Bangalore, June 14, 2010: To curb the menace of unregulated use of reproductive technologies and to protect the medical, social and legal rights of concerned people, Indian Council for Medical research (ICMR) has prepared an assisted reproductive technologies (regulation) bill 2010.

The bill details procedures for accreditation and supervision of infertility clinics (and related organizations such as semen banks) handling spermatozoa or oocytes outside of the body, or dealing with gamete donors and surrogacy, ensuring that the legitimate rights of all concerned are protected, with maximum benefit to the infertile couples/individuals within a recognized framework of ethics and good medical practice. Besides that, the guidelines for the research on embryos have also been formulated in the bill and at the same time strict restrictions have been imposed to control misuse.

Advisory board for reproductive technology

The establishment of National Advisory Board for Assisted Reproductive Technology is expected to help in regulation of reproductive technologies. The board would be free to exercise the jurisdiction and powers and discharge the functions and duties conferred or imposed on the board by or under this act.

The board would be responsible for looking into the setting of minimum requirements related to staff and physical infrastructure for the various categories of assisted reproductive technology clinics; regulations in respect of permissible assisted reproductive technology procedures; regulations in respect of selection of patients for assisted reproductive technology procedures; encouragement and promotion of training and research in the field of assisted reproduction; encouragement of the establishment and maintenance of a national database in respect of infertility. Also, in addition to the mentioned responsibilities, the board would perform any other functions and tasks assigned to it by the central government. The national board shall meet as and when necessary, not less than two times a year and would consist of  members, not exceeding twenty one.

The board will be chaired by Secretary, Department of Health Research, Government of India, would include a representative from the Ministry of Health and Family Welfare; and a nominee of an Indian professional society. There would be up to sixteen other experts of whom one each shall be a nominee of the Ministry of Health and Family Welfare and Indian Council of Medical Research, and at least six of whom would be women – in the fields of assisted reproduction, gynecology, embryology, andrology, bioethics, mammalian reproduction,medical genetics, social science, law, or human rights, to be nominated by the Central Government. The Chairman of National Board shall nominate a Vice Chairman from among its members.

The Member-Secretary of the Board  would be a senior scientist having knowledge of assisted reproductive technology, from the Department of Health Research or the Indian Council of Medical Research.

Regulating embryo research

Under the act, the Department of Health Research (DHR) will the regulatory agency for the research on embryos in the country. The sale of any gametes and embryos or their transfer to any country outside India for research would be absolutely prohibited and considered a criminal offense. Research would only allowed to be conducted on such gametes and embryos that have been donated specifically for research purpose with the permission of the Department of Health Research.

Persons or organization would have apply to the Department of Health Research for registration as a research institution permitted to conduct research on embryos.