 The issue of unethical clinical trials, flouting the legal boundaries, has been a concern for long. The last decade has seen India emerge as a favored destination for clinical trials, largely sponsored by foreign MNCs. There has been a massive rise in the number of clinical trials conducted in the country since January 2005, when restrictions on clinical trials of foreign companies were removed. The Indian Council of Medical Research itself admits that it is impossible to keep a check on these activities. The ICMR states that the data and reports of various trials are often difficult to find and in some cases do not even exist as many trials are abandoned or are not published due to negative or equivocal results. The recent expose of illegal trials in Indore by the Editor of Monthly Index of Medical Specialities has yet again brought the issue to the fore. Trials are regulated by Drugs Controller General India, which works under the Ministry of Health. If a trial is supposedly taking place in a country outside India, then you can conduct it in India also. Now the difficulty with this kind of a rule is how do you monitor whether a trial is taking place abroad or not. So these things are not at all implementable in our country. So to that extent the law is defective. Sama, resource group for women and health has been campaigning for poor vis-a-vis unethical clinical trials. News click in association with Sama did a story in July 2010 when it was found that 14,000 tribal girls of Khammam district of Andhra Pradesh were subjected to trials without their consent for a commercially licensed human papillomavirus vaccine manufactured by Merck. The vaccine claims to provide protection against cervical cancer. The vaccine trials in Khammam had to be discontinued after reports that four of the girls who had received the vaccine had died. What was shocking was that the exercise was conducted under the name of National Rural Health Mission with due permission from the state government. The trials were conducted with the active participation of the ICMR and the US-based International NGO, PATH. It raised serious concerns regarding the ease with which ethical norms were flouted, especially in the way guidelines regarding informed consent were disregarded. Such violations of ethics and law continue even today. Dr. Chandramohan Gulati, editor of Monthly Index of Medical Specialities, exposed in May 2011 a slew of unethical practices in the conduct of clinical trials in MGM Medical College in Dore. The editorial that he wrote for MIMS revealed that though 2,365 patients were enrolled for drug trials in five government medical colleges in Madhya Pradesh, six investigators from only one institute, MGM Medical College and Associated MY Hospital recruited 1,521 patients. It included a whopping number of 1,170 minors. Shockingly, for use of Tedela Phil in pulmonary hypertension, otherwise used for male erectile dysfunction, seven out of nine subjects were females, while one was a 17-year-old minor boy. No compensation was paid to her family. Not even one patient was paid in the medical trial in complete violation of ICMR rules. Even though trials were conducted using government infrastructure, the funds were deposited in investigators' personal accounts. Approval for the trials was not obtained from the on-site ethics committee, but non-verifiable entities situated in far-off places. So, the focus was that now the attention of these doctors has been diverted from their routine teaching and looking after the patient to conducting clinical trial on behalf of multinational companies. One of the major reasons for conducting clinical trials on third-world population is its cost effectiveness. If a clinical trial costs $100 in America, then the cost in India is only 20. In an interview with NewsClick, Dr. Amit Sengupta spoke about the larger context in which the indoor case should be seen. The whole issue of MGM Medical College indoor and the exposure that has been done by Dr. Gulati has to be looked in the wider context of government policy in India and the regulation that we have in the country. Today, we are joined by Dr. Amit Sengupta, who has been associated with all India People Science Network and Jan Swasthi Abhyan. Welcome to our show, Dr. Amit. So, Amit, industry and the government claim that opening up the opportunities for conducting clinical trials in India is essential to ensure that medical research improves in the country and the foreign investments also come in the country. The experience of the last five years, does that support the claim that the pharma companies and the government is making? Yes, first we need to understand that the whole premise based on which this argument is made that if we make it easier to conduct clinical trials in India, then our research capability will improve is entirely erroneous, because the way today for example, and we have about five or six years of experience now, since the whole process was made much easier in 2005. And what we clearly see is that one, most of these trials are conducted by foreign sponsors largely foreign multinational corporations. The design of these trials are worked out by the foreign sponsors and the data goes back to them. So, what you do in India is just to create the environment where you can conduct the trials, gather the data and send it back. It does nothing really to indigenous research capability. It does nothing really for Indian science. So in a sense, it is not very different from say a hundred years back when Indian Chad labor went into the West Indies, the only difference now is that they are wearing coats and ties. So this is based on the premise that if you allow foreign countries to come into your country and use your people for conducting trials more or less as guinea pigs, that will improve your research capability. It is not something that is borne out by the evidence or the experience of the last five or six years. Last year, clinical trials for HPV vaccines in Khamam district of Andhra Pradesh had to be stopped, because four tribal girls died in the process. So do you think that Indian subjects are being used as guinea pigs by the big pharma companies, international pharma companies? Let us examine what are the reasons that are used as to why clinical trials are done in India or why India has become one of the favorite destinations. One of the reasons that is put forward is that patients in India are treatment naive, which essentially means that they do not have access to public health, which basically means that the fact that the Indian people are deprived of public health is an advantage that we wish to use to make a little bit of money for a few people. The second sort of reason that is put forward is that the costs are lower. The costs are lower because people in India who become subjects of clinical trials are much more vulnerable. They are vulnerable on one hand because they do not have access to health care. So being a participant in a clinical trial often is the only way when you can access health care, especially in a disease where the cost of medication is very high. So or you are much more easily induced through payments. So what you are basically doing is utilizing the vulnerability of the Indian population. Now you can call that a guinea pig, you can call that anything, but essentially that's what the whole clinical trial business is predicated upon. The Indian Council of Medical Research itself admits that it is very tough to keep a check on the mushrooming ethical review committees that have come up. And we know that a lot of these committees actually receive foreign funds. So in this context, how can the regulation be done and within the given legislation that exists, what changes would you like to propose where we can actually deal with this matter effectively rather than just saying that something unethical is happening on the ground. We have various gaps in the system which do not lend themselves to a situation where you can actually run ethical clinical trials. You have one what we call the ethical gap. There are huge problems of ethical norms not being followed in clinical trials. You have what is what you can call a public health gap that because people do not have access to health care, so they are vulnerable and become subjects of clinical trials. You have what is called a regulatory gap. In 2005, when the norms were liberalized for clinical trials, you had less than 100 clinical trials a year taking place now. You have more than a thousand taking place now and you just do not have the regulatory mechanism to be able to actually oversee the conduct of clinical trials including the conduct of ethics committees that are now mandatory. And you also have what you can call a capacity gap. In the six years, there has not been a concomitant rise in the number of personnel that you require technically equipped to conduct clinical trials. So, essentially what you are seeing is a huge increase in clinical trials without a concomitant increase in the kind of in the kind of facilitatory environment that you require to conduct these trials in an ethical manner. Now, that does not mean that India should not be a place where you conduct clinical trials. But the point is that if you are going to actually conduct clinical trials to promote Indian science, to promote Indian capability, the number of trials, the trial sites, who conducts these trials have to keep pace with the various regulatory and other mechanisms. Thank you, Amit. It was nice having you on our show. Thank you.