Regulation of Assisted Reproductive Technology

April 19, 2023

The Indian government has recently tightened regulations for Assisted Reproductive Technology (ART), which is commonly used to treat infertility through vitro fertilization (IVF). The health ministry’s move aims to regulate the mushrooming money-making industry that often carries out unnecessary procedures to make profits.

Limiting the Number of Oocytes and Embryos

The government has directed IVF clinics to follow compliance procedures with respect to the retrieval of oocytes, which are developing eggs in a female. It has limited the number of oocytes that can be retrieved in one cycle to prevent ovarian hyperstimulation. The government has also put a cap on the number of embryos that can be transferred to the female during the treatment cycle. The regulations specify that a gynaecologist should transfer only 1-2 embryos in the uterus during a treatment cycle, depending upon the medical condition of the patient. The transfer of three embryos is allowed only in exceptional circumstances, such as advanced maternal age, recurrent miscarriages, and recurrent implantation failure. The move is expected to prevent multiple births like triplets or quadruplets and decrease morbidity in newborns, thus reducing the pressure on the healthcare system.

Regulations for Oocyte Retrieval and Donor Consent

The government notification says that clinics shall retrieve oocytes from the donor after taking their consent. Clinics must make efforts to retrieve not more than seven oocytes during one cycle, retrieve all formed follicles, and ensure controlled ovarian stimulation of the woman to prevent ovarian hyperstimulation. The regulations also mention that for the welfare of the donor, there must be health insurance for her. It is important to ensure that one donor is not repeated and has given her consent for the same. However, in selected donors where a higher number of follicles are stimulated, capping the number of oocytes during one cycle at seven may be worrisome as it can increase the risk of morbidity in donors with higher numbers of stimulated follicles.

Impact of the Tightening of Regulations

The government’s move to regulate the ART industry is a significant step in ensuring the safety of patients undergoing these treatments. The regulations will have an impact on the growing IVF industry and help put an end to unnecessary procedures undertaken by clinics just to make money. Experts say that many IVF clinics across the country operate with semi-trained staff and no expertise in the field, putting patients’ lives at risk. Hence, regulations are required from time to time to regulate the industry.

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