Last month, National Human Rights Commission asked Indian Council of
Medical Research and the office of Drugs Controller General of India to
provide a detailed report on the status of clinical trials being
conducted in India. NHRC’s demand is in the wake of growing number of
deaths taking place while conducting clinical trials in the country
during the last two to three years. As per the health ministry’s
records, 671 persons had died during clinical trials last year and a
majority of them were sick volunteers. And the ministry admits that most
of the dead volunteers were not given any compensation by the CROs or
the pharmaceutical companies. It is unfortunate that the pharmaceutical
companies and their agents getting away with this kind of gross
unethical practices in the name clinical trials. Ever since the clinical
trials started on a big scale in the country, reports were appearing in
the media about the unethical practices indulged in by CROs in clinical
research. The health ministry is fully aware of this fact but has not
been taking any serious steps to bring in effective regulation in this
sector. This is despite the demands for enforcing proper regulations to
monitor and control clinical trials from various sections of the
society. A public interest litigation is expected to come up in the
Allahabad High Court calling for a ban on all clinical trials until
specific laws to govern trials are in place. Civil society groups have
alleged that clinical trial monitoring is not mandated under the Drugs
& Cosmetics Act 1940 and yet the government is regulating the trials
as per the provisions of the Act.
The health ministry has been
working for last ten years to put in place a set of comprehensive rules
to regulate clinical research with flow of large number of contract
research jobs into the country. Country cannot afford to have such
laxity in enforcing appropriate laws to this vital area of medical
research. Multinationals and CROs are aware of this deficiency in law
and they are fully exploiting the situation at the cost of human lives.
What the country has a set of guidelines after amendment of the Schedule
Y of Drugs & Cosmetics Act. There are no indications when these
rules will be finalised and implemented. It is in the background of this
uncertainty, health ministry made it mandatory for the CROs to register
themselves in July 2009 to have some accountability. Even this
registration process is not progressing as expected. Ethics Committees
at most of the trial sites are also not active with no proper monitoring
of trials. Considering this dismal state of affairs in regulating
clinical trial sector, NHRC's action is a welcome step to generate some
public interest and action.
Source: Pharmabiz
