The Delhi High Court has upheld the government's move to classify all medical devices as drugs under the Drugs and Cosmetics Act.
The Union government has the right to make this decision, observing that it wants to follow international rules and protect the rights of the patients, said a division bench of Justices Rajiv Shakdher and Tara Vitasta Ganju.
The order dated Sept. 1 came after the Surgical Manufacturers and Traders Association challenged two notifications: one in 2020 and another in 2018.
The 2018 notification brought four medical devices—nebulisers, blood pressure monitors, digital thermometers, and glucometers—within the ambit of 'drug' as defined under the act. In the 2020 notification, the Ministry of Health said all medical devices used on people and animals should be considered drugs.
The association had argued that the notifications were issued without effective consultation with stakeholders and imposed an unnecessary financial burden on micro, small, and medium enterprises. It contended that many of these devices were already regulated under other statutes or standards.
The bench pointed out that the government had done similar things in the past. They had classified 15 different types of medical devices as drugs through notifications. So, this was not a new or untested approach.
The bench said the 2018 notification was valid and should not be criticised just because it added two more devices—nebulisers and glucometers—which were not originally discussed during the Drugs Technical Advisory Board's 80th meeting in July 2018.
The court pointed out that in 2019, the ministry had formed a team of experts to put all non-notified medical devices under regulations. This team met with different stakeholders also involved in this matter to get their input.
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