Last Updated on September 24, 2023 by The Health Master
Medical Devices as Drugs
This pivotal decision comes after the Surgical Manufacturers and Traders Association filed petitions challenging the government’s notifications in 2018 and 2020, initially declaring four specific medical devices as “drugs” and subsequently extending this classification to encompass all medical devices.
Background: Medical Devices as Drugs
The Court’s Verdict
The petitions filed by the Surgical Manufacturers and Traders Association have been categorically rejected by a bench chaired by Justice Rajiv Shakdher.
The court firmly upheld the government’s stance that deeming medical devices “drugs” falls within the realm of a policy decision.
They contended that there was no compelling reason for judicial interference due to the absence of arbitrariness or unreasonableness in this decision.
The bench, which also included Justice Tara Vitasta Ganju, emphasized that the Ministry of Health and Family Welfare (MHFW) had made a calculated policy decision to encompass all medical devices within the definition of “drug.”
This, they noted, was a matter of policy, and they found no substantial flaws in this shift. The court cautioned that overturning this decision would be akin to discarding the valuable for the inconsequential.
Recommendation for Improvement
While affirming the government’s policy, the court acknowledged the need to address certain issues in the implementation of the regulatory regime for medical devices.
It encouraged the relevant authorities to promptly resolve any hiccups encountered during the transition.
Here’s a breakdown of the key points made by the High Court in its ruling:
The court emphasized that the decision to classify medical devices as “drugs” was a matter of policy.
In its wisdom, the Ministry of Health and Family Welfare (MHFW) deemed it appropriate to bring all medical devices under the regulatory framework of the expression “drug.”
Absence of Arbitrariness:
The court found no grounds for interference, as there was no evidence of arbitrariness or unreasonableness in this shift in policy.
It acknowledged that such policy decisions are within the purview of the government.
Patient Safety and International Alignment:
The MHFW had multiple reasons for this policy shift, including aligning with international regulatory norms and safeguarding patient interests.
The court recognized occasional errors in an otherwise robust policy, designed with patient safety in mind.
Chronology of Events
- 2018: The central government initiated the process by classifying four specific medical devices—nebulizers, blood pressure monitoring devices, digital thermometers, and glucometers—as “drugs” under the regulatory framework.
- 2020: A significant milestone was reached when the government expanded the classification to include all medical devices as drugs.
Rationale Behind the Decision
The court delved into the reasons behind this policy shift:
Alignment with International Standards:
MHFW sought to align India’s regulatory framework with international standards, a move intended to enhance patient safety and foster harmonization in the global medical device market.
Another key motivation was to further the interests of patients by ensuring that medical devices undergo rigorous scrutiny and adhere to stringent quality standards.
The court pointed out that the government had implemented the policy in a calibrated manner, allowing manufacturers, importers, sellers, and distributors ample time to adapt to the new mandatory licensing regime.
The court underscored that, unless there was a clear violation of fundamental rights, mere errors in a robust policy designed with patient safety in mind could not be overturned through judicial review under Article 226 of the Constitution.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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