Production plants of majority of local pharmaceutical firms have been classified not suitable for manufacturing of medical drugs by World Health Organization (WHO), a situation which require massive retooling, according to a new Government policy document.
An analysis on the local manufacturing plants compliance with WHO Good Manufacturing Practice (GMP) standards by the United Nations Industrial Development Organisation revealed local manufacturing plants are not meeting the minimum standards.
The facilities were graded from A to C, with A being the highest grade denoting compliance with WHO-GMP standards and C being the lowest.
Of the eight companies in the local industry, only two attained a B-grade for compliance to WHO standards while six scored grade C, meaning the facilities are highly inadequate or unsuitable for pharmaceutical production.
“A reputation for quality manufacturing to international standards is necessary for the Zimbabwean pharmaceutical sector to become a major player in Africa. A programme of GMP upgrading of industry (plant refurbishments and improvements in Quality Management Systems) will be implemented,” reads part of the Pharmaceutical Strategy in Zimbabwe (2021-2025) launched last week.
‘In this regard, MCAZ will design a programme for enforcing minimum standards over an established period in order to promote quality improvements. An awareness-raising about concepts of Quality Assurance and skills training will also be undertaken.
“The drug development system will assist the sector to improve its international competitiveness as there will be wider range of products to choose from.”
Despite having a fairly strong infrastructure base, the country’s pharmaceutical industry is operating way below its potential due to funding constraints. Companies such as Caps Pharmaceuticals, which used to produce about 65 percent of the country’s medical supplies has been operating below its capacity due to lack of adequate working capital.
The new policy seeks to boost local production of pharmaceutical products to reduce overreliance on imports, which presents a huge potential risk to health security.
The country imports nearly 90 percent of pharmaceutical products. Production of essential drugs is expected to double to 60 percent by 2025 while revenues are projected to increase to US$150 million from about US$32 million.
This would be supported by private and public investments amounting to US$45 million. About US$43 million is needed for upgrading factories and product development while US$2 million is for infrastructure. The Pharmaceutical Sector Revitalisation Fund will also be set up to provide funding for the development of the sector.
The roadmap would be anchored on key pillars namely research and development, expedited registration processes of new pharmaceutical products, export orientation, compliance with good manufacturing practices and State support.
The local pharmaceutical industry consists of nine pharmaceutical companies, which are CAPS Pharmaceuticals, Varichem Pharmaceuticals, Pharmnova, Datlabs, Plus Five Pharmaceuticals, ZimPharm Graniteside and Gulf Drug. Ecomed produces veterinary products.