After three years of bringing out draft guidelines for stem cell research regulation in consultation with DST, DBT and CSIR, the Indian Council of Medical Research (ICMR) is finally introducing revised national guidelines, which will be officially released in January 2006.

Dr Vasantha Muthuswamy, senior deputy director general, ICMR told Pharmabiz that a high-level meeting of an expert committee will be held at New Delhi on January 5, 2006 after which the new guidelines will be put forth in the public domain for reactions, recommendations and opinion. Public consensus will be obtained by mid 2006. The new guidelines are a result of the joint effort of ICMR and the DBT.

ICMR will also collect public opinion on embryonic stem cell research as there are lots of ethical issues associated with it, she added.

A national apex committee will be set up which will monitor and direct the policy implementation in the country. Each institution involved in stem cell research will be 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 is likely to host the secretariat of the apex committee, Dr Muthuswamy added.

The Union Health Minister has approached the Cabinet with the proposal of bring out a legislation, and if things go as planned, the legislation can be in place in 2006.

Currently, there is both hope and hype on the scope of benefits derived from stem cell research. India is in a learning curve. Necessary infrastructure for conducting stem cell research should be in place before making claims of stem cell research capabilities.

Organisations such as Reliance Life Sciences, AIIMS, CCMB, TIFR, LVPEI have already started working on stem cell research. The major sources of stem cells have been identified as adult stem cells, cord stem cells, feta stem cells, cadaveric stem cells and embryonic stem cells. The centres working on adult stem cells would require prior approval and be registered with the national apex committee.

Muthuswamy noted that many organisations in India were jumping into stem cell research without having good manufacturing practices (GMP) and good tissue practices (GTP) approval.

For cord blood banks, DCGI approval may 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, and thus, stricter regulations should be in place, she pointed.

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.

"India is supporting therapeutic cloning at present. But there is a school of thought that believes if therapeutic cloning is permitted, organisations in stem cell research will take up reproductive cloning too. India will deal the issue with caution," said Muthuswamy.

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.

Seeing the hype in stem cells research, there are fears that this commoditisation may lead to commercialisation and black marketing which is an ethical issue that India should be ready to deal with in the coming years.