The Clinical Research industry has been in a state of dilemma with the
changing regulatory scenario of India. It started with an upsurge of projects between
2005 and 2010 and then a steady decline in the last 5 years. The Government has reacted
to this paradigm shift by instituting new regulations with more stringent measures
to check compliance and conduct of the clinical research activities. The prime
area of focus has been to increase the regulatory vigilance over investigators, sponsors,
ethics committees and the institutions, thus ensuring protection of the subject rights,
safety and wellbeing.
We aim at emphasizing the need to shift the priority zone from ‘developing measures
to cover subject rights and safety’ to directly ‘empowering subjects’ by making them
aware of their rights and responsibilities. Our endeavor is to cover the current healthcare and clinical research status and
the regulatory reforms in India; highlighting the ‘need of the hour’ that demands an urgent attention and swift engagement.
We also propose ways to achieve this goal of spreading education and awareness regarding clinical research among
the masses and visualizing the impact it would make on the nation’s health status.
Considering the exponentially growing healthcare needs, the changing trends of the disease burden and the great potential
of the nation for supporting clinical research activities, it is essential to map ways to capacitate the general population to
contribute to the scientific developments and healthcare advancements without affecting their rights, safety and wellbeing.
The new regulations would then act as an agonist to aid in making India a nation that delivers fair, scientific, ethical
and good quality research.