Delhi High Court Dismisses Petitions Challenging Government’s Classification of Medical Devices as Drugs
Introduction
In a recent development, the Delhi High Court has ruled in favor of the Union government, dismissing two petitions filed by the Surgical Manufacturers and Traders Association (SMTA). The SMTA had sought to quash two key notifications issued by the government, including one that classified all medical devices as drugs. The court’s decision, rendered on September 1, comes after a legal battle surrounding the classification of medical devices in India.
Background
The dispute centered on two crucial government notifications. The first, dated December 3, 2018, brought four specific medical devices – nebulisers, blood pressure monitoring devices, digital thermometers, and glucometers – under the definition of drugs. The second notification, dated February 11, 2020, expanded this classification to include all medical devices.
The SMTA argued that the 2018 notification exceeded the agenda set for the 80th Meeting of the Drugs Technical Advisory Board (DTAB) on July 25, 2018. While the meeting’s agenda initially focused on blood pressure monitoring devices and digital thermometers, the DTAB extended its scope to include nebulisers and glucometers without adequate consultation.
Regarding the 2020 notification, the association contended that it deviated from the intended scope of Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940. However, the government’s legal counsel maintained that these notifications were well within the law’s purview. They emphasized that the industry was provided ample time to transition to a regulatory regime, with fees lower than those imposed in other countries, and ongoing efforts to fill regulatory body positions.
Court’s Ruling
The Delhi High Court, after considering both arguments, ruled in favor of the government. The court found that the central government had the authority, through consultations with the DTAB, to classify medical devices as drugs, and this had been done in the past. The court also acknowledged that the Ministry of Health and Family Welfare (MoHFW) had granted sufficient time for industry players to adapt to the regulatory framework.
The court recognized that the decision to classify all medical devices as drugs was a matter of policy. It affirmed the Ministry’s reasons, such as aligning with international regulatory standards and prioritizing patient safety. The court stressed that mere policy errors, if any, should not be subject to judicial review unless they constituted a clear violation of fundamental rights.
Ultimately, the court refused to interfere with the government’s notifications, asserting that there was no manifest arbitrariness in the shift towards regulating all medical devices. The court urged the government to address any issues that may arise during the regulatory process.
Implications
The court’s decision not only upholds the government’s notifications but also underscores the importance of patient safety in regulating medical devices. It recognizes the potential risks associated with medical devices, even those considered simple home appliances, and the need for standardization to prevent potential fatalities.
Additionally, the court rejected arguments related to existing regulations and fees, stating that these factors did not render the notifications invalid. It also dismissed claims that the regulatory regime would significantly impact healthcare costs, citing a lack of supporting data.
In conclusion, the Delhi High Court’s ruling reaffirms the government’s authority to classify medical devices as drugs and emphasizes the critical role of regulation in ensuring patient safety and public health.
