India's first womb transplant: ICMR says Pune hospital did not seek permission to perform rare surgery

The Indian Council of Medical Research (ICMR) has mooted some concerns about the country's first womb transplant, performed last week in in Pune.

ICMR spokespersons told TOI that the Pune hospital had not sought 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 procedure required for a uterus transplant includes approval from a registered ethics committee and from ICMR. However, as reported, GCLI only got a licence from the state's directorate of health services, but did not get the required approval by ICMR. Pune's Galaxy Care Laparoscopy Institute (GCLI), however, claimed 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 of experimental 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.

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Another senior doctor from ICMR was quoted as saying that Maharashtra government should not have given its approval without prior permission from ICMR. 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.

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