Kenya is a rapidly developing country based in East Africa. There are 48 local pharmaceutical manufacturing industries with 21 industries actively manufacturing generic drugs for local and export market. Despite this, the country still relies heavily on imported drugs to service the public health needs. In 2010, the country imported $409 million worth of drugs. In the same year, donor communities spent an additional $693 million to purchase drugs for pandemic diseases including malaria, tuberculosis and HIV. The local pharmaceutical industries only managed to access 30% government and private sector spending in the pharmaceutical market and almost none from the donor communities. In addition local companies exported $59.4 million (2010) to other East Africa countries. Efforts to increase revenue in the local market and through pharmaceutical exports are hampered by lack of adequate infrastructure.
UBRICA performed a gap analysis in the Kenyan pharmaceutical arena and recognized an unmet need in pharmaceutical research and development. Kenya lacks a vibrant biomedical research and development sector within the country. A vibrant Research and development sector in both public and private sectors can boost innovation and industrial development. Kenya has the largest number of pharmaceutical manufacturing plants in East and Central Africa. The companies develop generic drugs and possess an unlimited capacity to grow the local market share as well as exports. However generic drug development is hampered by lack of a bioequivalence lab. Bioequivalence is a mandatory study required for registration of generic drugs in most countries.
Background of Bioequivalence
What is Bioequivalence? Bioequivalence is a term in pharmacokinetics used to assess the in vivo biological equivalence of two different (generic vs. brand) proprietary preparations of a drug. Two pharmaceutical products are bioequivalent if after administration of similar doses, their bioavailability (rate and extent of availability) are pharmaceutically equivalent. A finding of pharmaceutical equivalence presumes that the efficacy and safety outcomes of both drugs are equal.
All 48 industries in Kenya lack the capacity to perform bioequivalence studies within the country. To access bioequivalence services Kenyan companies outsource the services to foreign firms located in the USA, Brazil, Asia and Europe with only one bioequivalence lab located in South Africa. The cost of performing the bioequivalence studies is prohibitive and ranges from $30,000 to $100,000 with long turnaround times.
Local manufacturing companies also lack the capacity to achieve World Health Organization (WHO) mandated quality standards including ISO, good laboratory practice (GLP) as well as good manufacturing practice (GMP) standards required for producing quality, safe and effective medicines.
UBRICA proposes the following three objectives:
- Establish a bioequivalence laboratory by January 2016
- Establish generic drug manufacture by June 2016
- Establish pharmaceutical drug development by June 2017