India setting out guidelines for stem cell research

Stem cells are expected to dramatically improve the ability of drug companies to screen new drugs for side effects much earlier in the development process. Given that this is expected to significantly lower costs and shorten the time it takes to develop a new drug, India is looking to set forth new guidelines for stem cell research, reports The Pharma Letter’s India correspondent.

The need for rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments was recently highlighted by the Indian Council of Medical Research (ICMR) which issued the revised draft National Guidelines for Stem Cell Research, in association with the Department of Biotechnology (DBT).

Drawing the line on research related to human germ line gene therapy and reproductive cloning, the regulator has banned research on in-vitro culture of intact human embryos, beyond 14 days of fertilization and clinical trials involving transfer of xenogeneic cells into a human host.