Ethiopia is undergoing significant evolution in its pharma regulatory landscape. What are the most critical regulatory reforms underway, and how do you envision international partners contributing to this transformation?
Frehiwot Abebe: Ethiopia, with a population of over 130 million, is currently reforming its local pharmaceutical manufacturing sector. More than 85 per cent of our pharma are imported, so our visit to India had two main objectives: first, to learn from India’s journey in becoming a global pharma hub, and second, to promote investment opportunities in Ethiopia.
Strengthening the regulatory framework has been essential. Over the past two to three years, we have worked continuously with the World Health Organisation to meet global regulatory benchmarks. Recently, we achieved Maturity Level 3 for pharma products, which indicates that our regulatory system is now stable, reliable, and supportive of local manufacturing and export.
To create a more responsive regulatory environment, we assessed our challenges—particularly delays in responsiveness and communication. We have now digitised the entire system, enabling companies to apply online for product registration and submit all required documentation electronically.
India accounts for more than 70 per cent of our pharma imports, so during our visit we sought feedback directly from Indian investors. Some challenges they highlighted included delays in GMP inspections. We have already begun working on improving the speed and efficiency of GMP assessments.
Overall, our approach is rooted in collaboration— learning from investors, understanding their challenges, and continuously improving our regulatory system.
Local manufacturing is a strategic priority for many African nations. What is Ethiopia’s long-term vision for building domestic pharma production capacity, and where do you see the strongest opportunities for collaboration with Indian companies?
Abebe: Local manufacturing is not just a priority—it is a national commitment. Our focus is on leveraging existing opportunities and learning from established manufacturing ecosystems like India.
One major challenge earlier was the availability of foreign exchange (forex) for importing raw materials. However, recent macroeconomic reforms have liberalised forex access, significantly reducing this barrier.
We also revised our procurement guidelines. Previously, these guidelines did not favour local manufacturers. Today, we provide 100 per cent procurement preference for quality-assured locally manufactured products. Only if a product is unavailable locally do we consider imports.
To encourage investment, we now offer minimum fiveyear and up to seven-year market guarantee frameworks for companies establishing manufacturing units in Ethiopia. Whether through joint ventures, FDI, or other models, investors are assured of a stable and predictable market.
In addition, we provide a 25 per cent price preference, duty-free exemptions, and benefit from Ethiopia’s strong connectivity—our national airline can reach most global destinations within eight hours, making Ethiopia a strategic manufacturing and export hub for Africa.
Our visit to India is meant to communicate these reforms and opportunities, as many investors may not be fully aware of the advantages Ethiopia now offers.
What specific incentives or policy measures exist for foreign investments in Ethiopia’s pharmaceutical sector?
Abebe: We offer a robust set of incentives:
- Dedicated industrial parks with infrastructure tailored for pharmaceutical manufacturing.
- Tax-free import of raw materials, along with several other tax exemptions.
- Procurement incentives, including a 25 per cent price preference for local manufacturers.
- Advance payments—for instance, when procuring one million tablets of paracetamol, local manufacturers may receive up to 30 per cent advance support.
- Long-term market guarantees of up to seven years.
- Regulatory facilitation, including faster approvals and guidance. These measures are intended to provide certainty, reduce risk, and make Ethiopia an attractive destination for pharma investment.
Capacity building is crucial to sustaining healthcare progress. Which domains such as GMP compliance, digital health, or supply chain modernisation are Ethiopia prioritising for technology transfer and skill development from India?
Abebe: Ethiopia has a predominantly young and educated population—over 60 per cent youth. However, one gap we identified is the need for greater hands-on skills and technical expertise within the pharmaceutical workforce.
We are strengthening industry–academia linkages Local manufacturing is not just a priority— it is a national commitment Frehiwot Abebe State Minister, Ministry of Health, Ethiopia Bhavin Mukund Mehta Vice Chairman, Pharmexcil January 2026 EXPRESS PHARMA 25 to address this, but collaboration with India is vital. We hope to learn from India’s experience in building skilled manpower across pharmaceutical and vaccine manufacturing.
Currently, Ethiopia has achieved Maturity Level 3 for medicines, but not yet for vaccines. India, on the other hand, has reached Maturity Level 3 in vaccine manufacturing. During our meetings with the Indian FDA in Delhi, we discussed how India built its capabilities and how Ethiopia can replicate similar systems to elevate our vaccine regulatory maturity.
We are also initiating plans to establish a vaccine manufacturing industry in Ethiopia in the coming years, and India’s experience will be invaluable.
Strengthening the supply chain is essential, especially as Africa’s healthcare market is projected to grow significantly. What are the key supply chain challenges for Ethiopia?Abebe: Ethiopia is indeed a growing market, and with that comes increasing demand for efficient supply chain systems. Our challenges include ensuring reliable distribution networks, enhancing cold-chain infrastructure, improving last-mile delivery mechanisms, and integrating digital systems for better tracking and monitoring.
Strengthening partnerships, building technical capacity, and modernising logistics are central to meeting future demands.
How have India’s pharmaceutical exports to Ethiopia evolved over the past 5–7 years, and which product categories are driving the strongest growth?
Bhavin Mukund: India’s pharmaceutical exports to Ethiopia have shown steady growth over the past five to seven years, increasing at a rate of around 6–8 per cent annually. The largest share of exports continues to be antibiotics, which remain Ethiopia’s top priority category.
What regulatory, logistical, or market related challenges do Indian pharma companies face in Ethiopia, and how is Pharmexcil helping them navigate these hurdles?
Mukund: The primary challenge involves registration timelines. Indian companies exporting to Ethiopia often require fast-track registration for their products. This is where Pharmexcil plays an active role. If a company’s dossier is delayed or stuck in the regulatory system, we intervene to facilitate and expedite the process. Our support ensures quicker clearances and smoother market entry for Indian pharmaceutical products.
How is Pharmexcil collaborating with Ethiopian authorities and industry stakeholders to enhance regulatory alignment, streamline approvals, and improve ease of doing business?
Mukund: Our focus is on improving the ease of doing business and ensuring affordable access to high quality medicines in Ethiopia. One key initiative is working toward acceptance of Indian Pharmacopoeia (IP) by Ethiopian regulators. If Ethiopian authorities recognise IP standards, it can result in a 15–20 per cent reduction in drug prices for the local market. This aligns with our objective of supporting affordable healthcare, strengthening regulatory cooperation, and making Indian pharmaceuticals more accessible in Ethiopia.
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