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Stem-cell draft norms ban cloning, restrict embryonic research

P.T. Jyothi Datta

  • Stem-cell research categorised into prohibited, restricted, permitted areas
  • Regulatory clearance to be done at two levels — national or institutional
  • Mumbai , Feb. 22

    STEM-cell research has had globally hi-profile supporters, including `Superman' actor, the late Christopher Reeve. It has vocal detractors as well.

    But India expects to put its draft national guidelines on stem-cell research in public domain, to initiate a debate on contentious issues such as embryonic stem-cell research, a senior official with the Union Health Ministry said.

    Stem-cells are unspecialised cells that can be coaxed into developing like other cells in the body, such as the heart cells, brain and blood. Sections of the scientific community see such research providing a break-through in illnesses such as Parkinson's and Alzheimer's. However, embryonic stem-cell research evokes strong ethical debates, since cells are got from foetal tissues.

    The national guideline, drafted by the Indian Council of Medical Research (ICMR) and the Department of Bio-Technology (DBT), proposes to decentralise the procedure of regulatory clearance. But safety-catches are provided in the guidelines by demarcating stem-cell research into prohibited, restricted and permitted areas, the official told Business Line.

    While cloning falls into the prohibited category, embryonic stem-cell research falls into the restricted category where specific clearance can be got if all procedural and ethical guidelines have been adhered to.

    Regulatory clearance will be done at two levels, at a broad national level or an institutional level. Embryonic stem-cell research, for instance, will require clearance from the national level body that would have representation from other relevant ministries as well.

    All other forms of research could get their regulatory clearance from the respective institutional stem-cell committee, which in turn would be expected to give a six-month report on the clearances it has given to the national committee.

    The DBT and ICMR had met in late January to iron out final details and a debate on the guidelines is likely to be initiated in different regions possibly in May, the official said.

    Special care is being taken regarding embryonic stem-cells as there are issues related to how the cells are sourced, whether informed consent was taken from the individual, how these cells would be used, whether there is infrastructure to store it etc., the official said.

    The source of the embryonic cells would be fertility clinics, where spare cells would be available. No embryo would be created solely for the purpose of getting the stem-cells, the official clarified.

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