To control prices, medical devices to be treated as drugs from April 1

Aditi Tandon

Tribune News Service

New Delhi, February 12

All medical devices manufactured and sold in the country will be defined as drugs from April 1 and regulated under the Drugs and Cosmetics Act, 1940.

At present, only 24 high-risk medical devices, including cardiac stents, are regulated as drugs by the Central Drugs Standards Control Organisation, the apex drug regulator of the country. From April 1, all devices from disposable syringes, catheters, intraocular lenses and nebulisers to condoms, tubal rings, umbilical tapes and even blood pressure-monitoring devices will be covered by the definition of drugs for the purpose of the law and regulated as that.

A Health Ministry notification said all medical device manufacturers will also have to register themselves on a centralised online portal for the purposes of quality control and assurance.

The registration will be voluntary for the first 18 months from April 1 after which the process will become mandatory.

The newly notified rules further classify medical devices in four categories — low risk, moderate low risk, moderate high risk and high risk. The first two categories of devices would have to also subject themselves to strict quality control mechanisms within 30 months after the enforcement of new rules and the last two segments of devices would get 42 months to come under the compliance regime.

The move will mean that the government can eventually bring the devices it wants under price control. Recently the government has reduced the prices of cardiac stents and orthopaedic implants, which are already covered as drugs under the law and can, therefore, be price controlled and regulated.

The shift to a regulatory regime for all medical devices, government sources say, was necessitated in the wake of a regulatory vacuum for the devices that have a direct impact on human health.