Great Lakes Institute of Management, Chennai, India

Priyamvada Sivasubramanian has a Masters in Economics from Stella Maris College , India , a Masters in Journalism from the Asian College of Journalism, India and an MBA from the Great Lakes Institute of Management, India. She is a freelance journalist and is the Chief Editor of ‘Gravity’ (a business journal).

Ms. Sriranjini Sivasubramanian (the paper co-author) is a practicing lawyer in India & is a Faculty at the Department of Human Rights and Duties Education, Ethiraj College for Women (Autonomous), Chennai , India

In this paper the authors seek to examine the dimensions of individual self determination and expresses concern at the prolific growth of clinical trials, often unregulated, in India. A review of population control strategies also reveals an alarming trend for the growing number of ‘nari’ guinea pigs who have been subjected to clinical trials often without ‘informed consent’ and in most cases through ‘the engineering of consent’. The authors have sought to highlight that medical or scientific experimentation on humans without free consent has been ascribed as falling within the ambit of ‘torture’ under the International Bill of Rights. Nevertheless the international community recognising that human experimentation cannot be wished away has over the years opted for ‘informed consent’ in place of ‘free consent’. While the Nuremberg trials brought to light the horrors of medical experimentation on human beings, and tried to articulate a restraining formula by stressing the concept of “informed consent,” the trials also recognized that “Medical science cannot, unless it is to be brought to a standstill, dispense with the application in suitable cases of new remedies and procedures not yet fully tested. Nor can it do entirely without scientific experiment on human beings itself.” The authors have examined the ethical guideline for research on human subjects prepared by The Central Ethics Committee on Human Research (CECHR) of The Indian Council for Medical Research and draw attention to glaring instances of how these guidelines have been observed more in its breach despite landmark Apex Court rulings against fraudulent and dangerous clinical trials. The authors opine that with the introduction of the new Patent regime in India a quantum leap in clinical trials can well be expected both by Indian Pharmaceutical Companies and by MNCs who would rather outsource clinical trials to India to cut costs. While India has been the first country in the world to have a national family planning programme the thrust has moved away from promotion of reproductive health and a holistic approach that gives women and girl children greater access to education, better healthcare and a bigger share in development to the use of social and economic incentives and disincentives to reduce fertility and worse still, use of coercive measures to contain the growth of population.