The article has carried the quotes of Dr. Gautham, Dr Anand Eswaraiah (regulatory and ethical expert) and Dr. R.S. Sharma (ICMR).

India is all set to go down in the books for its first uterus transplant this month. While that is great news, many doctors are raising concern about the ethics and the "correct" protocol of the procedure.

If all goes as planned, India will see its first uterus transplant in a Pune hospital by the end of next week. Pune's Galaxy Care Laparoscopy Institute (GCLI) is set to perform uterine transplants on three women, who will be receiving the donor organs from their mothers. While that sounds like a great news, many doctors have raised concern regrading the ethics of the procedure and "the correct protocol" that may not be followed in the race to perform India's first uterus transplant.

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WHAT IS UTERUS TRANSPLANT?

Uterus transplantation, as the name suggests, is the surgical procedure in which a healthy uterus is transplanted into a female who does not have a viable uterus herself. As per records, there have been around 25 cases of uterus transplants in the world so far. Less than 10 of them have had a successful end.

Reports have it that one of the world's earliest uterus transplant was conducted in 1931 in Germany, on a Danish transgender woman who later died due to complications from organ rejection. There are records of uterus transplants being carried out in Saudi Arabia and Turkey, but none of them had a long-term successful outcome.

Finally, in 2012, a team of doctors led by Dr Mats Brannstrom, Professor of Obstetrics and Gynaecology at the University of Gothenburg in Sweden, conducted the world's first successful uterus transplant with a live donor.

In October 2014, a 36-year-old patient of Dr Brannstrom's became the world's first woman to give birth to a healthy baby via a transplanted uterus.

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INDIA'S FIRST UTERUS TRANSPLANT

The GCLI has received a green signal from Maharashtra's directorate of health services to go ahead with the uterus transplant procedure. However, some doctors claim that GCLI is not treating the uterus transplant as an "experimental procedure". Speaking to IndiaToday.in, regulatory and ethical expert Dr Anand Eswaraiah said, "GCLI is treating the [uterus transplant] procedure as a normal transplant, which it is not. Unlike heart or kidney transplant, uterus transplant is still an experimental procedure with a high rate of failure."

"Uterus transplant is still in its initial stages, and a lot about it is unknown," said Dr Eswaraiah. "The answers to such questions can only be found based on controlled researches, which should be conducted after attaining proper approvals."

"For an experimental procedure as such, approvals of boards like Indian Council of Medical Research (ICMR), Institutional Ethics Committee, etc. are needed," he said.

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CLINICAL TRIALS VS ACCEPTED PROCEDURES

Milann, a chain of fertility centres which is in the queue to perform uterus transplants itself, has raised concern about the procedure being carried out as a "routine" surgery and without the ICMR's approval. "There is a fine line between an experimental procedure and an accepted procedure. Uterus transplant is still in its nascent stages, it is an experimental procedure. Although there have been extensive research, its side effects are still unknown," Milann's Senior Vice President Operation, Dr Gautham TP, told IndiaToday.in.

Dr Gautham said that uterus transplants, as being done in countries like the US, Germany, etc., should be conducted as clinical trials. As for GCLI, it is unclear as to the license that they received from directorate of health services clears them for a clinical trial or a regular surgical procedure. It is also not clear if they have seek the ICMR's approval for the procedure.

Milann has received the permission to conduct uterus transplants (as a clinical trial) by the Indian Council of Medical Research (ICMR). "The proposal came to ICMR and we approved it as an experimental procedure. This is a clinical study and we have to check the feasibility of the procedure," said Dr RS Sharma, Scientist and Head of ICMR. Milann is also said to be collaborating Sweden's Dr Mats Brannstron to perform the uterus transplants in India. They have received ICMR's approval to perform the surgery on two women.

Depending on the results of the procedure, which is expected to be carried out in June, the ICMR would be deciding the next step for the clinical trial.

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THE 'FUZZY AREAS' OF ETHICS

Unlike that of the heart, lungs, liver, etc., uterus transplant is not a life-saving procedure. Based on this reason, the medical community has often raised concern regarding the practice of uterus transplants.

Apart from the fact that motherhood can be attained via adoption and surrogacy, the complications and low success rate of uterus transplant have fueled this debate even more. Nonetheless, many stand strong in support of this procedure with the belief that "every woman has the right to experience pregnancy".

"If conducted with necessary precaution, uterus transplant is a noble procedure," said Dr Eswaraiah. "It is a risky surgery that needs proper protocols, but that does not mean that it should not be encouraged." The GCLI is reportedly scheduled to perform India's first uterus transplant some time next week. The hospital could not be reached for a comment.