Supreme Court Rejects Challenge To Centre's Notification Bringing Medical Devices Within Definition Of 'Drugs'

The Supreme Court on Thursday(January 25) declined to interfere with Delhi High Court's ruling which upheld the Central Government notifications to include medical devices such as nebulizers, blood pressure monitoring devices, digital thermometers, and glucometers as "drugs”.

The bench consisting of the Chief Justice of India DY Chandrachud and Justices JB Pardiwala and Manoj Misra dismissed the SLP filed by Surgical Manufacturers and Traders Association considering that the order to be reasoned adequately in light of welfare interests.

CJI explained that the notification has to be done to bring standard regularizations for the safety of the patients at large. “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 (inaudible) for these kinds of things.”

The petitioner contended that no proper consultation has taken place with the medical board as the board members only consisted of those experts belonging to the drug industry and not with the medical devices industry. The grievance was in light of improper compliance with statutory requirements on consultation.

The Counsel appearing for the petitioners argued, “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”

Section 5 (2) of the Drugs and Cosmetics Act, 1940 provides that the DTAB shall consist of the following members (having total 16 subclauses on member requirements) :

“(i) the Director General of Health Services, ex officio, who shall be the Chairman;

(ii) the Drugs Controller, India, ex officio;

(iii) the Director of the Central Drugs Laboratory, Calcutta, ex officio;

(iv) the Director of the Central Research Institute, Kasauli, ex officio;

(v) the Director of the Indian Veterinary Research Institute, Izatnagar, ex officio;

(vi) the President of the Medical Council of India, ex officio;

(vii) the President of the Pharmacy Council of India, ex officio;

(viii) the Director of the Central Drug Research Institute, Lucknow, ex officio;

(ix) two persons to be nominated by the Central Government from among persons who are in charge of drug control in the States;..........”

The CJI was of the opinion that the “High Court has very copiously looked at the matter” and highlighted that if the board takes experts from the medical devices industry that could lead to a conflict of interest, “ Obviously your regulators cannot be from that industry”. The bench however dismissed the petition observing that without standardization it's ultimately the patients who end up paying the cost of sub-standard devices.

Background

In September 2023, the Delhi High Court upheld the validity of of a 2020 notification issued by the Union Ministry of Health & Family Welfare notifying all medical devices, intended for use on human beings or animals, as drugs within the meaning of Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940.

A two-judge bench, consisting of Justice Rajiv Shakdher and Justice Tara Vitasta Ganju, noted that the Union Government, in its discretion, deemed it appropriate to categorize all medical devices under the term "drug." stating the decision to be evidently a policy choice.

“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 said.

The court was addressing two petitions filed by the Surgical Manufacturers and Traders Association, challenging both the 2020 notification and a 2018 notification that categorized four medical devices (nebulizer, blood pressure monitoring device, digital thermometer, and glucometer) as "drugs."

Concluding the consideration of the petitions, the bench highlighted that prior to these notifications, the Union Government had previously issued multiple notifications classifying fifteen categories of medical devices as drugs. Hence, the approach has been well-established and proven, stated the bench.

Case Details : Surgical Manufacturers And Traders Association v Union Of India Diary No. 53762-2023