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India proposal would bring stem cells under government regulation



An amendment to India’s Drugs and Cosmetics Act has been proposed by the Union health ministry that would bring stem cells and cell-based products under the scope of the law. Under the proposal, stem cells and their derivatives would need to follow protocols mandated for any new drug development.

The Times of India reports that the ministry said that stem cells and products that are substantially altered, amounting to a change in biological characteristics or those subjected to gene editing or modification, will be treated as a drug and must seek the regulator’s approval before coming to the market. However, autologous stem cells — where the individual’s own stem cells are used for treatment — are considered “minimal manipulation,” and as such would not come under the scrutiny of the drug regulatory body.

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