New Delhi: The health ministry has tightened regulations for Assisted Reproductive Technology (ART), commonly used to treat infertility through in vitro fertilization (IVF), with an aim to make fast bucks. Industry has to be reined in.
The government has asked IVF clinics to follow compliance procedures regarding the retrieval of oocytes (a developing egg in a woman), limit the number of oocytes in a cycle and put a cap on the number of embryos transferred May go. woman during treatment cycle
The government also reminded clinics that the procedures should be conducted in women of advanced maternal age and those experiencing recurrent miscarriages.
The tightening of regulations will impact the booming IVF industry and help curb unnecessary procedures being performed by clinics just to make money.
The ministry also regulated the process of embryo transfer in the uterus.
The Assisted Reproductive Technology Regulation, 2023 mentions that a gynecologist should transfer 1-2 embryos into the uterus during a treatment cycle, depending on the medical condition of the patient.
Only in exceptional circumstances—such as advanced maternal age, repeated miscarriages and repeated implantation failure—can up to three embryos be transferred. In any case, doctors cannot transfer more than three embryos.
Welcoming the government’s move, Dr Archana Dhawan Bajaj, IVF specialist at Nurture Clinic in New Delhi said, “This initiative will bring in more transparency and provide doctors with clear guidelines on what they can and cannot do. This will ensure the safety of the patient. Now that the government has capped the number of embryo transfers, i.e. 1-2 in a cycle and 3 embryos in rare cases, the biggest advantage of this capping is that it will prevent multiple births like three or four children.”
In addition, it will reduce morbidity in newborns and thus, reduce the pressure on the healthcare system.
Experts said many IVF clinics across the country function with semi-trained staff and no expertise in the field which puts patients’ lives at risk. Hence, there is a need for such rules from time to time to regulate the industry.
The government notification states that clinics shall retrieve the oocytes from the donor after the consent of the donor and for retrieving oocytes from the donor, the clinics shall not attempt to retrieve more than seven oocytes during one cycle.
Further, the notification states that the clinics shall retrieve all formed follicles and ensure controlled ovarian stimulation of the woman to prevent ovarian hyperstimulation.
Many couples with infertility problems opt for IVF. According to the Indian Society of Assisted Reproduction, there are 27.5 million infertile people in India.
“For the welfare of the donor, there should be a health insurance for him, and we should ensure that a donor is not repeated and has given his consent for the same. Because you cannot control the number of eggs that are stimulated. Retrieving seven eggs from an over-stimulated person can increase the donor’s morbidity. For example, if a donor has PCOD (Polycystic Ovarian Disease), she will have many follicles and if we retrieve all the follicles If not taken, she is at risk of ovarian hyperstimulation, which can increase the risk of morbidity. Therefore, in selected donors where a high number of follicles are stimulated, the capping of seven eggs during a cycle may be of little concern, said Dr Bajaj.
Queries sent to the Ministry of Health were answered.
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