After years of research and hard work, the Indian Council of Medical Research (ICMR) will submit the final guidelines for stem cell research regulation to the Union Health Ministry next week.
"The final document for the guidelines for stem cell research regulation is ready and is being printed at present. It will be ready by April 7 and will be submitted to the health ministry next week. It will also be published in the ICMR's website", a senior ICMR official confirmed.
The ICMR has been working on this important regulation guidelines for a long time. In fact, the ICMR had more or less completed the draft guidelines almost a year back, but it has been waiting for some annexure from the department of biotechnology. Though the department of biotechnology had submitted the annexure some time back, some errors were crept in which further delayed the final submission of the guidelines.
The government felt the need for a regulation in stem cell research in the wake of reports that institutions are entering stem cell research without having good manufacturing practices (GMP) and good tissue practices (GTP) approval from the authorities.
Experts are of the view that given the height of excitement and hype in stem cells research in the country, there are fears that in the coming years India should be geared to deal with a situation like the commoditisation of stem cell that will lead to commercialisation and black marketing which is an ethical issue. They also caution that India is supporting therapeutic cloning at present. But if therapeutic cloning is permitted, organisations in stem cell research will take up reproductive cloning too.
The guidelines will prescribe specific standards needed for a medical institution to carry out stem cell therapy. The move is to put an end to the questionable moves of several private institutions to perform stem cell therapy for various illnesses. The guidelines will also make it clear the government stand on export of stem cells for research purposes.
There are three sources identified for human stem cell collection: human embryos, umbilical chord blood and adult stem cells from bone marrow tissues and blood. The regulation is brought to prescribe strict procedures for stem cells sourcing from each of these sources.