India’s current regulatory architecture for approving novel treatments is ambiguous and assigns overlapping functions to different governmental bodies. Human germline editing and reproductive cloning are banned by the National Guidelines for Stem Cell Research, although there are no specific and enforceable laws.
Research involving human germline gene therapy, reproductive cloning, and clinical trials involving “xenogeneic” cells—tissues or cells belonging to individuals of different species—is not allowed. However, in vitro studies—genome modifications to an embryo that will not be carried to term—are allowed. Human embryos that have undergone modification may not be developed beyond 14 days of fertilization.
Because of the legal ambiguities, human gene editing regulation in India is viewed as prime for malpractice, misuse and manipulation. The Indian Journal of Medical Ethics points out that India’s guidelines “are not legally binding and are seen as unenforceable because of the large population and lack of specific criminal laws to act as a deterrent”. The Indian Council of Medical Research is debating a law that if passed unambiguously would ban germline gene editing.
Products/Research
None
Regulatory Timeline
2019: Indian Council of Medical Research, in consultation with the Department of Biotechnology and the country’s top drug regulator, the Central Drugs Standard Control Organisation, drafts law banning germline gene editing and prohibiting the use of gene editing to induce “unnatural advantages” like enhanced physical functions or selection of particular traits to create designer babies.
2017: The third iteration of the National Guidelines for Stem Cell Research is released, banning the commercial use of stem cells by the Department of Biotechnology (DBT) and the Indian Council of Medical Research (ICMR).
2013: The second iteration of the National Guidelines for Stem Cell Research is released, addressing concerns from stakeholders that the original iteration lacks “statutory backing” and “legislative weight.”
2007: The first iteration of the National Guidelines for Stem Cell Research is released.
2000: Ethical Guidelines on Biomedical Research Involving Human Subjectsprohibits germline therapy.
NGO Reaction
None
Additional Resources
- Genetic Literacy Project’s FAQ on gene editing
- Are We Ready for Designer Babies? Analysis of law, policy and ethics surrounding germline genetic engineering, Nishith Desai Associates
