Jahanvi Agarwal
The Supreme Court has declined to intervene in the Delhi High Court’s endorsement of Central Government notifications categorizing medical devices, including nebulizers, blood pressure monitoring devices, digital thermometers, and glucometers, as “drugs.”
The dismissal came in response to a Special Leave Petition (SLP) filed by the Surgical Manufacturers and Traders Association. The bench, led by Chief Justice of India DY Chandrachud, along with Justices JB Pardiwala and Manoj Misra, justified the decision by emphasizing the necessity for standardized regulations to ensure patient safety.
CJI Chandrachud clarified, “The point is that this has been done for the patient’s safety because if it is not notified, it completely goes out of the range of regulation. The idea is actually to protect patient safety…the object really is to promote patient welfare and safety to ensure that people are not (inaudible) for these kinds of things.”
The petitioner argued that proper consultation did not take place, as the board members were exclusively from the drug industry, neglecting the expertise from the medical devices sector. The counsel for the petitioners 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.”
The Supreme Court, however, expressed confidence in the Delhi High Court’s detailed examination of the matter. CJI Chandrachud emphasized the potential conflict of interest if regulatory board members were selected from the medical devices industry. Despite acknowledging the concerns raised, the bench upheld the decision, highlighting that without standardization, patients could bear the cost of sub-standard devices.
This legal saga traces back to a 2020 notification by the Union Ministry of Health & Family Welfare, classifying all medical devices as “drugs” under the Drugs and Cosmetics Act, 1940. The Delhi High Court, in September 2023, upheld the validity of this notification, considering it a policy choice aimed at aligning with international regulatory norms and prioritizing patient interests.
The case, initially brought by the Surgical Manufacturers and Traders Association, contested both the 2020 notification and an earlier 2018 notification that identified specific medical devices as “drugs”. The Supreme Court noted that the Union Government had previously issued multiple notifications categorizing fifteen categories of medical devices as drugs, establishing a consistent regulatory approach.
Case Name: Surgical Manufacturers And Traders Association v. Union Of India
Diary Number: 53762/2023
Bench: Chief Justice of India DY Chandrachud, Justices JB Pardiwala and Manoj Misra.