VIBHU BAKHRU, J.

1. The petitioners have filed the present petition impugning the Notification No. S.O. 4379 (E) 07.09.2018 (hereafter ‘the impugned notification’) issued by respondent no. 1 (Central Government) under Section 26A of the Drugs and Cosmetics Act, 1940 (hereafter ‘the Act’). By the impugned notification, the Central Government has prohibited the manufacture for sale, sale or distribution for human use of the Fixed Dose Combination (FDC) of the formulations Aceclofenac + Paracetamol + Rabeprazol (hereafter referred to as ‘the said FDC’).

2. The petitioners have challenged the impugned notification on several grounds including: (i) that the same has been issued in violation of principles of natural justice; (ii) that the impugned notification are based on the recommendations of the sub-committee of Drug Technical Advisory Board (DTAB), which has been made without application of mind; (iii) that the impugned notification has been passed without following the directives issued by the Supreme Court in Union of India vs. Pfizer Limited and Others, 2018 (2) SCC 39 and (iv) that the said FDC has a sound therapeutic justification and poses no risk to human beings.

3. Th