Stem cells guidelines to become law, draft to be tabled in Parliament
In a major initiative by the Indian Council of Medical Research (ICMR) and the department of Biotechnology, Government of India, the stem cell guidelines are expected to become law and be ready for implementation by the stem cell companies in June this year.
The ICMR and DBT are ready with the guidelines draft which will be tabled in Parliament in all probability by the end of February or early March. Prior to the presentation in Parliament, the ICMR and DBT will have a debate in five cities to ensure that no misreading of guidelines is made. The cities where the debate will be held are Bangalore, Hyderabad, New Delhi, Mumbai, Pune or Chennai.
Dr Balasubramanian, director of research at LV Prasad Eye Institute of India (who is also the chairman of the National Task Force and the president of the Stem Cell Research Forum of India which is the consortium of all stem cell research initiatives in the country) said that the guidelines would eventually become a law regulating this field of medicine. The rules will provide framework of cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices) and GCP (Good Clinical Practices) for the stem cell companies.
At a press conclave prior to the official launch of Stem Cell Research Forum of India meet which is being held in Bangalore over the next four days, Prof. Alok Srivastava, professor and head of the department of haematology, CMC Vellore and project director, stem cell research, said, "Right now the guidelines followed are similar to the Transplantation of Human Organs Act 1994. But the National Task Force on Stem Cells has mandated a separate set of rules to monitor the use of stem cells which is showing favourable disease control in the case of myocardial infraction and leg ischemia".
The Indian market for stem cell therapies is expected to touch $20 billion by 2010. Current global market size is around $540 billion and growing at 15 percent, informed Dr. Satish Totey, secretary, Stem Cell Research Forum of India and Chief Scientific Officer, Stempeutics, Manipal Health Systems.
Prof Srivastava said that 11th Five Year Plan was expected to see a 300 percent hike in the budget allocation for stem cell research.