Assessment of the pharmaceutical manufacturing industry in Kenya to forecast local production sufficiency
Vugigi, Sarah Kadesa
MetadataShow full item record
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.