Big news for those undergoing IVF, new rules set for sperm banks and fertility clinics

Nowadays, a large number of people are taking the help of IVF i.e. in vitro fertilization technique to fulfill their dream of becoming parents. IVF and fertility centers have mushroomed across the country. In such a situation, keeping in mind the safety of patients and the quality of treatment, the government has taken very strict and important steps.

In this regard, the Central Drugs Standard Control Organization (CDSCO) has issued a new order. According to this, now only those fertility clinics and sperm banks will get the necessary lab items (consumables) related to IVF, which are registered under the rules made by the government.

What is the new order of CDSCO?

This order clearly states that those fertility clinics or sperm banks which are not registered under the Assisted Reproductive Technology (ART) and surrogacy laws, will no longer be able to purchase essential lab products used in IVF procedures. Let us tell you that CDSCO is the organization of the country which sets the standards of medicines and medical equipment. The organization has given strict instructions to all those companies and suppliers to sell their goods (IVF products) only to recognized and registered centres.

Why was this decision taken?

It had come to the notice of CDSCO that essential and sensitive products for IVF are being sold in the market even to those clinics which have not registered. This is a very serious problem. Unregistered clinics often do not follow proper standards. CDSCO has clearly said that supplying such medical products to unregistered institutions poses a threat to the health and safety of patients, to stop which this step has been taken.

Supply of which things will be banned?

Under this new rule, many essential items used in the IVF process will not be supplied to unregistered clinics.

• IVF Media: This is a special kind of chemical or solution. When an embryo is created by mixing the egg and sperm of the parents in the lab, it is kept safe and developed in this solution.
• Cryopreservation Media: It is used to freeze embryos or sperm.
• Reagents: Chemicals used in various tests and procedures in the lab.
• Other Consumables: All other necessary equipment and materials used during IVF.

What do legal rules say?

CDSCO has clarified in its order that all these products used in IVF are regulated under the Medical Devices Rules, 2017. This means that it is very important to have a license to make them or to import them from abroad. At the same time, it is mandatory for all IVF clinics and sperm banks in the country to register themselves under two main laws, the Assisted Reproductive Technology (Regulation) Act 2021 and the Surrogacy (Regulation) Act 2021.

Also read: Is IVF successful the first time, what is the process and how much does it cost?

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