Indian Society for Clinical Research (ISCR), an association of clinical
trials professionals, has alleged that there was a slow-down in granting
approvals for trials in the recent past and also urged the regulatory
authorities to address the issue.“ISCR is fully supportive of
the initiatives undertaken to create a more robust and regulated
environment in India for the conduct of clinical research, one which
ensures the practice of the highest standards of ethics and quality and
where patient rights and safety are protected. However, ISCR would like
to express its concern with regard to the slowdown in granting approvals
for clinical trials in the country which has the greatest impact on
patients for many of whom clinical trial provides early access to a new
treatment and for others, the last option or hope of a cure. Without
clinical trials there can be no new therapies,” a spokesman of ISCR said
in a statement.The association pointed that the Working Group
on Disease Burden for the 12th Five Year Plan referred to the “triple
burden of disease” that developing countries like India were 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 the 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 need. 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. Clinical trials should not come to a standstill and impede the
process of finding better and more effective medicines for our
population,” the statement said.“We hope that in the greater interest of patients, the regulatory authorities will address this concern on priority,” it said.
Source:Pharmabiz
Source:Pharmabiz
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