The Ethiopian Government published its Pharmaceutical Manufacturing Sector Strategy and Action Plan (2015 -2025) yesterday, explaining that the aim is to make the country’s drug manufacturing sector fully good manufacturing practices (GMP) compliant by 2025.
This will require a considerable effort as – according to the report – currently only two Ethiopian companies are GMP-compliant, although two more are about to acquire GMP certificates from the PIC/S.
But, despite the challenge, the rationale for improving standards is clear according to Prof Tsige Gebre-Mariam from Addis Ababa University’s School of Pharmacy.
“There are major public health and economic benefits to be derived from local production of essential medicines and a thriving domestic pharmaceutical industry” Gebre-Mariam told us.
He cited improved access to medicines, enhanced protection against counterfeits and reduced reliance on imports among the benefits of local production, explaining that at present only 20% of medicines used in the country are produced locally.
“Ethiopia aspires to be self-reliant in essential medicines and this can be achieved by developing a viable and value-added manufacturing industry for medicines” Gebre-Mariam said, adding that the approach will create jobs and promote skills development.
Local producers will also be better placed to meet specific local demand according to Gebre-Mariam, who said: “The disease burden in Ethiopia and other developing countries is not any more limited to communicable diseases; non-communicable diseases are on the rise.”
API manufacture
The Government's strategy will involve producing both active pharmaceutical ingredients (APIs) and finished dosage forms with efforts being tailored to meet the country’s needs.
“Ethiopia is planning to produce medicines for neglected tropical diseases, which apparently are not the problem of the US and Europe” Gebre-Mariam said.
He predicted that at least one local manufacturer would be making APIs by 2020 and suggested as many as four will be producing a limited number of drug actives by 2025.
Gebre-Mariam also expects – after sufficient production capacity and R&D infrastructure is established - that Ethiopian API and drug firms will supply other markets.
“All market aspirations and success are based on market law- competitiveness… Ethiopia will explore the niche areas as it is endowed with huge potential” he said, citing the country’s soil and plant flora as a diverse untapped resource for potential new medicines.