Tuesday, April 26, 2011

ICMR panel to monitor transfer of biological samples for research, trade

The government has decided to tighten its control over the transfer of "biological material" for research and commercial purposes. On Monday, a committee was constituted by the Director General of Indian Council of Medical Research (ICMR), which after analysing "expected outcomes" and its "implications", will allow "transfer" of such material for commercial and research purposes.

The committee will "consider" the cases related to transfer of biological material for commercial purposes, "evaluate" where infectious biological material/samples are proposed to be transferred — from foreign research centres to Indian diagnostic laboratories/research centres or vice-versa — and "consider" transfer of human biological waste material for commercial purposes. Sources said the mover was important in the context of the latest report by Lancet on the superbug.

Sources said information specifying name and address of the institution/agency providing bio-material, agency where bio-material is proposed to be transferred, nature and type of bio-material to be transferred, number of samples to be transferred, purpose of transfer of the material (including the type of research, investigations to be carried out), approval of the head of the organisation, source of funds through which transfer of samples will be financed, expected outcomes/future leads, implications on National Health Programmes will have to be placed in the knowledge of committee.

The committee will be sent a duly filled up application form for transfer of samples, copy of Material Transfer Agreement (MTA), clearance from an ethics committee, copy of patient information sheet giving details on the utilisation of samples of the patient for a particular research/ R&D study and the kind of benefit (direct/indirect or no benefit) for appropriate decision-making by the patient.

The committee will also have a copy of "import certificate" issued by the relevant foreign regulatory authority to the foreign laboratory receiving the Indian biological samples.

Source: The indian Express, April 26, 2011

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