Lingzi (Susan) Zhang1, Brooke Ellison2
1University of Pennsylvania, Philadelphia, PA 19104, 2 Center for Compassionate Care, Medical Humanities, and Bioethics, Health Science Center, Stony Brook University, Stony Brook, NY 11794
*Editors: Shivek Narang, Serena Yang, Jessica Guo
Stem cells are precursor cells that can develop into specialized cells, such as neurons.[1] Stem cell research has become more popular in India for its potential in regenerative medicine and applications in bioengineering.[2] In addition, the global politicization of stem cell research has propelled India to introduce stem cell-related policies to improve its global status.[1]
Although prior guidelines for conducting biomedical research with human subjects existed in the early 2000s in India, most researchers did not abide by them because they were non-binding and controversial.[1] Therefore, due to a lack of enforcement of the guidelines, in the mid-2000s, a significant number of unproven stem-cell treatments emerged.[3] In 2007, the National Stem Cell Guidelines were published to regulate stem cell-related activities. The document was revised in 2013 and most recently in 2017.[4] There are 10 sections in the 2017 National Guidelines for Stem Cell Research: ethical consideration, scientific consideration, level of manipulation, categorization of research, basic research, translational research including clinical trials, banking, procurement, exchange, publicity.[3] The document mainly clarified that advertising, commercialization, and publicity of any kind of unproven stem cell therapies are not permitted and stated the types of stem cell research that are permitted, while establishing a two-level (national and institutional level) review, approval, and monitoring of clinical research involving stem cells.[3] The document also addressed various ethical concerns, such as the protection of stem cell donors’ privacy and procurement of stem cells.[3]
However, even after the 2017 guidelines were published, many clinics in India continued to offer unproven stem cell therapies to obtain profit.[4] Such issues were mainly caused by challenges in the enforcement of guidelines and cultural factors. First, the guidelines were not formal laws.[4] Therefore, violations of these guidelines did not result in legal consequences, which explains why many clinicians ignored the guidelines. Second, the rules and regulations were incoherent; for instance, some of the terminologies, such as “minimally manipulated stem cells,” contained ambiguity, which can mislead patients.[4] Third, the regulatory bodies that made the guidelines did not have enforcement abilities nor legal power to punish violators; in addition, there were 7 regulatory bodies involved in stem cell regulations, which made enforcement difficult and inefficient.[4] Besides, the social and cultural factors in India, such as deference to clinicians, made patients more vulnerable, for it was against the norm to challenge clinicians.[4]
In order to protect these patients and stop the fraudulent advertisement of stem cell therapies, legal backups of guidelines are needed to better enforce the regulations.[4] The public should also be educated and updated on the status of stem cell research in countries like India through different media platforms to further protect patients.
References
[1]Mittal, Sanjay. “Stem Cell Research: The India Perspective.” Perspectives in Clinical Research, vol. 4, no. 1, 2013, p. 105, doi:10.4103/2229- 3485.106408.
[2]“India Setting out Guidelines for Stem Cell Research.” The Pharma Letter, 25 July 2017, www.thepharmaletter.com/article/india-setting-outguidelines-for-stem-cell-research.
[3]Lahiry, Sandeep, et al. “The National Guidelines for Stem Cell Research (2017): What Academicians Need to Know?” Perspectives in Clinical Research, vol. 10, no. 4, 2019, pp. 148–54., doi:10.4103/picr.picr_23_18.
[4]Tiwari, Shashank S., and Pranav N. Desai. “Unproven Stem Cell Therapies in India: Regulatory Challenges and Proposed Paths Forward.” Cell Stem Cell, vol. 23, no. 5, 2018, pp. 649–652., doi:10.1016/j.stem.2018.10.007.