The Delhi High Court has upheld the validity of a 2020 notification issued by the Union Ministry of Health & Family Welfare notifying all medical devices, intended for use on human beings or animals, as drugs within the meaning of Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940.

A division bench comprising Justice Rajiv Shakdher and Justice Tara Vitasta Ganju observed that the Union Government, in its wisdom, thought it fit to bring all medical devices within the ambit of the expression “drug”, which is clearly a policy matter.

As long as MHFW has the power to do so, no fault can be found with the 1st 2020 Notification whereby all medical devices were brought within the purview of the expression “drug”. MHFW’s reasons are manifold, which include the desire to align itself with the international regulatory regime and to further the interest of the patients,” the court said.

The bench added that mere errors, if any, in the policy, which is otherwise robust and devised bearing in mind patient safety, cannot be upturned in exercise of the power of judicial review under Article 226 of the Constitution of India, unless it is a clear case of demonstrable violation of fundamental rights, including Articles 14 and 21.

The court was deciding two petitions moved by Surgical Manufacturers and Traders Association challenging the 2020 notification as well as a 2018 notification which brought four medical devices (nebuliser, blood pressure monitoring device, digital thermometer and glucometer) within the ambit of “drug”.

Closing the petitions, the bench said that before the said notifications, the Union Government in the past had issued various notifications classifying fifteen categories of medical devices as drugs. Therefore, the route is both tried and tested, the bench said.

The court also observed that the the expression “such devices” under Section 3(b)(iv) of the Drugs and Cosmetics Act has to be read with the latter part which alludes to the devices as may be specified by the Central Government by Notification in the Official Gazette after consultation with the Drugs and Technical Advisory Board.

Furthermore, the bench noted that the Union Ministry had constituted an expert committee in 2019 to bring all non-notified medical devices under the regulatory regime and that the said committee met various stakeholders.

In our view, MHFW has granted sufficient time to manufacturers, importers, sellers and distributors sufficient time to transition to a regulatory regime. The 2nd 2020 Notification was necessitated, as with the issuance of the 1st 2020 Notification, the provisions of the 1940 Act would have straightaway become applicable for all manufacturers unless exemption was granted to enable the applicants to transition to the amended regime,” the court said.

The bench also said that the 2018 Notification is sustainable and cannot be found fault with only because it included two other devices, i.e., nebuliser and glucometer, which were initially not on the agenda of DTAB’s 80th meeting.

The fact that the Legal Metrology Act, 2009 covers certain devices such as blood pressure monitors and digital thermometers or that the glucometers are required to adhere to the standards stipulated by BIS would not render the 2018 Notification invalid. At worst, it could be a case of over- regulation, but that by itself would not result in the 2018 Notification being declared invalid in the eyes of the law,” the court said.

It added,

Thus, for the foregoing reasons, no interference is called for with the impugned notifications. The Association has failed to demonstrate that Sections 3(b)(iv) and 5(2) are violative of Article 14 and/or 21 of the Constitution. To our minds, there is no manifest arbitrariness or unreasonableness in the shift in policy of bringing all medical devices within the ambit of a regulatory regime.


Citation: 2023 LiveLaw (Del) 788

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