Clinical trials of drugs in India have seen a drastic
fall this year after toughened norms were introduced following Supreme
Court directives.
Not only have the number of trial
approvals in the country reduced, there has also been a significant
reduction in the number of sponsoring pharma firms applying for such
approvals.
Official Health Ministry data shows that
until January 31 this year, only six trials had been approved. Even
these pertained to older applications where the Drug Controller General
of India had asked the applying firms to make some amendments.
Sources
say until April, only around 12 approvals have been granted by the DCGI
for trials of drugs in India. Pending applications for trials as of
today are just 70.
This is in sharp contrast to the
past when the number of Global Clinical Trials (GCTs) approved for
conduct in India was in hundreds
Though in 2008 the
DCGI had granted just 65 approvals for trials, the number in 2009 rose
sharply to 391. The trend continued with a whopping 500 GCTs being
allowed in 2010 and 325 in 2011 followed by 262 approvals in 2012.
Admitting
that there has been a drastic fall in fresh applications for conduct of
global clinical trials of drugs in the country, DCGI GN Singh told PTI,
“The safety and well being of Indian subjects participating in clinical
trials is the foremost in our minds.
“This is why
the Government has tightened the norms putting the onus of safety of
participants on firms conducting the trials. It is for the first time
that such norms have been put in place.”
As many as
2,262 people died in these trials during the past five years, leading to
a public outcry and Supreme Court intervention for stricter norms for
holding drug trials. The apex court had rapped the Health Ministry for
allowing Indians to be used as “guinea pigs” in the conduct of drug
trials.
Also before the new rules were put in place,
the average compensation awarded per death was a meagre Rs 2.2 lakh as
per Health Ministry data.
The Government recently
notified new rules for the conduct of drug trials in India, making it
mandatory for investigators and sponsors to address issues of serious
adverse events such as death of subjects involved in trials and fixing a
formula for grant of adequate compensation in such cases.
Pharma
firms, the sources say, have been discouraged to apply for new trials
due to recent stringent norms which the Government has notified as a
precondition for grant of approvals.
The new rules
which came into force this year, for the first time, propose a formula
for minimum compensation to be paid by the sponsoring firm in case of
serious adverse events such as death or injury of the trial participant.
New rules also require the setting up of independent ethics committees under medical institutes to monitor ongoing drug trials.
These committees must now be registered with the DCGI prior before the conduct of clinical drug trials.
In
the older system, pharma company hosting the trial could set up its own
committee and have its own investigators for inquiring into serious
adverse events.
Currently pegged at USD 500 million,
India’s clinical research market was projected to more than double and
cross USD one billion mark by 2016 driven by a large and easy-to-access
population with much lower cost than in the developed world.
Source: The Hindu
