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Regulatory News
10 June 2013
by Louise Zornoza

India Establishes Advisory Committee for Stem Cell Products and Cell-Based Therapies

India's Ministry of Health and Welfare (MOHW) issued an order on 3 June 2013 establishing a High Powered Committee to advise it on the regulation of stem cell products and other cell based therapies. The Committee will consist of four members, including a representative from the stem cell industry, and must submit a report with its recommendations to the Ministry within two months. 

The terms of reference for the Committee include:

  • Reviewing the current status of stem cell therapy in India
  • Making specific recommendations as to the scope of regulatory authority for the Central Drugs Standard Control Organization (CDSCO) concerning stem cell products and stem cell research
  • Indicating areas that do not fall within the scope of regulation by the CDSCO but need supervision by other bodies
  • Suggesting conditions for the approval of proposed indications
  • Reviewing existing guidance and modifying it to make it a CDSCO document
  • Recommending future actions that should be undertaken by the CDSCO to make it an effective stem cell regulator
  • Preparing a road map for collaboration and training with international regulatory agencies
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