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By Sandhya Srinivasan Dr Vasantha Muthuswamy, who helped draw up the guidelines for biomedical research in India, discusses the difficulties of ensuring that the trials being conducted in the country do not risk the lives of Indians
She has been called the Queen of Bioethics. Dr Vasantha Muthuswamy, head of basic medical sciences at the Indian Council of Medical Research, was responsible for coordinating the ICMR’s guidelines for biomedical research, finalised in 2000. Dr Muthuswamy was a keynote speaker at Indian Journal of Medical Ethics’ National Bioethics Conference held in Mumbai in the last week of November. She spoke about the difficulties of ensuring that the hundreds of trials being conducted in India do not risk the lives of Indians. Excerpts from the interview: We keep reading reports of unethical research. The latest seems to be clinics advertising stem cell procedures. We also read that the ICMR is aware of such things but has no control over them. We are a research organisation and have issued guidelines (ICMR: Ethical guidelines for biomedical research on human subjects, 2000). But we are not a policing authority and we have no legal authority to take any action against anybody. Even if the guidelines become law, there will have to be someone to implement the law, and this authority may or may not be the ICMR. The Drugs Controller General is the regulatory authority for clinical trials. Schedule Y of the Drugs and Cosmetics Act applies to trials of new drugs, but permission must be sought from the DCGI for other trials as well, of drugs which have received approval in other countries but have to be marketed in India. But there are laws governing research in India. Under the Drugs and Cosmetics Act all trials in India should follow the ICMR guidelines of 2000. The Medical Council of India (MCI) Act, amended in 2002, states that all research in India carried out by physicians has to follow the ICMR guidelines. So there is indirect power to enforce our guidelines. The Drugs Controller doesn’t have any responsibility for stem cell research. We drafted the stem cell guidelines at the request of the Drugs Controller. But now he says that the DCGI comes into the picture only when there is a tangible product; the stem cell is biological tissue so it comes under the purview of research. So it has to be done under the ICMR. We developed guidelines for stem cell research in 2002 and put them on our website. We have now revised these in consultation with the department of biotechnology and the final guidelines should be out by the end of this year. We have suggested a national apex body for cell-based therapy with membership for all scientific agencies. What regulatory role does the ICMR play in research? The ICMR has a mechanism of review for its own institutions, and so do other government agencies. The problem is with the private labs. There is no one supervising them. If we are funding the research then we do supervision. If we are not giving funding, then there is nothing. Now, if there was registration of all research … Which agencies have control over different aspects of supervision of a trial? Every doctor is governed by the MCI Act. Any doctor doing wrong in a trial or in practice can be prosecuted. The hospital can be closed. The MCI Act is very strong, the MCI has the power to take punitive measures. Whether they are using the power or not, we cannot say. The Drugs Controller has authority over any clinical trial for which DCGI permission has been sought and functions under the Drugs and Cosmetics Act. (Trials of recombinant or biotechnology products come under the Environmental Protection Act and the Department of Biotechnology and the Ministry of Environment have a regulatory role.) But if someone did a trial without asking the Drugs Controller because it is an approved drug and something goes wrong then the Drug Controller will not come to know. It has to come to their attention in some way… That’s right, somebody has to make a complaint to them. But they have the power on hearing or reading a report, they can institute an inquiry. People may have the power to act but they don’t take action because they are under-resourced… Lack of resources is always a problem. They also feel that unless a complaint comes they cannot take action on their own. People ask whether participants in some of these trials are able to give informed consent to participate. If you look at the quality of informed consent in the whole country, you will see that it is suspect. Who really explains trials to participants, except in a few centres? We are trying to improve the whole system, the informed consent process, so that people are able to take the time to explain to participants. If you look at it, generally (the doctor/ researcher) will say, “We are doing this treatment, we are going to use this medicine, we think it will work,” and immediately (the patient/ participant) says, “Yes we agree.” And that is the reality of the situation. A lot of ICMR research is done in public hospitals on people who don’t have any options. The ICMR’s guidelines do define a vulnerable population, but this is open-ended. I would characterise all public hospital patients as vulnerable populations. Whether it is the public sector or the private sector where we think the patients are more knowledgeable, the situation is the same. Patients think doctors are doing something for their good. I don’t think there is any difference between public and private institutions. The understanding of the whole thing is the same. Since we are a government institution, we do the trials at the hospitals which are attached to us … we are also doing this in private hospitals…. The ICMR is a funding agency and trials are done in hospitals where we do give funding, so private institutions are also involved. But we tell them the procedures -- ethics committee approval, informed consent, and so on. This country is changing, a lot of improvement has taken place, but we have a long way to go. There are a number of regulatory changes in India encouraging clinical trials here. What are the implications of such changes? Schedule Y of the Drugs and Cosmetics Act was amended in 2005. Earlier, we required that all foreign drugs be retested at one phase below the highest phase of testing abroad. Now parallel global clinical trials have come. Schedule Y now permits concomitant phase 2 and phase 3 trials. India can become part of global trials. But even then phase 1 has to be repeated for safety. But if we become part of a global trial, a part of a global movement to develop drugs, we can demand an affordable price. So if a new anti-malarial drug is developed by a multinational company, India is part of the global trial; India can have a claim on it. What proportion of these new drugs is relevant to India? We will never approve drugs not relevant to India, but how can you say a drug is not relevant to India? All drugs are needed. We have more cancer cases in India than in other countries. We are going to be a diabetic capital even as we struggle with malaria, etc. What do you fear? The fear is that India is being projected as a global hub for clinical trials. Will the ethics committees of each institution be strong enough? For example, will they understand the implications of post-trial benefits? Now the pharmaceutical industry will have its strategies, like selecting 30 centres with 10 cases each to arrive at the statistically valid sample of 300, but it is invalid per centre. Will the local institutional ethics committee have the power to ask the right questions?
Should such responsibility be left to local institutional committees? They may give in to pressures which the ICMR would have the power to withstand. That’s the only way of controlling research at the moment. We think that ethics committees have certain powers, you have to empower them to ask questions. The second concern is that all these new contract research organisations are coming up to get their clinical trials done fast. Now some of them may be good, some may not be that good. Their intentions or ulterior motives may be different. And they get paid for the trials… What about monitoring? There’s nobody. We don’t have a monitoring mechanism. The DCGI gives approval and we get data, but how are they doing the trial, are they fudging the data? Things will change from this coming year. Now, whenever permission is granted by the Drugs Controller for a clinical trial, they are going to send clinical trial monitors. The Drugs Controller is training a group of people as inspectors. That’s also why we had the conference in Hyderabad, about the need for a clinical trial registry in India, so we know what’s happening. There is a need to regulate the CROs, at least registering them, getting centralised information, so we know their credibility. And the ICMR is working on strengthening IECs. Right now we are doing a survey of 40 IECs in six states. We want to strengthen the ethics review mechanism. Then we will see about accreditation. What do you think about a law to regulate research? Is there such a law in the offing? A law will not guarantee anything – look at how the laws on transplants, on sex selection, are broken. But having a law will help for those who are afraid of scrutiny, who are conscientious. The group misusing the law will do so anyway. But with a law you can ask questions, conduct an inquiry, take action…. The bill was ready two years ago. We amended it on the basis of comments from the law ministry and sent it to the health ministry. Now it is up to the health ministry to get it cleared in the next session. InfoChange News & Features, December 2005
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