DCGI asks ICMR to chart guidelines for stem-cell research

Mumbai: Even as issues related to embryo research is being debated globally, the Indian government has decided to come clear in the scope and purview of stem-cell research in the country.

Drug Controller General of India (DCGI) has recently sought the help of Indian Council of Medical Research (ICMR) to expand the draft guidelines for stem-cell research, incorporating the technical issues involved in embryological research.

The guidelines submitted by ICMR a few months ago cover just the regulatory aspects in the area of stem-cell research and the authority now wants to clearly define all parameters, including collection, maintenance, preservation and therapeutic areas for the research-and-usage criteria.

The Expert Group on Stem Cell Research will be meeting soon to work out an elaborate document that would encompass all complex issues involving stem cell research, say ICMR sources.

About 18 experts in the field of stem-cell research and regulatory affairs from across India will work along with Dr A Tandon of the All India Institute of Medical Sciences to frame the document.

A national ethics committee comprising experts is also proposed to look into specific proposals in the area of stem-cell research.

The Expert Group, while formulating the guidelines, will also look into permitting cloning for therapeutic purposes, it is learnt. This is keeping in mind the global developments in this direction and since the UK has already given the green signal for therapeutic cloning.

The committee would have participation from the Department of Biotechnology, Department of Science and Technology, Centre for Scientific and Industrial Research, ICMR and DCGI apart from biomedical experts and legal experts.

All stem-cell-based research proposals will be brought under the purview of the apex committee, which will be responsible for examining the scientific, technical, ethical, legal and social issues. The proposals will first go to the Institutional Ethical Committee and then to a scientific peer preview committee before being placed before the apex committee.

All cell-lines generated need to be registered with this committee and all proposals for therapeutic trials should obtain the clearance of the apex committee before submitting to DCGI.