CDSCO asks states to maintain vigil on unlicensed IVF device sales

Regulator flags rise in unlicensed IVF device sales as smaller fertility centres turn to cheaper alternatives amid pricing pressures and lack of awareness

The Central Drugs Standard Control Organisation (CDSCO) has asked all states and Union Territories to keep a tight watch on firms that are importing, manufacturing, and selling medical devices used in the in-vitro fertilisation (IVF) process without a valid licence.

 

In a circular dated March 27, Drug Controller General of India (DCGI) Rajeev Raghuvanshi said some firms are selling medical devices such as intrauterine insemination kits (IUs) and centrifuges for sperm washing used for assisted reproductive technology (ART)-related procedures without obtaining a licence from the licensing authority under the Medical Device Rules (MDR), 2017.

 

“In light of the above, you are requested to keep strict vigil and ensure no such devices used for IVF and ART-related procedures are being imported, manufactured, distributed, and sold without abiding by the Drugs and Cosmetics Act, 1940 and MDR,” the letter stated.

 

The warning comes at a time when India is seeing a proliferation of IVF clinics, with the country’s total fertility rate (TFR) of 1.9 children per woman being below the replacement level of 2.1.

 

India currently has over 2,000 IVF clinics with a market size of around $1.4 billion, making it the second-biggest IVF services provider after the United States of America (USA).

 

While there is no public number available, industry insiders say that roughly 40–50 per cent of clinics might still be buying from firms that are not licensed.

 

“The super-speciality business is seeing an expansion into Tier-2 and Tier-3 cities, with several small players looking to provide services at lower price packages,” an industry executive told Business Standard.

 

He added that these centres achieve this by using devices available at lower prices from non-licensed sellers, often at discounts of at least 30 per cent.

 

Another reason, IVF centre owners said, could be plain ignorance due to a lack of regulation. “There was no regulation in place till the introduction of the Assisted Reproductive Technology Bill, 2022, leading to a lack of standardisation in the industry,” said Manika Khanna, chairperson and managing director at Gaudium IVF.

 

She added that small standalone centres, to some extent, may also not be aware that they have to ensure that their devices come through the right channels.

 

India currently sees around 200,000 to 250,000 IVF cycles annually, and the market is expected to grow to 400,000 cycles by 2030, with smaller cities forming a good chunk of the clientele.

 

“With the mushrooming of centres, several players have resorted to extremely competitive pricing, which has led to a drop in basic standards of people who work inside the lab, such as embryologists and clinicians,” another executive said.