The Union health ministry has constituted a high powered committee for the regulation of stem cell and other cell based therapies being practised in the country. Prof Lalji Singh, vice chancellor of Benarus Hindu University (BHU), Varanasi is the chairman of the committee. The committee will have to submit its report within two months.
Dr Gopal Pande, chief scientist, CCMB Hyderabad, a member from the Stem Cell industry and an expert member from the academic, both to be nominated by the chairman, are the other members of the four-member committee which will review the current scenario of stem cell therapy in the country.
The committee will make specific recommendation on the scope of central drugs standard control organisation (CDSCO) in the effective regulation of stern cell products and stem cell therapy and research. The committee has also been asked by the ministry to indicate the area which doesn’t fail within the domain of CDSCO but needs supervision of other bodies, if any.
Besides, the committee has been asked to suggest the prerequisite to be fulfilled for the approval of proposed indications for the stern cell product or therapy with specific differentiation of who will control claims mentioned under therapy (which may fall out of domain of (CDSCO). The committee also has to review the existing draft Guidance document and modify or replace it to make it a CDSCO’s regulatory document.
The other mandates given to the committee are to suggest future scope and points of action that should 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; and to suggest road-map to establish collaboration and training programme with international regulatory agencies.