India: Goverment seeks to define stem cells as drug, regulate use in therapy - (The Economic Times via NewsPoints Desk)

  • India's health ministry has proposed an amendment to the Drugs and Cosmetics Act that would permit the country to regulate stem cells and stem cell-based therapeutics, as reported The Economic Times Monday.

  • In the proposal, stem cells and stem cell-based products would both be categorised as drugs, subjecting them to protocols mandated for drug development.

  • The notification did not clarify the status of autologous stem cells.

  • "It's a draft and definitely requires more clarity," commented Indian Council of Medical Research official Geeta Jotwani, adding "we are discussing the contents and will submit our suggestions to the health ministry."

  • "In a country where stem cell therapy is already exploited, there has to be absolute clarity in defining it," Jotwani stressed, continuing "the health ministry has to define immune therapy, gene therapy and stem cells individually in the Drugs and Cosmetics Act, else the risk of exploiting the science will remain."

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