Government and international donors should expand financing for promising neglected-disease product development projects, says report on research and development

Despite India’s rapid economic development and growing technological prowess, it continues to suffer from widespread poverty and bears a burden of infectious diseases, including tuberculosis, malaria and many other neglected diseases. The country will have to strengthen its health system to reduce this burden and make medicines accessible, especially for the poor, a latest report on India’s research and development has said.

New health technologies—such as affordable and locally adapted drugs, vaccines and diagnostics can also make a big contribution to combating disease in India. For some serious diseases, there are currently no effective drugs or vaccines, whereas for others, existing technologies are too expensive and require infrastructure that is not broadly available, or are ill suited in other ways to local needs. For instance there are no vaccines against malaria or dengue fever and no affordable and accurate point-of care tests for tuberculosis.

‘India’s Role in Global Health R&D’ -- a report by the Results for Development Institute under its Centre for Global Health Research and Development Policy Assessment programme -- suggests that the capacity of Indian firms and of the Indian biomedical system as a whole to create and bring new health technologies to market is still limited. Indian firms require subsidy of some kind to work on products with very small markets, such as leishmaniasis or typhoid fever. Also, there is a class of neglected but useful disease products that these firms see as commercially viable.

Crucially, there are big differences across product types and stages of R&D. The greatest opportunities for neglected disease R&D are probably in vaccines and diagnostics, though firms working in these areas are smaller than the leading drug manufacturers. These firms are investing in R&D and are interested in at least some of the neglected disease products. The drug firms, in contrast, are primarily focused on building their generic drug business and on global markets, the report done by Paul Wilson and Arthi Rao said.

Indian companies are most able to contribute in three ways: by developing more affordable or locally adapted versions of existing products; by bringing to market some new products to which technological barriers are not too high; and by participating in specific aspects of international product development initiatives in areas where they have a cost or other advantage.

The Indian government and international partners can help strengthen Indian health R&D capacity and ensure that this capacity is used to meet public health needs in India and other developing countries through action in four areas.

First, both the government and international donors should expand financing for promising neglected disease product development projects, including for late-stage clinical trials and for new, innovation-driven firms. Joint financing schemes, such as the existing collaboration between the Department of Biotechnology and the Welcome Trust, are a promising way to channel international funding for R&D.

Second, international partnerships that provide technical assistance and access to technology should also be expanded. Although bilateral partnerships like the Program for Appropriate Technology in Health’s assistance to India’s rotavirus project have been very useful, access to some technologies and relevant know-how could be shared on a more open, multilateral basis. The ‘Technology Hub’ for influenza vaccines created by the World Health Organization (WHO), which made production know-how available to developing country manufacturers, is one possible model.

In addition, shared resources, such as sample banks and intellectual property landscapes in key technology areas, could accelerate product development.

Third, both the Indian government and international health donors and procurement agencies could give neglected disease product development a big boost by sending clearer signals about the products they wish to buy, technical standards that will have to be met, and approval and procurement procedures.

This is particularly true for diagnostics, where product needs and assessment processes have not been well defined either in India or by relevant international agencies and donors. Greater coordination between the public health and research-funding agencies of the Indian government is also important.

Fourth, the Indian system for regulating pharmaceutical and biotechnology R&D needs to be streamlined, and systems and capacity for evaluating new technologies strengthened. Although some arms of government recognise this need, and promising initiatives are underway, progress has been slow so far. At the same time, international systems for assessing and recommending products, especially WHO’s prequalification programme for diagnostics, need to be expanded so they can handle more products more rapidly.