Devices As Drugs The Debate Continues

The Centre’s notification on medical devices to be treated as drugs has created a difference of opinion with experts questioning the approach behind the move

- Prathiba Raju

The government’srecent notification oncategories of medical devices including an entire range of implantable devices as drugs, to ensure the supply of safe devices, and monitoring the introduction, has perturbed the medical devices community. Informing that the government’s intentions are good, yet these could have some far reaching impact. Experts in the medical devices segment also argue that the decision is half-baked and has left them questioning the approach taken.

The Union Health Ministry recently notified that eight more categories of medical devices including the entire range of implantable devices will be known as drugs — MRI equipment, PET, bone marrow separators, dialysis machines, CT scan and defibrillators — which is set to come into effect from April 2020.

Elucidating the background of how medical devices are regulated in India, Sumit Goel, Partner, Healthcare Advisory, KPMG in India, informed that till 2017, there were very limited regulations and in a bid to regulate the medical devices, the Government of India in February 2017 notified the new Medical Device Rules 2017, by exercise of powers conferred by the Drugs and Cosmetics Act.

For the medical devices to be regulated under the Medical Device Rules 2017, a medical device has to be notified under the said Act as ‘drugs’ by the Central Drugs Standard Control Organization (CDSCO). Initially, only 15 categories of medical devices were notified under the said Act and hence, covered under the Medical Device Rules.

Hence, classifying these medical devices as drugs is more of a legal technicality rather than an attempt by the government to regulate these devices along the line of drugs. However, different set of rules apply to medical devices under the Medical Device Rules-2017.