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.
Clear
advantages
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.
Source: THE HINDU-3rd December,2017
