Country’s leading fertility centre, Milann, has received the approval for uterus transplant from the Indian Council of Medical Research (ICMR). This would be the first case of uterus transplantation in the country.
The ICMR has set up a committee that supervises human organ transplantation rules in India. City-based Milann has been given approval to conduct uterus transplant on two female patients and the procedure will be undertaken as a research project as per the ICMR guidelines.
As per the committee’s directive, a research protocol, consent forms and ethical reviews from two separate registered ethics committees were obtained by Milann, further to which the hospital was granted permission from the ICMR to conduct the transplant.
The minimum requisite of experience to carry out this procedure, as per the Human Organ Transplant Act, by a clinical team is not available in any group outside the Swedish group.
Milann also obtained permission from the Medical Council of India (MCI) for the participation of Swedish doctors for the procedure, which is yet another mandatory requirement.
Dr. Kamini Rao, Medical Director of Milann, and a pioneer in the field of Reproductive Medicine, said, “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.”
According to Dr. R.S. Sharma, Scientist and Head ICMR, the proposal was approved as an experimental procedure. “Being a clinical study, it is important to check the feasibility of the procedure.”
Clinical drug trials or other research involving patients or volunteers as per the guidelines of the ICMR can be undertaken, provided ethical considerations are borne in mind.
Violation of the existing ICMR guidelines in this regard shall constitute misconduct. Consent taken from the patient for trial of drug or therapy, which is not as per the guidelines shall also be construed as misconduct.
Dr. Gautham Pranesh, VP Operations, Milann, said, “The fundamental question is if the uterus transplants procedure is an “accepted clinical procedure” or “a research procedure” as on today. The regulatory procedures, competent authorities, objectives and approval bodies are different for both paths.”
“We are of the opinion in line with the world that it is still a research procedure whereas other institutes are treating it as a standard accepted textbook procedure,” he added.