Bangalore based Milann, country’s leading fertility centre, becomes the first hospital in India to receive permission for Uterus Transplant from the Indian Council of Medical Research (ICMR). Milann has been given approval to conduct uterus transplant in two female patients & the procedure will be undertaken as a research project as per the ICMR guidelines.

Researchactivities involving human participants in India is regulated by ICMR (IndianCouncil for Medical Research) and DCGI (Drug Controller General of India). ICMRalso has a committee that supervises human organ transplantation rules inIndia.As per the committee’s directive, a research protocol, consent forms,ethical reviews from two separate registered ethics committees were obtained byMilann, further to which the hospital was granted permission from ICMR toconduct the transplant.

The minimumrequisite of experience to carry out this procedure, as per the Human OrganTransplant Act, by a Clinical team is not available in any group outside theSwedish group. Milann also obtained permission from MCI (Medical council ofIndia) for the participation of Swedish doctors for the procedure which is yetanother mandatory requirement.

Dr.Kamini Rao, Medical Director of Milann and a pioneer in the field ofReproductive Medicine said, “Good Clinical Practices are mandatory in the case of experimentalprocedures along with ethics committee review and approval of the protocols andconsent forms, ensuring that rights of the patients are protected.”

According to Dr.R.S Sharma, Scientist and Head ICMR, “The proposal came to ICMR andwas approved as an experimental procedure. Being a Clinical Study it isimportant to check the feasibility of the procedure”.

Clinicaldrug trials or other research involving patients or volunteers as per theguidelines of ICMR can be undertaken, provided ethical considerations are bornein mind. Violation of existing ICMR guidelines in this regard shall constitutemisconduct. Consent taken from the patient for trial of drug or therapy whichis not as per the guidelines shall also be construed as misconduct.

Commentingon the same, Dr. Gautham Pranesh, VP Operations, Milann said, “The fundamental question is if theuterus transplants procedure is an ‘accepted clinical procedure’ or ‘a researchprocedure’ as on today. The regulatory procedures, competent authorities,objectives and approval bodies are different for both paths.We are of opinionin line with the world that it is still a research procedure whereas otherinstitutes are treating it as a standard accepted textbook procedure”.