FM AUGUST 2018 ISSUE1 - digital edition

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trialomics
Charting a new course
Shedding ambiguity, India’s clinical trial climate is evolving
to be more proactive and responsive, after a long
indecisive phase
Dr Arun Bhatt
Dr Bhatt is a consultant
on clinical research &
development from Mumbai.
arun_dbhatt@hotmail.com
I
n 2005 Schedule Y of Indian Drugs and
Cosmetics Act was amended to permit conduct
of Phase 2 and Phase 3 clinical trials concurrent
with Western countries in compliance with Indian
drug regulations and global standard of clinical trial
conduct–Good Clinical Practice (GCP). This standard
requires that all stakeholders – pharma industry
sponsor, clinical research investigators, and ethics
committee (EC)–ensure that rights, safety, and wellbeing
of clinical trial participants are protected.
However, frequent media stories focusing on ethical
deviations and exploitation of clinical trial subjects
from lower socioeconomic and educational
background, and 2012 Supreme Court writ petition
against clinical trials compelled the Indian regulatory
authorities–Central Drugs Standard Control
Organisation (CDSCO)- to strengthen clinical Trial
regulations. Major changes in the regulations made
in 2013 were:
1. Rule 122DD: Regulatory requirements for
registration of ECs
2. Rule 122DAB: Financial compensation and
free medical management for subjects who
suffer from serious adverse events – injury or
death–related to clinical trial to be paid by the
industry sponsor
3. Audio-visual (AV) recording of informed consent,
including the procedure of providing information
to the subject and his understanding, by
the investigator
These changes have made ECs, investigators, and
industry sponsors more responsible and accountable
for protection of clinical trial participants. In addition,
for clinical trial approval (CTA) the sponsor must
submit assessment of a) risk vs. benefit to patients
b) innovation in new therapy vis-à-vis existing
therapy and c) unmet medical needs. The sponsor
should give an undertaking that the company will
apply for marketing authorization of new drug in
India after successful completion of clinical trial and
submit details of financial support to the investigator
for the conduct of trial. To strengthen the review,
oversight and monitoring of clinical trials, the
government established a 3-tier structure – subject
expert committee (SEC), technical committee, and
apex committee. As these regulatory changes made
CTA process long and uncertain, the number of new
clinical trials dropped. In response, the government
made 1) pragmatic modifications in compensation
conditions, 2) limited AV consent requirements to
vulnerable subject in clinical trials of New Chemical
Entity /New Molecular Entity trials, and 3) empowered
ECs to take decisions regarding academic trials with
non-commercial objectives and concerning site issues
such as number of clinical trials per investigator,
need for relevant infrastructure, and addition of a
new investigator. The regulatory review process has
been simplified, which now requires Global Clinical
Trial approval by SEC without the need for review by
technical committees unless the sponsor or CDSCO
disagree with SEC opinion. These changes have
improved the predictability and timelines.
Indian regulatory environment for clinical trials is
gradually evolving from being volatile, unpredictable,
complex and ambiguous (VUCA) to proactive,
unambiguous, time bound and responsive to
fundamental ethical requirements of protection
of rights, safety and wellbeing of clinical trial
participants
50 / FUTURE MEDICINE / AUGUST 2018