PIL against Health Ministry notifying 8 medical devices as DRUGS, Delhi HC seeks Centre reply

It was submitted that notifying blood monitoring devices, digital thermometers, nebulizers and glucometers as DRUGS will result in a substantial hike in their prices which would make them unaffordable for a large segment of society.

New Delhi: The Delhi High Court has sought the Centre's response on a plea challenging its decision to notify blood monitoring devices, digital thermometers, nebulizers and glucometers as 'drugs' under the Drugs and Cosmetics Act.

A bench of Chief Justice D N Patel and Justice C Hari Shankar issued a notice to the Health Ministry whose notification has been challenged by an association representing manufacturers and traders of surgical and other medical equipment. The court asked the ministry to file its reply before the next date of hearing on December 11.

Medical Dialogues had earlier reported that in a significant move to provide safety to patients and regulate the quality of diagnostic and medical devices in India, the health ministry had notified eight medical equipment, including all implantable devices, as "drugs" under Section 3 of the Drugs and Cosmetics Act, effective from April 1, 2020.

Also Read: Eight medical devices including CT, MRI, X-ray notified as DRUGS by the health ministry

The association, in its PIL, has contended that none of the notified devices has a drug component and therefore, bringing them under the ambit of the Act was an arbitrary decision.

The petition, filed through advocates Harsh Kumar, Bhagya Yadav and Aditya Raj, claims that the notification would create an unwarranted burden of expenditure on importers, traders and manufacturers of these devices and consequently, it would be passed on to the consumers.

It said notifying the devices as drugs will result in a substantial hike in their prices which would make them unaffordable for a large segment of society.

As per a recent PTI report, apart from seeking quashing of the notification, the association has also challenged the Constitutional validity of provisions of the Act.

Read Also: Delhi HC restricts Lee Pharma from infringing copyright of Mankind Pharma