ASSESSMENT OF THE PHARMACEUTICAL MANUFACTURING INDUSTRY IN KENYA TO FORECAST LOCAL PRODUCTION SUFFICIENCY
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Date
2017-10
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Abstract
The World Health Organization’s global strategy on public health aims to support
Member States to improve access to essential medicines. The desire of Kenya
Government to implement this is expressed by formulation of Kenya National
Pharmaceutical Policy (2010) which encourages local production of essential
medicines for self-sufficiency. The pharmaceutical manufacturing industry in Kenya
is engaged in production of various types of dosage forms but its capacity and
capability to produce essential medicines for Kenyans have not been determined. The
aim of this study was to assess the pharmaceutical manufacturing industry in Kenya
to forecast local production sufficiency. This was attained by evaluating the
manufacturing capability, production capacities and compliance with international
marketing authorization standard of the Kenyan pharmaceutical industry. The 24
licensed manufacturers of medicines for human use were assessed. Data was
collected on the current drug situation in Kenya by scanning Pharmacy and Poisons
Board database to determine range of products that are registered in Kenya. Local
pharmaceutical manufacturer’s product lists, Kenya Essential Medicines list and
pharmaceutical tender lists of three major procurers in Kenya (Kenya Medical
Supplies Authority, Kenyatta National Hospital and Mission for Essential Drugs and
Supplies) were examined to establish the proportion of products which was
manufactured locally. Prices competitiveness and market share of local products
were evaluated and subsequently, pharmaceutical equivalents of 150 locally
manufactured essential medicines were determined. Data on production capacity for
5 years (2010-2014) and compliance of facilities with good manufacturing practices
standard and other prerequisites of marketing authorization was obtained using a
structured questionnaire. Results showed that solid dosage forms were majority (54.9
%) of local products and sterile preparations were minority (2.7 %). Locally
manufactured products accounted for 14.5 % of registered and 21.5 % of retained
products. Local firms manufactured 38.4 % of products listed as essential medicines
and 55.6 %, 24.5 % and 21.8 %, respectively, of pharmaceutical products procured
by Kenya Medical Supplies Authority, Kenyatta National Hospital and Mission for
Essential Drugs and Supplies. The overall percentage of local pharmaceutical
equivalents was 32.5 % for registered products. There was no variation between
mean prices of local and imported pharmaceutical equivalents. Scatter diagrams
demonstrated that imported pharmaceutical products comprised both low and highly
priced brands. The overall utilized production capacity (two shifts) was 21.5 %;
tablets (24.1 %), capsules (12.8 %), liquids (25.3 %), dry syrups (21.8 %), external
preparations (21.3 %) and oral rehydration salts (23.6 %). This study projected the
year for self-sufficiency in non-sterile medicines produced in the local industry as
2043. Good manufacturing practices standard was satisfactory at 11 facilities while
the rest were striving to achieve compliance. Research and development of new
products was limited in most facilities with 1 % of the workforce deployed in this
department. It is concluded from this study that Kenya depends heavily on imported
drugs for her essential medicines needs. Majority of local products were less
competitive than imported products and production capacity was underutilized.
Majority of manufacturers adhered to current good manufacturing practice standards
but were inadequate in research. This study recommends augmentation of research
and development by the local pharmaceutical industry to generate new products. In
addition, substantial government support is required to propel the industry to
improve product range, product competitiveness and production capacity utilization.