SC seeks details of all clinical trials
9 Oct 2012 12:58 AM GMT
The Supreme Court Monday asked the central government to provide details of clinical trials being conducted throughout the country, their side effects and deaths, if any.
A bench of Justice R M Lodha and Justice Anil R Dave, while asking the central government to furnish the details, also issued notice to all state governments, seeking to know whether they were being kept in the loop regarding clinical trials in their states.
The court asked the central government to furnish the details of number of applications received by Directorate General, Drugs and Cosmetics, for clinical trials from 1 January, 2005 to 30 June, 2012. It also asked the government to furnish details of the number of patients who suffered side effects on account of these clinical trials and the nature of these side effects.
The court also sought information on the number of patients who died on account of these clinical trials and the compensation that was paid to these people who suffered side-effects or their next of kin in case of deaths.
The court wanted to know if the states have any special laws or regulations to regulate clinical trials.
Leaving none in doubt about its seriousness, the court said: ‘We are very serious about the matter. We can pass one line order asking all these clinical trials which effects many people must stop forthwith.’   Â
A bench of Justice R M Lodha and Justice Anil R Dave, while asking the central government to furnish the details, also issued notice to all state governments, seeking to know whether they were being kept in the loop regarding clinical trials in their states.
The court asked the central government to furnish the details of number of applications received by Directorate General, Drugs and Cosmetics, for clinical trials from 1 January, 2005 to 30 June, 2012. It also asked the government to furnish details of the number of patients who suffered side effects on account of these clinical trials and the nature of these side effects.
The court also sought information on the number of patients who died on account of these clinical trials and the compensation that was paid to these people who suffered side-effects or their next of kin in case of deaths.
The court wanted to know if the states have any special laws or regulations to regulate clinical trials.
Leaving none in doubt about its seriousness, the court said: ‘We are very serious about the matter. We can pass one line order asking all these clinical trials which effects many people must stop forthwith.’   Â
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