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.
“The health ministry is well aware of the unethical practices mushrooming in the country, says Geeta Jotwani, deputy director general of ICMR, a research arm of the health ministry. “Protection of human subjects participating in clinical studies is sacrosanct.”
Doctors and stem cell practitioners welcomed the move. The proposed regulation 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 patients suffering from Duchenne muscular dystrophy or spinal cord injuries, he adds.
Defining a drug category of stem cells and their derivatives requires amending the Drugs & Cosmetics Act of 1940.
India’s Central Drugs Standard Control Organization said in an April 4 notification that it would exempt from the new rules so-called minimally manipulated autologous stem cells.
“If a doctor is extracting biomaterial like bone marrow or blood or fat during a surgical procedure and doing minimal manipulation, such as filtering or resizing, and using it back in the same patient in the same surgical sitting, it would not be under the drugs and cosmetic law,” Rajput says. “It’s like a routine surgery done by doctors in India after a proper informed consent.”