The Centre has tightened rules governing the supply of important laboratory products used in IVF procedures, directing manufacturers and suppliers to provide them only to registered fertility centres.
The move comes at a time when fertility clinics are facing increased scrutiny following allegations by a Gurugram couple that their embryos were mixed up at an IVF centre in South Delhi.
The products covered under the advisory are not medicines given to patients. They include specialised media, chemicals and laboratory consumables used during procedures such as fertilisation, embryo culture and cryopreservation, News18 reported.
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Supplies restricted to registered centres
In a circular issued on June 23, the Central Drugs Standard Control Organisation (CDSCO) said these products are regulated under the Medical Devices Rules, 2017.
According to the circular cited by News18, “The media, reagents, etc., intended for use in Assisted Reproductive Technology such as In-Vitro Fertilisation, Cryopreservation, etc., are also covered under the purview of the said rules and a license is required to import or manufacture such products under Medical Devices Rules, 2017."
The regulator also noted that such products were being supplied to facilities outside the approved system.
It stated, “It has been brought to the notice of this office that Assisted Reproductive Technology Media etc. are being supplied to facilities other than those that are registered under the said Acts, thereby posing risk to patient health and welfare."
The CDSCO has now reportedly asked manufacturers, importers and suppliers to ensure that these products reach only centres registered under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021.
Per News18, the circular states, “In light of the above, it is hereby informed that all the stakeholders are requested to ensure that the supply of such products shall be carried out to the centres that are registered under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021, to safeguard ethical reproductive healthcare practices in India."
Doctors underline the importance of regulation
Doctors say the quality and traceability of these laboratory products directly affect IVF outcomes.
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Dr Anupama Gangwal told News18, “IVF is a very sensitive kind of medical procedure where factors like quality, safety, and traceability of media and consumables directly impact patient-related outcomes and the safety of embryos. Any supply of IVF-related products to unregistered or unverified centres creates a serious risk, mainly including infection, poor laboratory, misuse of technology, and compromised technology care."
Per News18, Dr Rini Sharma described the advisory as a “positive step", adding that stronger regulatory standards can improve safety, accountability and patient confidence in fertility treatment.
FAQs:
Why has the government tightened IVF supply rules?
The move aims to ensure IVF products reach only registered fertility centres and improve patient safety.
Which IVF products are covered under the new rules?
The rules cover laboratory media, reagents and consumables used in IVF and embryo preservation procedures.
