease and happiness.

>NIPRD provides research support to the herbalists and researchers from universities and polytechnics who desire to register their products with NAFDAC or for other purposes.

>NIPRD has successfully collaborated with local and international organizations e.g. NIAID/NIH, required in the drug discovery value chain.

>NIPRD is ccollaborating with Institute of Human Virology, University of Maryland towards development of anti-HIV phytomedicine for treatment and management of HIV/AIDs and capacity building.

>Recently, the West African Health Organization (WAHO) awarded a joint fellowship to NIPRD for the development of medicinal plant Pharmacopoeia.

>NIPRD studies also established the baseline CD4 count in Nigeria for the first time.

>Preparation of fixed dose combination drug (NIPRIBOL) for the treatment of Ebola Virus Disease.

>Intervention R&D project on large scale use of antibiotics in Livestock and effects on human health in relation to antimicrobial resistance.

>Pilot study of FCT – completed and report submitted to the Presidency through FMoH. Memo presented at 2016 National Council on Health (NCH) and approval granted by the HMOH for nationwide scale-up and submission of proposal for funding.

>2014 National Syphilis surveillance Project : Surveillance study on syphilis in collaboration with FMOH with report submitted to NASCP/FMOH.

>Quality testing of samples of 2014 National HIV Sero prevalence sentinel survey among women accessing ANC-PMTC services in Nigeria: Project completed and report submitted to NASCP/FMOH

>Development of new oral morphine solution through a $20,000 Research Grant from American Cancer Society – Project affected by the current Government Policy of mopping all grants in Foreign Currency channeling them into CBN accounts.

>Quality evaluation of dispenser bottles used in the production of bottled water within Abuja municipal area council of Federal capital Territory and Environs.

>Provision of consultancy services and scientific verification of claims to local herbal industry practitioners.

>Publication of 55 scientific papers in peer reviewed journals by NIPRD Scientists

>Resuscitation and uploading of NIPRD JOPAT online.

ANDI Center of Excellence for phytomedicine R&D award 2011;

ANDI Hub 2011- 2016

ANDI Best poster award for three scientists

EDCTP, Japanese scientific grant

>Grossly inadequate Capital Cost and Running cost (overhead)

>Highly Inadequate Power supply to NIPRD

>Brain drain of Research Fellows

>Inadequate Equipment for our Central Lab Facility

>Dilapidated Administration and Finance Block

>>> Scaling up DMU and re-commercialization of NIPRISAN : Presently the Social production of NIPRISAN (an anti-sickling phytomedicine) is going on.

>>> Full Commercialization of developed and trade marked herbal medicinal products towards job and wealth creation.

>>> Nationwide scale up of antimicrobial resistance study . (Pilot study in FCT concluded)

>>> Completion of R and D studies on re purposed EVD drug.

>>> Supporting and strengthening NIPRD-Industry partnership in the following areas of its endeavor:

– Capacity building in critical needs of the Pharmaceutical and Health Industry

– R&D of Active Pharmaceutical Ingredients (APIs)

– Drug discovery, development and production (Field, bench, pilot production and clinic)

– Pharmaceutical Technology and quality assessments.

Academic groups: UK & Europe, USA, India, Ethiopia, South Africa

Industry: Korea, South Africa, India, China

Institutions: NAFDAC, University of Abuja, University of Ibadan, University of Jos, University of Nigeria, Nsukka, NIMR,

NIPRIMUNE™ , NIPRISAN™, NIPRIMAL™, NIFADIN™, NIPRID OIL™, NIPRITAB™, NANOMET™

As Presented by Karniyus S. Gamaniel, PhD, OON, FPSN, FPCPharm Director General/Chief Executive Officer