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Any new Act or Bill always makes the headline of the newspapers in India because politicians are waiting eagerly to use that to their advantage. The Assisted Reproductive Technology Rules, Act 2022 might be one of these. Do not worry, we are here for you today to share a clear and unbiased description of this new act introduced by our Ministry of Health and Family Welfare on 7th June 2022. Our IVF specialists will clarify all the important changes and regulations which are made compulsory by the central government and must be followed by the Assisted Reproductive Technology Clinics and banks. (Rules of ART Act 2022)

We are fully aware that new laws and guidelines always create disruption and confusion for the common folks and therefore, we took the responsibility of stepping forward and giving you a brief about what all is “Rules of ART Act 2022”. The major area of focus and the new regulations are mainly for the ART clinics and banks only but, knowing how you will be benefitted from these new rulebooks is a must. You should also understand what will be your responsibility after this act and what obligations the ART clinic or bank must follow. It is vital as only the best IVF center like Origyn IVF will make sure that you are fully aware of your rights and roles as others are mostly here for monetary gains.

Let’s jump up and start unravelling the new Assisted Reproductive Technology Act 2022.

New Levels of ART Clinics

The central government has set up two different levels for ART clinics with different permissions and a set group of medical practices which can be practiced by them.

The ART clinics are divided into two groups, Level 1 and Level 2. The level 1 ART clinic only reserves access to assist couples with the Intrautine Insemination (IUI) procedure. The Ministry of Health and Family Welfare has specifically guided that all Level 1 ART clinics will only be limited to performing IUI procedure for couples trying to conceive.

When it comes to Level 2 ART clinics their scope of operations is much larger, they can perform all the procedures related to embryos, egg retrieval, transfer, fertilization and much more. It is a must that the ART clinics operate as per their certified levels and always limit what procedures they are allowed to perform.

New Rules for ART Banks

The Ministry of Health and Family Welfare has modified and updated certain responsibilities that ART banks must follow to stay in business. The banks will be responsible for the collection, monitoring and proper registration of donors whether it is a sperm donor or egg donors. They must maintain appropriate and up-to-date records of all the donors and any changes should be informed to the National Registry immediately.

Registration Regulations

There are also new forms and regulations that ART banks and clinics must follow to get themselves registered and start their business. The Assisted Reproductive Clinics that will be carrying out ART procedures must register themselves to the concerned authority using Form-1 and for ART banks, Form-2 is mandatory.

Other Vital Obligations

• Grievance Cell-

The central government has clearly guided the clinics and ART that, they must have a grievance cell on the premises. A grievance cell will play a major role in assisting couples who wish to make a complaint regarding the service they received in the clinic or the bank.

• Preservation of Embryos

The ART clinics must adhere to new changes and they must preserve the unused embryos for future utilization on the same patient. The authorities have strictly prohibited the use of preserved embryos on any other couple except the one who donated them.

• No Pre-Implantation Genetic Testing-

This is one of the major and important regulations which has to be followed by the clinics and the banks and any misconduct will be counting a criminal offence. The clinics must ensure that there is no pre-implantation genetic testing for determining the sex or changing any genetic traits of the embryo as per personal preferences.

• Cryopreservation-

The Ministry of Health and Family Welfare has made some clear-cut rules regarding the procedure of cryopreservation. As per the ministry, any couple or patient who wants to preserve the embryo for more than 10 years must ask the clinic or bank and they must take prior permission from the National Board.

• Consent Form-

As per the New Rules of ART Act 2022, there is a whole lot of new consent which must be signed and collected by the ART clinics and banks to begin the procedures and collect semen and embryos. The government has introduced designated forms for each of the processes from collection to retrieval and the ART clinics must get them filled before and store them appropriately.

• Medical Examination of Donors –

In order to ensure the safety of the couples and make sure that the ART clinics follow the best safety practices, the government has made some tests compulsory for sperm or egg donors. These are standard tests for detecting transferrable diseases like –

1) HIV (Type-1 and Type-2)
2) Hepatitis B
3) Hepatitis C
4) Treponema Pallidum also known as Syphilis

• Insurance Coverage-

The Ministry of Health and Family Welfare has made new regulations for egg donors. The ministry has made it compulsory for the ART clinics and banks that, they ensure to make sure that the couple buys general health insurance coverage in favour of the donor for a period of at least one year and that too, from a company or an agent recognized by the Insurance Regulatory and Development Authority. The amount should be sufficient to cover all the expenses which might be needed in case of any complications while egg retrieval. Also, the couple needs to sign an affidavit which must be sworn before a Metropolitan Magistrate or a first-class Judicial Magistrate giving a guarantee as per section 22(4)(ii) of the Assisted Reproductive Technology Act, 2021.

We at Origyn IVF understand that a new piece of information can be difficult to handle and understand, therefore, being the best IVF centre in Delhi, we wanted to help you out in understanding this new act. Our IVF experts are always dedicated to delivering you the latest information and best treatment and with this new act, we are sure that the IVF journey of a couple will be more secure and smooth. If you still have doubts or want to consult one of the best IVF center in Delhi, you can reach out to us or contact us @8080809084