1. Clinical trials in India: new statistics, new
Ever since the clinical trials have come under the scanner of
the Supreme Court of India ("SC")
following its order on January 3, 2013, the regulatory agencies,
the Drug Controller General of India
("DCGI") and the CDSCO have intensified
the monitoring of the clinical trials and the government had also
set up Apex Committee and Technical Committee to supervise the
clinical trials. In the last few years, they have issued notices in
235 cases and inspected 577 clinical trial sites. Increased
proactive steps and new guidelines have resulted in a sharp decline
in the number of clinical trial approvals. Till the end of August
this year, the DCGI has given permission to only 162 clinical trial
The government had also constituted 12 New Drugs Advisory
Committees ("NDACs"). The NDACs met 78
times and evaluated 1,122 applications for approval of
clinical trials, new drugs and fixed dose combinations. Among these
applications, 331 were related to approval of Global Clinical Trial
("GCT"), which included clinical trials
of new chemical entities and NDACs have recommended for approval of
285 applications. For 46 applications, no recommendation have been
made. Out of the above 285 applications, DCGI has given approval to
conduct clinical trials in 162 cases.
As per the directions by the SC to consider the views of all the
states, a meeting of the Chief Secretaries, Health Secretaries of
the State Governments and the Administrators of the Union
Territories was convened by the Union Health Ministry. With a view
to further streamlining clinical trials and minimizing the
irregularities in the sector, some states have suggested
restricting the trials only to the government-run hospitals in the
Keen on improving the current scenario, government has proposed
a new Drugs and Cosmetic (Amendment) Bill, 2013, now under the
scrutiny of the Parliamentary panel. The idea is to have a separate
chapter on clinical trials and put all the existing guidelines and
instructions from the DCGI under the framework of law. It has
comprehensive provisions to monitor the trials and also deciding
compensations to the victims. Further, an expert panel has been
appointed under Prof Ranjit Roy Chaudhury, which recommended
several changes including creation of a Central Accreditation
Council to oversee the accreditation of institutes, clinical
investigators and institute ethics committees for clinical trials
in the country. It also suggested that trials should be carried out
only at centers which have accreditation.
PSA view - India needs a robust system
for conducting clinical trials and to ensure that trials are
conducted in a scientific and ethical manner and in compliance to
the regulatory provisions. There have been allegations that the
approvals to the clinical trials are coming hard and slow after the
SC order thereby impacting the overall performance of the clinical
trials sector. This sector has great potential to grow but the slew
of legislations and guidelines has already stopped several CROs to
suspend trials here. As the government is aware of the implications
from investments perspectives, it has started taking proactive
measures to streamline the sector and gain back the confidence of
the foreign players in the market, while also keeping the concerns
and safety of subjects involved in the overall process.
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