LAWS(DLH)-2025-4-38

GLENMARK PHARMACEUTICALS LIMITED Vs. UNION OF INDIA

Decided On April 24, 2025
Glenmark Pharmaceuticals Limited Appellant
V/S
UNION OF INDIA Respondents

JUDGEMENT

(1.) Heard the learned counsel for the parties.

(2.) These petitions instituted under Article 226 of the Constitution of India assail the validity of notification dtd. 15/4/2025 (hereinafter referred to as the Impugned Notification) issued by the Ministry of Health and Family Welfare (Department of Health and Family Welfare), Government of India whereby the Government has restricted the manufacture, sale or distribution of all formulations of fixed dose combination of Chlorpheniramine Maleate + Phenylephrine Hydrochloride subject to the condition that the manufacturers shall mention the warning 'fixed dose combination shall not be used in children below four years of age' on the label and package insert or the promotional literature of the drug.

(3.) Various grounds have been urged to impeach the Impugned Notification, including that before issuing the Impugned Notification, opportunity of hearing was not provided to the manufacturers and other stakeholders which is mandatory in terms of the law laid down by the Hon'ble Supreme Court in Union of India and Anr. v. Pfizer Limited And Others, (2018) 2 SCC 39.