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The Assisted Reproductive Technology (Regulation) Bill, which is likely to be passed during the ongoing session of Parliament, will regulate research on human embryos in the country. As per the draft Bill, the sale of any human gametes and embryos or their transfer to any country outside India, for research is absolutely prohibited.
The import or export of frozen human gametes and embryos shall be considered as transfer of biological material for therapeutic use and shall be permitted as per the rules made in this behalf for exchange of human biological material and with the permission of the National Registry of the Assisted Reproductive Technology Clinics and Banks in India of the Indian Council of Medical Research (ICMR).
As per the Bill, the research shall be conducted on such gametes and embryos that have been donated for such purpose in India only.
No research shall be conducted using embryos except with the permission of the National Registry of Assisted Reproductive Technology Clinics and Banks in India of the Indian Council of Medical Research. Any person or organisation, by whatsoever name called, may apply to the department of health research (DHR) for registration as a research institution permitted to conduct research on embryos.
While granting permission on an application for registration made under sub-section (5), the DHR may prescribe, and the applicant shall be bound by such terms and conditions as it thinks fit. The DHR may, if it has reasonable grounds to believe that any of the terms and conditions under sub-section (6) have not been fulfilled, the department may call for the production of such documents or the furnishing of such evidence as may be required; inspect, or order any officer authorised in this behalf to inspect, any premises related to the grant of registration; suspend the registration of the research institution, after giving all concerned parties adequate opportunity to be heard; and make such guidelines as it think fit to provide for research on human embryos.
Subject to the provision of section 56, the department of health research shall, on advice from National Board and National Registry of Assisted Reproductive Technology Clinics and Banks in India of the Indian Council of Medical Research ensure that no research shall be conducted on any human embryo created in vitro unless such research is necessary in public interest to acquire further scientific knowledge; no research is conducted on any human embryo, other than embryos given for storage to an assisted reproductive technology bank under sub-section (3) of section 53, unless full and informed consent in writing is obtained from the persons from whom such embryo was created; no advertisement is issued, and no purchase, sale or transfer is made, of any human embryo created in vitro or any part thereof, except in accordance with the provisions of this Act; no human embryo created in vitro is maintained for a period exceeding fourteen days or such other period as recommended by the National Board; no work is done leading to human reproductive cloning; and such other terms and conditions that may be provided by the National Registry of Assisted Reproductive Technology Clinics and Banks in India of the Indian Council of Medical Research.
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