Nearly ten days after a Pune hospital first announced that it had successfully conducted India's first uterus transplant, it finds itself facing questions from India's apex body for medical research.
The Times of India reports that the Indian Council of Medical Research (ICMR) has declared that Pune's Galaxy Care Laproscopy Institute did not take its permission for conducting the procedure. "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," ICMR director-general Dr Soumya Swaminathan said. The Bengaluru hospital in question is the Milann International Institute of Training and Research in Reproductive Health, which had received ICMR's approval to carry out uterus transplants on two women earlier this month.
Swaminthan added that ICMR's permission was not required for established clinic procedures but that the protocol was different for a uterus transplant. "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," Swaminthan said.
Several senior doctors have pointed out that uterus transplants are still at an experimental stage, with no guarantee of pregnancy. Moreover, the procedure has also raised ethical questions on the health risks the transplant poses to women as it is not a life-threatening condition. "Good clinical practices are mandatory in the case of experimental procedures along with ethics committee review and approval of the protocols and consent forms, ensuring that rights of the patients are protected," Dr Kamini Rao, medical director of Bengaluru's Milann hospital, told the Times of India earlier this month.
In response to ICMR's statement, Galaxy Care Laproscopy Institute has said that no permission was required for "clinical procedures," and that there had been no protocol violation since they had been granted a license to perform uterus transplants for five years by the Maharashtra government's Directorate of Health Services.
After conducting the first transplant on a 21-year-old woman on 19 May, the Pune hospital carried out a second transplant on a 23-year-old woman from Vadodara. Doctors from the hospital told the Hindustan Times that the two recipients were doing fine and that 42 more women, including two from Ireland and one from UK, had registered with it for a similar surgery.
The Pune hospital is not new to controversy. Ahead of its first uterus transplant, Swedish doctor Dr Mats Brännström, who performed the world's first successful uterus transplant surgery, had alleged that it had "no preparation at all" for the complicated surgery.