Dr Anant Bhan, Adjunct Faculty, Yenepoya University, Manipal, and researcher in Bioethics and Global Health, was recently at the International Conference on Historical Trends and Contemporary Challenges in the Practice of Medicine in India organised at IIT-Madras. Bhan’s presentation titled Regulatory Reform: Role of Activism, Evidence and Inclusiveness spoke of the growth of clinical research in India that included outsourced clinical trials. His focus was on the conduct of unethical clinical trials, exploitation of vulnerable clinical trial participants, lack of monitoring mechanisms and the need for instituting clear guidelines for compensation in case of adverse trial-related consequences or death. Edex caught up with the physician who trained to be a doctor but left clinical practice and got involved in community health research.
Why is regulation of clinical trials important to addressing challenges on the healthcare front in India?
Medicine is intrinsically linked to clinical research. The whole concept is to create a new drug that works for the health of the population. The clinical trials we’ve seen in the past need to be studied to address questions like how much of those were outsourced and how much of those, though conducted in India, failed to benefit our local population. That’s one of the things to worry about from an ethics perspective. Is it purely outsourced to India because it is cheaper to do so? Are there enough doctors who can do it? What kind of participants do you get? Are they poor, vulnerable? If yes, are they adequately informed about the risks involved?
Now that we recognise that there is a problem with clinical trials, we should have regulatory reforms. Regulatory reforms are usually driven by court cases. They’ve been quite a few representative cases in the recent years in the Supreme Court, for example, that have driven a lot of the regulatory reform. We need to look at the process, of how representative it is, does it take into view all the views of the stakeholders, importantly clinical trial participants. It seems to be the case that clinical trial participants are not really having a voice in India, in terms of driving some of the reforms.
What are the laws regulating clinical trials in India?
The Drugs and Cosmetics Act 1940 is the main act which regulates drugs and devices in clinical trials in India, regulates the import, manufacture and distribution of drugs in India to ensure safety, effectiveness and conformity to state quality standards. We also have guidelines from the Indian Council of Medical Research that regulate clinical trails. Often, people take recourse to international guidelines like the Declaration of Helsinki (The Declaration is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association. It is widely regarded as the cornerstone document on human research ethics). There have been a lot of new Gazette notifications which have come in over the last couple of years mostly driven by court cases; the SC has asked the Ministry of Health and Welfare to address these concerns. A revised version of Drugs and Cosmetics Act was put up in the public domain for feedback but has a very short window period for feedback — only two or three weeks.
When you see the process of who are giving feedback and the decision making committees, it’s merely representative of the industry but not of academia, folks who do RTIs of clinical trials, patient research organisations, activists, etc. Part of the challenge is to see who’s driving the process. Industry is an important stakeholder but not the only stakeholder. That is why we need to ensure a process which is more democratic and one that listens to the voices of all the stakeholders.
What is the gender element in your study on clinical trials?
There have been a lot of people who have looked at gender issues more broadly. I think they become more operative when you have clinical trials in areas like vaccine. So there is this controversy about Human Papilloma Virus (HPV) vaccines may prevent infections by certain types of human papillomavirus; associated with the development of cervical cancer, genital warts, and other cancers. There was a cultural aspect of this whole intermix with sexuality and also prevention. Those who were involved were mostly adolescent girls coming in from hostels and tribal areas, schools in the hinterlands not in the city.
I have not seen a lot of gender disaggregated data, but if you look at what is available, you will find that it is often women who have their kids participate in it. They feel that is the only way they can get good quality medical care. The expectation is that at clinical trials you’ll get high quality clinical care whereas in normal public health services you may not.
What has the contribution of private medical institutions been in this sort of activism?
Activists are mostly from NGOs. There have been individual medical practitioners both in the public and private sector. A lot of it is driven by civil society and individual physicians. There may be some whistle blowers interested in vaccine policy, who look at whether it will benefit kids in India before including it in the National Immunisation Programme.
Why is it important for medical students to be a part of what you are doing?
It’s important for them to have a greater sense of what’s happening with clinical trials. This experience will give them the social dimension of understanding a disease.
suraksha@newindianexpress.com