After Embryo Mix-Up Allegation, Govt Tightens Rules On Sale Of IVF Lab Supplies

Last Updated:June 27, 2026, 09:00 IST

The advisory covers specialised liquids, chemicals and other laboratory supplies used to grow, preserve and handle eggs and embryos during IVF treatment.

The country’s apex drug regulatory agency has tightened rules governing the sale of key products used in IVF treatment, saying they should be supplied only to registered fertility clinics, News18 has learnt.

The move comes at a time when fertility centres are under scrutiny following allegations by a Gurugram couple — now parents of twin girls — that their embryos were mixed up at a South Delhi-based IVF clinic.

The products covered under the new advisory are not medicines taken by patients. They are specialised liquids, chemicals and other laboratory consumables used to grow, preserve and handle eggs and embryos during IVF treatment. The objective of the government’s move is to ensure that these products do not reach unregistered centres, as doing so could put patients at risk.

Government Says IVF Supplies Were Reaching Unregistered Centres

In a circular issued on June 23, the Central Drugs Standard Control Organisation (CDSCO) said these products are regulated as medical devices and require licences for import or manufacture.

According to the circular, “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 said it had found that these products were being supplied beyond licensed fertility centres.

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."

To stop this, the CDSCO has asked manufacturers, importers and suppliers to sell these products only to clinics and banks registered under India’s Assisted Reproductive Technology and surrogacy laws.

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."

Why Do Doctors Say This Matters?

While patients may never see these products, doctors told News18 that they are essential to every IVF procedure. Restricting their supply to registered clinics, experts believe, is an important step towards safer fertility treatment.

According to Dr Anupama Gangwal, senior consultant in obstetrics and gynaecology at Cocoon Hospital, the quality and traceability of laboratory products are central to a successful IVF procedure.

“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."

She said the circular is an important step because it ensures that only licensed fertility centres have access to these specialised products.

“The government crackdown is a significant step towards safeguarding couples seeking fertility treatment and ensuring that the centre has necessary ART licensing and services are well delivered only through licensed and clinically equipped centres. Patients should always verify whether an IVF clinic is well registered and follows approved medical and ethical protocols before beginning any medical treatment."

Similarly, Dr Rini Sharma, director of Noida-based Kailash IVF, called the advisory a “positive step", saying it strengthens the quality framework for fertility treatment.

She said IVF depends on carefully controlled laboratory processes, making the quality of these products critical.

“Assisted Reproductive Technology is a highly specialised field that relies on precise laboratory processes and quality-controlled products at every stage of treatment. Measures that promote adherence to established regulatory standards contribute significantly to maintaining consistency, safety and reliability in patient care."

According to Dr Sharma, ensuring that these products reach only registered fertility centres will help improve accountability and patient confidence.

“The emphasis on ensuring that these products are supplied through appropriately registered ART centres and banks aligns with the broader objective of fostering a well-regulated and patient-centric healthcare ecosystem."

About the Author

Himani ChandnaSenior Associate Editor

Himani Chandna, Senior Associate Editor at CNN-News18, tracks healthcare, pharma and medical research, bringing clarity to complex science and policy.

News india After Embryo Mix-Up Allegation, Govt Tightens Rules On Sale Of IVF Lab Supplies

Read More