Usha Sharma – Mumbai
The Ministry of Health and Family Welfare, Government of India, has decided to set up a four-member high-powered committee in order to formulate regulation of stem cell and other cell-based therapies in India. The committee will review the existing therapies and finalise the parameters of stem cell regulation guidelines. It is expected that the report will be presented to the Ministry of Health and Family Welfare in the next three months. The new proposed committee will be monitored by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
Prof Lalji Singh, Vice Chancellor, Banaras Hindu University, who has been nominated as the Chairman of the high powered committee said, “So far I have not received any official communication from the Ministry of Health and Family Welfare. Some time back I had put a proposal to the Government of India and suggested that they form a separate committee for stem cell and other cell-based therapies. I am happy to know that the Government of India accepted my proposal and has taken a step forward.”
Commenting on the need for such a committee, Singh said, “Since ages there has been a hue and cry to make guidelines in order to regulate stem cell and other cell-based therapy industry. However, the Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT) were both wary of accepting stem cell regulation under their respective umbrellas.”
The primary area of functioning of the proposed high-powered committee of stem cell and other cell-based therapies is to review the status of the stem cell research therapy in India. We will be identifying the different types of stem cell therapies to come under the regulation. For eg. live cell transplant, organ transplant will not come under these stem cell regulation guidelines. Something like bone marrow (autologous stem cell) will certainly come under the format. Autologous stem cells will be strictly regulated and will need to follow quality parameters. Besides this in-vitro and multiple in-vitro will certainly come under regulatory control with strict quality control parameters, revealed Singh.
As per an order issued by the Ministry of Health and Family Welfare, Dr Gopal Pande, Chief Scientist, CCMB Hyderabad will also be a member of the proposed committee. Two more experts, one each from the stem cell industry and from academia, need to be nominated.
As required by the Ministry, the committee will submit its report within two months after the formation of the proposed committee. The committee will be reviewing the existing draft guidance documents and modify / replace it with CDSCO’s regulatory documents.
It will suggest the future scope and points of action which need to be included in the CDSCO activities to make it an effective regulator of stem cell therapy in India and also to indicate the role of other bodies.
The terms of reference of the committee’s report also include suggestions on the prerequisites which need to be fulfilled for the approval of proposed indications for the stem cell product or therapy with specific differentiation of who will control the claims mentioned under therapy (which may fall out of domain of CDSCO). A road map to establish collaboration and training programme with international regulatory agencies will also be part of the committee’s suggestions.
Singh also mentioned, “We will be having a separate testing laboratory as per international GLP (good laboratory practice) standards. All cells can be tested and certified and then sold and used by patients. If we find it necessary, we will set up a separate committee for monitoring this activity.”