LI Network
Published on: 06 September 2023 at 16:35 IST
The Delhi High Court has recently upheld Central government notifications that categorize all medical devices as drugs under the Drugs and Cosmetics Act.
In the case of Surgical Manufacturers & Traders Association v. Union of India, a Bench comprising Justices Rajiv Shakdher and Tara Vitatsa Ganju observed that this issue pertains to policy, and unless the Union Health Ministry’s authority to do so is in question, there is no fault with the 2020 notification.
The court noted that the Ministry had multiple reasons for this decision, including aligning itself with international regulatory standards and safeguarding patient interests.
The judgment, dated September 1, stated, “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 court added that errors in a policy, even if present, cannot be overturned by the Court during judicial review unless it is a clear violation of fundamental rights.
This ruling came in response to petitions filed by the Surgical Manufacturers and Traders Association challenging a 2018 notification that classified four devices as drugs and a subsequent 2020 notification that classified all medical devices as drugs under the Act.
The petitioners argued that specific sections of the Act were unconstitutional for violating Articles 14 and 21 of the Constitution and that the implementation of the notifications had placed a burden on stakeholders. Consequently, they sought the quashing or amendment of the provisions and notifications in question.
The Court noted that sub-clause (iv) of Section 3(b) of the Act allows the Central government to categorize such devices as ‘drugs’ after consulting the Drugs Technical Advisory Board (DTAB) if they are intended for use in diagnosing, treating, mitigating, or preventing disease or disorder in humans or animals. It also recognized that the Central government had previously issued various notifications to classify medical devices as drugs.
The Court acknowledged that the Central government had set up an expert committee in 2019 to bring all non-notified medical devices under the regulatory regime. Therefore, it concluded that the Health Ministry had given manufacturers, importers, sellers, and distributors sufficient time to transition to the regulatory regime.
The Court emphasized that the policy shift was based on expert advice from the DTAB and was in the public interest. It found no arbitrariness or unreasonableness in the shift in policy to include all medical devices in the regulatory regime.
However, the Court urged the Union Health Ministry to address any issues in the regulatory regime swiftly.
The pleas were subsequently disposed of, with advocates representing the Surgical Manufacturers and Traders Association and the Union Health Ministry presenting their cases before the Court.