The Ministry of Health & Family Welfare Government of India has decided to constitute a high Powered Committee for the regulation of stem cell

The Ministry of Health & Family Welfare Government of India) has decided to constitute a high Powered Committee for the regulation of stem cell and other cell based therapies being practiced in India. The main terms of reference of the High Powered Committee would be as follows:

  • Review the current scenario of stem cell therapy in the country.
  • Make specific recommendation on the scope of CDSCO in the effective regulation of stem cell products and stem cell therapy/research.
  • Indicate the area which doesn’t fall within the domain of CDSCO but needs supervision of other bodies, if any.
  • Suggest the pre-requisite to be fulfilled for the approval of proposed indications for the stem cell product or therapy with specific differentiation of who will control claims mentioned under therapy (which fall out of domain of CDSCO)
  • Review the existing draft Guidance document and modify/replace it to make it a CDSCO’s regulatory document.
  • 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 role of other bodies.
  • Suggest road map to establish collaboration a training program with International Regulatory Agencies.