In the wake of Clinical Centres in the state functioning against
the principle of human research ethics, the government has decided to formulate
a Clinical Trial Registry in the state under the Drugs Control Department.
The state drugs controller has been entrusted with
formulating the guidelines for the Clinical Trial Registry. The officials have been asked to prepare the guidelines on the
basis of the government's direction and the guidelines will be
prepared in two months time.
The registry will include details of
study title, hospitals and clinicians involved, type of research and inpatient
details.
The government had decided to go for Clinical Trial
Registry based on the recommendations of a committee under the Chairmanship of
V N Rajashekharan Pillai. The committee was formed based on various media
reports that illegal clinical trials were being conducted in the state. It was
found that the institutions that conduct clinical trials in the state were not
following the conditions stipulated as per rules. The committee also pointed
out that the patients for study were being recruited through medical camps in
interior villages and mostly illiterate or people from low income groups are
targeted for these studies.
Source: The New Indian Express
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