Question : STEM CELL BANKING



(a) whether stem cell banking is under regulatory framework in the country;

(b) if so, the details thereof;

(c) if not, the reasons therefor; and

(d) the steps taken/proposed to be taken to govern stem cell banking in the country?

Answer given by the minister


THE MINISTER OF STATE FOR HEALTH AND FAMILY WELFARE(SHRI S. GANDHISELVAN)

(a) to (c) No separate regulatory framework for stem cell banking has been established. Till date stem cell banking only  referred to cord blood banking. The cord Blood or cord blood stem cell banking was considered under the same regulatory requirements as for blood  banking for which license from Drug Controller General of India is required.

(d) Indian Council of Medical Research and Department of Biotechnology jointly have formulated guidelines for Stem Cell Research and Therapy in the year 2007. The guideline document covers the requirements for banking and registry of human embryonic Stem Cell Lines only.  In view of recent field developments and public opinion on emerging issues in the area of stem cell research, these guidelines are being debated in four regions of the country.