Abstract

India proposes to legitimize stem cells and stem-cell-based products and categorize them as drugs, the health ministry announced last month. The proposal follows guidelines developed by the Indian Council of Medical Research (ICMR), which has been advocating for stringent rules for stem cell use. “Protection of human subjects participating in clinical studies is sacrosanct,” says Geeta Jotwani, deputy director general of ICMR, a research arm of the health ministry. Doctors and stem cell practitioners welcomed the move to regulate stem cell use, which will eliminate unethical players from the market, says Bhagat Singh Rajput, an orthopedic consultant and stem cell transplant surgeon at the HCG Apex Cancer Centre, Mumbai, and a vice president of India’s Stem Cell Society. The rules will pave the way for treating people who have Duchenne muscular dystrophy or spinal cord injuries, Rajput adds. India’s Central Drugs Standard Control Organization said in an April 4 notification

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