New manufacturing cluster to produce pharmaceutical drugs

THE ESTABLISHMENT of a local manufacturing Active Pharmaceutical Ingredient (API) Technology Innovation Cluster to make health care affordable by strengthening the South African pharmaceutical value chain, is “long overdue”.

This is according to the Innovative Pharmaceutical Association SA (Ipasa), reacting to the recent announcement that the Technology Innovation Agency, the Department of Science and Innovation, and North-West University will establish a local API cluster to enable a dynamic South African pharmaceutical manufacturing industry and access to critical and modern drugs. The country currently spends about R15 billion annually on imported APIs.

With an initial R13 million investment, the cluster aims to stimulate industry competitiveness and worldclass API manufacturing in South Africa by leveraging existing skills, technologies and facilities in the country.

Ipasa chief executive, Dr Konji Sebati, said in the wake of the Covid19 pandemic, the negative effects of limitations on international trade directly affected the ability to import APIs from China and India, affecting the provision of drug products in the local health-care system.

Once the global market opened slowly, goods from these countries went to the highest bidder, and South Africa was left waiting in line, she said.

“This is long overdue and a great move for the country. We support the local manufacturing of API.

“With the current pandemic, it is evident that we can’t depend on

“This pandemic has really been a wake-up call Konji Sebati Ipasa chief executive

them (other countries) for things we can do locally. We have the resources here, the expertise, infrastructure and human technical skills, we have chemical manufacturing facilities.

“This pandemic has really been a wake-up call,” Sebati said.

The cluster strategy will be underpinned by realigning current capabilities at various higher education institutions, science councils and commercial companies towards a focused API process synthesis and engineering programme.

“With support from actors across the value chain, such as the national Department of Health, the Department of Trade, Industry and Competition, the Industrial Development Corporation and various industry associations, the cluster aims to establish a cohesive approach to the development of the pharmaceutical sector’s value chain by localising production of this primary input material,” the Department of Science and Technology said.

“The collaborative approach supports not only technology development, but also joint advocacy to unlock constraints in the policy and regulatory environments, as well as challenges within the local procurement value chain to ensure market uptake of the APIs.”

The cluster is establishing a dedicated pilot-scale API chemical laboratory, which will comply with regulations and support the analytical testing required during the synthetic process of API molecule development.