Nearly 40,000 centres and clinics offering Assisted Reproductive Technology (ART) services such as in-vitro fertilisation (IVF) in India will be inspected for the first time in the coming weeks as the Centre sets out to ensure that they maintain the standards and norms prescribed.
Less than one fourth of the fertility centres in the country are registered as of now as registration was not mandatory before the ART (regulation) Act was enacted in 2021.
In a letter sent out to state governments, the Union health ministry has asked them to prepare for the inspection of the facilities and scrutiny of the applications as it readies to notify the rules of the ART (Regulation) Act, 2021.
Senior officials in the ministry told Moneycontrol that while about 10,000 ART clinics and sperm and egg banks are registered with the Indian Council of Medical Research, which is also the nodal agency under the ART Act, they have never been scrutinised before.
“Their registration was earlier approved based on self-declaration but now the inspections are meant to assess if these centres maintain what they claim and have minimum standards prescribed,” said an official in the reproductive and child health division of the ministry.
During the inspection of the fertility clinics, officials attached with state health departments will check for details such as whether equipment is maintained as per norms, number of staffers and their qualifications, as well as record keeping and treatment modalities offered to patients.
The ART act, which was passed by Parliament late last year, seeks to set minimum standards and codes of conduct for fertility clinics and provides for the “safe and ethical practice of assisted reproductive technology services”, such as IVF, intrauterine insemination (IUI), and gestational surrogacy.
It also aims to introduce protections for egg donors, gestational surrogates, and children conceived through ART services.
Regulating the fertility industry
The need to streamline the industry and curb malpractices has been felt over the last two decades as a majority of ART clinics are not registered and their practices and use of equipment have often raised questions.
An official attached to ICMR said that the inspections, as per the provisions of the Act, will look to assess if ART clinics are appropriately equipped with essential facilities and have medical practitioners with the requisite qualifications.
The Act requires all the practitioners to be registered with the National Medical Commission in order to carry out ART procedures.
Key provisions of the Act include protecting the egg donor with insurance cover, limiting multiple embryo implantation needs, and the rights of children born through ART procedures.
Importantly, it prescribes stringent punishment for those practicing sex selection, sale of human embryos or gametes, or running agencies, rackets and organisations in violation of the law.
Dr Nandita Palshetkar, a fertility expert in Mumbai who also headed the Federation of Societies of Obstetricians and Gynaecologists in India earlier, said that the clauses of the Act will standardise operating procedures to ensure uniform costs and global quality standards for the IVF process across the country.
“We are waiting for the rules to be notified as of now. But overall, the Act is good news for the industry and patients even though smaller centres may suffer in the beginning due to the minimum standard of services now being specified,” she said.
Shobhit Agarwal, CEO at Nova IVF fertility, pointed out that the Act emphasises transparency and ethical practices and ensures there are quality clinicians and embryologists.
Fertility treatment to get costlier?
Dr Rita Bakshi, founder of RISAA IVF, said that while the Act has many provisions to protect the interests of all parties, there are several provisions that are troubling as well.
“Due to severe increase in paperwork and administration work, the cost of treatment will likely go up and will affect couples from the lower middle classes who may then not be able to opt for assisted reproduction,” she said.
Bakshi pointed out that the Act has also fixed the number of times a donor can give her eggs and put a stop to commercial egg donation.
“Those couples that need donor eggs or donor gametes will have reduced pregnancy rates due to the lower number of eggs collected from the donor,” she added.
Agarwal, too, said that limitations in the availability of donors and the premium care in fertility treatments will come with a certain cost attached.“However, we are bullish that the ART Act will regulate the fertility sector,” he said.