The Indian Council of Medical Research (ICMR) is giving final touches to the draft guidelines for stem cell research regulation in the country, it is learnt. Once this exercise is complete, the guidelines will be submitted to the Union Health Ministry for making them into legislation.

Sources in the ICMR said that the draft guidelines for stem cell research regulation is almost ready and will be submitted to the Health Ministry within a month's time. "We are just waiting for some annexure from the department of biotechnology. Once we get it, the draft proposal will be submitted to Health Ministry," a senior official in the ICMR said.

The need for a regulation in stem cell research arose in the wake of reports that some institutions in the country have jumped into stem cell research without having good manufacturing practices (GMP) and good tissue practices (GTP) approval from the authorities. Organisations such as Reliance Life Sciences, AIIMS, CCMB, TIFR and LVPEI are the early entrants to the stem cell research in the country.

The guidelines allow export of stem cells for research purposes. The guideline also prescribes 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.

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 being brought to prescribe strict procedures for stem cells sourcing from each of these sources.

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.

After years of research and hard work, the ICMR has prepared the draft guidelines in consultation with department of science and technology (DST), department of biotechnology (DBT) and centre for scientific and industrial research (CSIR). The guidelines were announced early in 2006 and asked for reactions, recommendations and opinions from the public for obtaining consensus on the issue. Last date for ascertaining constructive comments from the general public and experts ended on June 30, 2006. The ICMR and DBT assessed the public comments on the guidelines and additions and deletions were made accordingly.

The draft proposes a national apex committee on stem cell research and therapy (NAC-SCRT) for monitoring and to direct the policy implementation in the country. Each institution involved in stem cell research is expected to establish an institutional committee for stem cell research and therapy. The national apex committee will alone be responsible for approving embryonic stem cell research activity in the country. ICMR will act as the secretariat of the apex committee.

For cord blood banks, DCGI approval will be mandatory. Infrastructure, protocols and standard operation procedures (SOPs) will be critical for obtaining the approvals. As per an estimate, there are about 25 million births every year. MNCs are now eyeing at collecting, using and exporting cord blood. So, strict regulations have been proposed in this area.

As of now, there are 500 in-vitro fertilisation clinics (IVFs) in India and these clinics need to be registered. Once legislation is in place, IVFs can be monitored effectively. It is proposed that no research will be permitted on a live aborted foetus and cells obtained from foetuses will not be patented for commercial purposes.