CIC asks Bhopal hospital to reveal details of drug trials
Nitin Sethi, TNN | Mar 26, 2013, 02.59 AM IST
NEW DELHI: The Bhopal Memorial Hospital and Research Centre, set up in the wake of the gas tragedy, has been asked to reveal all details of clinical trials carried out at the centre including that of patients who died during the drug trials.
The hospital has been at the centre of a long standing controversy over carrying out drug trials on poor gas victims but had refused to reveal information claiming confidentiality of the client - the drug companies, the hospital and the patients. The CIC has over-ruled the objections by the hospital and ordered it to reveal all information.
The hospital also contended that the trials were conducted when it was run by a trust - an autonomous body -- and was not getting any grants from the central or the state government. It noted that the hospital had been taken over by the government only in July 2010 since when the RTI rules should apply.
But the CIC said, "Even if the patients do not agree to the disclosure of the requested information, it is still open to this commission to order disclosure of information in the larger public interest. Given the fact that a number of drugs manufactured by foreign/Indian companies were tried on these poor, helpless victims of the gas tragedy, I am of the opinion it would be in the larger public interest to disclose the requested information."
The CIC decision could also open the door for information to be revealed on other clinical trials in India which have been mired in controversy as well.
The petitioner, Bhopal gas tragedy activist Rachna Dhingra, had previously obtained information about the Bhopal hospital from the Drug Controller General of India which shed light on eight trials and detailed 13 deaths in three such trials. But records show that the Bhopal hospital had conducted at least 15 trials.
The CIC has ordered the hospital to reveal details of people on whom the trials were conducted, the funds the hospital got to carry out the trials from different drug companies or other agencies, the number of patients that died, the drug companies involved as well as the records of review of the trials by the Institutional Review Board.
The hospital has been at the centre of a long standing controversy over carrying out drug trials on poor gas victims but had refused to reveal information claiming confidentiality of the client - the drug companies, the hospital and the patients. The CIC has over-ruled the objections by the hospital and ordered it to reveal all information.
The hospital also contended that the trials were conducted when it was run by a trust - an autonomous body -- and was not getting any grants from the central or the state government. It noted that the hospital had been taken over by the government only in July 2010 since when the RTI rules should apply.
But the CIC said, "Even if the patients do not agree to the disclosure of the requested information, it is still open to this commission to order disclosure of information in the larger public interest. Given the fact that a number of drugs manufactured by foreign/Indian companies were tried on these poor, helpless victims of the gas tragedy, I am of the opinion it would be in the larger public interest to disclose the requested information."
The CIC decision could also open the door for information to be revealed on other clinical trials in India which have been mired in controversy as well.
The petitioner, Bhopal gas tragedy activist Rachna Dhingra, had previously obtained information about the Bhopal hospital from the Drug Controller General of India which shed light on eight trials and detailed 13 deaths in three such trials. But records show that the Bhopal hospital had conducted at least 15 trials.
The CIC has ordered the hospital to reveal details of people on whom the trials were conducted, the funds the hospital got to carry out the trials from different drug companies or other agencies, the number of patients that died, the drug companies involved as well as the records of review of the trials by the Institutional Review Board.
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