Earlier this year the Health Ministry notified the Assisted Reproductive Technology Regulations (ART), 2023, which are aimed at providing donors and patients with better medical care and security.
But the new provisions have pushed up the already sky-high medical costs and are proving to be a challenge for treating doctors and couples wanting to have children through ART because of the restricted and limited resource availability in terms of donors, according to industry insiders.
The new ART provisions impose restrictions on the number of times a donor, male or female can donate (sperm/oocyte) in their lifetime, and specifies age limits for donors.
The provision states that an oocyte donor should be an ever-married (persons who have been married at least once in their lives) woman having at least one living child of her own (minimum three years of age). She can donate oocyte only once in her lifetime and not more than seven oocytes can be retrieved. Also, an ART bank cannot supply gamete (reproductive cell) of a single donor to more than one commissioning couple (couple seeking services). Additionally, parties seeking ART services will be required to provide insurance coverage in the favour of the oocyte donor (for any loss, damage, or death of the donor). A clinic is prohibited from offering to provide a child of pre-determined sex. Also checking for genetic diseases before the embryo implantation is needed.
While welcoming the safety measures and transparency the new provisions bring, Archna Dhawan Bajaj, gynaecologist, Nurture IVF said that the restrictions significantly limit the opportunities for ART couples to find suitable donors.
India, much like the rest of the world, is facing a dip in fertility rates and further limiting available donors is likely to bring in more challenges, experts say.
Adds Dr. Bajaj, “The demand will exceed the supply, leading to increased costs for ART cycles. Couples seeking egg or sperm donation will face higher expenses as additional investments such as insurance may be required. Also determining the exact number of cycles needed for successful conception is difficult. On average, the best outcomes are observed when couples undergo back-to-back cycles. Most individuals require more than one cycle to conceive, often needing two to three cycles for a higher chance of success.”
Overall, the new ART laws restricting the number of donation attempts “have the potential to increase costs and create challenges for couples relying on assisted reproductive techniques,” she said.
Prachi Benara, consultant, Birla Fertility and IVF, too said that costs which previously hovered around a few lakhs depending on the nature of technology needed have been pushed up 1.5 times.
Stating that the challenges aren’t huge for healthcare providers in the organised sector, Shobhit Agarwal, CEO of Nova IVF and Fertility, noted that the provisions will hit the unregulated sector and untrained persons exploiting donors and couples.
“A regulation like this is a big step towards preventing congenital abnormalities and in the long run will help the community and eliminate exploitation of donors. However, for couples who need more donor cycles, the cost has certainly gone up in terms of insurance and other legal formalities. A woman may need more than one ART cycle to have a positive result. Seven oocytes may not be enough to produce a viable embryo for a successful pregnancy,’’ he said.