Delhi High Court upholds Health Ministry notifications categorising all medical devices as drugs under Drugs and Cosmetics Act

The Delhi High Court recently upheld Central government notifications categorising all medical devices as drugs under the Drugs and Cosmetics Act. [Surgical Manufacturers & Traders Association v. Union of India].A Bench of Justices Rajiv Shakdher and Tara Vitatsa Ganju observed that the issue was a matter of policy, and as long as the Union Health Ministry has the power to do so, no fault could be found with the 2020 notification in question.It noted that the Ministry's reasons were manifold, including the desire to align itself with the international regulatory regime and to further the interest of the patients."MHFW, in its wisdom, thought it fit to bring all medical devices within the ambit of the expression “drug”. This 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 judgment dated September 1 stated..The Bench added that mere errors in a policy, which is otherwise robust and devised bearing in mind patient safety, cannot be overturned by the Court while exercising the power of judicial review under Article 226 of the Constitution, unless it is a clear case of violation of fundamental rights..The ruling came in petitions moved by the Surgical Manufacturers and Traders Association challenging a 2018 notification that classified four devices as drugs, and a subsequent 2020 notification classifying all medical devices as drugs under the Act.The petitioners contended that sub-section (iv) of Section 3(b) (definition of "drug”) and Section 5(2) (composition of Drugs Technical Advisory Board) of the Act were unconstitutional for violating Articles 14 and 21 of the Constitution. They also contended that the implementation of the notifications had placed an onerous burden on stakeholders. Accordingly, the petitioners sought quashing or reading down of the provisions and the notifications in question..The Court noted that sub-clause (iv) of Section 3(b) of the Act gives the Central government leeway to bring within the ambit of the expression 'drugs' such devices that are intended for internal and external use in the diagnosis, treatment, mitigation or prevention of disease or disorder both in human beings or animals, after consultation with the DTAB.Further, it observed that the Central government in the past had issued various notifications to classify medical devices as drugs..The Court also took into account the fact that the Central government had constituted an expert committee in 2019 to bring all non-notified medical devices under the regulatory regime.Thus, the Court took the view that the Health Ministry had granted sufficient time to manufacturers, importers, sellers and distributors to transition to a regulatory regime..It further underlined that the shift in policy was based on expert advice rendered by the DTAB and was in public interest."That the policy shift should have confined itself to critical medical devices as against non-critical devices meant for transient use is also misconceived as the shift in policy is, firstly, based on expert advice rendered by DTAB and secondly, is in public weal and therefore, in our view, requires no intercession," the Court emphasized..Before parting with the judgment, the Bench noted that the notifications were not violative of the rights to equality and life/personal liberty."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. Our postscript is, if we were to allow the writ petition, figuratively speaking, we would be throwing away the baby with the bathwater." However, it asked the Union Health Ministry 'to quickly iron out the kinks' in the concerned regulatory regime under the Act.The pleas were accordingly disposed of..Advocates Adit S Pujari, Maitreya Subramaniam and Kajal Dalal appeared for the Surgical Manufacturers and Traders Association.Central Government Standing Counsel Kirtiman Singh and Vikram Jetly with Advocates Shreya V Mehra, Durgesh Nandini and Shreya Jetly represented the Union Health Ministry..[Read judgment]