Supreme Court bans clinical trials
Need of the hour : Proper monitoring and stringent
laws on violators
The Central Health and Family Welfare Ministry
has banned the clinical trials after the intervention of Supreme Court on
asking the Centre and the State governments as to what steps have been taken to
save the patients from the dangerous clinical trials by the multinational
companies, who are creating havoc in the country and failing to stop the
rackets which has caused deaths.
It is not a good thing that on the issues
relating to public interest, the court should ask all the time to the
governments. Moreover, it was necessary because
of the fact that during the last of two and a half year, there had been 1317
deaths and about 2000 clinical trials are already going on, for which the
authenticity of documents would be reexamined.
According to Drug Controller, GOI, India
It is pertinent to mention that for the first time when six tribal girls
from Gujarat and Andhra Pradesh involved in
the clinical trials of anti-cervical cancer HPV vaccine died, the government
has admitted that 1725 persons have lost their lives to drug trials in last
four years.
In fact, Pharmaceutical industry has become a powerful industry, driven
only by profit. The MNCs conduct clinical trials of new drugs, on the people
who are economically weak and underprivileged. The poor, who has become a trial
subject in lieu of a meager amount of money.
Many of the drugs being tested
are not even of specific relevance to the country and could have been tested
anywhere. Equally shocking is the fact that the rules, under the Drugs and
Cosmetics Act, entirely trust the trial investigator with the reason attributed
for the death of a subject. This is resulting in gross under-reporting of
actual deaths during clinical trials.
No doubt, in our country,
guidelines do exist for enrolment of volunteers for clinical trials, which
include obtaining consent, clearance of trial from an institutional ethics
committee, due care of the volunteers, during and after the trial, if any
physical injury occurs to the volunteer but they have a weak legal sanction. More-over, doing clinical trials without
giving proper knowledge to the patients is illegal.
The improper clinical trials
not only put the patients in danger on which the trials are conducted but would
create a havoc for all those patients who are given the medicines after its
sanction. No doubt, such trials were
also being conducted in the past but using the citizens of an independent and
democratic country, is a blot on our system.
Since the cost of testing in
India is 80 per cent less than in the developed world, firms come here, there
is need to frame rules to specify that trials will be allowed only in cases
where the firm in question undertakes to make the drug available to Indians at
affordable prices.
The need of the hour is that laws against such damaging clinical
trials should be made stringent and heavy penalties should be imposed on the
violators.
###
