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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.
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