The Central Bank of Nigeria (CBN), has released comprehensive guidelines for accessing the Healthcare Sector Research and Development Intervention Scheme (HSRDIS).
The scheme will provide up to N50 million and N500 million for the Research activities and Development/Manufacturing activities respectively according to the guidelines released by the apex bank.
The HSRDIS is designed to trigger intense national R&D activities to develop a Nigerian vaccine, drugs and herbal medicines against the spread of COVID-19 and any other communicable or non-communicable diseases.
This will be achieved through the provision of grants to biotechnological and pharmaceutical companies, institutions, researchers, and research institutes for the research and development of drugs, herbal medicines and vaccines for the control, prevention and treatment of infectious diseases.
The Scheme is intended to boost domestic manufacturing of critical drugs and vaccines to ensure their sustainable domestic supply. Thus, reducing the dependence on imported drug products (synthetic and herbal) and vaccines for the control, prevention and treatment of infectious diseases in Nigeria.
According to the guidelines released by the CBN, activities eligible for consideration under the Scheme shall include:
- Research and development of candidate drugs, herbal medicines and vaccines validated by relevant health authorities for the control, prevention and treatment of infectious diseases;
- Manufacturing of drugs, herbal medicines and vaccines validated by relevant health authorities for the control, prevention and treatment of infectious diseases;
- Red biotechnological R&D in new health technology for the control, prevention and treatment of infectious diseases;
- Research partnership between academia and industry into the development drugs and vaccines for the control, prevention and treatment of infectious diseases;
- Research and development into validated phytomedicines for the control, prevention and treatment of infectious diseases;
Candidate vaccines undergoing pre-clinical testing or trials shall not be eligible for consideration under this Scheme.
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In applying for the grant, the applicant shall be required to have conducted pre-clinical testing of the candidate drugs, herbal medicines and vaccines, and obtained certification from relevant health authorities for further research and development.
The Grant Limit will provide maximum of N50 million for Research activities and maximum of N500 for million Development/Manufacturing activities.
The approved amount will be disbursed to the beneficiaries in tranches subject to approved milestones achieved.
The grant sets a limit of not more than 2 years for Research activities from the date the fund was released to the beneficiary and maximum of 1 year for Development/Manufacturing activities from the fund release date.
The Body of Experts (BoE), whose Chair will be appointed by the CBN, shall be responsible for the review and evaluation of submitted research proposals, as well as recommend for financing R&D projects with high potential to contribute to the development of the Nigerian vaccines for infectious diseases.
The composition of the BoE shall be as detailed below:
- Two (2) independent research specialists appointed by the CBN;
- One (1) nominee from National Agency for Food and Drug Administration and Control (NAFDAC);
- One (1) nominee from Nigeria Institute for Pharmaceutical Research and Development (NIPRD);
- One (1) nominee from Nigeria Centre for Disease Control (NCDC)
- One (1) nominee from Nigeria Institute of Medical Research (NIMR) and;
- One (1) nominee from the Federal Ministry of Health.
- The applicant(s) shall submit its application, with relevant documentation of validation from relevant health authorities, trial results, patent registration details (if any) and development timetable to the Body of Experts (BoE).
- The BoE shall evaluate applications and recommend to the CBN
- The CBN shall review for documentation adequacy and completeness;
- Upon approval, the approved grant sum shall be released to the applicant’s account with any PFI of his/her choice.
- The beneficiary shall submit periodic progress report on the project to the CBN.
The CBN says it “shall have proprietary right over all financed R&D outcomes or products. Equally, licensing protocol for the mass manufacturing of developed drugs, phytomedicines”
“The vaccines shall be defined by the BoE in accordance with the World Health Organisation’s current Good Manufacturing Practices (cGMP. The BoE shall conduct Periodic joint monitoring of research and development activities.”