TNN Oct
16, 2013, 06.58AM IST
HYDERABAD:
Following the incidents of pharmaceutical companies indulging in malpractices
in conducting clinical trials on humans in 2011 in Hyderabad, the National Human Rights Commission (NHRC)
has come out with guidelines on conducting clinical trial of drugs. The NHRC
had constituted an expert committee in drug regulation and clinical trials
which has come up with several recommendations.
The first thing the committee
pointed out was that subjects who were normal healthy persons and who
participated in the bioavailability/bioequivalence study in the Hyderabad
incident were not given proper information on the risks involved in the study
and were also exploited for money. The participants were also not provided
proper medical care for subsequent side-effects.
One of the main recommendations of
the NHRC committee is that ethics committee should be set up in all
institutions undertaking studies on human subjects and should be registered
under the Drugs and Cosmetics Act and Rules. A standard Operating Procedure (SOP)
should be followed in all clinical trials/clinical studies, based on the
prevailing good clinical practices (GCP) guidelines issued by the Central Drugs
Standard Control Organisation (CDSCO) and the Indian Council of Medical
Research (ICMR).
While setting up an ethics committee
is a must, making the members aware of the provisions of various Acts is also
necessary, the NHRC said. For the purpose, it was recommended that
regional/state training centres be set up where a common minimum syllabus would
be covered in a course on ethical guidelines.
"Informed consent procedure
should be standardized and simplified. Information given to patient should
include details of risks involved. It should also inform about the rights of
participants for compensation in case of injury or death during the study as
per the provisions of the Act, regulations and rules," the NHRC said.
It
will not suffice if pharmaceutical companies take the written consent of
persons who are illiterate. An audio-video CD by the investigator should be
shown to participants for their knowledge about the study. There should also be proof of them having seen it.
The procedure for recruitment of
participants/volunteers for the trial should be documented and participants
should be provided medical care from the time of enrollment in the study.
It may be mentioned here that
several people who were subjects in clinical trials of drugs conducted on
humans in Guntur district by a Hyderabad-based pharmaceutical company had to be
hospitalized due to various complications. The NHRC responded immediately and
sent a two-member team to speak to victims directly and come to a conclusion
about what went wrong.
Several instances of deaths have
been reported from other parts of the country during clinical trials. In fact,
the parliament was informed that 436 people died during clinical trials in the
country in 2012. In 2011, as many as 438 people had died and in the year 2010
there were as many as 668 deaths due to clinical trials.
Posted by:
Gauri Shah(Faculty)
29.10.2013
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