The Parliamentary Standing Committee on Health and Family Welfare has recommended expeditious drafting of the guidelines and formulation of the national policy in stem cell therapy. The latest report of the committee said there was a need for extensive research in stem cell therapy, promising cure of chronic health problems.
Expressing unhappiness with the delay in drafting the guidelines, the committee pointed out that the guidelines remained at the draft stage even after three years. The guidelines for helping regulation of stem cell research had been put on the Indian Council of Medical Research (ICMR) website in 2002 for consultation. The committee emphasised that the approval process of draft guidelines on the cases pending before the Drugs Controller-General of India should be accelerated in view of many clinics claiming good results in the treatment of incurable diseases through this therapy.
The ICMR website says that the draft guideline for stem cell research and regulation is currently under revision.
As per the earlier plans, the Health Ministry was supposed to set up a national level regulatory system to monitor and sanction the stem cell research programmes in the country. The ministry had received the expert recommendations from Indian Council of Medical Research (ICMR) on the formation of such an expert body.
The ICMR proposals included the plans for a national apex committee as the official regulator of stem cell research programmes. The committee will have to look into the possible issues related to the sourcing of stem cells and transfer of materials.
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 regulations were to prescribe strict procedures for stem cells sourcing from each of these sources
There is also the need for specified procedures for stem cell transfusion to avoid all contentious issues that are likely to emerge while using stem cells for treatment of diseases like leukaemia, anaemia and other blood-born disorders. The existing regulations on blood transfusion were expected to be widened in scope for the disciplinary conduct of treatment involving stem cell transfusion.