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Red Revolution Report Summary

Project ID: 313769
Funded under: FP7-IDEAS-ERC
Country: Switzerland

Mid-Term Report Summary - RED REVOLUTION (Red Revolution: The Emergence of Stem Cell Biotechnologies in India)

It is widely predicted that Indian medical biotechnology sector will soon outperform its global success story in information technology. India is emerging as a leading player in stem cell technologies. The research is producing in-depth understanding of both production and regulation of these novel biogenetic entities. To capture these developments as they unfold presents a historic opportunity to document a potentially revolutionary scientific invention in the making. The main aim of the research is to examine and analyze the emerging shape of India’s swift inroads into regenerative biotechnological developments.

The project is producing in-depth understanding of the regulatory domain in India and the emerging changes to India’s ongoing initiatives in controlling the burgeoning rise of stem cell technologies. In particular the research is examining the emerging ethical debates and the inherent mechanics of the regulatory processes.

The research has tracked inter and intra country medical migrations and therapeutic viability of stem cells in India’s robust private sector. The project is documenting patient experience and narratives of healing and recovery post stem cell treatments in India. These findings will have long-term implications for how we explain the role of scientific breakthroughs on a global scale and the gains and losses incurred in seeking to govern stem cells through standardized ethical and regulatory procedures. Ironically the Indian case is revealing how despite lax regulation private initiatives are producing therapeutic breakthroughs that need further examination in order to verify the veracity of these claims.

The project is piecing together critical evidence to suggest that the private and public sector symbiosis in the emerging stem cell bioeconomy is largely benefitting from soft touch regulation. However, in the face of proposed new regulations the research is trying to understand the impact, if any, on India’s ability to profitably capitalize on stem cell technologies. At present the project is examining the relationship between the state and emerging new ‘experimental citizenship’ in the context of regulatory moves favouring clinical trials as a means of reigning in unregulated stem cell interpolations in the private sector. In order to understand the rapid spread of stem cell technologies in the proposed regulatory landscape in India the project is examining: (a) the Indian Council of Medical Research and Department of Biotechnology (ICMR-DBT) as well and the Drug Controller General of India (DCGI) guidelines (b) private and public stem cell banking initiatives (c) private clinical practice (d) public and private research laboratories (e) commercial viability of innovation. The eventual ambition is to produce a robust stem cell map of India detailing research, therapeutic, commercial, and banking spread.

In brief, against the backdrop of these developments the project is sharpening its focus on the ethical and legal governance of the burgeoning rise of stem cell technologies; availability of stem cell therapies; the global movement of patients seeking treatments; the rapid spread of stem cell banking across India and the underlying bioeconomy consolidating around the regenerative sector.

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