The 40-page draft is available on the ICMR and DBT’s websites, and is open to public comments and concerns till July 31. “Stem cells have a lot of potential in disease management. Our last guidelines came out in 2013, but a lot has changed since then, making us feel the need to update our guidelines. We want to encourage people to do research in stem cells, but at the same time want to ensure nothing unethical is carried out,” ICMR director general Dr Soumya Swaminathan told TOI.
On the mention of gene editing techniques, she said, “We want our researchers to take up work in this field. US researchers have been working on gene editing for cancer, HIV, etc, but we in India haven’t yet come to that point. We have included CRISPR-Cas9 (gene editing tool) in the guidelines, but only for research in somatic (normal or non-reproductive) cells.”
The guidelines mainly seek to curb malpractice. Dr Jotwani said stem cells are only offered as clinical trials in the West, but are offered as therapies in India. “We have received many complaints. Now on, all institutions carrying out research must register with the National Apex Committee for Stem Cell Research and Therapy .”
A senior Mumbai doctor said, ” An autologous stem cell extraction (using a person’s own stem cells) and processing doesn’t take the sort of money–almost Rs 10 lakh–being charged from patients. This kind of exploitation should stop” The guidelines also state that stem cell research can only be carried out in laboratories and institutions that comply with GLP (good laboratory practice) and GMP (good manufacturing practice).
Incidentally, ICMR had asked doctors of the 500-odd clinics doing stem cell work in India to report progress. None did within the December 2016 deadline.
“There is no conclusive work on stem cells to prove that they can help patients with conditions like Duchenne muscular dystrophy , mental retardation or autism,” said Dr Vrajesh Udani, head of paediatric neurology, Hinduja Hospital.