Big news for IVF seekers, new rules set for sperm banks and fertility clinics. CDSCO has implemented a new rule, under which now only fertility clinics and sperm banks registered under the ART and Surrogacy Act will be able to purchase the necessary equipment for the IVF lab.
Nowadays, a growing number of people are resorting to IVF (in vitro fertilization) to fulfill their dream of becoming parents. IVF and fertility centers have mushroomed across the country. In light of this, the government has taken a significant and important step to ensure patient safety and quality of treatment.
The Central Drugs Standard Control Organization (CDSCO) has issued a new order in this regard. According to this, only those fertility clinics and sperm banks that are registered under government regulations will receive the necessary lab supplies (consumables) for IVF.
What is the new order of CDSCO?
This order clearly states that fertility clinics or sperm banks that 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. The CDSCO is the national body that sets standards for medicines and medical equipment. The organization has strictly instructed all companies and suppliers to sell their products (IVF products) only to accredited and registered centers.
Why was this decision taken?
It has come to the attention of the CDSCO that essential and sensitive products for IVF are being sold to unregistered clinics. This is a very serious problem. Unregistered clinics often do not adhere to proper standards. The CDSCO has clearly stated that supplying such medical products to unregistered institutions poses a threat to the health and safety of patients, and this step has been taken to prevent this.
Which items will be banned from supply?
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 chemical or solution. When an embryo is created in the lab by combining the parents' eggs and sperm, it is stored and developed in this solution.
- Cryopreservation Media: It is used to freeze embryos or sperm.
- Reagents: Chemicals used in various tests and procedures conducted in the lab.
- Other Consumables: All other necessary equipment and materials used during IVF.
What do the legal rules say?
In its order, the CDSCO clarified that all these products used in IVF are regulated under the Medical Devices Rules, 2017. This means that a license is essential to manufacture or import them from abroad. Meanwhile, all IVF clinics and sperm banks in the country are required to register under two key laws: the Assisted Reproductive Technology (Regulation) Act, 2021, and the Surrogacy (Regulation) Act, 2021.
