India's first uterus transplant under cloud as ICMR says nod not sought
Indian Council of Medical Research said that the hospital did not seek its permission for the procedure
The protocol required for a uterus transplant includes approval from a registered ethics committee as well as from ICMR
BENGALURU: The Indian Council of Medical Research (ICMR) has raised some concerns about the country's first uterus transplant, conducted in Pune last week.
ICMR spokespersons told TOI that the hospital did not seek its permission for the procedure. ICMR director general Dr Soumya Swaminathan said: "No permission was sought by the Pune-based hospital. Till now, ICMR has approved uterus transplant only as an experimental procedure under a research protocol. Only a Bengaluru-based facility has been granted this permission."
Swaminathan added, "According to current guidelines, nobody needs ICMR's permission for any other established procedures. However, when it comes to a uterus transplant the protocol is otherwise. As it is mostly tried as an experimental procedure for research purpose in our country, for which permission is granted based on ethical protocols, and the transplant involves several risks with only a few procedures emerging successful, ICMR's approval is necessary before it is tried on any patient," she added.
The protocol required for a uterus transplant includes approval from a registered ethics committee as well as from ICMR. However, as reported, GCLI only got a licence from the state's directorate of health services, but did not get it approved by ICMR.
Pune's Galaxy Care Laproscopy Institute (GCLI), however, insisted that no permission is required for clinical procedures.
Dr Shailesh Puntambekar, oncosurgeon and medical director, GCLI said: "ICMR's permission is required only in case ofexperimental procedures and not for clinical procedures as informed to me by ICMR itself. We have approval from the state government; hence, there has been no protocol violation. Several senior doctors from ICMR were informed about the transplant and following the state government's nod for the transplant, ICMR ensured we could go ahead with the procedure." "All three patients who have undergone the uterus transplant are doing fine and we've planned a press conference on Saturday. We haven't neglected the patient's safety," he added.
Another senior doctor from ICMR said the Maharashtra government should not have given its approval without ICMR's permission. He said: "In case of other transplants like kidney, liver and heart, ICMR's permission isn't required and state governments can give direct approval under the Transplant of Human Organs Act (THOA). However, in uterus transplant, which is rare, less successful and risky, ICMR's permission should have been sought to ensure patients' safety."
"THOA does not cover novel and research transplants," said Dr Kamini Rao, medical director of Bengaluru- based Milann Fertility Clinic.