Clinical trials of untested drugs creating havoc: SC
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It had directed the Union government to come out with details of the deaths, if any, and the side effects and compensation, if any, paid to the victims or their family members.
The court's direction came during the hearing of a public interest litigation (PIL), filed by NGO Swasthya Adhikar Manch, alleging large-scale clinical drug trials across the country by various pharmaceutical firms using Indian citizens as guinea pigs in those tests.
The bench had, however, refrained from passing any blanket ban on the trials and, instead, sought a comprehensive reply from the Centre on various issues.
The NGO had alleged that the clinical trials by several pharmaceutical companies were going on indiscriminately in various states.
However, the Madhya Pradesh government had contended that the states cannot be faulted for the tests as the permissions for trials were granted by the Central government without consulting them.
The argument, however, did not impress the bench which had pointed out that the said clinical trials were conducted in state governments hospitals whose employees and doctors were under the control of the respective state governments.
It had then proceeded to issue notices to all the states, through their chief secretaries, for their responses and posted the matter for further hearing after eight weeks.
Prior to introduction of a new drug for use by humans, a company is required to conduct clinical trials to study its effects on people.
Detailing several cases of alleged illegal drug trials in Indore, the NGO has said in its petition, "Over 3,300 patients were used for the tests. Approximately 15 government doctors were involved. About 40 private doctors in 10 private hospitals were involved.
"Clinical trials were conducted on 233 mentally-ill patients, 1,833 children in the age group of one day to 15 years.... Approximately Rs. 5.5 crore were paid to the
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