The Delhi High Court upholds the centre's decision notifying all medical devices as drugs.

IN THE HIGH COURT OF DELHI AT NEW DELHI

Judgement reserved on 27.02.2023

Judgement pronounced on 01.09.2023

THE SURGICAL MANUFACTURERS & TRADERS ASSOCIATION

THROUGH ITS AUTHORISED REPRESENTATIVE                                                                                                                             ..... Petitioner

Through: Mr Adit S. Pujari, Mr Maitreya

Subramaniam, and Ms Kajal Dalal,

Advocates.

versus

UNION OF INDIA                                                                                                                                                                                   ..... Respondent

Through: Mr Kirtiman Singh, CGSC, with Ms

Shreya V. Mehra and Ms Durgesh

Nandini, Advocates.

SURGICAL MANUFACTURERS AND TRADERS ASSOCIATION                                                                                                         ..... Petitioner

Through: Mr Adit S. Pujari, Mr Maitreya

Subramaniam, and Ms Kajal Dalal, Advocates.

versus

UNION OF INDIA                                                                                                                                                                                 ..... Respondent

Through: Mr Vikram Jetly, CGSC with Ms

Shreya Jetly, Advocate.

CORAM:

HON'BLE MR JUSTICE RAJIV SHAKDHER

HON'BLE MS JUSTICE TARA VITASTA GANJU

RAJIV SHAKDHER, J.:

Prefatory Facts:

1. These are two writ petitions filed by the Surgical Manufacturers and Traders Association [hereafter referred to as “the Association”] to assail, among other things, two notifications.

1.1. The first writ petition, i.e., WP (C) 10514/2019 [hereafter referred to as “2019 writ petition”], lays a challenge to the Notification dated 03.12.2018 [hereafter referred to as “2018 Notification”]. In addition to it, challenge is also laid to Section 3(b)(iv) and Section 5(2) of the Drugs and Cosmetics Act, 1940 [hereafter referred to as the “1940 Act”].

1.2. Insofar as WP (C)10478/2020 [hereafter referred to as “2020 writ petition”] is concerned, it seeks to assail the Notification dated 11.02.2020 bearing no. SO 648(E) [hereafter referred to as “1 st 2020 Notification”]. These notifications will be collectively referred to as “the impugned notifications” unless the context requires otherwise.

2. Both notifications have been issued by the Central Government via the Ministry of Health and Family Welfare [hereafter referred to as “MHFW”]. Significantly, both notifications deal with medical devices. The 2018 Notification brought four medical devices within the ambit of “drug” as defined under Section 3(b)(iv) of the 1940 Act. The 1st 2020 Notification has spread the net to cover all medical devices to the consternation of the Association.

3. The Association claims to be a registered society representing over 400 members, spread all over India, who are in the business of manufacturing and trading in surgical, medical, hospital, and healthcare equipment and supplies both within India and those imported into the country.

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