All medical devices sold in the country will now be regulated as ‘drugs’, and come under the purview of the Drugs and Cosmetics Act.
The government said medical devices and medical technology equipment used for “diagnosis, monitoring, treatment, investigations and for supporting or sustaining life” will be categorised as ‘drugs’, under the Drug and Cosmetics Act, 1940, from April this year.
At present, over 30 devices including syringes, cardiac stents and orthopaedic implants are classified as drugs (under Medical Device Rules), leaving a whole host of med technology companies “largely unregulated”.
The development is expected to bring in important changes for the sector over the next few years — one, their prices will be governed (as per the Act), and second, in case of a violation, they could be penalised in a court of law.
The over $15-billion medical devices industry is heavily import-dependent with 70-80% — including imaging equipment (CT and MRI scanners), cardiac stents, orthopaedic implants, syringes, surgical gloves, glucometers, and critical care equipment — cornering a large share.
With this, quality, certification and pricing of devices will be under government lens. The Act will ensure that they are safe and conform to quality standards, and will be subject to an annual price increase of 10%.
However, there is a specific timeline for the regulation to kick in — broadly, in respect of devices which are low and moderate risk, 30 months, while for moderate-high and high-risk devices, 42 months, from April 1.
This means there will be a long wait before all the higher risk devices are regulated, experts said.
The decision was taken after consultation with the Drugs Technical Advisory Board, the notification added.
It says all devices including “an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings,…. and which may assist in specific purposes of diagnosis, prevention, monitoring, treatment or alleviation of any disease, will be classified as a drug”.
Click following links to download the notifications:
In a separate notification, the government under section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board, amended the Medical Devices Rules, 2017.
Under the new, Medical Devices (Amendment) Rules, 2020, devices will need to be registered with the Central Licensing Authority through an online portal, established by Central Drugs Standard Control Organisation.
The notifications lists 37 devices and equipment whose quality and manufacturing standards will be regulated, which includes a host of devices and equipment like nebulisers, blood pressure monitoring device, glucometer, digital thermometer, all implantable medical devices equipment, CT scan equipment, MRI Equipment, defibrillators.