ALKEM LABORATORIES LTD. Vs. UNION OF INDIA

JUDGEMENT

(1.) These petitions have been filed challenging the Notification bearing SO No. 4380 (E) dated 07.09.2018, issued by the respondent no.1, prohibiting the manufacture, sale and distribution for human use of drug Fixed Dose Combination (FDC) of Nimesulide + Diclofenac with immediate effect. The above Notification has been passed by the respondent no.1 exercising its power under Section 26A of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the "Act").

(2.) Section 26A of the Act is reproduced hereinunder:-

(3.) As the present petition has a history attached to it, it would be useful to first briefly indicate the same.