It is encouraging to note that a new National Health Policy is under consideration, but it is important that this policy focuses as much on unmet medical needs as on preventable diseases. The value and role of clinical research in ensuring better and more effective treatment for several thousands of patients in India is often overlooked. It is only through clinical research that we have found and will be able to find newer and better medicines to treat our population and reduce mortality rates for various diseases, including those unique to our part of the world. The Government of India sponsored Working Group on Disease Burden for the 12th Five Year Plan refers to the ‘triple burden of disease’ that developing countries like ours are facing arising from communicable diseases, emerging non-communicable diseases related to lifestyles and emerging infectious diseases. In the larger context of India’s unique healthcare requirements and growing incidence of endemic diseases and emerging lifestyle diseases, we need clinical research to develop new and effective medicines and vaccines to tackle our mammoth disease burden and unmet medical needs. India has 16 per cent of the world’s population and 20 per cent of the global disease burden and yet, less than two per cent of global trials take place in India. If we have to find better and more cost effective cures for these diseases in a population that is multi-racial and heterogeneous, it is necessary to conduct clinical research in India.
We therefore need a robust, regulatory framework that ensures that clinical research is conducted in a fair and transparent manner, safeguarding the interests of patients while keeping in line with the basic tenets of science is the need of the hour. The National Health Policy under consideration by the new government must take into consideration the value that clinical research can play in improving the health indices of our country.
We also believe in the need to create a sound clinical research ecosystem that encourages local research and innovation. Global trends have highlighted the positive correlation between growth of the clinical research industry and biopharma innovation. A slowdown in the growth of the clinical research industry is detrimental to the culture of biopharma innovation that the government of India is trying to drive and encourage and could represent a lost opportunity for our researchers and scientists. There are several biopharma companies, not for profit organisations, and teaching and medical institutions in the country interested in doing industry-leading and valuable research for diseases that affect our populations. We need to encourage such innovation and not deter the scientific and medical community from continuing in the quest to find safer and more effective treatment for our disease burden.
A focus areas of the new ministry is public health education and awareness. We need to foster an environment where patients participating in clinical research and investigators doing clinical research do not do so in fear of its consequences. Public health education on the value of clinical research and the rights and responsibilities of patients is much needed to address the misinformation and negative perceptions that exist about the clinical research process.
The Health Policy must also address the issue of infrastructure and capacity building in the area of clinical research.
– Suneela Thatte, President, ISCR
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