India introduces national directives relating to the use of stem cells

Publié le : 28 March 2014

 National directives in terms of stem cell research "provide ethical and scientific indications". They provide a framework for research and clinical trials in India through the introduction of restrictions.

These directives prohibit recourse to stem cells in several fields of research, namely research relating to germinal gene therapies (which induce gene transfer at the embryonic stage) and reproductive cloning. At the same time, clinical research involving the transfer of xenogeneic cells (i.e. belonging to another species) to a human being is also prohibited. Furthermore, all areas of research involving the creation of human embryos specifically for this purpose are prohibited.

Other restrictions. Clinical trials using differentiated cells obtained from human embryo stem cells and IPS cells must be authorised by the Drug Controller General of India (DCGI). The importing of "drugs", including therapeutic products and cells must be authorised in advance by the DCGI.

Conversely, research comprising the introduction of human embryo stem cells or IPS in animals is authorised "if the human stem cells significantly contribute to the development of the animal’s brain or gonads".

These directives have been compiled by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT), and announced by the Minister for Health.

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