‘Public-private sector coordination needed in TB diagnostics’ – Conversation – Express Pharma Pulse

‘Public-private sector coordination needed in TB diagnostics’

Dr Mark D Perkins, science officer with the Global Programme on Tuberculosis in WHO and manager of Diagnostics for the UNDP/ World Bank/ WHO special programme for Research and Training in Tropical Diseases (TDR), talks to Vijaya K on WHO initiatives in tropical disease management and the role of private sector in development of TB diagnostics. Excerpts:

What are your plans for India in TB diagnostics?
We are planning to set up a TB diagnostic evaluation centre in India for which we are in talks with the TB Research Centre in Chennai. The WHO and TDR have plans to set up a TB Specimen Bank which would cater to the need for a well-characterised clinical material from patients with TB symptoms to rapidly evaluate and control quality diagnostics tests. India is a critical player in tropical diseases because of its geography, population, history, economic conditions. We do have some projects underway for which we are looking at funding in India.

What are the technical & economic features of development of TB diagnostics?
The production cost of diagnostics is much lower as compared to vaccines. Simple diagnostics development require just few hundred thousand dollars. Hence, a large number of companies get involved in drug discovery and development of TB diagnostics. Unfortunately, most of the companies are not making heavy investments in tool optimisation of area research. More often they take reagents or ideas that are developed in academic setting, which results in manufacturing of mediocre diagnostics products. Diagnostics lack regulatory rules because they are not regulated like drugs. There is no pathway to ensure that good manufacturing practices are maintained in diagnostic development. A protocol has to be drawn for diagnostics and regulatory norms should be made complex.

Is the market lucrative for TB diagnostics?
Out of total ten leading companies engaged in diagnostics, only three are involved in TB diagnostics. They produce high-end and expensive diagnostic tools that are seen for sale in big laboratories. The companies that are involved in diagnostic tests will have the biggest impact in developing countries where as TB is seen more in the smaller countries. In fact many companies are trying to move away from this because this is not a big market.

How does WHO initiate public-private sector coordination in TB diagnostics development?
There should be coordination between private and public sector in the area of health distinguished from the area of business. Private public partnerships will be receptive in helping address the health needs when there is a market.

In India the problem is not the size of the market but the chaos in the market. In India despite public sector participation, TB is handled largely by the private sector, which has only complicated the situation. Private sector in India tends to use a broad variety of methodologies of treatment that are ineffective and below standards. The diagnostic methodologies as well may be quite chaotic. Presently India needs to organise the market rather than expand the market.

WHO is working on improving private sector care of patients. The Indian Medical Association should be a key partner in public-private sector coordination for education and sustained efforts. The Indian government should involve in setting up partnerships with the industry. Biotech companies, both small and medium, involved in diagnostic work are looking at large markets for TB products. So their goal is to make expensive products. The difficulty is in getting the companies to invest enough funds to come up with less expensive actual products of excellent tool development work. WHO is trying to lower industry obstacles. We hope to have low cost diagnostics in the private and the public market for TB diagnostics. Our goal is to see that the population is not neglected for want of these diagnostics. Our aim is to procure simple and sophisticated TB diagnostics.