By Vishwanath Mohan
With a huge talent pool and growing demand for innovation in drugs and medical devices to address the rising disease burden, it is time we created a favourable environment for clinical trials in the country. Epidemiological transition, in recent decades, compounded with the burgeoning population as well as widespread malnutrition and poverty, have resulted in the steep rise in both communicable and non-communicable diseases in the country, across all age groups. To counter this rising burden of disease, there is a compelling need for local clinical trials.
Despite the pressing demand for clinical trials, after a peak in 2009-2010, the clinical research sector in India is continually contracting. According to theJournal of Clinical Research and Bioethics, India represents 17.5% of the world’s population but conducts only 1.4% of global clinical research. This is unfortunate, considering we have all the requisite factors, such as English-speaking health-care professionals, a large number of experts, steady economic growth, access to world-class technologies, strong IT- and data-management infrastructure, access to ethnically diverse patient populations and competitive operational costs. All these factors present clear advantages for clinical research.
We have been lagging in this area primarily because the regulatory system in India for clinical research has become increasingly a deterrent for biopharmaceutical- and device-companies which sponsor clinical trials. The existing legal framework lacks credibility, in terms of predictability and transparency, in the criteria and protocols governing clinical research. Data suggest that improvements in the overall policy environment can have a significant impact on attracting and securing greater investment and the associated economic gains. A study, “Medical research in India and the rise of non-communicable disease”, published in the British Medical Journal in 2016, brings out the multifaceted and far-reaching benefits of clinical trials to the health-care delivery system. It states: “health research is not only crucial to the development of new diagnostic tools and treatments, it goes on to guiding the planning of health-care services in the appropriate direction, facilitating continuous evaluation and improvement of medical care, and allowing a thorough investigation of risk factors and disease associations”.
Clinical trials also seem to be misunderstood in the media and have sometimes been portrayed as experimental procedures, where new products are being unsafely tested on people. Admittedly, there have also been instances of lapses in confidentiality or non-adherence to protocols or shortcomings in getting informed consent from participants and these are to be totally condemned. However, this cannot be a cause for throwing the baby out with the bathwater, and everyone conducting clinical trials must not be looked at with suspicion. There are numerous honest doctors and scientists, who do world-class research in India, and these individuals and their institutions should be encouraged to conduct clinical research.
Fixing the edges
Fortunately, things have started to change recently. Recognising the importance of local clinical trials in developing better and safer drugs, the Government of India is now working on new policies that could ensure swift approvals to begin clinical trials without making compromises on patient safety. The Government has taken steps such as recognising ethics committees, centralising a system whereby adverse side-effects can be appropriately investigated by the Drugs Controller General of India and formally recognising centres which are capable of conducting clinical trials in accord with regulations. To reap the benefits of clinical trials, our objective should be to bring about more clinical research in the country while maintaining high standards to ensure patient safety and accuracy of data. The new policy, which also promises to be more transparent, includes some major amendments such as single-window clearance for clinical trials. To further speed up the availability of new and effective drugs, the Government has proposed waiving off clinical trials for those drugs that have already proved their efficacy in developed markets.
Hopefully, with increasing political will to create a favourable environment for research by foreign investors and to give domestic research and development the essential push, we will be able to build a stronger research ecosystem that promotes ongoing innovation.
Dr. Vishwanath Mohan is Chairman and Chief Diabetologist, Dr. Mohan’s Diabetes Specialities Centre
Source: The Hindu