“Who is monitoring them? The sponsors should set up monitoring committees to ensure the safety of the person undergoing trial and the implementation of the ICMR guidelines,” Senior Deputy Director General, Indian Council for Medical Research (ICMR) Vasantha Muthuswamy.

The ICMR’s ethical guidelines for biomedical human research have recently been revised in response to advances in reproductive technologies and research. Speaking on the sidelines of the second National Bioethics Conference, in Bangalore on Thursday, Dr Muthuswamy said as per the ICMR guidelines all hospitals should have ethics committees and they should be responsible for not only giving their approval for the clinical trial.

She said this is a new concept in India. “The ICMR guidelines should be converted into a Bill not only for clinical trials but also for research. We have recommended it to the Centre; it is pending before the Health Ministry. The problem will persist even then, if the Ministry does not put stringent monitoring mechanisms in place,” said Dr Muthuswamy.

Multinational (pharmaceutical) companies have set up data safety and monitoring boards for conducting clinical trials but the Indian firms don’t have the resources. “India is being projected as the global hub for clinical trials by industry and its associations like FICCI, CII and ASSOCHAM but very little has been done to monitor the trials. Protection of the individual’s needs and safety should be monitored; whether he or she had given an informed consent and the amount of compensation paid to the subject in the event of an injury during the trial,” she said. “People are not protected by insurance. Whereas the sponsors have the insurance cover, there’s no insurance for the subjects of trial. Insurance is a grey area in the country,’ she said.