FROM THE DIRECTOR’S DESK
The Centre for Drug Discovery, Development and Production (CDDDP), is a MacArthur Foundation funded Centre of Excellence at the Faculty of Pharmacy, University of Ibadan, Nigeria. The Centre was set up in 2012 as a platform for world-class training in drug discovery, development, production and medicine regulation as well as to provide opportunities and services for research and development of quality medicines that meet the specific needs of Nigeria, sub-Saharan Africa and the whole of Africa in general. The Centre, which MacArthur Foundation refers to as the “First of its Kind in Africa” was designated by New Partnership for African Development (NEPAD)/African Medicine Regulation Harmonization (AMRH) in 2014 as one of the eleven Regional Centres of Regulatory Excellence (RCORE) in Africa with the oversight functions for (i) training on regulatory science; (ii) development of clinical trial oversight structures and clinical trial expertise; and (iii) improvement on quality assurance/quality control (QA/QC) to attain international accreditation.
The justification for establishing this centre is due to the fact that about 90% of drugs used in Africa are imported from Asia including India, China, Pakistan and others and it is extremely difficult and complex to regulate such products effectively from manufacture of active pharmaceutical ingredients (API) to finished pharmaceutical products (FPP). This causes circulation of products that are compromised in quality and has led to unimaginable large number of various brands of some pharmaceutical products such as antimalaria combination therapies (ACTs). It is therefore easier for the national regulatory agencies (NRAs) such as NAFDACto regulate manufacturers and distributorshere in Nigeria rather than regulatefacilities and medicines that are produced in Asia and other countries.
Nigeria is well positioned to take a lead in ensuring and encouraging local manufacture and regulation of quality medicines in Africa. For instance, Nigeria’s population is about 170 million people and 25% of the whole of Africa and 51% of West Africa are Nigerians. Out of about 150 pharmaceutical industries in West Africa, Nigeria has about 130. The pharmaceutical companies in Nigeria produce at 30% capacity which is far below expectation. The reason is that it is cheaper to import than to produce here due to lack of strict regulatory guidelines and lack of critical mass of professionals in this sector. Therefore we need to empower our local production, even if we do not discover new medicines for now, it is important that we develop, manufacture and regulate already existing ones. Nigeria has the human capacity to carry it out.
- The Centre’s programme is implemented under the six broad headings of
- i. Capacity building
- ii. Curriculum development and implementation
- iii. Workshops & Conferences
- iv. Research projects and
- v. Services
The Centre has a Postgraduate course and runs short-term courses, workshops and conferences.
The centre has developed two postgraduate programmes which have been approved by University of Ibadan senate namely :
1. Postgraduate Diploma in Drug Development (PDDD)
2. Masters in Drug Development and Regulatory Pharmacy (MDDRP)
The PDDD commenced with students from various sectors including some members of academic staff of the Faculty of Pharmacy for the 2013/2014 session as a special part time programme whereby semesters are taught in modules of two-three weeks to capture a semester.
This is to take care of students who are actively working or seeking a job.
One module or semester is spent in Kilimanjaro school of Pharmacy (KSP),
Moshi Tanzania to capture practical and hands-on drug manufacture and
documentation for registration and regulation. The staff member’s involvement
will further strengthen the capacity building exercise and training-of-trainers
(TOT) as a way of sustaining the programme if and when foreign partners cannot participate fully.
Tutors are drawn from partners in USA and experts in Nigeria. The first set of PDDD students
graduated in December 2015 and other sets are ongoing. Other activities so far include:
1. Establishment of drug quality assurance laboratory for analysis of drug, food and cosmetic products in circulation within the country and West African sub-region.
2. Bioequivalence studies for generic medicines under strict regulatory guidelines.
3. Toxicological and safety studies for orthodox and phytomedicines.
4. Clinical trials of medicines in both animal and human models.
5. Development and manufacture of herbal medicines.
6. Hands-on training on SOPs, drug analysis etc.
7. Certificate training on Good Pharmaceutical Practices