cover story
“Clinical research scenario witnessing
continuous improvements”
While there was a phase in India when the number of clinical trials came
down drastically, the situation has of late seen a good turnaround, writes
Dr Renu Razdan, former Vice Chairperson, ACRO
D
espite having almost 17
percent of the world’s
population and almost 1820 percent of the world global
disease burden, only 1.4 percent
of the global clinical trials
currently take place in India. For
the past few years, due to
uncertainty in regulations and
hence judicial intervention, India
has been viewed as a destination
non conducive to the conduct of
clinical trials. This period started
in 2010 and continued till end
of 2013.
Biopharmaceutical companies
missed out on opportunities to
conduct clinical trials in India and
academic clinical trials could also
not be conducted. This was a major
loss to Indian patients as well who
in addition to suffering from
diseases like tuberculosis, cholera,
and malaria etc., also suffer from
lots of diseases that were once
considered as diseases of western
industrialized society. Hence unmet
needs of Indian patients were not
addressed. Additionally, lot of
developments in medical science
and advanced research were missed
by highly skilled and young
professionals of India.
Hope the worst is over!
From 2014 onwards, the
substantial changes and
improvements have taken place
due to active Central Drug
Standard Control Organization
(CDSCO) officials, academicians,
20
BioVoiceNews | July 2016
Though the
indigenous
companies have
started to again
consider conducting
clinical trials in India,
there still exists
hesitation in the mind
of global investors
which needs to be
taken care of.
clinical research professionals of
society and industry. As a result
lot of improvements in systems
and processes have been
undertaken by Indian regulators
leading to major improvements in
clinical research scenario in India.
Major improvements seen
towards conduct of clinical
research and trials in India are
the following:
Predictable approval timelines
with the expansion of the Subject
Expert Committees of the health
ministry has created 25 panels of
experts for various therapeutic
areas to be known as Subject
Expert Committees. Feedback
from the industry is that this has
resulted in reduced approval
timelines which are averaging six
to seven months from submission
to final approval as compared to
18 months earlier.
Revision in Drugs and
Cosmetics Act and Rules –
Ministry of Health and Family
Welfare, Government of India
have issued several Gazette
Notifications since 2013 to
introduce amendments in D&C
Act and Rules.
Assurance for marketing of the
investigational drug – The
sponsor of clinical trial needs to
submit an undertaking
concerning marketing of the
investigational drugs in India
after successful completion of
Phase 3 clinical trials.
Registration of Ethics
Committees – Registration of
Ethics Committees with CDSCO
has been mandated w.e.f. Feb 8,
2013. Clinical Trials can be
reviewed and approved only by
registered Institutional Ethics
Committees whereas Independent
Ethics Committees can only
review non interventional clinical
trials. Around 950 ECs have been
registered till date.
Increased manpower at
CDSCO offices to reduce review
timelines – Several new positions
including Assistant Drug
Inspectors (ADIs) have been
recruited at CDSCO offices.
Introduction of online portal
(Sugam) for submission, review
and tracking of applications for
Import and Registration, Medical
Devices and Diagnostics,
Cosmetics and Ethics Committee.
Online submission of Global