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April 22, 2009
Clinical Trials – Added Stringent
Measures On Their Way!
The clinical trial framework in India is all
set to get a facelift. The Ministry of Health and Family Welfare
is soon going to amend the Drugs and Cosmetics Rules, 1945, by
inserting an added schedule to the already existing Schedule Y
(which deals with the requirements and guidelines for permission
to undertake clinical trials in India) as well as a new Rule
122DAB. The proposed amendments, which have already been
approved by the Drug Technical Advisory Board (“DTAB”)
and the Drugs Control Committee, and now await notification, is
intended to be brought about in view of India’s rapid growth in
the pharmaceutical sector and it being one of the prime clinical
trial markets, which has attracted multinationals globally who
have their eyes set on India for the next few years at the
least.
The proposed new Schedule ‘Y1’ will contain rules relating to
clinical trials including regulations for registration of
clinical trials and Contract Research Organizations (“CROs”),
penalty provisions for violations committed, registration of the
ethics committees and on-site audits of trials.
Until now, the regulations dealing with clinical trials did not
specifically cover penalty related provisions in instances where
clinical trials were not being conducted in accordance with the
required regulations nor have there been adequate provisions
dealing with compensation of the clinical study subjects at the
time of an injury arising to a particular study subject.
However, with the new Schedule Y1, it is intended to impose
penalty in the form of ten years of imprisonment for violating
clinical trial norms. Moreover, mandatory conduct of audits of
the clinical trials are also proposed which may come as a timely
relief to most multinational companies who enter into
arrangements with CROs and where they find it cumbersome to
monitor and ensure appropriate safeguards are in place including
adherence to quality norms while conducting the trials.
Another essential aspect is that of registration of the CROs for
the conduct of clinical trials, which is expected to be made
mandatory from June 2009, as soon as the proposed amendments are
notified. Registration will ensure that the minimum requirements
for a CRO to be able to conduct a clinical trial are adhered to.
Once an effective mechanism is put in place for the registration
of CROs, the Drug Controller General of India (“DCGI”)
also aims at slowly getting applicants who wish to conduct
clinical trials to register themselves online with the Clinical
Trials Registry-India (“CTRI”) which was
launched in July 2007 by the National Institute of Medical
Statistics, Indian Council of Medical Research. However,
registration at the CTRI is currently only voluntary. It is
proposed to be made mandatory sometime in June this year in
order to publicly make available, from a single source,
information about ongoing trials in the country, thereby
streamlining and enhancing the accountability and transparency
of clinical trials in India, thereby reducing the loopholes in
each and every clinical trial.
Considering India is one of the preferred destinations for
clinical trials and the rapid rise in the number of trials being
conducted in India, bringing about changes in the regulations
for effective implementation of the clinical trials is the need
of the hour to make sure India continues to enjoy its strong
position in the clinical trial market and where there is a
possibility of greater expansion on an even larger scale!
-
Khushboo Baxi, Dr.
Milind Antani
&
Gowree
Gokhale
You can direct your queries or
comments to the authors
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