Indian Council of Medical Research washes hands off drug trials in Bhopal hospital
According to ICMR director general Dr VM Katoch, which took over administration of BMHRC in 2012, doctors who erred in clinical trials will have to fend for themselves. During his visit here on Sunday, Dr Katoch told TOI, "If laid down procedures at the time of the clinical drug trials were followed, only then the system would stand by these doctors. It is like everything else that we have inherited by takeover of BMHRC."
Dr Katoch's remark follows an affidavit in the Supreme Court by Union health secretary, Keshav Desiraju. On December 13, Union ministry of health and family welfare admitted that 215 gas victims patients were enrolled out of a total 279 patients for clinical trial.
Sources said a team of central drug standard control organization (CDSCO) had carried out an inspection of one clinical trial at BMHRC in 2010. Its findings showed some deficiencies like non-payment of compensation to the patients for participation, non-reporting of serious adverse events with prescribed timelines among others. Swasthya Adhikar Manch, an NGO, also filed a petition raising this issue.
Terming ICMR more as a safe passage for erring doctors, activist Rachna Dhingra said, "How is ICMR different from DOW, which also does not take onus of Bhopal gas leak? ICMR needs to take onus of these deaths and proactively reveal all information related to drug trials carried out in BMHRC.
She said unethical and illegal drug trials should be investigated. DCGI audit reports of three trials show that 13 gas victims have died as a result of drug trials, she said.
Dr Katoch said resignation of consultants was not a surprise. They were demotivated after private share was stopped by ICMR, as per central government norms. "Nobody is bigger than the organisation," he said.
Consultants, on the other hand, have frequently complained delayed Central government procedures hindering patient care. A breath later, Dr Katoch credited the doctors for establishing BMHRC as a specialty hospital in central India.
NGOs working for gas victims allege that ICMR is yet prove its competence in running a tertiary care hospital, on which lakhs of gas victims depend. On an optimistic note, Dr Katoch said, vacant posts will be filled by ICMR in the next six months.
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