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The National Human Rights Commission has written to the Union Health Ministry to seek their view on guidelines prepared by the NHRC on clinical trials including compensation and risks involved. The guidelines, framed by an expert committee of NHRC, have suggested that ethics committees should be set up in all institutions undertaking studies on human subjects and should be registered as per the Act. The NHRC's expert committee also suggested that standard operating procedures (SOPs) should be written down and followed in all clinical trials based on prevailing good clinical practices (GCP) guidelines for biomedical research on human participants and there should be an effective mechanism for monitoring the implementation of the SOPs.
Ethics committees should be constituted as per the Act and all ethics committee members should familiarise themselves with various aspects of ethics guidelines and provisions of Act, rules etc for clinical trials, it said. Information given to patients should include details of risks involved as per the current knowledge and it should also inform about the rights of the participants for compensation in case of injury or death during the study as per the prevailing provisions of Acts and regulations.
Procedure for recruitment of participants and volunteers for the trial should be documented in the SOP. Guidelines for the procedure should be framed with due deliberation and should be in consonance with ethical guidelines for biomedical research.
Participants of the clinical trial should be provided medical care from the time of enrolment in the study, for the duration of study and for the period of follow up as specified in the protocol, the guidelines on clinical trials suggested. The Commission in a statement said that it has also decided to file an affidavit before the Supreme Court and intervene in the pending matter related to clinical drug trials.
Earlier, the Health Minister said that 436 people had died due to serious adverse events during clinical trials. Such deaths are investigated to arrive at the causal relationship, if any, Azad had said in parliament. In 2011, 438 cases of SAE were reported, of which 16 were believed to be due to clinical trials while the previous, 668 cases of SAE were reported, of which 22 were caused due to trials. (Read: Can ethical committees stop illegal clinical trials? )
The health ministry reported that there were only nine cases of irregularities in clinical trials during the last three years. Reports suggested that a phase IV clinical trial for an HPV vaccine was carried out on unsuspecting tribal girls. There were also reports of deaths of seven girls in the same trial which led to suspension of the whole process a year later (April 7, 2010) and a committee was constituted to enquire into the alleged irregularities, said a senior health ministry official. (Read: Human rights group asks Health Ministry to explain illegal clinical trials)
There were also indications that on several counts where the NGO which was conducting the aforementioned trials behaved irregularly. In some cases the consent forms actually read You will not be charged for your daughter to receive the vaccine . However, the NGO conducting the trials was let off with a warning letter only asking them to be careful in future, the official said. (Read: India s drug control body s hall of shame) Various sources also suggested that major global pharmaceutical companies were using India as their testing ground for different drugs for cancer and antibiotics. The SC had also pointed out the government s failure to halt unethical clinical trials by multinational drug companies on Indian patients who were used as guinea pigs . Referring to a May 2012 report of the Parliamentary Standing Committee on health and family welfare, Judges R.M. Lodha and Anil R. Dave said it really pains us that illiterate people and children of India are being used as guinea pigs by the multinational drug companies . The health ministry data shows the number of trials being approved has also gone down: from 529 permissions granted in 2010 to 283 in 2011 and 253 in 2012.