The Centre is yet to finalize the policy of stem cells even after a draft for the same was submitted early this year. The policy draft was made by Dr Vasantha Muthuswamy of Indian Council of Medical Research (ICMR) and a team of experts after several months of preparation.
The draft of the policy was actually ready in 2006 end and was expected to be finalized last year. After the preparation of the draft, Dr Muthswamy retired from the service sometime last year. The government has not appointed any one to the position of Dr Muthuswamy. This is stated to be one reason for the delay in finalization of the policy.
Use of stem cells is being seriously pursued in the US and Europe as a new form of therapy and Indian research centres and large hospitals have been engaged in advanced pilot studies. Many of such pilot studies in the country have also proved that Mesenchymal stem cells are effective and free from be allergenic and immunogenic reactions. The encouraging initial response should be further studied to establish proof of concept.
The Indian market for stem cell therapies is expected to touch $20 billion by 2010. Current global market size is around $540 billion and is growing at the rate of 15 per cent.
With allopathic treatment modalities having certain limitations in treating chronic diseases, medical scientists are now dependent on regenerative medicine or stem cell therapy. Medical experts across the globe have explored its benefits for spinal cord injuries, leg ischemia and myocardial infraction. "The Central government should now speed up the implementation of the Stem Cell Policy. In fact, legislation for stem cell usage is a critical component to pursue the next level of research", Dr. Ramananda Nadig, president and deputy dean, Clinical Research Education and Management Academy (CREMA) told Pharmabiz.
Three sources for human stem cell are human embryos, umbilical cord blood and adult stem cells from bone marrow. There is need to usher in regulation at the earliest to prescribe strict Standard operating procedures for stem cells sourcing from each of these sources, he added.
There are many medical institutions and research centres which are engaged in stem cell research which makes it indispensable to have a set of regulations in place for good manufacturing practices (GMP), Good Lab Practices (GLP) and Good Tissue Practices (GTP) approval from the authorities.
Currently, India has around 10 stem cell dedicated companies including Stempeutics, part of the Manipal Group and Reliance Life Sciences. The research centres are Centre for Cell and Molecular Biology (CCMB), Hyderabad, LV Prasad Eye Institute, Hyderabad, All India Institute of Medical Sciences, New Delhi CMC, Vellore to name a few.
There are companies like LifeCell Chennai and Cryo Stem Cell Bangalore engaged in cord blood banking for which the Union government has formulated guidelines for storage only. There are no rules however related to the use of cord blood cells to treat health conditions.
Currently, regulatory approval are sought from the Drugs Control General of India and ICMR for stem cells approvals for human use. A policy on Stem cells will help put an end to the questionable moves of several private institutions to perform stem cell therapy for various illnesses, pointed out Dr Nadig.