Published: 2021-05-25

Clinical trials on healthy volunteers in Mumbai and Ahmedabad: expanding the framework of expropriation

Navneet A. Wadkar


Background: Healthy volunteers (HVs) in phase I clinical trials in India are often motivated by financial compensation. Historical expropriation and every day struggle for life of HVs which contributes to normalization of the risk are often ignored as contributing factors to normalization of risk. Therefore this research was aimed to study expropriation experiences of the HVs.

Methods: This research has employed qualitative and exploratory research design. The purposive sampling method was used to recruit nine HVs from two cities Mumbai and Ahmedabad.

Results: All of the HVs and their family members were alienated from land and livelihood in their villages through different social, economic, political and cultural processes. The financial compensation was a primary motivation and not altruism. The compensation amount was spent to pay debts, medical and other emergencies, consumer goods and alcohol. To maximize their earnings, HVs have participated in consecutive and/or more than one trial simultaneously.

Conclusions: The serial participation of the HVs in phase I trials has exposed them to serious risks which they are unable to recognize unless severe adverse events (SAE) occurred. The existing scholarship suggests that the perceived risk by healthy volunteers normalized through attractive financial incentives and serial participation. But findings of this research indicate that state induced violence, caste, class, gender based violence and everyday struggle of survival are also major contributing factors.



Clinical trials, Healthy volunteers, Expropriation, Phase I

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Fisher JA. Feeding and bleeding. Sci Technol Hum Values. 2015;40(2):199-226.

Fisher JA. Expanding the frame of “voluntariness” in informed consent: structural coercion and the power of social and economic context. Kennedy Inst Ethics J. 2013;23(4):355-79.

Fisher JA, Kalbaugh CA. Altruism in clinical research: coordinators’ orientation to their professional roles Nurs Outlook. 2012;60(3):143-8.

Cooper M. Life as Surplus: Biotechnology and Capitalism in the Neoliberal Era. 1st ed. Seattle: University of Washington Press; 2008.

Thiers FA, Sinskey AJ, Berndt ER. Trends in the globalization of clinical trials. Nat Rev Drug Discov. 2008;7(1):13-4.

Ladin Z. Globalization of Clinical Trials Promise and Reality. Germ. 2008.

Center for Studies in Ethics and Rights. Fact sheet: Ethical concerns in clinical trials in India: an investigation, 2009. Available at: Accessed on 14 October 2020.

Ministry of Health and Family Welfare. Fact sheet: Drugs and Cosmetics (Second Amendment) Rules India, 2005. Available at: Accessed on 14 October 2020.

Clinical Trials New Horizon-India, 2008. Available at: Accessed on 15 October 2020.

The Functioning of the Central Drugs Standard Control Organization (CDSCO) (Parliamentary Standing Committee Report No. 59), New Delhi; 2012. Available at: newcommittee/reports/englishcommittees/committee%20on%20health%20and%20family%20welfare/59.pdf. Accessed on 15 October 2020.

Complaint regarding receiving crores of rupees from multi-national drug companies through drug trials by occupying govt. posts by conducting illegal trials, registered in the bureau vide no-344/10 (Investigation Report). Bhopal. 2011.

Bhopal Gas Peedith Mahila and Udyog Sanghatan v. Union of India and Ors, Writ Petition (Civil) No. 33 of 2012 (2012).

Sama. Fact sheet: Findings from a Visit to Bhadrachalam: HPV Vaccine ‘Demonstration Project’ site in Andhra Pradesh, 2010. Available at: Accessed on 15 October 2020.

Manch SA. Union of India and Ors, Writ Petit. 2012.

Edelblute HB, Fisher JA. Using “clinical trial diaries” to track patterns of participation for serial healthy volunteers in u.s. phase i studies. J Empir Res Hum Res Ethics. 2015;10(1):65-75.

Rajan S. Experimental values: indian clinical trials and surplus health. New Left Rev. 2007;45.