|
DCGI initiates slew of measures to streamline conducting clinical trials
|
|
Ramesh Shankar, Mumbai
August 26 , 2016
|
|
|
The Drugs Controller General of India (DCGI) Dr GN Singh has initiated a
slew of measures to streamline for conducting clinical trials in the
country by creating strong regulatory platform for ensuring safety,
rights and well beings of the trial subjects.
The DCGI decided to
consolidate functions in such a way that India may become a favourable
destination for doing clinical trials and create conducive environment.
That may enable the sector to enter swiftly into drug discovery and
address issues of emerging diseases and assist the patients to get safe
and high quality medicines at affordable prices.
In this regard,
the DCGI already removed the restrictions on the number of clinical
trials an investigator can undertake at a time. At present, no
investigator should conduct more than three trials at any given period
of time. Removing the restriction, the DCGI empowered the Ethics
Committee to take a final call on the number of clinical trials an
investigator can do at any given time after examining the risk and
complexity involved in the trials.
Close on the heels of this
decision, the DCGI removed another bottleneck by allowing clinical
trials in less than 50-bedded hospitals. Currently, no clinical trials
can be conducted at site having less than 50-bedded hospitals. After
doing away with this provision, the DCGI decided that the Ethics
Committee will examine and decide whether the clinical trial site is
suitable for trial or not, irrespective of number of bed. However, the
DCGI suggested that the site should have emergency rescue and care
arrangements along with all other necessary facilities required for that
particular clinical trial.
In yet another measure, the DCGI also
removed the bottleneck of requirement of no objection certificate (NOC)
from DCGI for addition of new clinical trial site or investigator in
clinical trials. Instead, the DCGI decided that the respective Ethics
Committees after due deliberations can approve proposals for addition of
sites and investigators and no NOC from DCGI, in the normal course,
should be necessary. However, the applicant would inform DCGI about any
such addition or deletion and thereafter, if no objection is received
from DCGI, it would be deemed to have concurrence of CDSCO.
The
DCGI measures to streamline the conductance of clinical trials do not
end there. As regards requirement of approval of Review Committee on
Genetic Manipulation (RCGM) under Department of Biotechnology for r-DNA
derived drugs like insulin, monoclonal antibody, etc, it was decided
that the applicant may submit parallel application to RCGM and DCGI
seeking approval to conduct clinical trial. However, the DCGI shall
complete the scrutiny of application and permission only after RCGM
clearance was received.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|