Nairobi, Kenya - The United Nations Economic Commission for Africa (ECA)’s AfCFTA-anchored Pharmaceutical Initiative undertook a fact finding mission to Biodeal Laboratories in the Republic of Kenya from 7th to 8th February, 2022. The fact finding mission was part of ensuring due diligence as ECA continues to facilitate the acquisition of resources required for the proposed scaling-up of expansion of pharmaceutical production on the continent.
The fact finding mission was led by Ms Jane Karonga, Economic Affairs Officer and AfCFTA-anchored Pharmaceutical Initiative Project Lead. Ms Karonga inaugurated the mission by providing background to the Pharmaceutical Initiative. She highlighted that the Africa Continental Free Trade Area (AfCFTA)-anchored Pharma Initiative, is a pilot project that seeks to develop the capacity of African countries to ease the burden on their health systems through three pillars; facilitation and advocacy of local production, continental pooled procurement, and harmonized regulatory, quality, and standards of medicines and related medical products.
In furtherance, she stated that the mission was a follow up to the Good Manufacturing Practices (GMP) review and Technical Review Panel (TRP) conducted on Biodeal Laboratories in 2021 to enable the manufacturer to meet the acceptable pharmaceutical manufacturing standards.
In response, the Chief Executive Officer of Biodeal Laboratories, Mr. Nihal Shah commented, ‘the company has made tremendous strides to address the issues raised in the GMP inspection and TRP reports. I am also proud to inform ECA that Biodeal Laboratories Ltd has moved from high risk to low-medium risk as per the inspection carried out in November 2021 by the Kenya Pharmacy & Poisons Board’.
To conclude the mission, the AfCFTA-anchored Pharmaceutical Initiative team was taken on a tour of the manufacturing facility which is partitioned into different manufacturing sections; the tablet section; the creams & ointments section; the liquids section; and the capsules section. The team commended Biodeal Laboratories on the diversity of the product lines, especially the maternal and child health products that could be scaled up if sufficient resources could be mobilized
Both teams agreed that collaboration with key continental partners and capacity building are key to leading the business to the next stage. It was agreed that the ECA will work to provide technical support to address challenges pertaining to regional market access.
AfCFTA-anchored Pharmaceutical Initiative
As part of its mandate to deliver on Agenda 2063, the SDGs and operationalization of the African Continental Free Trade Area (AfCFTA) by translating ideas into action and in line with its commitment that private sector and public sector dialogue yields tangible outcomes, the ECA went on to conceptualize the AfCFTA-Anchored Pharmaceutical Initiative. Commissioned in 10 selected pilot African countries which include Comoros, Djibouti Eritrea, Ethiopia, Madagascar, Mauritius, Kenya, Rwanda Seychelles, and, Sudan. The AfCFTA-anchored Pharma initiative’s key objective is to address socio-economic-related challenges facing African member countries in improving access to maternal, neonatal and child-health (MNCH) essential medicines and commodities and the creation of fiscal space to the African Governments given the emerging trend of rising government debts.
With the implementation of AfCFTA -anchored Pharmaceutical Initiative, Africa will be in a stronger position to address the twin challenges in the pharmaceutical industry: (i) in the short-to-medium term, by using the AfCFTA as a platform for harmonizing national standards as well as pooled procurement of medicines and pharmaceutical products, and (ii) in the long-term, through increased investment in pharmaceutical production and exports.
BioDeal Laboratories
Biodeal laboratories Ltd was established in 1988 in Kenya, with its first manufacturing plant completed in 1992 focusing mainly on generic drug production. The company has a chemical and microbiology laboratory and a product development laboratory. Currently, it employs 192 people, 155 of which are in production.
The company was chosen to be part of the ECA business development program following the launch of an Expressions of Interest (EOI) for African pharmaceutical manufacturers to produce 107 maternal-child health (MCH) and essential health products. This is being undertaken to help increase access to affordable, quality-assured medicines and other medical supplies in the era of rising government debts accelerated by the socio-economic impacts of the COVID-19 pandemic.
The EOI was a step towards the implementation of the Africa Continental Free Trade Area (AfCFTA)-anchored Pharma Initiative, a pilot project that seeks to develop the capacity of African countries to ease the burden on their health systems through localized production of medicines, pooled procurement and a harmonized regulatory and quality framework. According to ECA estimates, Africa imports about 94% of its pharmaceutical and medical product needs from outside the continent at an annual cost of $16 billion.
For more information Contact
Communications Section
AfCFTA-anchored Pharmaceutical Initiative
PO Box 3001
Addis Ababa
Ethiopia
E-mail: segolame.evans@un.org
fdereige@gmail.com