India curbs supply of IVF consumables to unregistered clinics

New Delhi: India is moving to cut off supplies of critical IVF media, reagents and laboratory consumables to unregistered fertility clinics, in a regulatory crackdown aimed at curbing unauthorized reproductive healthcare in the country.

The directive, issued by the country’s apex drug and medical device regulator, the Drugs Controller General of India (DCGI), follows concerns that sensitive medical devices are being supplied to unverified, non-compliant medical facilities across the country.

In a circular dated 23 June, DCGI Rajeev Raghuvanshi directed states/UTs and zonal and sub-zonal offices of the Central Drugs Standard Control Organisation (CDSCO) to strengthen ground-level monitoring and ensure that non-registered centres are blocked from accessing critical IVF consumables.

“It has been brought to 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 DGCI said.

The move comes amid growing concerns over the proliferation of fertility centres in India, one of the world’s fastest-growing IVF markets.

According to consultancy IMARC Group, India’s IVF market was valued at $864.6 million in 2024 and is projected to reach $3.4 billion by 2033.

Queries emailed to the DCGI office were unanswered till press time.

“This is a timely and welcome step towards safeguarding patient safety and maintaining the highest standards in assisted reproduction,” said Dr Hrishikesh Pai, consultant gynaecologist & IVF specialist, Lilavati Hospital, Mumbai, and Fortis hospitals Delhi & Chandigarh. “IVF is a highly specialized medical procedure where the quality, traceability, and proper use of laboratory consumables directly influence treatment outcomes and embryonic development.

Restricting supplies to unregistered facilities will help curb unauthorized practices, reduce risks to patients and strengthen confidence in fertility treatment services, he said.

The DCGI circular noted that currently, these products are being used by assisted reproductive technology clinics and banks registered under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021 for the regulation of safe and ethical practice of assisted reproductive technology services.

Dr Anupama Gangwal, senior consultant in obstetrics and gynaecology at Cocoon Hospital, Jaipur, said the supply of IVF products to unregistered facilities can expose patients to infection risks, poor laboratory practices and misuse of reproductive technologies. “This is a significant step towards safeguarding couples seeking fertility treatment and patients should always verify whether an IVF clinic is well registered and follows approved medical and ethical protocols before beginning any medical treatment.”