India: A Powerhouse of Innovation for Neglected Diseases?

Posted: 08/28/2012 4:11 pm The BRIC countries -- Brazil, Russia, India, and China -- are playing an increasingly important role in innovation. Their growing domestic markets demand goods that meet their specific needs, and their dynamic export industries are moving beyond simple imitation. This change is true in health technologies, such as vaccines, drugs and diagnostics, as well as in IT and other areas.As innovation capabilities in emerging economies grow, many are looking to these countries to correct the global health research and development (R&D) imbalance that leaves the poor without needed products such as an improved tuberculosis (TB) vaccine or tests to help diagnose patients in remote rural settings.India, which has already played such an important role in manufacturing affordable antiretroviral drugs, vaccines, and other essential health commodities for developing countries, has been a focus of these hopes. But is India ready to play a leading role in health R&D? Are Indian companies interested in new products for the poor, or are they focused, like their more established Western competitors, on more lucrative opportunities serving patients who can pay more for medicines? Over the past year, the Results for Development Institute (R4D) has taken a close look at the potential of Indian innovators to create life-saving technologies for diseases of the poor.R4D's study concludes that India has much to contribute to global health R&D, but Indian innovators cannot meet this challenge alone, and important obstacles still have to be addressed. Furthermore, India's potential over the next few years is different across different classes of products, with the country better poised to contribute in vaccines and diagnostic tests than in traditional drug development.Until India's formal compliance with the Agreement on Trade Related Aspects of International Property (TRIPS) in 2005, Indian firms didn't have to come up with brand new products to stay in business. Instead, flexibilities in the country's intellectual property rules allowed firms to build business models around efficient, low-cost production of existing health technologies, helping them to provide vital medicines to millions of patients around the world. Indian pharmaceutical and biotechnology companies spent little on R&D, and didn't have an incentive to build strong links with scientists, in India or abroad.Since the implementation of TRIPS seven years ago, firms have had to adjust their business strategies, and many have started to invest in new product development. But different sectors have approached this shift in different ways, with important implications for global health:The Indian vaccine industry has been gradually building its R&D capacity for at least a decade. Spurred by the prospect of sales to the Global Alliance for Vaccines and Immunizations (GAVI), firms have strengthened their capabilities in biotechnology, built collaborations with international partners, and moved from basic vaccines to more sophisticated technologies. They have retained a focus on markets in low- and middle-income countries and an interest in neglected diseases. In 2010, Serum Institute of India launched a new meningitis vaccine for Africa's Meningitis Belt, developed with help from the Gates Foundation, the Program for Appropriate Technology in Health, and the CDC. In the next year or two, Bharat Biotech is hoping to start selling a new $1 rotavirus vaccine developed by India scientists in collaboration with international partners and with financial support from India's Department of Biotechnology, the US National Institutes of Health, and Gates. Rotavirus is responsible for hundreds of thousands of child deaths around the world, and a new low-cost vaccine could give a big boost to prevention strategies in developing countries. The Indian drug industry, on the other hand, has shown less interest in new products for neglected diseases. Although India's drug firms have done a remarkable job in improving access to important generic medicines, especially antiretroviral drugs for HIV, their R&D programs today focus largely on non-communicable diseases affecting mostly wealthy populations. And although some drug firms are investing in new drug development, drug discovery in India is still in its infancy. India's diagnostics industry may be one to watch in coming years, as new diagnostic tests are generally cheaper and quicker to develop than drugs and vaccines, and India's own market may be large enough to support the necessary R&D. Until recently, Indian diagnostic companies have concentrated mostly on copycat or follow-on tests. More recently, though, some new innovation-driven firms have started up. For example, Achira Labs, a start-up company in Bangalore, has developed a fabric-based diagnostic platform that allows field staff to perform medical tests on a small square of silk that costs just a few cents to manufacture. Another new company, Bigtec, has partnered with one of India's most established diagnostic companies, the Tulip Group, to develop a portable PCR machine that holds promise for diagnosing infectious diseases in non-clinical settings. Complementing industry efforts, many public-sector laboratories are also working on new tests. If these efforts succeed, India's test developers could make an important contribution to public health in India and elsewhere, as more accurate, cheaper, and easier-to-use tests could greatly facilitate control of many important infectious diseases, including TB. Indian firms may also have a role to play in producing tests for non-communicable diseases, such as heart disease, that could be used by poor patients in areas that have little or no laboratory infrastructure. Although the different sectors of India's biomedical industry will likely follow distinct trajectories, R4D's study found that they share a series of common challenges, including shortages of qualified R&D managers, weak venture capital markets, and out-of-date and overwhelmed regulatory systems. The Indian government is beginning to address these issues through significant investments in education, financing, regulatory reform and infrastructure, but there is a way to go before these systemic challenges will be overcome.One of the study's key findings is that strengthening innovation in general will not be enough: specific measures will be necessary to harness India's growing technological prowess for public health purposes.In most cases, markets for neglected disease products are too small to cover the costs of R&D, and Indian firms face the same incentives as today's multinational firms to innovative for wealthy populations. Stronger and more predictable demand from India's own government health services for needed vaccines, drugs, and tests would help, but programs to support R&D in key areas should be expanded as well.Those initiatives must be driven by the Indian government, but donor agencies and international partners should continue to lend a hand by creating funding programs that complement government initiatives and focus on diseases of the poor, promoting technology transfer and clarifying the patent landscape for needed products, and articulating their top international procurement priorities.These are just a few of the steps that international partners can take to help India fulfill its promise as a developer of new global health technologies.