Delhi HC issues notice to Health Ministry on notification declaring medical devices as drugs

New Delhi [India], December 16 : The Delhi High Court on Wednesday issued a notice on a plea moved by Surgical Manufacturers and Traders Association against a notification issued by the Ministry of Health and Family Welfare, whereby all devices intended to be used especially for human beings or animals have been declared as drugs, as defined under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940.
The bench of Justice DN Patel and Justice Prateek Jalan sought a response from the Union of India after hearing the submission of Advocate Aditya S Pujari represented the petitioner association and slated the matter for January 29, 2021.
The Association has previously also challenged an earlier notification which notified some medical devices namely the digital thermometer, nebuliser, blood pressure monitoring device and glucometer as drugs. The same is also pending before the Delhi High Court.
Advocate Pujari and Advocate Kajal Dalal, representing the petitioner Association, submitted that the Draft Medical Devices (Safety, Effectiveness and Innovation) Bill, 2020 is pending and has already been circulated for internal discussion and the impugned notification passed by the Ministry of Health and Family Welfare, Union of India only serves as a stop-gap arrangement and is liable to be quashed.
The petition also seeking direction to declaring the impugned notification dated February 11, 2020, as ultra-vires Section 3(b)(iv) of the Act in the interest of justice.
The petition claims that it is brought without consideration of the petitioner association and other similar stakeholders. It will undue hardship to stakeholders on the supply and demand side. The petition also claims that it would create an unwarranted burden of expenditure on importers, traders and manufacturers and would be passed on to the consumers.