The Indian Council of Medical Research and Department of Biotechnology have released proposed stem cell research guidelines that are intended to clarify stakeholder responsibilities, delineate rules on pre-clinical and clinical trials, and widen regulations to include banking of biological tissues and stem-cell imports and exports.
The draft guidelines, released in March and open for public comment, deal specifically with research rather than therapy. They address the procurement of gametes, embryos and somatic cells in a responsible and ethically sensitive manner and categorize stem cell research into three areas: permissible, restricted and prohibited. The guidelines also state that “clinical use of stem cells as standard of care, outside of approved clinical trials, is not permitted . . . [u]ntil the indications, efficacy and long term safety of the procedure is established.” This provision was reportedly included to stop the practices of health-care providers who claim to offer stem cell-based therapy in the country. Oversight parameters are also outlined in the proposal. See Bloomberg BNA Life Sciences & Industry Report, May 18, 2012.