On Thursday, January 25, the Supreme Court decided not to intervene in the Delhi High Court’s decision that upheld the Central Government’s notifications classifying medical devices like nebulizers, blood pressure monitoring devices, digital thermometers, and glucometers as “drugs.”
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NEW DELHI: The Supreme Court of India upheld the inclusion of certain medical devices within the definition of “drugs”, affirming the Delhi High Court’s ruling and the Central Government’s notifications. This significant move, aimed at enhancing patient safety and aligning with international regulatory standards, marks a pivotal moment in India’s healthcare regulatory framework.
The Supreme Court bench, led by Chief Justice of India DY Chandrachud and including Justices JB Pardiwala and Manoj Misra, dismissed the Special Leave Petition (SLP) filed by the Surgical Manufacturers and Traders Association. The association had challenged the government’s decision to categorize medical devices such as nebulizers, blood pressure monitors, digital thermometers, and glucometers as drugs. The Court found the Delhi High Court’s order to be well-reasoned, particularly in light of the welfare interests at stake.
Chief Justice Chandrachud emphasized the necessity of this notification for patient safety, stating,
“The point is that this has been done for the Patients’ safety because if it is not notified it completely goes out of the range of regulation, the idea is actually to protect patient’s safety…the object really is to promote patient welfare and safety to ensure that people are not deprived for these kinds of things.”
The petitioners argued that the consultation process was flawed, as the medical board primarily consisted of experts from the drug industry, lacking representation from the medical devices sector. They contended,
“They are experts in drugs no doubt, but they are not experts in medical devices. Not one of the members of the board, the DTAB (Drugs Technical Advisory Board), not one of them is from the medical devices industry.”
However, the Court, referencing Section 5 (2) of the Drugs and Cosmetics Act, 1940, which outlines the composition of the DTAB, supported the High Court’s thorough examination of the matter.
The Chief Justice pointed out the potential conflict of interest if the board included experts from the medical devices industry, stating,
“Obviously your regulators cannot be from that industry.”
The Supreme Court’s decision aligns with the Delhi High Court’s earlier ruling in September 2023, which upheld the validity of the 2020 notification issued by the Union Ministry of Health & Family Welfare. This notification brought all medical devices intended for human or animal use under the definition of “drugs” as per Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940. The Delhi High Court, comprising Justice Rajiv Shakdher and Justice Tara Vitasta Ganju, recognized this as a policy choice by the Union Government, aimed at aligning with international standards and prioritizing patient interests.
The High Court had stated,
“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.”
Before these notifications, the Union Government had already classified fifteen categories of medical devices as drugs through multiple notifications. The approach, as noted by the bench, was well-established and proven effective.
This ruling by the Supreme Court not only upholds the government’s decision but also sets a precedent in the regulation of medical devices in India. It underscores the importance of patient safety and the need for stringent regulatory measures in the healthcare sector. The decision is a step forward in ensuring that medical devices meet the necessary safety and quality standards, ultimately benefiting the health and well-being of the public.
Case Title:
Surgical Manufacturers And Traders Association v Union Of India Diary No. 53762-2023.
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