The Indian Council of Medical Research (ICMR) has submitted the final guidelines for stem cell research regulation in the country prescribing strict procedures for souring and the use of stem cells by research institutions.

Striking a severe blow against commercialization of human embryos for stem cell research, the ICMR guideline said that termination of pregnancy should not be sought with a view to donate fetal tissue in return for possible financial or therapeutic benefits.

To avoid the exploitation of the gullible people by the unscrupulous elements, the guidelines specifically prescribe that informed consent to have a termination of pregnancy and the donation of fetal material for purpose of research or therapy should be taken separately. It also says that the medical person responsible for the care of the pregnant woman planning to undergo termination of pregnancy and the person who will be using the fetal material should not be the same. The woman shall not have the option to specify the use of the donated material for a particular person or in a particular manner.

The guideline strictly prohibits any research related to human germ line genetic engineering or reproductive cloning and any in-vitro culture of intact human embryo, regardless of the method of its derivation, beyond 14 days or formation of primitive streak, whichever is earlier. It also prohibits transfer of human blastocysts generated by SCNT or parthenogenetic or androgenetic techniques into a human or nonhuman uterus.

Any research involving implantation of human embryo into uterus after in-vitro manipulation, at any stage of development in humans or primates has also been prohibited by the ICMR. Besides, it also prohibits that the animals in which any of the human stem cells have been introduced at any stage of development should not be allowed to breed. Research involving directed non-autologous donation of any stem cells to a particular individual is also prohibited.

The ICMR guidelines on stem cells holds significance as stem cell research raises many ethical, legal, scientific, and policy issues that are of concern to the policy makers and public at large. Like any other scientific advances, it also raises questions about balancing the promises offered by stem cell therapy against its potential harm for appropriate application.

Guidelines for Stem Cell Research and Therapy has been prepared for adult, cord blood and embryonic stem cells in response to the support provided by the Government to facilitate stem cell research in India so as to improve understanding of human health and disease, and evolve strategies to treat serious diseases.