Delhi HC seeks Centre’s response on PIL against digital thermometer, BP monitor being notified as drugs

Government think-tank NITI Aayog has proposed to bring all medical devices under one regulatory regime in a phased manner and have a separate Medical Devices Administration (MDA) with four divisions.

The Health Ministry notification has been challenged by an association representing manufacturers and traders of surgical and other medical equipment. The Delhi High Court has sought the Centre’s response on the plea challenging its decision to notify blood monitoring devices, digital thermometers, nebulizers and glucometers as ‘drugs’ under the Drugs and Cosmetics Act.

The association, in its Public Interest Litigation (PIL), has contended that none of the notified devices have a drug component and therefore, bringing them under the ambit of the Act was an arbitrary decision. According to the petition, the notification would create an unjustifiable 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.

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 the association representing manufacturers and traders of surgical and other medical equipment.

Apart from seeking quashing of the notification, the association has also challenged the Constitutional validity of provisions of the Act.